Sellers and marketers of kratom products available online and in stores in the United States
The FDA monitors kratom products sold in the U.S. and has concerns about their safety and marketing claims. Kratom is a botanical product that consumers often use to self-treat various conditions including pain, anxiety, opioid withdrawal, and other health issues, though the FDA has not approved it as a drug or dietary supplement with proven safety and efficacy.
Requirements
Kratom products are not FDA-approved as drugs or dietary supplements
Kratom is commonly marketed for treating pain, cough, diarrhea, anxiety, depression, and opioid-related conditions
FDA has enforcement concerns and safety concerns regarding kratom products
Typical consumption is reported at less than 6 g per use by regular users
Why it matters
Making unsubstantiated health claims about kratom or failing to comply with FDA enforcement expectations could result in product removal, account suspension, or legal action against your business.
Sellers and marketers of kratom products in the U.S., including online and brick-and-mortar retailers
The FDA considers kratom an unapproved substance that cannot be legally sold as a drug, dietary supplement, or food additive in the U.S. market. Kratom products lack FDA approval and do not meet the safety requirements for any of these categories. Selling kratom in any form violates federal law.
Requirements
Kratom cannot be marketed as a drug product (approved or over-the-counter)
Kratom cannot be marketed as a dietary supplement (deemed adulterated under FD&C Act section 402(f)(1)(B))
Kratom cannot be added to conventional foods or marketed as a food additive (deemed unsafe under FD&C Act section 409)
Health claims linking kratom to medical treatment (pain, opioid withdrawal, anxiety, etc.) are not permitted
Why it matters
Selling kratom products in violation of these rules exposes you to FDA enforcement action, product seizure, and potential legal penalties.
Sellers and distributors of kratom products, particularly those making health or therapeutic claims
The FDA has identified significant safety concerns with kratom, including risks of opioid-like effects (sedation, nausea, constipation, physical dependence, and potentially fatal respiratory depression) and potential for substance use disorder. The FDA is actively working to prevent false or misleading health claims on kratom products and protect consumers from violative products, while states may have their own separate regulations.
Requirements
Do not make false or misleading labeling claims about unproven health benefits of kratom
Be aware that kratom may produce opioid-like effects including physical dependence and respiratory depression
Check applicable state regulations and prohibitions on kratom, which vary by location
Understand that the FDA is actively monitoring and enforcing against violative kratom products
Why it matters
Selling kratom with unproven health claims or without compliance with state/federal regulations exposes you to FDA enforcement action, product seizure, and legal liability for consumer harm.
Drug companies interested in kratom-related drug development; consumers and healthcare professionals using or monitoring kratom products
The FDA is conducting research studies to better understand kratom's safety profile and how it affects humans, including a single-dose study already submitted for peer review and a new human abuse potential study starting September 2024. The FDA recognizes that kratom could potentially be developed as a drug therapy and encourages companies interested in drug development to contact the FDA for guidance, while also asking consumers and healthcare professionals to report any adverse reactions.
Requirements
FDA is funding and conducting safety studies on kratom to evaluate its effects in humans
Drug companies developing kratom-based therapies should contact FDA's Center for Drug Evaluation and Research for guidance
Consumers and healthcare professionals should report any adverse reactions to FDA's MedWatch program or Safety Reporting Portal
FDA is gathering scientific information since kratom contains alkaloids (mitragynine and 7-OH) that bind to opioid receptors in the brain
Why it matters
If you're selling or promoting kratom products, you should be aware that the FDA is actively researching kratom's safety and may use findings from these studies to inform future enforcement or regulatory actions against unapproved health claims.
Companies and sellers marketing kratom products containing 7-hydroxymitragynine; health care professionals and consumers
The FDA is actively restricting and seizing products containing 7-hydroxymitragynine (7-OH), a compound derived from kratom, due to safety concerns. The agency has issued warning letters to companies marketing these products and encourages reporting of any adverse health reactions.
Requirements
Do not market products containing 7-hydroxymitragynine without FDA approval
FDA may seize non-compliant products
Report any adverse reactions to FDA MedWatch program or Safety Reporting Portal
Firms may receive warning letters for violations
Why it matters
Selling 7-OH kratom products exposes you to FDA enforcement action including product seizure and warning letters, which can result in listing removal and legal liability.
All online sellers and websites offering prescription drugs to U.S. consumers
The FDA warns that buying prescription drugs from unsafe online pharmacies is illegal and can be dangerous or deadly. The FDA issues warning letters to websites selling prescription drugs illegally. Consumers are advised not to purchase prescription drugs from these unsafe sources.
Requirements
Do not sell prescription drugs without complying with federal law.
Avoid operating or promoting unsafe online pharmacies.
Ensure all prescription drug sales are legal and safe.
Why it matters
Violating these rules can lead to FDA enforcement actions, including warning letters and potential legal consequences.
Online pharmacy operators and sellers offering prescription drugs to U.S. consumers
The FDA prohibits online pharmacies from selling prescription drugs illegally, including unapproved drugs, drugs without prescriptions, and drugs without proper safety warnings. Safe online pharmacies must require a doctor's prescription, maintain U.S. licensing, employ licensed pharmacists, and provide verifiable contact information. Selling prescription drugs through unsafe online channels violates federal law and poses serious health risks to consumers.
Requirements
Must require a valid doctor's prescription for all prescription drug sales
Must be licensed with a state board of pharmacy
Must employ a licensed pharmacist on staff
Must provide a physical U.S. address and telephone number
Cannot sell unapproved drugs, drugs of unknown origin, or drugs without FDA-required safety warnings
Why it matters
Violating these rules constitutes illegal activity under federal law, exposes you to FDA warning letters and enforcement action, and creates serious liability for consumer harm.
Online pharmacy operators and anyone considering promoting or partnering with pharmacy websites
This is an FDA enforcement index listing websites that have received warning letters for illegally operating as online pharmacies. These sites are flagged for not meeting regulatory requirements such as employing licensed pharmacists or maintaining proper state pharmacy board licensing.
Requirements
Do not operate as an online pharmacy without a licensed pharmacist on staff
Maintain valid state board of pharmacy licensing
Recognize that the listed websites have been formally warned by the FDA for illegal operation
Understand this list is not exhaustive—other unlicensed pharmacies may also exist
Why it matters
Operating or promoting an illegally run online pharmacy exposes you to FDA enforcement action, legal penalties, and loss of ability to sell on platforms like TikTok Shop.
Online pharmacy websites and sellers distributing prescription medications like tramadol without proper authorization
This is a list of websites that the FDA has issued warning letters to for illegally selling tramadol and other controlled pharmaceuticals online without proper licensing or prescriptions. These pharmacies were operating without FDA authorization or proper state pharmacy licenses.
Requirements
Do not sell prescription medications without a valid pharmacy license
Do not sell controlled substances like tramadol without FDA authorization
Do not operate an unlicensed online pharmacy
Expect FDA enforcement action and warning letters if operating illegally
Why it matters
Selling prescription or controlled medications without proper authorization exposes you to FDA enforcement, warning letters, and potential legal prosecution.
Online pharmacies and digital storefronts operating without FDA licensure or state pharmacy board approval, particularly those selling prescription drugs
The FDA issued warning letters to several illegal internet pharmacy operations, including rxmedkart.com and rxshopmd.com, for operating as unlicensed pharmacies and selling prescription medications without proper regulatory oversight.
Requirements
Do not operate a pharmacy without proper FDA and state licensing
Do not sell prescription medications without a licensed pharmacist and valid prescriptions
Comply with state pharmacy regulations and federal pharmacy laws
Discontinue unlicensed pharmacy operations immediately upon FDA notice
Why it matters
Operating an unlicensed pharmacy exposes you to FDA enforcement action, including warning letters, product seizure, and criminal penalties—and puts customers at serious health and safety risk.
Online pharmacy operators and illegal internet medication sellers, including entities like Power All Pharma, Pharmacy 2 Home, and Dream Pharmacy 24/7
This is an FDA enforcement index entry documenting warning letters issued to internet pharmacies operating without proper licensing or regulatory compliance. The FDA took action against specific online pharmacy operations for selling medications illegally.
Requirements
Operating a pharmacy without FDA licensing or state pharmacy board registration is prohibited
Selling prescription medications online without valid prescriptions and licensed pharmacist oversight is illegal
Internet pharmacies must comply with federal and state pharmaceutical regulations
Why it matters
If you sell medications online, you must be a licensed pharmacy—unlicensed operators face FDA warning letters, legal penalties, and platform removal.
Online pharmacy operators and anyone selling prescription medications or controlled substances on digital platforms
This is an FDA enforcement index listing illegal online pharmacies that have received warning letters for selling prescription medications without proper licensing or FDA oversight. These websites operate unlawfully and have been flagged by the FDA for regulatory violations.
Requirements
Do not operate or promote unlicensed online pharmacies
Do not sell prescription medications without proper FDA and state pharmacy licensing
Do not source or distribute medications from known illegal pharmacy networks
Comply with FDA regulations for legitimate internet pharmacy operations
Why it matters
Operating an unlicensed pharmacy or selling prescription drugs without proper authorization exposes you to FDA enforcement action, including warning letters, product seizures, and criminal prosecution.
Online pharmacy sellers and any TikTok Shop sellers offering prescription medications or pharmaceutical products
This is an FDA enforcement index listing internet pharmacies that have received warning letters for operating illegally. These sites were flagged by the FDA for violating pharmacy regulations, typically by selling prescription medications without proper licensing or oversight.
Requirements
Do not operate an unlicensed internet pharmacy or sell prescription drugs without proper FDA and state licensing
Do not source products from or operate through domains listed in FDA warning letter enforcement actions
Ensure all pharmaceutical sales comply with federal pharmacy regulations and state licensing requirements
Maintain proper documentation of pharmacy credentials and product sourcing
Why it matters
Operating an unlicensed pharmacy or selling prescription medications illegally exposes you to FDA enforcement action, including warning letters, product seizures, and criminal penalties, and will result in immediate account suspension and removal from TikTok Shop.
Online pharmacy businesses and dropshipping operations selling medications without FDA licensure or approval, including entities like Meds4U, JCM Dropship, and similar unlicensed pharmacy retailers
This is an FDA enforcement action against unlicensed internet pharmacies that were operating without proper authorization. The FDA issued warning letters to these entities for illegally distributing medications online without regulatory compliance.
Requirements
Do not operate as an online pharmacy without proper FDA licensure and state pharmacy board authorization
Do not sell or distribute prescription medications or unapproved drugs through unlicensed channels
Comply with federal pharmacy regulations before engaging in any medication sales or distribution
Why it matters
Operating an unlicensed pharmacy exposes you to FDA enforcement action, warning letters, legal liability, and potential criminal penalties—and your listings or accounts will be removed from platforms like TikTok Shop.
Online pharmacies and medication retailers, including Az Medicinal Shop, Thedonrx.net, Rablon, IceRx, TeraPharm, JCM Dropship, and Meds 4 U
This is an FDA enforcement index listing internet pharmacies and medication retailers that received warning letters for regulatory violations. The list identifies specific companies that the FDA found to be operating illegally or in non-compliance with pharmacy regulations.
Requirements
Companies on this list received FDA warning letters for violations
These entities are flagged as non-compliant with federal pharmacy regulations
Operating without proper licensing or authorization is prohibited
Selling medications through unauthorized channels is restricted
Why it matters
If you operate an online pharmacy or sell medications, operating without proper FDA compliance and licensing exposes you to warning letters, enforcement action, and your business being shut down.
Online pharmacy retailers, pharmacy affiliate programs, and internet-based prescription drug distribution networks
This is an FDA enforcement index listing internet pharmacy operations and affiliate programs that have received warning letters for regulatory violations. These entities are documented examples of non-compliant pharmaceutical sales channels.
Requirements
Do not operate as an unlicensed pharmacy or pharmaceutical distributor
Do not participate in affiliate programs that sell prescription medications without proper licensing
Ensure any pharmacy operations comply with state and federal pharmacy regulations
Obtain required licenses and follow FDA/DEA requirements for drug distribution
Why it matters
Operating as an unlicensed pharmacy or participating in non-compliant pharmaceutical sales exposes you to FDA enforcement action, warning letters, fines, and potential criminal liability.
Online pharmacies and platforms selling prescription drugs or controlled substances without FDA authorization
This is an FDA enforcement action targeting illegal internet pharmacies that were operating without proper licensing and regulatory oversight. These platforms (including Instabill ECS-Rx, Medstore.biz, and others listed) were selling prescription medications and controlled substances without valid pharmacy licenses or prescriptions.
