Sellers offering any food or dietary supplement for sale, including conventional foods and dietary supplements
Any claim about nutrient levels in food (like "low fat" or "high protein") cannot be used on product labels or marketing unless specific requirements are met. This federal rule applies to all foods sold for human consumption, including dietary supplements.
Requirements
Nutrient content claims (statements about nutrient levels) are restricted on labels and labeling
The restriction applies to nutrients that must be included in nutrition labels per FDA rules
Claims cannot be made expressly or implicitly about nutrient characterization without meeting unspecified requirements (note: the policy text provided is incomplete)
Why it matters
Violating nutrient content claim rules can result in product delisting, regulatory action, or legal liability—sellers must verify all nutrient claims comply with FDA labeling standards before listing.
All food sellers and dietary supplement sellers listing products for sale, including both conventional foods and dietary supplements
Any claim about nutrient levels on food or supplement labels—whether explicit (like "low sodium") or implied—must follow strict federal rules. You cannot make nutrient content claims on labels or product descriptions unless they comply with FDA regulations.
Requirements
Nutrient content claims (statements about nutrient levels or ranges) are prohibited unless they follow FDA Subpart D, Part 105, or Part 107 regulations
Direct statements about nutrient content (e.g., "low sodium," "contains 100 calories") are subject to these rules
Rules apply to both label statements and all labeling materials
Why it matters
Unauthorized nutrient claims can result in product delisting, refusal of sale, or regulatory action—get this wrong and you may face enforcement.
All sellers and creators making nutrient content claims on food labels or in food marketing, including dietary supplement sellers
Nutrient content claims—statements suggesting a food has or lacks certain nutrients—are regulated by the FDA and must follow specific rules. Implied claims (like "high in fiber" or "healthy") are treated the same as explicit ones. The rules vary based on who the food is intended for and what type of product it is.
Requirements
Cannot make nutrient content claims on foods intended for infants and children under 2 years old unless specifically allowed by FDA regulations
Minor spelling variations of defined terms are allowed if not misleading (e.g., "hi" instead of "high")
Dietary supplements cannot claim to be "calorie free" or "low calorie" and simultaneously claim calories, fat, saturated fat, or cholesterol, with limited exceptions
If a substitute product performs differently than the original food, you must include a clear disclaimer on the label
Why it matters
Violating these rules can result in label recalls, product delisting, and regulatory enforcement action from the FDA.
Food manufacturers and TikTok Shop sellers making relative nutrient claims such as "light," "reduced," "added," "extra," "plus," "fortified," or "enriched" on product labels
When you make a "relative" nutrient claim comparing your product to another food (like "50% less fat"), you must clearly identify which reference food you're comparing to and state exactly how much less (or more) of that nutrient your product has. The comparison information must appear right next to your main claim in the required font size.
Requirements
State the name of the reference food you're comparing to
Show the percentage or fraction difference (e.g., "50% less fat than Brand X")
Place comparison details immediately adjacent to the main claim
Use font size matching regulatory requirements
For "light," "reduced," etc. claims, reference food must be a similar product (same category)
Why it matters
Unclear or missing comparison information can result in label violations, product seizure, or TikTok Shop listing removal.
Food manufacturers and retailers making nutrient content claims (like "low sodium" or "high fiber") on meal-sized or main dish products sold in the US
This FDA rule defines what qualifies as a "meal" or "main dish" product so manufacturers can legally make nutrient content claims about them. A meal must weigh at least 10 oz and contain multiple food groups; a main dish must weigh at least 6 oz and contain portions from at least two food groups. Sauces, condiments, and garnishes don't count toward these requirements.
Requirements
Meals must weigh ≥10 oz per serving and contain ≥3 portions (40g each) from ≥2 of 4 food groups
Main dishes must weigh ≥6 oz per serving and contain ≥40g from ≥2 of 4 food groups
Sauces, condiments, gravies, and garnishes don't count toward food group requirements
Nutrition label must accompany any nutrient content claim made on the product
Why it matters
If your product doesn't meet these weight and food group standards, you cannot legally make nutrient content claims on the label, which limits marketing flexibility and could result in regulatory action if non-compliant claims are found.