Requirements
Do not operate as an unlicensed pharmacy
Do not sell prescription medications without valid prescriptions from licensed healthcare providers
Do not sell controlled substances without proper DEA licensing and oversight
Obtain and maintain valid state pharmacy licenses before selling any regulated medications
Why it matters
Operating an unlicensed internet pharmacy violates federal law and can result in FDA warning letters, criminal prosecution, and platform removal—TikTok Shop and similar platforms do not permit such sellers.
Online sellers and marketplaces offering pharmacy or prescription medication services
This is an FDA enforcement index documenting illegal internet pharmacies that have received warning letters for operating without proper licensure or regulatory approval. These sites were shut down or warned for selling prescription medications illegally online.
Requirements
Do not operate an unlicensed pharmacy
Do not sell prescription medications without proper FDA and state pharmacy board licensing
Do not facilitate sales through known illegal pharmacy networks or payment processors that support them
Why it matters
Operating an illegal pharmacy exposes you to FDA enforcement action, account suspension, and potential criminal liability.
Online sellers or platforms offering pharmaceuticals and prescription medications
This is an FDA enforcement index listing illegal or non-compliant internet pharmacies that have received warning letters. These pharmacies were operating without proper licensing or were selling prescription drugs illegally online.
Requirements
Do not operate as an unlicensed internet pharmacy
Do not sell prescription drugs without valid pharmacy licensing and DEA authorization
Comply with FDA regulations for legitimate online pharmacy operations
Avoid the enforcement actions that led to these warning letters
Why it matters
Operating an unlicensed internet pharmacy can result in FDA warning letters, legal enforcement action, and platform removal—TikTok Shop prohibits illegal drug sales entirely.
Online pharmacies and sellers operating internet pharmacy businesses without proper FDA authorization
This is an FDA enforcement index listing internet pharmacies that received warning letters for violating federal pharmacy regulations. The listed entities (247Med, Can America Global, Bulk 2 USA, American Pharmacy Group, Global Drug Supply, and Steroid Bazaar) were warned by the FDA for illegal pharmacy operations.
Requirements
Do not operate as an unlicensed internet pharmacy
Do not sell prescription drugs without valid pharmacy licensing
Do not operate under names on the FDA's warning letter enforcement index
Comply with federal pharmacy regulations and licensing requirements
Why it matters
Operating an unlicensed internet pharmacy or selling prescription medications without proper authorization can result in FDA warning letters, legal enforcement action, and business shutdown.
Companies and sellers marketing cannabis-derived products, including CBD and delta-8 THC products
The FDA issues warning letters to companies selling cannabis-derived products like CBD and delta-8 THC that violate regulations. The FDA actively monitors the market and takes enforcement action against these products to protect public health, often coordinating with state regulators.
Requirements
FDA monitors the marketplace for non-compliant cannabis-derived products
Firms may receive warning letters for violations
FDA coordinates with state regulatory partners on enforcement
Products must comply with FDA regulations to avoid enforcement action
Why it matters
Selling non-compliant cannabis-derived products can result in FDA warning letters and enforcement action, which puts your business at legal and operational risk.
Companies and sellers marketing cannabis-derived products, including CBD and delta-8 THC products
The FDA actively monitors and takes enforcement action against companies that market cannabis-derived products, including CBD and delta-8 THC, to protect public health. The agency will continue to issue warning letters and take legal action against firms selling these products, working with state regulators as needed.
Requirements
FDA actively enforces against CBD and delta-8 THC product marketing
The agency coordinates with state regulatory partners on enforcement
Warning letters have been and will continue to be issued to non-compliant firms
Ongoing marketplace monitoring is in effect
Why it matters
Selling unapproved cannabis-derived products exposes you to FDA enforcement action, warning letters, and potential legal consequences.
Cannabis-derived product sellers, specifically Trew Balance and related entities (TKO Distribution, LLC; Latro Inc.; Bailey's Wellness LLC)
Trew Balance is a cannabis-derived product company that has received an FDA warning letter, indicating the company's products violate FDA regulations. This means the firm has been officially notified of compliance violations and must take corrective action.
Requirements
Do not sell non-compliant cannabis-derived products
Address FDA compliance violations cited in the warning letter
Cease distribution of products that violate FDA regulations
Why it matters
FDA warning letters signal serious enforcement risk; failure to comply can result in seizure of products, criminal prosecution, and business closure. Other sellers should use this as a cautionary example of regulatory violations to avoid.
Cannabis-derived product sellers and distributors, including TKO Distribution, LLC, Latro Inc., Bailey's Wellness LLC, Holista LLC, and similar companies selling through websites like puredozo.com, baileyscbd.com, and trewbalance.com
The FDA has issued warning letters to companies selling cannabis-derived products (including those from TKO Distribution, LLC and others listed) for violations of federal regulations. This means these businesses were operating outside legal boundaries and must correct their compliance issues or face enforcement action.
Requirements
Companies named in warning letters must cease violating FDA regulations
Sellers of cannabis-derived products must ensure compliance with federal enforcement standards
Any seller offering similar products should review FDA guidance to avoid warning letter status
Non-compliance can result in product seizure, injunctions, or other enforcement actions
Why it matters
Selling non-compliant cannabis-derived products can result in FDA enforcement action, product removal from platforms, business shutdown, or legal liability—making compliance verification essential before listing these products.
Companies selling cannabis-derived products (CBD, hemp-derived items) that lack FDA approval or proper regulatory compliance
This is a reference to an FDA enforcement action listing that documents companies which received warning letters for selling cannabis-derived products (like CBD) without proper authorization or compliance with federal regulations.
Requirements
Cannabis-derived products require proper FDA compliance and authorization before sale
Companies on this enforcement index received FDA warning letters for violations
Selling unapproved cannabis-derived products exposes sellers to FDA enforcement action
Why it matters
If your company or product is listed in FDA warning letter databases, your TikTok Shop listings will be prohibited and your account may face suspension or removal.
Companies and sellers offering CBD, cannabis-derived, or hemp-derived products with health or medical claims (including pet products like those sold by Holista LLC, Bailey's Wellness LLC, and others listed)
This is an FDA enforcement index listing companies that have received warning letters for illegal marketing and sale of cannabis-derived products (CBD and related compounds). The FDA found these businesses making unauthorized health claims and selling unapproved drugs.
Requirements
Do not market cannabis-derived products as treatments, cures, or preventatives for disease
Do not make unsubstantiated health claims about CBD or hemp products
Cannabis-derived products sold as drugs require FDA approval (which is rarely granted)
Consult FDA regulations before making any health-related claims
Why it matters
Selling cannabis-derived products with health claims can result in FDA warning letters, product seizure, and legal enforcement action against your business.
Companies selling cannabis-derived products (CBD, hemp-derived products) online, including House of Alchemy/Hamet & Love LLC, Pico IV Inc., Holista LLC, and others listed in the 2024 FDA warning letters index
This is an FDA warning letter index listing companies that received enforcement notices for selling cannabis-derived products (like CBD) in violation of federal law. These companies were flagged for regulatory violations and FDA enforcement action.
Requirements
Do not sell unapproved cannabis-derived products (CBD, hemp extracts, etc.) as food, supplements, or cosmetics
Ensure any hemp-derived products comply with FDA regulations and state law
Be aware that making unsubstantiated health claims about CBD products triggers FDA enforcement
Companies on this list received official warning letters and must cease non-compliant practices
Why it matters
Selling non-compliant cannabis-derived products can result in FDA warning letters, product seizure, and legal enforcement action that shuts down your business.
Anne's Daye Ltd dba Tampon Innovations and sellers of cannabis-derived products subject to FDA enforcement
This is a reference to an FDA warning letter issued to Anne's Daye Ltd (operating as Tampon Innovations) regarding cannabis-derived products. The firm appears on the FDA's 2024 enforcement index for warning letters related to cannabis products, indicating regulatory action was taken against them.
Requirements
The company received an FDA warning letter in 2024
Cannabis-derived products are subject to FDA enforcement scrutiny
Sellers should review FDA warning letter databases if selling similar products
Why it matters
If you sell cannabis-derived products, you risk FDA warning letters and enforcement action if your products don't comply with federal regulations.
Root Bioscience Brands, LLC dba Naternal and companies selling cannabis-derived products without proper FDA authorization
The FDA has issued enforcement action against Root Bioscience Brands, LLC (operating as Naternal) for selling cannabis-derived products in violation of federal regulations. This company was identified as part of the FDA's warning letter enforcement index targeting unauthorized cannabis product sales.
Requirements
Cannabis-derived products cannot be legally sold without FDA approval
Companies operating websites selling such products are subject to FDA enforcement action
Selling these products exposes businesses to warning letters and potential legal consequences
Why it matters
Selling unauthorized cannabis-derived products violates federal law and can result in FDA warning letters, product seizures, or legal enforcement action against your business.
White Label Leaf, LLC and Flying Monkey US, LLC (cannabis-derived product sellers)
White Label Leaf, LLC and Flying Monkey US, LLC are named in an FDA warning letter index for cannabis-derived products. This indicates the FDA has issued enforcement action against these companies for violations related to how they market, label, or sell cannabis-derived products.
Requirements
These companies have been subject to FDA enforcement action
The warning relates to cannabis-derived products
Companies named in this index should review FDA compliance requirements for cannabis products
Similar businesses should avoid violations that triggered this enforcement action
Why it matters
Sellers of cannabis-derived products can face FDA warning letters and enforcement action if they violate labeling, marketing, or safety requirements—risking product removal and legal consequences.
Cannabis-derived product sellers and distributors, specifically companies including Hippy Mood, Root Bioscience Brands (Naternal), White Label Leaf, Flying Monkey US, Earthly Hemps, and Mary Jane's Bakery Co.
The FDA has issued warning letters to companies selling cannabis-derived products, including Hippy Mood and several other businesses. These companies were operating in violation of FDA regulations governing the marketing and sale of cannabis-derived substances.
Requirements
FDA enforcement action has been taken against these specific businesses
These companies are cited in the FDA's Warning Letters enforcement index for cannabis-derived products
Selling cannabis-derived products without proper FDA compliance carries enforcement risk
Why it matters
Appearing on the FDA's warning letter list indicates serious regulatory violations; selling similar products without compliance could result in FDA enforcement action against your business.
Companies selling cannabis-derived and CBD products, including Earthly Hemps, White Label Leaf/Flying Monkey US, Hippy Mood, Mary Jane's Bakery Co., Life Leaf Medical CBD Center, and similar retailers
These companies have received FDA warning letters for selling cannabis-derived products (including CBD and hemp products) that violate federal regulations. The FDA has identified these businesses as operating outside compliant channels and selling products that do not meet legal standards.
Requirements
Do not sell unapproved cannabis-derived products as food, dietary supplements, or drugs
Do not make unsubstantiated health claims about CBD or hemp products
Ensure products comply with FDA regulations before listing or selling
Avoid operating under the business models used by these warned companies
Why it matters
Selling non-compliant cannabis-derived products can result in FDA enforcement action, product seizures, and legal liability—these warning letters show real enforcement consequences.
Companies selling cannabis-derived products (including CBD) online, specifically Mary Jane's Bakery Co. LLC and similar retailers listed in the FDA Warning Letters enforcement index
This is an FDA enforcement action listing companies that have received warning letters for illegally marketing cannabis-derived products, including CBD. Mary Jane's Bakery Co. LLC is one of the companies identified as selling products that violated FDA regulations.
Requirements
Do not make unsubstantiated health or medical claims about cannabis-derived products
Do not market CBD as a drug or dietary supplement without proper FDA approval
Comply with FDA regulations on what products can be legally sold and how they can be labeled
Understand that companies in this enforcement index have been warned for violations
Why it matters
If you sell cannabis-derived products, receiving an FDA warning letter can result in enforcement action, product seizure, and forced removal from marketplace platforms like TikTok Shop.
Companies selling cannabis-derived products, particularly CBD products and mushroom-based products online (including Mary Jane's Bakery Co. LLC, Life Leaf Medical CBD Center, Grow God LLC, and Shamrock Shrooms)
The FDA issued warning letters in 2023 to specific companies selling cannabis-derived products (particularly CBD) that were operating in violation of federal regulations. These warning letters indicate that the FDA has identified enforcement action against businesses that marketed, sold, or distributed CBD and related products without proper authorization or in violation of food and drug laws.
Requirements
Cannabis-derived and CBD products are subject to FDA enforcement action
Selling CBD products online without proper compliance exposes your business to FDA warning letters
Companies in this space must follow federal food and drug regulations
Why it matters
If you sell CBD or cannabis-derived products, your business could face FDA enforcement, warning letters, and potential legal consequences if you do not comply with federal regulations.
CBD and cannabis-derived product sellers operating websites listed in the FDA's 2023 warning letter index, including GrowGod LLC, Shamrockshrooms.com, Life Leaf Medical CBD Center, and similar retailers
This is an FDA enforcement index listing companies that received warning letters in 2023 for selling cannabis-derived products (such as CBD, delta-8, or other cannabinoids). The FDA determined these companies were making illegal claims, selling unapproved products, or otherwise violating federal regulations.
Requirements
Understand that selling cannabis-derived products without FDA approval or making unsubstantiated health claims violates federal law
Review why your company received a warning letter (typically for illegal marketing, unapproved product claims, or improper product categorization)
Correct violations and cease non-compliant sales practices to avoid further FDA enforcement action
Ensure any cannabis products comply with state and federal regulations before selling
Why it matters
Companies on this list face potential product seizures, injunctions, criminal referrals, and loss of sales channels; listing on TikTok Shop or promoting these products could result in account suspension or removal.
The FDA issued warning letters in 2023 to cannabis-derived product companies (including East Fork Cultivars, Hemp XR, and Discover CBD) for violations of federal regulations. This index documents enforcement actions taken against firms selling CBD and hemp-derived products online.
Requirements
Companies listed received FDA warning letters for regulatory violations in 2023
Violations relate to marketing and/or manufacturing of cannabis-derived products
The specific violations are not detailed in this excerpt, but referenced companies should review their individual warning letters for compliance requirements
Selling cannabis-derived products without FDA compliance may result in enforcement action
Why it matters
If your firm sells hemp or CBD products online, you could face FDA warning letters and enforcement action if your products violate federal regulations—review this index to ensure your company isn't listed and understand the compliance risks.
Companies selling cannabis-derived and hemp products (CBD, hemp oil, etc.), particularly those making health or medical claims
This is an FDA enforcement action listing companies that have received warning letters for making unauthorized health claims about cannabis-derived products (CBD and hemp products). The FDA found these companies were marketing their products as treatments or cures for diseases without proper approval, which violates federal law.
Requirements
Do not make disease treatment or cure claims for CBD or hemp products without FDA approval
Do not market cannabis-derived products as drugs or therapeutic agents
Companies listed have received formal FDA warning letters and should expect enforcement action
Comply with FDA regulations on supplement and drug labeling requirements
Why it matters
Selling cannabis-derived products with unauthorized health claims can result in FDA warning letters, product seizures, and legal enforcement action against your business.
CBD and cannabis-derived product sellers and retailers, including companies like Koi CBD, LLC, Northland Vapor Company, North Carolina Hemp Exchange, and others listed in the FDA warning index.
This is an FDA enforcement index listing companies that have received warning letters for cannabis-derived products (CBD) they were selling. The list identifies specific businesses and their websites that the FDA found to be in violation of regulations.
Requirements
Do not make unsubstantiated health claims about CBD or cannabis-derived products
Comply with FDA regulations for marketing and sale of these products
Do not sell products that violate federal enforcement guidance
Be aware that selling similar products or making similar claims may trigger FDA warning letters
Why it matters
If you sell CBD or cannabis-derived products and make similar claims or marketing practices, you risk receiving an FDA warning letter, which can result in product removal, fines, and reputational damage to your business.
Cannabis-derived product sellers and retailers, including The Haunted Vapor Room and similar CBD/hemp businesses
This is an FDA enforcement index entry listing companies that have received warning letters for selling cannabis-derived products (like CBD) in violation of federal regulations. The Haunted Vapor Room is one of several businesses named in FDA enforcement action for non-compliance with cannabis product regulations.
Requirements
Cannabis-derived products must comply with FDA regulations
Sellers must not market unapproved cannabis products for medical use or as dietary supplements
Businesses receiving warning letters must remediate violations or face further enforcement action
Why it matters
If your business is named in an FDA warning letter index, you face potential product seizure, injunction, or criminal prosecution—and TikTok Shop will likely suspend or remove your listings.
Cannabis-derived product sellers and distributors, specifically the companies named: Koi CBD LLC, The Haunted Vapor Room, North Carolina Hemp Exchange LLC, Nikte's Wholesale LLC, and Exclusive Hemp Farms/Oshipt.com
This is an FDA enforcement action listing companies that have received warning letters for selling cannabis-derived products (such as CBD) in violation of federal regulations. These companies are identified as having violated FDA rules regarding the marketing, distribution, or claims made about their cannabis-derived products.
Requirements
Do not sell cannabis-derived products with unsubstantiated health claims
Do not market CBD or hemp products as drugs or dietary supplements without FDA approval
Comply with FDA regulations on product labeling and advertising
Be aware that selling non-compliant cannabis-derived products may result in warning letters and enforcement action
Why it matters
If you sell cannabis-derived products, failing to comply with FDA regulations can result in warning letters, product seizure, and legal enforcement action that disrupts your business.
Nikte's Wholesale, LLC and any sellers operating similar cannabis-derived or hemp product businesses
This is an FDA enforcement action listing against Nikte's Wholesale, LLC for violations related to cannabis-derived products. The company received a warning letter from the FDA, indicating it was operating in non-compliance with federal regulations governing the marketing and sale of hemp or CBD products.
Requirements
Do not market unapproved cannabis-derived products as drugs or with unsubstantiated health claims
Comply with FDA regulations governing hemp and CBD product manufacturing, labeling, and distribution
Cease any operations that violate federal cannabis-related enforcement guidelines
Why it matters
Operating a cannabis-derived product business without FDA compliance exposes you to warning letters, product seizure, and potential legal action that can shut down your business entirely.
Cannabis-derived and hemp product sellers operating online, including companies like Exclusive Hemp Farms, Dr. Smoke LLC, Nikte's Wholesale, and Delta Munchies LLC
This is an FDA enforcement index listing companies that have received warning letters for selling cannabis-derived products (including hemp and CBD products) in violation of federal regulations. These companies are documented examples of businesses the FDA has taken action against.
Requirements
Do not make unsubstantiated health claims about cannabis or hemp-derived products
Do not sell unapproved drug products containing cannabis derivatives
Comply with FDA regulations on what can be marketed and sold
Understand that violation of these rules results in FDA warning letters and enforcement action
Why it matters
If you sell hemp or cannabis-derived products on TikTok Shop, you risk FDA enforcement action, warning letters, and potential legal consequences if you make prohibited claims or sell non-compliant products.
Delta Munchies LLC and sellers marketing or selling cannabis-derived products (such as delta-8, delta-10, or other hemp-derived cannabinoids)
Delta Munchies LLC is listed in an FDA enforcement index for cannabis-derived products, indicating the company has received a warning letter from the FDA for violations related to the marketing or sale of these products.
Requirements
Delta Munchies LLC is subject to FDA enforcement action
Selling cannabis-derived products without proper FDA compliance creates legal and business risk
Companies must comply with FDA regulations governing hemp-derived cannabinoid marketing and sales
Why it matters
If you sell similar cannabis-derived products, you face potential FDA warning letters, product seizures, or legal action if you do not meet FDA compliance requirements.
Sellers of cannabis-derived products (CBD, Delta-8, Delta-10, and similar compounds) on any platform including TikTok Shop
These companies have received FDA warning letters for selling cannabis-derived products (like CBD and Delta-8) that violated federal regulations. The FDA found violations related to unsubstantiated health claims, improper product labeling, or marketing these products as drugs without approval.
Requirements
Do not make unsubstantiated health or medical claims about cannabis-derived products
Ensure accurate product labeling and ingredient disclosure
Do not market cannabis-derived products as drugs or treatments without FDA approval
Verify your company is not on the FDA enforcement warning list before selling
Why it matters
Selling cannabis-derived products that violate FDA rules can result in warning letters, product seizures, legal action, and your TikTok Shop account being suspended or terminated.
Cannabis-derived and CBD product companies that received FDA warning letters in 2022, including Purecraft LLC, Medical Mikes Inc., PharmaCanna, Delta Munchies LLC, and Suprimo Imports
The FDA issued warning letters to several cannabis-derived product companies in 2022, including Purecraft LLC, Medical Mikes Inc., PharmaCanna, Delta Munchies LLC, and Suprimo Imports. These companies were cited for regulatory violations related to their cannabis or CBD products. This listing documents enforcement actions taken by the FDA against these specific firms.
Requirements
Companies listed received official FDA warning letters for violations
The violations relate to cannabis-derived product manufacturing, marketing, or claims
These are public enforcement actions documented by the FDA
Non-compliance with FDA requirements for cannabis products
Why it matters
Sellers offering cannabis or CBD products should review FDA enforcement actions to understand what violations trigger warnings and avoid similar compliance failures that could result in legal action against their business.
Sellers and companies marketing or selling CBD and cannabis-derived products
The FDA actively pursues enforcement action against CBD and other cannabis-derived products that violate federal regulations. This is a notice that several companies have received warning letters for non-compliance, signaling that the FDA monitors the marketplace for violations and will take action to protect public health.
Requirements
CBD and cannabis-derived products are subject to FDA enforcement action
The FDA monitors the marketplace and works with state regulators
Companies selling these products must comply with FDA authorities and regulations
Failure to comply can result in warning letters and enforcement action
Why it matters
If you sell CBD or cannabis-derived products without proper FDA compliance, you risk receiving a warning letter, having your listing removed, or facing legal enforcement action.
Companies and sellers marketing or distributing CBD and cannabis-derived products, including brands like CBD American Shaman, CBDFX, Infusionz, and others listed in the FDA enforcement index
The FDA has issued warning letters to multiple companies selling CBD and cannabis-derived products, citing enforcement action against these specific businesses. These companies are listed on the FDA's enforcement index as having violated regulations regarding the marketing and sale of CBD products.
Requirements
Do not market cannabis-derived or CBD products with unsubstantiated health claims
Comply with FDA regulations on dietary supplements and drug classifications
Do not operate similarly to the businesses named in warning letters if selling CBD products
Be aware that marketing CBD products without proper authorization subjects you to FDA enforcement action
Why it matters
If you sell CBD or cannabis-derived products, the FDA actively enforces against companies making improper claims, and appearing on the enforcement index can result in takedown actions, fines, and loss of selling ability on platforms.
CBD and cannabis-derived product sellers, including companies like CBD American Shaman, CBDFX, Infusionz, and others listed in the FDA's warning letter database
This is an FDA enforcement index listing companies that have received warning letters for illegally marketing cannabis-derived products (CBD). These companies made unsubstantiated health claims or failed to comply with FDA regulations for their CBD products.
Requirements
Companies listed have received FDA warning letters for regulatory violations
CBD products cannot be marketed with unsubstantiated health or therapeutic claims
Sellers must comply with FDA regulations for drug claims and product labeling
This is an enforcement record, not a complete list of all companies with violations
Why it matters
Selling CBD products with unsubstantiated claims or failing to meet FDA requirements can result in warning letters, product seizures, and legal enforcement action that directly impacts your business.
CBD and cannabis-derived product sellers, particularly those selling online through e-commerce platforms similar to the listed companies
This is a list of companies that have received FDA warning letters for selling CBD-derived products in violation of federal regulations. These companies were operating without proper compliance and their products were determined to be unapproved drugs or made illegal health claims.
Requirements
Do not sell CBD products with unsubstantiated health claims
Do not market CBD as a drug treatment without FDA approval
Ensure compliance with FDA regulations before selling cannabis-derived products
Be aware that selling non-compliant CBD products can result in FDA enforcement action and warning letters
Why it matters
Selling non-compliant CBD products can result in FDA warning letters, product seizures, legal penalties, and platform removal—affecting your ability to operate your business.
Sellers and distributors of cannabis-derived and cannabinoid products, including CBD retailers and similar firms operating online.
The FDA has issued warning letters to cannabis-derived product companies for regulatory violations. These firms were selling cannabinoid products without proper FDA compliance, and their operations have been flagged for enforcement action.
Requirements
Do not sell unapproved cannabis-derived products
Ensure products meet FDA regulations before listing or marketing
Obtain proper documentation and compliance before operating a sales platform
Verify your business is not on the FDA enforcement list
Why it matters
Selling non-compliant cannabis-derived products can result in FDA warning letters, enforcement action, and account suspension on TikTok Shop or other platforms.