Food manufacturers and sellers using nutrient content claims in brand names, soft drink makers using the term "diet," and dietary supplement sellers making percentage claims for vitamins, minerals, or dietary ingredients.
This rule creates narrow exceptions allowing certain nutrient claims that weren't formally defined by the FDA to remain in use if they were already part of a product's brand name before October 1989, or if they meet specific legacy compliance rules. Sellers can use these grandfathered claims only if they're truthful and non-misleading, and must still follow all other labeling requirements.
Requirements
Pre-October 25, 1989 brand names with nutrient claims can continue if not false or misleading
"Diet" soft drinks from before that date may continue use; new soft drinks must comply with current regulations
Percentage claims for vitamins/minerals can be made without specific FDA authorization if not prohibited by regulation
Percentage claims for dietary ingredients without established RDI/DRV must show the actual amount per serving next to the percentage (e.g., "40% omega-3, 10mg per capsule")
Why it matters
Using claims that don't meet these exemptions can result in false advertising violations, product seizure, or labeling correction requirements; understanding the grandfather rules prevents costly reformulation or rebranding.
TikTok Shop sellers and creators promoting food and beverage products, especially those selling to restaurants, serving immediate consumption food, or marketing packaged foods with nutrient claims.
This rule explains what nutrient content claims (like "low fat" or "high protein") don't apply to, which foods and situations get special treatment, and how restaurants and certain sellers can make these claims more flexibly. It also covers when implied claims can be used in brand names and how to label bottled water with fluoride.
Requirements
Infant formulas and medical foods are exempt from these nutrient claim rules entirely
Restaurants and food service establishments can use nutrient claims without full disclosure statements if they have a reasonable basis (using databases, recipes, or computation methods)
Restaurant claims don't require lab testing if preparation methods are documented and controlled
Brand names with implied nutrient claims need FDA authorization; fluoridated bottled water can be labeled with fluoride-related terms
Why it matters
If you sell food or beverages, using unapproved nutrient claims or failing to meet the specific requirements for your business type (retail vs. food service) can result in labeling violations and regulatory action.
All TikTok Shop sellers listing foods or dietary supplements making health-related claims
This rule defines what counts as a health claim on food or dietary supplement labels. A health claim is any statement or symbol that suggests a relationship between the product and a disease or health condition. This includes direct statements, brand names, symbols, or images that imply health benefits.
Requirements
Health claims must clearly characterize the relationship between the product and a disease or health condition.
Claims can be explicit or implied through words, symbols, or images.
Third-party references that imply health benefits are also considered health claims.
Labels must comply with these definitions to avoid misleading consumers.
Why it matters
Incorrect or unapproved health claims can lead to regulatory action and removal of listings, affecting your sales and reputation.
All food and dietary supplement sellers (including TikTok Shop sellers) making any claims linking products to disease prevention, health conditions, or health-related benefits.
This rule defines what counts as a health claim on food and dietary supplement labels—including direct statements, implied messages, symbols, and brand names that link a product to disease prevention or health conditions. Before you can make a health claim, your product must meet strict nutrient limits (caps on fat, saturated fat, cholesterol, and sodium), and the claim must be backed by competent scientific evidence. If your product exceeds these "disqualifying nutrient levels," you cannot make health claims unless a specific exception applies.
Requirements
Health claims include direct statements, implied messages, symbols, brand names, and "third party" references suggesting a link between your product and disease or health conditions
Your product must not exceed disqualifying nutrient thresholds: 13g total fat, 4g saturated fat, 60mg cholesterol, or 480mg sodium per serving (higher limits apply for meal/main dish products)
Claims must be backed by competent and reliable scientific evidence of the health benefit
Products cannot make health claims about diseases caused by essential nutrient deficiencies (e.g., scurvy)
Why it matters
Violating these rules can result in regulatory action, product removal from platforms, and legal liability—even subtle health implications through imagery or wording can trigger FDA enforcement if your product doesn't meet nutrient thresholds or lack scientific backing.