Companies and sellers offering cannabis-derived products (CBD beverages, oils, infusions, and similar products)
This is an FDA enforcement index listing companies that have received warning letters for making illegal claims or selling non-compliant cannabis-derived products (including CBD and similar substances). These companies violated FDA regulations by marketing their products as drugs or making unapproved health claims.
Requirements
Do not make drug claims or health benefit claims for cannabis-derived products without FDA approval
Do not market CBD or similar substances as treatments for diseases or conditions
Comply with FDA labeling and marketing requirements for dietary supplements or cosmetics
Avoid the business practices that led these named companies to receive warning letters
Why it matters
Selling non-compliant cannabis-derived products can result in FDA warning letters, product seizure, and legal enforcement action that shuts down your business.
Companies listed in the FDA Warning Letters index for cannabis-derived products, including Young Living Essential Oils, New Sun Inc., Fluxx Lab LLC, H2 Beverages Inc., Haniel Concepts Inc. (Free State Oils), and Plantacea LLC, among others
This is an FDA enforcement index listing specific companies that have received warning letters regarding cannabis-derived products. These companies are flagged for non-compliance with FDA regulations around marketing or making claims about cannabis-derived products.
Requirements
Do not make unsubstantiated health claims about cannabis-derived products
Do not market cannabis-derived products in violation of FDA regulations
Ensure compliance with FDA guidance on cannabinoid products
Products sold must comply with applicable federal and state cannabis regulations
Why it matters
Sellers of cannabis-derived products who fail to comply with FDA regulations risk receiving warning letters, enforcement action, and potential removal from platforms like TikTok Shop.
Haniel Concepts, Inc. DBA Free State Oils, LLC and their cannabis-derived product operations
This entry identifies Haniel Concepts, Inc. DBA Free State Oils, LLC as a company that received an FDA warning letter regarding cannabis-derived products. The company's website (www.freestateoils.com) was flagged by the FDA for enforcement action related to compliance issues with cannabis product regulations.
Requirements
Company received an FDA warning letter for cannabis-derived products
Website listed in FDA enforcement index
Subject to FDA compliance requirements for cannabis products
Failure to comply may result in further enforcement action
Why it matters
If you sell or promote cannabis-derived products, understand that the FDA actively enforces compliance, and non-compliance can result in warning letters and potential legal action that damages your business.
Plantacea, LLC dba Kahm and cannabis-derived product sellers making similar compliance violations
Plantacea, LLC (doing business as Kahm) has received an FDA warning letter for violating federal regulations related to cannabis-derived products. The company's website and business operations are cited as non-compliant with FDA requirements for these products.
Requirements
Cannot market cannabis-derived products in violation of FDA regulations
Must comply with FDA enforcement actions and warning letters
Business websites and operations must meet federal cannabis product standards
Why it matters
Failure to comply with FDA requirements for cannabis products can result in warning letters, enforcement action, and potential shutdown of your business.
Companies and sellers offering cannabis-derived products (CBD, hemp-derived cannabinoids) online or through e-commerce platforms
The FDA has issued warning letters to companies selling cannabis-derived products (including CBD and hemp-derived products) that make unsubstantiated health claims or violate federal regulations. These companies are on an FDA enforcement list, indicating they have been warned about non-compliance with FDA requirements.
Requirements
Do not make unsubstantiated health or therapeutic claims about cannabis-derived products
Comply with FDA regulations for product marketing and claims
Avoid selling products that violate federal cannabis and hemp regulations
Be aware that selling products similar to those on FDA warning lists carries enforcement risk
Why it matters
Selling cannabis-derived products with unlawful claims or non-compliant practices can result in FDA warning letters, product seizure, legal action, and account suspension on TikTok Shop.
Cannabis and hemp-derived product sellers, including companies like Ironmag Labs, Kahm, Hope Botanicals, ATL Rx Inc, Bio MD Plus LLC, and Delta 8 Hemp
The FDA has issued warning letters to Ironmag Labs and several other cannabis-derived product companies for violating federal regulations. These companies were flagged for enforcement action, indicating they are operating in violation of FDA rules governing cannabis and hemp-derived products.
Requirements
Do not market or sell cannabis-derived products in violation of FDA regulations
Companies operating similar businesses should review FDA enforcement letters for compliance guidance
Ensure products comply with applicable federal cannabis and hemp-derived product rules
Why it matters
Selling non-compliant cannabis or hemp-derived products can result in FDA warning letters, enforcement action, and potential removal from platforms like TikTok Shop.
Companies and sellers of cannabis-derived products, specifically: BioMD Plus LLC, Ironmag Labs, ATL Rx Inc, Delta 8 Hemp, Kingdom Harvest LLC, and M Six Labs Inc.
The FDA has issued warning letters to specific companies selling cannabis-derived products, indicating that these products are not FDA-approved and violate federal regulations. These companies are being called out by name for enforcement action due to non-compliance with cannabis product regulations.
Requirements
Cannabis-derived products sold by these companies have been determined to be non-compliant with FDA regulations
These specific companies have received official FDA warning letters
Products from these vendors should not be sold or promoted on TikTok Shop
Sellers should not model their cannabis product business practices after these enforcement targets
Why it matters
Selling products from FDA-warned companies or promoting unapproved cannabis products puts your TikTok Shop account at risk of suspension or permanent removal, and may expose you to legal liability.
Delta-8 hemp product sellers and companies marketing cannabis-derived products (specifically the listed companies: ATL Rx Inc, Bio MD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC, M Six Labs Inc, and Cureganics)
This is an FDA enforcement index listing companies that have received warning letters for selling delta-8 hemp products in violation of federal regulations. The FDA has taken formal enforcement action against these sellers for non-compliance.
Requirements
These companies have received FDA warning letters for violations
Delta-8 hemp products are subject to FDA enforcement scrutiny
Selling delta-8 products without proper compliance may result in warning letters and enforcement action
Why it matters
If you sell delta-8 or cannabis-derived hemp products, you face FDA enforcement risk including warning letters, which can lead to listing removal, fines, or legal action.
Companies listed in FDA warning letters for cannabis-derived products: Kingdom Harvest LLC, M Six Labs Inc., Cureganics, Bio MD Plus LLC, Delta 8 Hemp, and Heaven's Organics LLC
These companies have been cited by the FDA for manufacturing and selling cannabis-derived products (primarily Delta-8 THC products) without proper authorization or in violation of federal regulations. The FDA has issued warning letters to these specific businesses.
Requirements
These companies have received FDA enforcement action for cannabis-derived product sales
Products from these vendors may be illegal or non-compliant with federal standards
Selling or promoting products from these companies may violate platform policies and federal law
Why it matters
If you sell, source products from, or promote any of these cited companies on TikTok Shop or in creator content, you risk account suspension, product removal, and potential legal enforcement action.
Companies and sellers marketing cannabis-derived products (CBD, hemp oil, etc.) as health products, dietary supplements, or drugs
This is an FDA enforcement index listing companies that received warning letters for making illegal health claims or marketing cannabis-derived products (like CBD) as drugs or dietary supplements without proper FDA approval. These companies violated federal law by selling products that were not properly regulated or substantiated.
Requirements
Do not make unsubstantiated health claims about cannabis-derived products
Do not market CBD or hemp products as drugs without FDA approval
Do not sell cannabis-derived products as dietary supplements without meeting FDA requirements
Understand that the listed companies (Heaven's Organics LLC, M Six Labs Inc., Cureganics, etc.) are examples of enforcement actions
Why it matters
Selling cannabis-derived products with illegal health claims can result in FDA warning letters, product seizures, and legal penalties; TikTok Shop will remove listings that violate these federal rules.
CBD and hemp oil sellers, particularly companies selling cannabis-derived products like those named: Functional Remedies LLC (Synchronicity Hemp Oil), Cureganics, Heaven's Organics, Greenway Herbal Products, CBD Social, and UPSY LLC
The FDA has issued warning letters to cannabis-derived product companies (like Synchronicity Hemp Oil and others listed) for regulatory violations. These companies are specifically named as examples of enforcement action taken against CBD and hemp oil sellers who did not comply with FDA requirements.
Requirements
Do not make unsubstantiated health claims about cannabis-derived products
Comply with FDA regulations for dietary supplements or drug products depending on how your product is marketed
Avoid marketing CBD or hemp oil products in ways that violate FDA enforcement guidance
Understand that failure to comply can result in FDA warning letters and enforcement action
Why it matters
If you sell CBD or hemp oil products, operating without FDA compliance can result in warning letters, product seizure, and removal from platforms—these named companies are public examples of what happens when sellers violate FDA rules.
All TikTok Shop sellers and creators promoting or selling cannabis-derived products, including those associated with the listed companies.
The FDA has issued warning letters to certain companies selling cannabis-derived products, indicating these products may not comply with FDA regulations. Sellers must be aware that marketing or selling cannabis-derived products without FDA approval can lead to enforcement actions. This includes companies like Greenway Herbal Products LLC and others listed by the FDA.
Requirements
Do not market cannabis-derived products with unapproved health claims.
Ensure products comply with FDA regulations before listing or promoting.
Avoid selling products that have received FDA warning letters.
Verify product claims and compliance to avoid enforcement risks.
Why it matters
Non-compliance can lead to product removal, account penalties, or legal enforcement actions.
CBD and cannabis-derived product sellers, particularly companies marketing hemp-derived products with therapeutic or medicinal claims
This appears to be a list of companies cited in FDA warning letters for selling cannabis-derived CBD products that made unsubstantiated health claims or violated FDA regulations. The FDA took enforcement action against these businesses for marketing CBD products illegally.
Requirements
Do not make unsubstantiated health or therapeutic claims about CBD products
Comply with FDA regulations for cannabis-derived substances
Do not market unapproved CBD products as drugs or treatments
Ensure product claims are backed by scientific evidence
Why it matters
Selling non-compliant CBD products can result in FDA enforcement action, warning letters, product seizure, and legal liability—these companies received formal FDA citations for violations.
Companies listed in FDA warning letters for cannabis-derived products, including UPSY LLC, Nature's Highway, Rena's Organic, Greenway Herbal Products LLC, CBD Social, and Glenn Burkett Naples Corporation
The FDA has issued warning letters to specific companies selling cannabis-derived products (primarily CBD) for regulatory violations. This is an enforcement index listing companies that have received formal FDA warnings.
Requirements
Do not sell products from companies on this FDA warning list
Companies on this list have violated FDA regulations regarding cannabis-derived product claims or manufacturing
Selling products from these vendors may result in your own listing removal or enforcement action
Why it matters
Selling products from FDA-warned companies risks account suspension, listing removal, or legal liability on your platform.
Companies and sellers offering cannabis-derived products (CBD, hemp-derived products, etc.) online, particularly those making unauthorized health or drug claims.
This is a public record of FDA warning letters issued to companies selling cannabis-derived products (like CBD) that violated federal regulations. These companies received enforcement action because their products or marketing claims did not comply with FDA requirements.
Requirements
Do not make unproven medical or therapeutic claims about cannabis-derived products
Ensure compliance with FDA regulations for dietary supplements or drug claims
Avoid selling products that violate federal enforcement standards
Be aware that non-compliance can result in public warning letters and enforcement action
Why it matters
Selling non-compliant cannabis-derived products can result in FDA warning letters, enforcement action, and potential removal from sales platforms—putting your business at serious legal and financial risk.
Ageless Global, LLC and sellers operating under the associated domain names and brand names listed
Ageless Global, LLC and its associated websites (including cvk365.com, covid19mdhub.com, lionsfuel.com, mdimmunespray.com, and mdmouthspray.com) have been subject to FDA enforcement action. This is a public record documenting the company's inclusion in the FDA's warning letters index for cannabis-derived products.
Requirements
Company and its websites are documented in FDA enforcement records
Multiple domain names redirect to or operate under this entity
Associated with cannabis-derived product sales and marketing
Why it matters
If you operate under this company name or these domains, you are subject to FDA enforcement and should not replicate this business model; platforms like TikTok Shop may prohibit listings from companies with active FDA warnings.
Companies and retailers selling CBD and cannabis-derived products, particularly those making health or medical claims
This is an FDA enforcement index listing companies and websites that have received warning letters for making illegal or unapproved claims about cannabis-derived products (CBD). These companies violated FDA regulations by marketing products with unsubstantiated health claims.
Requirements
Do not make unsubstantiated health or medical claims about CBD products
Do not market CBD as a drug or medical treatment without FDA approval
Follow FDA labeling and advertising standards for dietary supplements and over-the-counter products
Verify your company and website are not on this FDA warning letter list
Why it matters
Selling CBD products with false or misleading claims can result in FDA warning letters, product seizures, and legal enforcement action against your business.
BioLyte Laboratories, LLC and any sellers marketing cannabis-derived products (CBD, hemp products, etc.)
BioLyte Laboratories, LLC received an FDA warning letter regarding cannabis-derived products. This indicates the FDA identified compliance issues with how the company manufactured, marketed, or sold CBD or cannabis-derived products.
Requirements
Cannabis-derived products must comply with FDA regulations on manufacturing and marketing claims
Sellers cannot make unsubstantiated health or therapeutic claims about CBD or cannabis products
Products must meet FDA standards for safety and labeling
Why it matters
FDA warning letters signal enforcement action; selling non-compliant cannabis-derived products can result in product seizure, injunctions, or civil/criminal penalties.
Sellers of cannabis-derived products, specifically Bee Delightful and similar companies marketing unapproved cannabis products online
The FDA issued a warning letter to Bee Delightful in 2020 for violations related to cannabis-derived products. This indicates the company was selling products that did not comply with FDA regulations.
Requirements
Do not make claims about cannabis-derived products without FDA approval
Ensure cannabis products comply with applicable state and federal regulations
Do not market or sell cannabis products that lack proper authorization
Why it matters
Selling unapproved cannabis-derived products can result in FDA enforcement action, warning letters, and potential legal consequences that could shut down your business.
Companies selling cannabis-derived products (CBD, hemp-derived products) including New Leaf Pharmaceuticals, Next L3vel Services Group, G&L Wellness, Wellness Bio Sciences Rx, and BIOTA Biosciences LLC
The FDA has issued warning letters to multiple companies selling cannabis-derived products (primarily CBD products) for making unapproved health claims and operating without proper regulatory compliance. These companies are on an FDA enforcement list, indicating they have been formally warned for violations.
Requirements
Do not make unapproved drug or health claims about cannabis-derived products
Cannabis-derived products require proper FDA compliance and cannot be marketed as drugs without approval
Sellers operating in this space should review FDA enforcement actions to understand prohibited practices
Companies on this warning list must take corrective action or face further FDA enforcement
Why it matters
If you sell cannabis-derived products, appearing on an FDA warning list or being subject to enforcement action can result in product seizure, fines, and loss of ability to sell on platforms like TikTok Shop.
CBD and cannabis-derived product sellers, including companies like Homero Corp, Wellness Bio Sciences Rx, BIOTA Biosciences, and The Dragontree Apothecary that have received FDA warning letters
This is an FDA enforcement index listing companies that have received warning letters for CBD and cannabis-derived products, often related to making unauthorized health claims or selling unapproved products. The list serves as a public record of firms the FDA has taken action against for violations in this product category.
Requirements
Do not make unsubstantiated health or therapeutic claims about CBD or cannabis-derived products
Do not sell unapproved drugs or products marketed as medical treatments
Comply with FDA guidance on what claims and marketing are permissible for hemp-derived CBD
Avoid selling products that violate federal enforcement actions
Why it matters
If you sell CBD or cannabis-derived products and appear on this enforcement list, your business faces legal penalties, product seizures, and loss of sales channels on platforms like TikTok Shop.
CBD and cannabis-derived product sellers, particularly those marketing products on e-commerce platforms like Avazo-Healthcare, Patriot Supreme, Blue Ribbon Hemp, and similar retailers.
The FDA issued warning letters to cannabis-derived CBD product sellers who made unauthorized claims about their products' ability to treat or prevent COVID-19. These companies violated FDA regulations by marketing products as drugs without proper approval and making unsubstantiated health claims during the pandemic.
Requirements
Do not claim CBD products can treat, cure, or prevent COVID-19 or any disease without FDA approval
Do not market cannabis-derived products as drugs or medical treatments
Do not make unsubstantiated health or therapeutic claims
Ensure all product claims are truthful and substantiated by reliable scientific evidence
Why it matters
Violating these rules results in FDA warning letters, potential product seizure, legal action, and removal from e-commerce platforms—making compliance essential to keeping your business operating.
Companies and sellers offering cannabis-derived products (CBD and hemp products) online, including For Our Vets LLC dba Patriot Supreme and other listed businesses
This is an FDA enforcement action documenting companies that have received warning letters for selling cannabis-derived products (particularly CBD) without proper authorization or in violation of federal regulations. The listed companies are examples of businesses that have been identified by the FDA as non-compliant.
Requirements
Do not sell unapproved cannabis-derived products or make unsubstantiated health claims
Comply with FDA regulations for any CBD or hemp-based products
Understand that selling these products without proper authorization can result in FDA warning letters and enforcement action
Review FDA guidance on cannabis-derived products before listing or promoting such items
Why it matters
The FDA actively enforces against non-compliant cannabis-derived product sellers; violations can result in warning letters, product seizures, and legal liability for your business.
Companies selling or marketing CBD products, specifically those listed in the FDA's warning letter index (Living Senior LLC, Project 1600 Inc., Avazo-Healthcare LLC, For Our Vets LLC/Patriot Supreme, CBD Gaze, and Apollo Holding LLC)
This is an FDA enforcement action listing companies that have received warning letters for making illegal or unsubstantiated claims about cannabis-derived CBD products. The FDA has determined these businesses violated federal law by marketing CBD products in ways that are not permitted.
Requirements
Do not make unsubstantiated health or medical claims about CBD products
Do not market CBD as a drug or treatment without FDA approval
Comply with FDA regulations on cannabis-derived product marketing
Be aware that violating these rules results in FDA warning letters and potential enforcement action
Why it matters
If you sell CBD products and violate these rules, you risk receiving an FDA warning letter, having your products seized, and facing legal enforcement action that could shut down your business.
Companies selling cannabis-derived products (CBD) online, including Apollo Holding LLC and similar retailers
This is an FDA enforcement index listing cannabis-derived products (specifically CBD) companies that have received warning letters for regulatory violations. Apollo Holding LLC, which operates apollohempire.com, is included on this list of companies subject to FDA enforcement action.
Requirements
Do not make unsubstantiated health claims about CBD products
Comply with FDA regulations for dietary supplements or drug products
Avoid marketing cannabis-derived products in violation of federal law
Ensure proper product labeling and documentation
Why it matters
Being listed on an FDA warning letter index can result in product seizure, site shutdown, and legal liability—selling non-compliant cannabis products puts your business at serious enforcement risk.
Noetic Nutraceuticals and sellers operating the domain nnlifestyle.com
The FDA has issued warning letters to Noetic Nutraceuticals (operating under nnlifestyle.com) for violating regulations related to cannabis-derived products. This listing identifies the company as an enforcement action target for non-compliant CBD product marketing or claims.
Requirements
Company received an FDA warning letter for cannabis-derived product violations
The warning relates to products sold or marketed through nnlifestyle.com
Company is identified in FDA's enforcement index for this category
Why it matters
If you are this company or selling similar products, you face FDA enforcement action risk and should immediately review compliance with cannabis product regulations to avoid product seizures, fines, or legal action.
CBD and cannabis-derived product sellers operating online, particularly those selling through dedicated e-commerce stores or websites
This is a list of CBD and cannabis-derived product companies that received FDA warning letters for regulatory violations. The companies listed operated online stores or e-commerce platforms selling these products without proper compliance with federal law.
Requirements
Do not make unsubstantiated health claims about CBD or cannabis-derived products
Ensure products comply with FDA regulations for unapproved drug claims
Maintain proper regulatory documentation and disclosures
Avoid marketing cannabis products in violation of federal law
Why it matters
Companies on this enforcement list received official FDA warnings, which can lead to product seizures, fines, and legal action—TikTok Shop sellers should avoid these compliance failures to prevent account suspension and legal liability.
CBD and cannabis-derived product sellers, particularly those making health or therapeutic claims about their products online
This is a reference to an FDA enforcement action against Native Roots Hemp and other CBD/cannabis-derived product sellers who were issued warning letters for regulatory violations in 2019. The listing indicates these companies faced FDA enforcement action, likely for making unauthorized health claims or selling unapproved drug products.
Requirements
Do not make unsubstantiated health or disease claims about CBD/cannabis products
Comply with FDA regulations regarding drug claims and product categorization
Avoid marketing cannabis-derived products as treatments or cures without FDA approval
Why it matters
Selling CBD or cannabis products with unapproved health claims can result in FDA warning letters, product seizures, and legal enforcement action that shuts down your business.
Companies and online retailers selling cannabis-derived products (CBD, hemp products, etc.) without FDA authorization or compliance
This is a reference to an FDA warning letter issued to Indigo Naturals for selling cannabis-derived products (likely CBD) without proper FDA approval or compliance. The company violated federal regulations governing how these products can be marketed and distributed.
Requirements
Cannabis-derived products cannot be sold as dietary supplements or marketed with unapproved health claims
Companies must comply with FDA regulations before marketing CBD and hemp products
Products must not make medical or therapeutic claims without FDA approval
Operating an online store selling non-compliant cannabis products violates federal law
Why it matters
Selling non-compliant cannabis-derived products can result in FDA warning letters, legal action, product seizure, and account suspension on platforms like TikTok Shop.
CBD and cannabis-derived product sellers operating websites like Koi CBD, Pink Collections Inc., Active CBD Oil, and other listed companies
The FDA has issued warning letters to multiple CBD and cannabis-derived product companies for violating federal regulations. This enforcement action identifies specific businesses and their websites that have been flagged for regulatory violations related to CBD product sales.
Do not operate under the same business model or practices as companies listed in FDA warning letters
Comply with FDA regulations for any CBD or hemp-derived products you sell
Ensure your products do not violate federal enforcement actions
Why it matters
FDA warning letters can result in product seizures, injunctions, and legal action against your business if you sell non-compliant cannabis-derived products.
CBD and hemp oil sellers, including companies like Natural Native LLC, Pink Collections Inc., Noli Oil LLC, Whole Leaf Organics LLC, Infinite Product Company LLLP, and Apex Hemp Oil LLC
The FDA has issued warning letters to cannabis-derived product companies for violations of federal regulations. These companies were selling CBD and hemp oil products that did not comply with FDA requirements for safety, labeling, or marketing claims.
Requirements
Do not sell cannabis-derived products (CBD, hemp oil) without FDA compliance
Do not make unapproved health or therapeutic claims about CBD/hemp products
Ensure proper labeling and safety documentation for any cannabis-derived products
Understand that selling non-compliant hemp or CBD products can result in FDA enforcement action
Why it matters
Selling non-compliant cannabis-derived products exposes your business to FDA warning letters, product seizures, and potential legal penalties that could shut down your operation.
Companies and sellers of cannabis-derived products (CBD oils, hemp oils) including Whole Leaf Organics LLC, Noli Oil LLC, Natural Native LLC, Infinite Product Company LLLP, Apex Hemp Oil LLC, and Bella Rose Labs
The FDA has issued warning letters to several companies that were selling cannabis-derived products (CBD and hemp oil products) in violation of federal regulations. These companies were marketing products in ways that violated FDA rules, such as making unsubstantiated health claims or selling products that do not meet regulatory standards.
Requirements
Do not make unsubstantiated health or medical claims about CBD or hemp oil products
Ensure products comply with FDA regulations before selling them
Do not market cannabis-derived products in ways that violate federal enforcement standards
Companies that have received warning letters must take corrective action or face further enforcement
Why it matters
If you sell CBD or hemp oil products, violating these rules can result in FDA warning letters, product seizures, and legal enforcement action that could shut down your business.
Companies selling cannabis-derived products (CBD, hemp oil, etc.) online or through retail channels
This is an FDA enforcement index listing companies that have received warning letters for selling cannabis-derived products (like CBD) in violation of federal regulations. These companies are flagged as having made illegal health claims or sold unapproved products.
Requirements
Do not make unsubstantiated health or therapeutic claims about cannabis-derived products
Do not sell cannabis-derived products as dietary supplements or drugs without FDA approval
Comply with FDA regulations on what can be claimed about hemp-derived compounds
Companies listed have received formal FDA warning letters for violations
Why it matters
Selling cannabis-derived products with illegal claims can result in FDA warning letters, product seizures, and legal enforcement action against your business.