Who this applies to
Food and dietary supplement sellers making health claims on products intended for human consumption
FDA regulations on health claims for foods allow companies to make certain health claims only if nutrient levels in the product don't exceed established "disqualifying levels" — unless the FDA has specifically approved an exception because the claim would help consumers eat healthier.
Requirements
Foods cannot have nutrient levels that exceed FDA-set disqualifying thresholds
Exceptions exist if alternative levels are established in FDA regulations (subpart E)
FDA may permit claims despite a disqualifying nutrient if it determines the claim supports healthy eating
Rule does not apply to infant formulas or medical foods
Why it matters
If your product's nutrient profile exceeds disqualifying levels, your health claims may be illegal and your listing could be removed unless you have FDA approval for an exception.
Anyone (sellers, manufacturers, researchers, or organizations) seeking FDA approval for a health claim on food or dietary supplement products
Anyone can submit a formal petition to the FDA requesting approval for a health claim about food or dietary supplements. You must submit the petition in a specific format—either as printed copies or on a computer disk using standard formatting like ASCII text.
Requirements
Submit an original plus one copy of the petition, or submit original plus computer-readable disk in standard format (such as ASCII)
Contact the Center for Food Safety before submitting a disk to confirm acceptable format and submission process
Health claim must be proposed as a formal regulation petition to the FDA
Why it matters
If you want to make a health claim on your product listings or marketing, you may need to go through this formal petition process rather than making claims on your own authority.
Food and dietary supplement companies or any interested person seeking FDA approval for a health claim on their product label.
This rule sets out the formal process for submitting a petition to the FDA to request approval of a health claim for a food or dietary supplement. You must provide detailed documentation, supporting evidence, and comply with specific formatting and transparency requirements when submitting your petition.
Requirements
Submit an original petition plus one copy (or original plus a standard-format computer disk)
Include all relevant scientific data, clinical studies, and published information with reprints
For lab studies: confirm compliance with good laboratory practice standards (21 CFR Part 58), or explain any non-compliance
For human studies: confirm compliance with institutional review requirements (21 CFR Part 56) and informed consent rules (21 CFR Part 50)
Provide your complete mailing address for FDA correspondence
Include English translations for any foreign-language materials
Why it matters
Filing an improper petition will delay or block FDA approval of your health claim, preventing you from using that claim in marketing—a critical limitation if it's central to your product positioning.
Who this applies to
Companies petitioning the FDA to make health claims about food products or ingredients
This FDA rule outlines what information and documentation a company must submit when petitioning to make a health claim about a food or ingredient. The petition must include scientific literature, data on safety and efficacy, environmental compliance documents, and a signed statement confirming the submission includes both supporting and opposing evidence.
Requirements
Submit copies of all literature searches and cited research supporting the health claim
Include all information on adverse effects and any segment of the population that could be harmed
Submit data showing the amount of the substance in representative foods using validated testing methods
Include either a categorical exclusion claim or environmental assessment under federal environmental rules
Provide a signed statement confirming the petition includes both favorable and unfavorable information
Why it matters
Without meeting these detailed documentation requirements, the FDA will reject the health claim petition within 100 days, preventing you from legally marketing the product with that claim.
Manufacturers, packers, and distributors of dietary supplements that make structure/function claims under section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act
If you sell a dietary supplement that includes a structure/function claim (a statement about how the supplement supports normal function or structure of the body), you must notify the FDA within 30 days of first selling that product. This notification requirement applies to dietary supplements making claims governed by federal food and drug regulations.
Requirements
Notify the FDA Office of Dietary Supplement Programs (HFS-810) within 30 days of first marketing the supplement
Notification must be sent to the Center for Food Safety and Applied Nutrition at the FDA address specified in the regulation
This applies to any dietary supplement bearing one of the statements listed in section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act
Why it matters
Failure to notify the FDA within the 30-day window can result in regulatory enforcement action, product delisting, or other penalties that could disrupt your business and sales.