Companies and sellers offering cannabis-derived products, particularly hemp oil and CBD products online
The FDA has issued warning letters to several companies that sell cannabis-derived products, including hemp oil and CBD products, for violations of federal regulations. These companies are listed by the FDA as examples of enforcement actions taken against sellers of unapproved cannabis products.
Requirements
These specific companies (Apex Hemp Oil LLC, Whole Leaf Organics LLC, Infinite Product Company, Bella Rose Labs, Sunflora Inc., and Healthy Hemp Strategies LLC/Curapure) have received FDA warning letters
Selling unapproved cannabis-derived products violates FDA regulations
Companies must comply with FDA requirements for product approval and marketing claims
Why it matters
If you sell cannabis-derived or hemp-based products without proper FDA approval, your business faces enforcement action, product removal, and legal liability.
Companies and sellers of cannabis-derived products, including CBD oils and hemp products listed by the FDA (Bella Rose Labs, Sunflora Inc., Infinite Product Company, Apex Hemp Oil LLC, Healthy Hemp Strategies LLC/Curapure, and Private I Salon LLC)
The FDA has issued warning letters to specific companies selling cannabis-derived products (primarily CBD oils and hemp products) for violations of federal law. This is an enforcement action list showing which businesses have been formally warned by regulators for non-compliant operations.
Requirements
Do not operate cannabis-derived product businesses in violation of FDA regulations
Avoid marketing or selling unapproved CBD or hemp products
Comply with FDA enforcement notices if you receive one
Understand that non-compliance can result in formal warning letters and potential enforcement action
Why it matters
Selling cannabis-derived products without FDA approval or in violation of federal regulations can result in warning letters, product seizures, and legal enforcement action that could shut down your business entirely.
Companies and sellers offering cannabis-derived products, CBD products, and hemp-based health items, including retailers and online storefronts
The FDA has issued warning letters to multiple companies selling cannabis-derived products (including CBD and hemp products) for violations of federal regulations. This indicates the FDA actively enforces against unauthorized health claims and unapproved drug marketing in the cannabis and hemp space.
Requirements
Do not make unsubstantiated health claims about cannabis or CBD products
Do not market hemp or cannabis products as drugs without FDA approval
Ensure compliance with federal regulations on dietary supplements and botanical products
Avoid selling products that violate FDA enforcement actions
Why it matters
Selling non-compliant cannabis or CBD products can result in FDA warning letters, legal enforcement action, and removal from e-commerce platforms like TikTok Shop.
Cannabis and hemp product sellers, particularly companies marketing CBD, delta-8, delta-10, or other cannabis derivatives as health/medical products
This is an FDA enforcement index listing companies that have received warning letters for illegal marketing and sale of cannabis-derived products, particularly those making unsubstantiated health claims. These companies are named examples of businesses that violated FDA regulations governing cannabis and hemp-derived products.
Requirements
Do not make unsubstantiated health or medical claims for cannabis-derived products
Do not market cannabis products as drugs or treatments without FDA approval
Do not sell products that violate FDA regulations on cannabis compounds
Companies making these violations may receive FDA warning letters and enforcement action
Why it matters
Selling cannabis-derived products with illegal claims can result in FDA warning letters, product seizure, legal action, and business shutdown—these listed companies serve as public examples of enforcement.
Companies selling cannabis-derived products online, including hemp-derived CBD and related products
This is an FDA enforcement index listing companies that have received warning letters for violations related to cannabis-derived products. These companies were cited for non-compliance with federal regulations governing how cannabis products are marketed, labeled, or sold.
Requirements
Do not make unsubstantiated health claims for cannabis or hemp products
Comply with FDA labeling and marketing requirements for cannabis-derived products
Do not operate outside FDA regulatory guidelines for these product categories
Understand that violation can result in FDA warning letters and enforcement action
Why it matters
If your cannabis or hemp product business receives an FDA warning letter, you face potential legal action, product seizure, and loss of ability to sell—these companies are examples of what happens when compliance requirements are ignored.
Companies selling cannabis-derived products, including Alternative Laboratories, Curaleaf Inc., Rooted Apothecary LLC, Herbal Healer Academy Inc., Advanced Spine and Pain LLC (Relievus), and Nutra Pure LLC (CBD Pure)
This is an FDA enforcement index listing specific companies that have received warning letters for violations related to cannabis-derived products. These companies are on notice that their products and claims have been flagged by the FDA as non-compliant with federal regulations.
Requirements
Do not make unapproved drug claims for cannabis-derived products
Ensure products comply with FDA regulations before marketing
Review your company's compliance status if you received an FDA warning letter
If your company is listed, remediate violations immediately
Why it matters
Companies on this FDA warning list face potential enforcement action, product seizure, or legal penalties if they continue selling non-compliant products; TikTok Shop will likely restrict or remove listings from flagged companies.
CBD and cannabis-derived product sellers operating websites like cbdpure.com, diamondcbd.com, curaleafhemp.com, and relievus.com (2018 enforcement action reference)
The FDA issued warning letters in 2018 to companies selling CBD and cannabis-derived products online, including Nutra Pure LLC (cbdpure.com), PotNetwork Holdings Inc. (diamondcbd.com), Curaleaf Inc., and Advanced Spine and Pain LLC. This is a historical enforcement record showing which companies received FDA warnings for their CBD/hemp product sales.
Requirements
This is an FDA warning letter enforcement index, not an active policy rule
Referenced companies received warnings in 2018 for CBD product marketing or claims
No specific requirements stated—this is a historical enforcement record
Why it matters
If you sell CBD or cannabis-derived products, understand that the FDA actively enforces against these categories and has a history of issuing warning letters to major retailers for compliance violations.
CBD product sellers and cannabis-derived product retailers, specifically those making unsubstantiated health claims or failing to comply with FDA regulations
The FDA issued a warning letter to Signature Formulations, LLC in 2018 for selling CBD products through their website cbdtechcenter.com. This indicates the company was operating in violation of FDA regulations regarding cannabis-derived product marketing and claims.
Requirements
Do not make unsubstantiated health or medical claims about CBD products
Ensure CBD products comply with FDA drug approval and labeling requirements
Avoid marketing cannabis-derived products as dietary supplements or drugs without proper authorization
Review FDA warning letters to understand enforcement priorities in this category
Why it matters
FDA warning letters precede enforcement action including product seizure, injunctions, and criminal prosecution—sellers of CBD and cannabis products face significant legal and business risk if they violate these regulations.
CBD and cannabis-derived product sellers, particularly those making health or therapeutic claims about their products
This is a historical FDA enforcement record documenting warning letters issued to cannabis-derived CBD product sellers (including Green Roads Health, Stanley Brothers, and Natural Alchemist) in 2016 for regulatory violations. The document references specific products, their label claims, and analytical results related to CBD content accuracy.
Requirements
CBD label claims must be accurate and substantiated
Products marketed with health claims are subject to FDA enforcement
Analytical testing results are used to verify label accuracy
Sellers of cannabis-derived products may face warning letters and enforcement action for non-compliance
Why it matters
The FDA has a history of issuing warning letters to CBD sellers with inaccurate label claims, which can result in product removal, fines, or legal action against your business.
CBD product sellers and manufacturers who made claims about CBD content in their products during 2016
This is an FDA enforcement index documenting warning letters issued in 2016 to companies selling CBD products, including Natural Alchemist and Green Roads Health. The index tracks product claims versus actual lab test results to identify misleading labeling or unsubstantiated CBD content.
Requirements
CBD label claims must match actual lab-tested content
Products are subject to FDA testing and enforcement action if claims are inaccurate
Firms may receive warning letters if analytical results do not support product labeling
Why it matters
Selling CBD products with false or unsubstantiated claims about CBD content can result in FDA warning letters and potential removal from sale.
CBD and cannabis-derived beverage products, specifically those marketed and sold through e-commerce channels like the referenced healthydoseofnature.com
This is an FDA enforcement case documenting a CBD product (Nano CBD Shooter) that was flagged in a warning letter. The table shows the product's CBD content, THC content, and THCA (inactive THC precursor) levels, all of which were tested and documented by the FDA during its investigation into non-compliant cannabis-derived products.
Requirements
Product labeling must accurately reflect actual CBD and THC content
THC and THCA levels must meet legal compliance thresholds (the product shown contained trace amounts)
Products are subject to FDA testing and enforcement verification
Sellers must maintain accurate manufacturing and ingredient documentation
Why it matters
CBD products face strict FDA scrutiny; selling non-compliant products can result in warning letters, product seizures, and legal enforcement action against your business.
This is an FDA warning letter example documenting a cannabis-derived hemp product that was tested and found to contain specific levels of CBD and other cannabinoids. The listing shows the product's cannabinoid profile and concentration data that triggered FDA enforcement action.
Requirements
Product claims and marketing must align with actual cannabinoid content tested
Accurate labeling of CBD, CBDA, CBN, and other cannabinoid concentrations is required
Products must be truthfully represented regarding potency and composition
Testing data should be available to support product claims
Why it matters
Misrepresented cannabinoid content or misleading claims about hemp products can result in FDA warning letters, product seizure, and enforcement action against your business.
CBD and cannabis-derived product sellers, particularly those marketing CBD oils with specific potency claims
This is an FDA enforcement action documenting a CBD product from Green Garden Gold that was found to have cannabinoid content issues. The product label claims 100 mg CBD per 15 ml bottle, but testing revealed discrepancies between labeled and actual cannabinoid levels, including undeclared CBDA and CBN.
Requirements
CBD products must have accurate labeling that matches actual cannabinoid content
All cannabinoids present (including CBDA and CBN) should be disclosed or properly accounted for
Third-party testing should verify label claims before marketing
Products must comply with FDA standards for potency accuracy
Why it matters
Mislabeled cannabinoid content can trigger FDA warning letters, product seizures, and loss of seller credibility on TikTok Shop or other platforms.
Sellers of CBD and cannabis-derived products, specifically those marketing products similar to Green Garden Gold's CBD oil products
This FDA warning letter documents a specific CBD product (Green Garden Gold's Strawberry Jam CBD-Oil) that was tested and found to contain measurable levels of CBD, CBDA, and CBN. The product listing and lab test results are part of an FDA enforcement action against cannabis-derived products being sold without proper authorization.
Requirements
CBD products must not be marketed or sold without FDA authorization
Lab testing results showing cannabinoid content (CBD, CBDA, CBN levels) are subject to FDA review
Products found in violation may trigger warning letters and enforcement action
Accurate disclosure of cannabinoid composition is required
Why it matters
Selling unauthorized CBD products exposes you to FDA warning letters, product seizure, and legal liability; TikTok Shop will remove listings for non-compliant cannabis-derived products.
All TikTok Shop sellers listing CBD or cannabis-derived products
This FDA policy highlights specific cannabinoid content levels in a CBD hemp oil supplement, indicating that products must accurately report their cannabinoid concentrations. It implies that sellers must ensure their product labels reflect true cannabinoid percentages to comply with FDA standards.
Requirements
Accurately measure and disclose cannabinoid content such as CBD, CBDA, and CBN on product labels
Ensure cannabinoid levels are within legal and FDA-accepted limits
Avoid making unverified health claims about cannabis-derived products
Why it matters
Non-compliance with FDA labeling and content requirements can lead to warning letters, product removal, or legal action, affecting your business credibility and sales.
All TikTok Shop sellers listing cannabis-derived products such as CBD oils
This FDA policy highlights enforcement actions against cannabis-derived products like CBD oils that may have inaccurate labeling or unapproved claims. Sellers must ensure their CBD products comply with FDA regulations regarding content and labeling. Mislabeling or unsupported claims can lead to warning letters and enforcement.
Requirements
Accurately label CBD and cannabinoid content on products
Avoid making unapproved health claims about cannabis-derived products
Ensure product content matches what is stated on the label
Why it matters
Non-compliance can result in FDA warning letters, risking product removal and damage to seller reputation.
Companies selling cannabis-derived or CBD products, specifically those marketing CBD oil balms and similar topical cannabis products
This is a reference entry in the FDA's enforcement index for cannabis-derived products, documenting the Healthy Hemp Oil PLUS+CBD Oil Balm product that was subject to FDA warning action. The entry shows the product's cannabinoid composition and dosage details as evidence of the regulatory violation.
Requirements
Products listed in the FDA warning index were found to violate federal regulations
The specific cannabinoid content (CBD, CBDA, THCA, CBN percentages) was documented as part of the enforcement action
Companies marketing similar unapproved cannabis-derived products may face FDA enforcement
Why it matters
If you sell CBD or hemp-derived products, the FDA has actively enforced against unapproved cannabis products, and your listing could face warning letters or removal if it violates federal regulations on unproven health claims or unapproved drug status.
Sellers of cannabis-derived CBD and hemp products, specifically those marketing CBD concentrates with cannabinoid content claims
This is an FDA enforcement action against Hempotion's CBD concentrate product sold on healthyhempoil.com. The FDA flagged this product because it failed to meet legal standards for hemp-derived CBD products, likely due to THC content, cannabinoid composition, or labeling inaccuracies that made it non-compliant with federal regulations.
Requirements
THC content must remain below the federal legal limit (0.3% or lower)
Cannabinoid composition (CBD, THC, CBDA, THCA, CBN) must match label claims
Products must be accurately labeled and tested to demonstrate compliance
Sellers must be prepared for FDA enforcement action if products fail these standards
Why it matters
Selling non-compliant CBD products can result in FDA warning letters, product seizures, and legal enforcement action against your business.
Sellers of cannabis-derived CBD products, particularly those marketing products with names like "Entourage Occam's Razor" or similar formulations
This appears to be a reference to an FDA enforcement action against Healthy Hemp Oil for their "Entourage Occam's Razor" product. The entry documents a cannabis-derived CBD product with specific cannabinoid concentrations (100 mg CBD, 0.66% CBN, 0.021% other compounds) that was subject to FDA warning. The exact nature of the violation is not detailed in this excerpt.
Requirements
Product from this manufacturer/brand may have been subject to FDA enforcement action
CBD and cannabinoid products require careful compliance with FDA regulations
Product labeling and cannabinoid concentration claims should be accurate and substantiated
Why it matters
This is an actual FDA enforcement case; selling unapproved or misbranded cannabis-derived products can result in warning letters, product seizure, and legal action against your business.
CBD and cannabis-derived product sellers, specifically Michigan Herbal Remedies LLC and similar retailers marketing CBD products
This is an FDA warning letter entry documenting a specific CBD product (Bluebird Botanicals Bulletproof CBD Blend sold by Michigan Herbal Remedies) that was flagged for enforcement action. The entry shows the product details, claimed CBD content (250mg per 1 fl oz), and test results indicating actual cannabinoid levels that may not match label claims or regulatory requirements.
Requirements
Product label claims must accurately reflect actual cannabinoid content verified by testing
CBD products are subject to FDA enforcement and warning letters
Sellers must ensure accurate CBD and CBDA levels on labels match laboratory test results
Compliance with cannabinoid content regulations is required
Why it matters
FDA warning letters signal enforcement action and product removal risk; inaccurate labeling of CBD products can result in regulatory penalties, customer liability, and delisting from platforms.
All TikTok Shop sellers listing cannabis-derived or CBD hemp oil products in the US market.
This policy highlights FDA warning letters related to cannabis-derived products, specifically focusing on the labeling and content of CBD hemp oil supplements. It indicates that products must accurately represent their CBD and cannabinoid content and comply with FDA regulations.
Requirements
Accurately label cannabinoid content including CBD, CBDA, and CBN levels.
Ensure product claims comply with FDA regulations to avoid warning letters.
Do not misrepresent product potency or ingredients.
Why it matters
Non-compliance with FDA rules can lead to warning letters, product removal, or legal issues affecting your TikTok Shop listings.
Sellers and retailers of cannabis-derived hemp oil products, particularly those marketing CBD products with specific cannabinoid profiles
This is an FDA enforcement record documenting a cannabis-derived hemp oil product (Endoca Hemp Oil from Michigan Herbal Remedies) that was flagged in a warning letter. The record shows the product's cannabinoid composition, including CBD, CBDA, THCA, and CBN levels, indicating the product was subject to FDA regulatory scrutiny.
Requirements
Products must accurately report cannabinoid content and composition
CBD products are subject to FDA enforcement action if they violate regulations
Sellers should be aware that products with detectable THCA or THC levels may face regulatory challenges
Marketing or selling hemp oil products requires compliance with FDA guidelines
Why it matters
This enforcement case demonstrates that the FDA actively monitors and takes action against cannabis-derived products that do not comply with regulations, putting sellers at risk of warning letters, product seizure, and legal liability.
Michigan Herbal Remedies, LLC and their Alternate Vape LUV-A-BULL cannabis vape product
This is a reference to an FDA warning letter issued to Michigan Herbal Remedies, LLC for their Alternate Vape LUV-A-BULL product. The document lists cannabinoid test results showing the product contained CBD, CBDA, THCA, and CBN. This appears to be part of the FDA's enforcement index documenting products that violated cannabis regulations.
Requirements
Product was tested and found to contain multiple cannabinoids including CBD, CBDA, THCA, and CBN
The vape formulation contained 100 mg CBD per 10 ml
Test results documented specific concentration levels for each cannabinoid
Product was subject to FDA enforcement action via warning letter
Why it matters
This warning letter indicates the FDA took enforcement action against this product, signaling that similar cannabis vape products may face regulatory scrutiny or prohibition depending on THC content and marketing claims.
All TikTok Shop sellers listing cannabis-derived or hemp-based products containing CBD or related cannabinoids.
This FDA warning letter highlights that products like Tasty Hemp Oil's CBD supplements must accurately represent their cannabinoid content and comply with regulatory standards. Sellers must ensure their hemp-derived products do not contain prohibited levels of THC or unapproved claims. Mislabeling or non-compliance can lead to enforcement actions.
Requirements
Accurately disclose cannabinoid content including CBD, THC, CBDA, and CBN levels.
Ensure THC content is within legal limits.
Avoid making unapproved health claims about the product.
Comply with FDA regulations regarding cannabis-derived products.
Why it matters
Non-compliance can result in FDA enforcement actions, product removal, and damage to seller reputation.
Michigan Herbal Remedies, LLC and sellers of cannabis-derived vape products, particularly hemp oil products marketed online
This is an FDA enforcement action against Michigan Herbal Remedies, LLC for their "Tasty Vape Hemp Oil - Just Peachy" product. The listing documents the product specifications (10ml, 100mg CBD content) and cannabinoid composition as part of a warning letter for cannabis-derived products.
Requirements
Do not sell cannabis-derived products (hemp oil) without FDA compliance
Ensure accurate labeling of cannabinoid content (CBD, CBDA, CBN percentages)
Comply with FDA enforcement standards for cannabis product distribution
Why it matters
FDA warning letters result in enforcement action, product removal, and potential legal consequences for non-compliance with cannabis product regulations.
Michigan Herbal Remedies, LLC and sellers of cannabis-derived products like CBD oil sprays
This is an FDA warning letter documenting that Michigan Herbal Remedies' PLUS+CBD Oil Spray product failed to comply with federal regulations. The product contained detectable levels of controlled cannabinoids (CBD, CBN, and CBDA) that exceeded allowable limits or were improperly labeled.
Requirements
Do not sell cannabis-derived products with unlisted or excessive cannabinoid content
Ensure accurate labeling of all active cannabinoid compounds and their concentrations
Comply with FDA regulations on CBD and other controlled cannabinoid limits
Conduct proper testing and documentation before marketing products
Why it matters
FDA warning letters can lead to product seizure, legal action, and permanent removal from sales platforms if you fail to correct violations.
Sellers and manufacturers of cannabis-derived products, particularly those marketing products like Morgue Juice containing CBD and related cannabinoids
This appears to be a product entry from an FDA enforcement index related to cannabis-derived products, specifically documenting cannabinoid (CBD, CBN, CBDA) content levels found in a product called Morgue Juice. The numerical values represent test results or reported concentrations of these compounds in the product.
Requirements
Products must have accurate cannabinoid content labeling that matches actual test results
CBD, CBN, and CBDA concentrations must be properly disclosed and tested
Products listed in FDA enforcement actions may indicate non-compliance with federal regulations
Why it matters
Products appearing in FDA warning letters indicate regulatory enforcement action, which can result in product removal, warning letters to manufacturers, or legal penalties for continued sale.
Sellers of CBD and hemp-derived products, particularly those marketing CBD oils and filtered hemp extracts
This FDA warning letter documents a cannabis-derived CBD product (iHempCBD Filtered CBD Hemp Oil) that was flagged for regulatory violations. The product contained specified levels of CBD, CBN, and other cannabinoids that likely violated federal or labeling requirements.
Requirements
Product must comply with FDA cannabinoid content limits and labeling accuracy requirements
CBD, CBN, CBDA and other cannabinoid levels must be truthfully disclosed and within legal thresholds
Products cannot make unsubstantiated health claims (the "Pain Bomb" branding suggests pain-relief claims that likely lack approval)
Laboratory testing and accurate serving size/concentration documentation is required
Why it matters
Selling non-compliant CBD products results in FDA warning letters, potential product seizures, store suspension, and legal liability—this specific case shows the agency is actively enforcing against mislabeled hemp products.
Sellers of cannabis-derived products, particularly CBD and CBN oils and topicals
This entry documents an FDA warning letter issued to Pain Bomb, LLC for a cannabis-derived CBD product that exceeded allowable levels of controlled cannabinoids. The product contained detectable amounts of CBN and CBD that violated federal limits for what can be legally sold.
Requirements
Products must not exceed federal limits on CBD content (0.033% detected vs. compliant threshold)
Products must not exceed federal limits on CBN content (0.82% detected)
All cannabinoid levels must be accurately tested and disclosed
Products marketed as hemp-derived must comply with THC and other cannabinoid restrictions
Why it matters
Selling non-compliant cannabis products can result in FDA warning letters, product seizure, and legal liability for your business.
CBD oil and cannabis-derived products listed on e-commerce platforms like Etsy
This is a reference to an FDA warning letter about a CBD oil product (Sana Te Premium Oils) sold on Etsy that contained 25.2% CBD per capsule. The data shows the product's cannabinoid composition, including trace amounts of THCA and CBN, which indicates the FDA was monitoring compliance with cannabinoid content standards.
Requirements
Products must accurately report CBD concentration (in this case 25 mg/capsule)
THC-related compounds (THCA, THC, CBN) must be properly tested and disclosed
Products sold online are subject to FDA enforcement and warning letters if they contain undisclosed or improperly labeled cannabinoids
Why it matters
If your CBD product is mislabeled, contains unexpected cannabinoids, or lacks proper testing documentation, you risk FDA enforcement action and delisting from your sales platform.
Sellers and manufacturers of cannabis-derived products subject to FDA enforcement actions
This appears to be analytical data from FDA warning letters showing cannabinoid content measurements (THCA, CBN, and CBD levels) in cannabis-derived products, but the text is fragmented and does not clearly articulate an enforceable policy rule or requirement.
Requirements
The provided text contains only lab test data and does not specify clear requirements. The data shows varying THCA, CBN, and CBD percentages across product samples, but no explicit compliance thresholds or standards are stated in the excerpt provided.
Why it matters
Understanding cannabinoid content limits is critical because FDA warning letters indicate non-compliance with federal regulations, which can result in product seizures, enforcement actions, or removal from platforms like TikTok Shop.
Sellers and manufacturers of cannabis-derived products containing CBD, THCA, or CBN in capsule form under FDA review or enforcement action
This appears to be raw analytical or test data from an FDA warning letter document about cannabis-derived products, showing measured levels of cannabinoids (THCA, CBN, and CBD) in capsule form. The data shows various concentration measurements but lacks clear policy language explaining what is prohibited, required, or allowed.
Requirements
Unable to extract clear requirements from the provided text, which appears to be data tables rather than policy language. The text shows cannabinoid concentration measurements (e.g., "25mg/capsule CBD", "THCA: 0.009%", "CBN: 0.12%") but does not state what levels are permitted, prohibited, or required to be disclosed.
Why it matters
FDA warning letters typically precede enforcement action; sellers should consult the full source document to understand what violations triggered the warning and what corrective actions are required.
Cannabis-derived product manufacturers whose websites or product names were modified and whose products were under FDA review
Some products from companies that changed their website and/or product names were not included in FDA warning letters about cannabis-derived products. This appears to be a reference note indicating which products were excluded from enforcement action due to firm changes.
Requirements
Products excluded from warning letters if the firm made changes to its website and/or product names
The exclusion appears to apply regardless of cannabinoid content levels (THCA, CBN, THC, etc.)
Why it matters
If your company is selling cannabis-derived products, updating your website or product names may affect FDA enforcement actions against your products, though this excerpt does not clarify the full implications.