Manufacturers, packers, and distributors of dietary supplements that include structure/function claims listed in FDA section 403(r)(6)
If you're selling a dietary supplement with certain structure/function claims on the label, you must notify the FDA within 30 days of first marketing the product. This notification is a required regulatory filing—not optional.
Requirements
Notify the FDA Office of Dietary Supplement Programs within 30 days of first marketing
Submit an original plus two copies of the notification
Address notification to: Office of Dietary Supplement Programs (HFS-810), CFSAN, FDA, 5001 Campus Dr., College Park, MD 20740
Applies only to products bearing one of the specified statements from section 403(r)(6)
Why it matters
Missing or late FDA notification can result in regulatory enforcement action, product seizure, or removal from sale on TikTok Shop.
Manufacturers, packers, and distributors of dietary supplements that make structure/function claims on labels or in labeling materials
Dietary supplement makers must notify the FDA within 30 days of first selling a product that makes structure/function claims (statements about how a nutrient or ingredient supports normal function). Every product label bearing such a claim must display a specific FDA disclaimer stating the claim hasn't been evaluated by the FDA and the product isn't intended to diagnose, treat, cure, or prevent disease.
Requirements
Notify FDA within 30 days of first marketing, including manufacturer name/address, claim text, ingredient name, and product name
Include disclaimer stating the claim has not been evaluated by FDA and the product does not diagnose, treat, cure, or prevent disease
Place disclaimer adjacent to the claim with no intervening material, or link it via symbol (asterisk)
Display disclaimer in bold type, minimum one-sixteenth inch font size, on each label or page where a claim appears
Why it matters
Failure to properly notify, disclaim, or display claims risks FDA enforcement action, product delisting, and legal liability for selling misbranded supplements.
TikTok Shop sellers who have been invited to sell dietary supplements and are manufacturers, importers, or repackers of those products
Selling dietary supplements on TikTok Shop is by invitation only. You must submit proof of FDA food facility registration (either a verification letter or screenshot from the FDA Direct website), and the registration must match the manufacturer or importer name on your product label and be valid at the time you apply.
Requirements
Access is invite-only; contact your Account Manager to apply
Permitted: beauty, fitness, vitamins/minerals, maternity, herbal, and sexual wellness supplements
Prohibited: weight management supplements, mental wellness supplements, and sexual performance enhancers
Must provide FDA food facility registration proof showing the registered establishment name, physical address, operation type, and current valid status
Why it matters
Without proper FDA registration documentation and category approval, your dietary supplement listings will be rejected and you cannot legally sell these products on the platform.
All TikTok Shop sellers listing dietary supplements
This FDA guidance explains how dietary supplement sellers can use nutrient content claims on their product labels. It clarifies what nutrient levels must be present to make such claims and whether claims not listed in FDA regulations are allowed. Sellers must follow these rules to label their supplements accurately and legally.
Requirements
You must only use nutrient content claims that meet FDA-defined nutrient level criteria.
You cannot use nutrient content claims that are not included in FDA regulations on your product labels.
Ensure all claims on supplement labels are truthful and not misleading.
Why it matters
Incorrect or unauthorized nutrient claims can lead to regulatory action and removal of your listings.
Dietary supplement manufacturers and sellers labeling products with nutrient content claims
Dietary supplement makers can only display nutrient content claims (like "high in vitamin C" or "good source of calcium") on product labels if the supplement actually contains the FDA-defined minimum levels of that nutrient. Any nutrient claims must match what the FDA has officially approved—you cannot use your own custom nutrient claims.
Requirements
Nutrient content claims require the supplement to meet FDA-defined minimum nutrient levels
Only use nutrient claims that are included in FDA regulations
Custom or non-FDA-approved nutrient claims are not permitted on labels
Why it matters
Using unapproved or unsupported nutrient claims can result in mislabeling violations, FDA warning letters, and removal of your product listings from TikTok Shop.