Firms selling cannabis-derived products that were subject to FDA enforcement in 2015
This is an FDA reference document showing warning letters issued to cannabis-derived product firms in 2015, along with lab test results for the cannabinoid content (THC, CBD, CBN, etc.) found in their products. It tracks which products triggered enforcement action and which were excluded due to website or product name changes.
Requirements
Products with certain cannabinoid profiles triggered FDA warning letters
Some products were excluded from warning letters if the firm changed its website or product names
Lab analysis measured actual cannabinoid content (THC, CBD, CBN, THCA, CBDA) against label claims
Why it matters
Cannabis-derived product sellers need to ensure their actual product composition matches label claims and stays compliant with FDA standards, or face warning letters and enforcement action.
Sellers marketing cannabis-derived pet supplements or wellness products containing THC, CBDA, THCA, or other non-CBD cannabinoids
This FDA enforcement action documents a warning issued to Canna Companion, LLC for selling cannabis-derived products (specifically capsules containing THC, CBDA, and THCA) without proper FDA approval or compliance. The product contained measurable levels of controlled cannabinoids that exceeded acceptable thresholds for unregulated supplements.
Requirements
Do not sell unapproved cannabis-derived products as dietary supplements
Products cannot contain THC or THC analogs without explicit FDA authorization
Cannabinoid content (CBDA, THCA) must be disclosed accurately and comply with state and federal regulations
Marketing cannabis products for pets requires compliance with veterinary drug regulations, not supplement rules
Why it matters
Selling non-compliant cannabis products can result in FDA warning letters, product seizures, and legal liability; TikTok Shop prohibits sale of controlled or unauthorized cannabis products.
CBD and cannabis-derived product sellers, particularly those marketing products as CBD-dominant with specified cannabinoid counts
This is an FDA enforcement case documenting that Ultra CBD products contained cannabinoids at levels that exceeded federal legal limits. The company was cited for selling CBD products with detectable THC levels above the 0.3% legal threshold and other cannabinoid content issues.
Requirements
Products must contain THC levels not exceeding 0.3% (w/w) by federal law
Products must be tested to verify cannabinoid content and purity
Labels must accurately reflect the actual cannabinoid profile found in testing
Sellers must not make claims about cannabinoid content that lab testing does not support
Why it matters
Selling CBD products with THC levels above 0.3% or misrepresenting cannabinoid content can result in FDA warning letters, product seizure, and legal enforcement action against your business.
Sellers and manufacturers of cannabis-derived CBD products, particularly those marketing products with specific cannabinoid content claims like "1oz 200mg Cannabinoids"
This FDA enforcement action against CBD Life Holdings LLC documents testing results for their "1oz 200mg Cannabinoids" product, showing cannabinoid levels that were either not detected or fell below specified limits (1 mg/g and 0.1% w/w). The data appears to be from an FDA warning letter regarding non-compliant cannabis-derived products.
Requirements
Cannabinoid content must not exceed 1 mg/g in tested samples
Total cannabinoid content must not exceed 0.1% (w/w)
Products must undergo lab testing with results documenting cannabinoid levels
False or unsupported potency claims can trigger FDA enforcement action
Why it matters
Failure to meet these limits or making unsupported potency claims can result in FDA warning letters, product seizures, and legal enforcement action against your business.
Sellers of cannabis-derived vape products and hemp-derived CBD products, particularly those sold through hempoilcare.com and similar e-commerce channels
This is a record from an FDA enforcement index documenting a warning letter issued for Hemp Pure Vape E-Drops: Peached, a cannabis-derived product sold by Hemp Oil Care. The product failed to meet labeling accuracy standards, with lab testing showing CBD content did not match claims, and the product tested negative for the advertised cannabinoids.
Requirements
Product labeling must accurately reflect actual cannabinoid content verified by lab testing
Claims about CBD or other cannabinoid presence must be supported by test results
Products testing negative for advertised cannabinoids cannot be legally marketed with those claims
Third-party lab verification is required to substantiate product composition
Why it matters
This is a documented FDA enforcement action; selling mislabeled cannabis-derived products can result in warning letters, product seizures, and legal liability for false advertising.
Sellers offering CBD and hemp-derived products, particularly vapes and topical salves
This appears to be an FDA enforcement index entry documenting warning letters issued for cannabis-derived products that made false or unsupported claims. The entries show specific product examples (CBD vapes and salves) where manufacturers were penalized for mislabeling cannabinoid content or making unsubstantiated health claims.
Requirements
Ensure cannabinoid content (CBD, CBDA) is accurately tested and labeled
Do not make health or therapeutic claims for CBD products without FDA approval
Maintain honest labeling—products tested as "negative for cannabinoids" cannot be marketed as containing active cannabinoids
Be aware that the FDA actively enforces against mislabeled cannabis-derived products
Why it matters
The FDA issues warning letters and can force product removal or legal action against sellers of mislabeled CBD products, which directly affects your ability to sell and could result in account suspension on retail platforms.
Sellers of cannabis-derived or hemp-derived products (particularly topical salves and oils) making CBD or cannabinoid content claims
This is an FDA enforcement action against Hemp Oil Care's Cibaderm Hemp Salve product for making false or misleading claims about its CBD content. The product was tested and found to be negative for cannabinoids despite claims on the label, indicating either mislabeling or lack of the advertised active ingredient.
Requirements
Products must contain the cannabinoid levels claimed on labels or marketing materials
CBD/cannabinoid content claims must be accurate and verified by testing
Product labeling must not make unsupported health claims about cannabis-derived ingredients
Third-party testing results should match actual product composition
Why it matters
Making unsubstantiated or false ingredient claims on hemp/CBD products can result in FDA warning letters, product removal, and legal enforcement action against your business.
Sellers marketing CBD and hemp-derived products, particularly those containing CBD drops or similar cannabis-derived wellness items
This is an FDA enforcement action against Hemp Oil Care's Cibdex Hemp CBD Complex Drops product, which was flagged in a warning letter for potential violations of federal regulations governing CBD and cannabis-derived products. The data indicates the product contains 1 mg CBD per serving with CBDA content levels noted.
Requirements
Product must comply with THC limits (≤0.3% by federal law)
Accurate CBD and CBDA content labeling is required
Products that make unsubstantiated health claims or violate FDA regulations may face warning letters and enforcement action
Why it matters
CBD products are subject to strict FDA oversight; selling non-compliant products can result in warning letters, product seizure, or legal enforcement action.
Hemp Oil Care and sellers of the Cibdex Hemp CBD Complex Drops - Unflavored product (1 fl oz, 1 mg CBD/serving, containing 0.3% hemp extract)
The FDA issued a warning letter to Hemp Oil Care regarding their Cibdex Hemp CBD Complex Drops product, indicating the agency identified compliance issues with how this CBD product was being marketed or formulated. This is an enforcement action documenting a specific product violation.
Requirements
Product was subject to FDA warning letter enforcement action
The specific product name, size, and CBD concentration are identified in the FDA's warning index
Sellers should assume this product formulation or marketing claims violated FDA regulations
Why it matters
If you sell this specific product or similar CBD formulations, you face the same FDA enforcement risk unless the underlying compliance issue has been corrected and documented.
Companies selling CBD-derived hemp products (like Cibdex Hemp CBD Complex Drops) as dietary supplements or food products without FDA approval
This is an FDA warning letter against Hemp Oil Care for marketing Cibdex Hemp CBD Complex Drops as a dietary supplement or food product. The product contains 1 mg of CBD per serving and the company was selling it without proper FDA approval or authorization, which violates federal law.
Requirements
Do not market or sell CBD products as dietary supplements, food, or food additives without FDA authorization
Understand that CBD is not an approved food or supplement ingredient under federal law
Be aware that THC content (0.3% or below) does not make a CBD product legal to market as a consumer product
Why it matters
Selling unapproved CBD products as supplements or food items exposes you to FDA enforcement action, product seizure, warning letters, and potential legal liability.
CBD and hemp-derived product sellers, specifically those selling products like CBD oils and vape liquids with claimed cannabinoid percentages
This is an FDA enforcement action against Hemp Oil Care for selling CBD products (specifically Hemp Honey CBD Oil and CBD Vape Oil) that contained false or misleading claims about cannabinoid content and purity. The products were tested and failed to meet the advertised specifications, with some showing no detectable cannabinoids despite claims of 21% CBD content.
Requirements
Products must actually contain the cannabinoid levels you claim (e.g., if you claim 21% CBD, testing must verify this)
Labeling and marketing claims about CBD potency must be accurate and substantiated
Products labeled as containing specific cannabinoid amounts cannot test as "negative for cannabinoids"
Third-party testing should confirm product composition matches marketing claims
Why it matters
Selling CBD products with false potency claims exposes you to FDA warning letters, potential removal from platforms, and legal enforcement action that could shut down your business.
Sellers marketing hemp-derived CBD or cannabis-derived products, including CBD oils, vape products, and honey-infused CBD items
The FDA has issued enforcement warnings against hemp-derived CBD products that make unsubstantiated health or therapeutic claims. Products labeled with specific CBD percentages or dosages (like "21% CBD" or "50 mg CBD") without FDA approval are subject to regulatory action.
Requirements
CBD products cannot be marketed with unsubstantiated therapeutic claims
Products tested and found negative for cannabinoids should not be marketed as containing specific cannabinoid percentages or amounts
Specific dosage claims (e.g., "50 mg CBD") require substantiation
Products must not be sold as dietary supplements, food, or cosmetics without proper FDA authorization
Why it matters
Selling non-compliant CBD products can result in FDA warning letters, product seizure, and forced removal from e-commerce platforms including TikTok Shop.
CBD and hemp oil sellers marketing vape oils, capsules, or other ingestible products with specific cannabinoid content claims
This is a warning letter from the FDA about Hemp Honey CBD Vape Oil products that were tested and found to be negative for cannabinoids—meaning they contained no measurable CBD despite claiming to have it. The FDA warned the manufacturer for misrepresenting product contents and potentially violating food and drug regulations.
Requirements
Do not market CBD products with false or unsubstantiated cannabinoid content claims
Do not sell CBD vape oils or ingestible hemp products that test negative for claimed active ingredients
Verify actual cannabinoid content through third-party testing before making label claims
Do not rely on marketing claims alone—product must contain what the label says it contains
Why it matters
Selling CBD products with false potency claims exposes you to FDA enforcement action, warning letters, product seizure, and legal liability—even if the product is otherwise compliant.
Sellers of CBD supplements and cannabis-derived products, particularly CBD capsules and oil extracts
The FDA issued warning letters to companies selling CBD products that tested negative for cannabinoids—meaning they contained little to no actual CBD despite being labeled as CBD supplements. This enforcement action targeted false or misleading labeling of CBD capsules and oil extracts.
Requirements
Products labeled as containing CBD must actually contain the cannabinoids claimed on the label
False or misleading claims about CBD content violate FDA enforcement standards
Products testing negative for cannabinoids while marketed as CBD products are subject to FDA warning letters
Why it matters
If your CBD products contain little or no actual cannabinoids, you risk FDA enforcement action, product seizure, and damage to your business reputation.
Sellers offering CBD hemp oil products and treatments containing 10g+ or higher CBD concentrations
This rule establishes cannabinoid testing and labeling standards for CBD hemp oil products. Products must meet specific threshold limits for cannabinoid content (CBDA at 0.1% or less, THCA at 0.03% or less, CBN identified only) and accurately declare CBD potency on labels.
Requirements
CBDA content must not exceed 0.1%
THCA content must not exceed 0.03%
CBN must be identified/tested but no specific limit stated
CBD potency declared on product label must match actual tested content
Why it matters
Mislabeled cannabinoid content or failing to meet these thresholds can result in FDA warning letters and product seizure, damaging your seller account and brand credibility.
Twin Falls Bio Tech, LLC and sellers of cannabis-derived products (specifically CBD/hemp products marketed as containing specific cannabinoid amounts)
This is an FDA enforcement action against Twin Falls Bio Tech, LLC for their product "Arisi-Tol," a CBD lozenge that was tested and found to contain THC levels exceeding federal limits. The company's product claims do not match the actual cannabinoid content verified through laboratory testing.
Requirements
Products must contain THC levels at or below the federal 0.2% limit
Advertised cannabinoid content (CBD, THC, etc.) must match actual tested levels
Multiple samples should be tested to verify consistency
Accurate labeling of all cannabinoid compounds present is required
Why it matters
Mislabeled or out-of-compliance cannabis products face FDA enforcement action, product seizure, and legal liability; selling non-compliant products can result in warning letters, fines, and removal from the market.