All TikTok Shop sellers listing dietary supplements making nutrient content claims on product labels.
This rule explains how sellers of dietary supplements can make nutrient content claims on their product labels. It covers what claims are allowed, the nutrient levels required to make those claims, label formatting, and when disclosure statements must be included. Sellers must follow FDA definitions and requirements to use these claims properly.
Requirements
You must only use nutrient content claims defined by the FDA.
Claims must meet specific nutrient level criteria set by the FDA.
Disclosure statements are required in certain cases and must meet size and placement rules.
Supplement Facts panels are required when making nutrient content claims.
Why it matters
Incorrect or unauthorized nutrient claims can lead to regulatory action and removal of listings.
All TikTok Shop sellers listing dietary supplements that make antioxidant or sugar-related claims.
This rule explains when and how sellers can make antioxidant nutrient content claims on dietary supplements. To make such claims, the antioxidant must have a recognized activity and usually an established Reference Daily Intake (RDI), though some exceptions like beta-carotene exist. Sellers must also follow specific labeling requirements when making claims about antioxidants or sugar content.
Requirements
Antioxidant claims must be based on nutrients with an established RDI or recognized antioxidant activity.
Beta-carotene can be claimed as an antioxidant even without an RDI.
All antioxidants present do not need to be listed when making an antioxidant claim.
Claims like "no sugar" or " no added sugars" have specific labeling rules and may require additional statements like "low calorie" for "sugar free" claims.
Why it matters
Accurate antioxidant and sugar claims help avoid regulatory issues and maintain consumer trust.
All TikTok Shop sellers listing dietary supplements making "high potency" or antioxidant claims
The FDA allows the term "high potency" to be used on dietary supplements if certain nutrient levels meet specific criteria. For multinutrient products, a certain number of nutrients must be at 100% of the Daily Value (DV) to qualify. Antioxidant claims must be based on recognized antioxidant activity, and specific rules apply to nutrients like beta-carotene that lack an established RDI.
Requirements
You can use "high potency" for individual nutrients or combination products if nutrient levels meet FDA criteria.
For multinutrient products, a minimum number of nutrients must be at 100% DV to claim "high potency".
Antioxidant claims must be based on recognized antioxidant activity.
Beta-carotene can be used in antioxidant claims despite lacking an RDI, but all antioxidants present must be listed when making such claims.
Why it matters
Using "high potency" or antioxidant claims incorrectly can lead to regulatory issues and listing removal.
All TikTok Shop sellers listing dietary supplements and multinutrient products
This policy explains how to properly use percentage claims on dietary supplement labels, including what counts as a simple or comparative percentage claim. It also clarifies when you can use the term "high potency" for individual nutrients or combination products, and the criteria for multinutrient products to qualify as "high potency."
Requirements
You must clearly define percentage claims as simple (stating a nutrient's percentage of Daily Value) or comparative (comparing percentages between products).
You can use "high potency" for individual nutrients if they meet certain potency criteria.
For combination products, including botanicals with vitamins, specific rules apply to using "high potency."
A multinutrient product must have a certain number of nutrients at 100% of the Daily Value to be labeled "high potency."
Why it matters
Using these claims incorrectly can lead to regulatory issues and affect your product's credibility and sales.
All TikTok Shop sellers listing dietary supplements
Health claims on dietary supplement labels describe how a product may affect health or reduce disease risk. These claims must be authorized by the FDA or be qualified with specific disclaimers if not fully authorized. Sellers must distinguish health claims from structure/function claims and follow rules on percentage claims and disclaimers.
Requirements
Only use FDA-authorized health claims or qualified health claims with agency-approved disclaimers.
Do not confuse health claims with structure/function claims.
Percentage claims must be accurate and clearly stated as simple or comparative.
Additional health claims require proper authorization or disclaimers.
Why it matters
Incorrect or unauthorized health claims can lead to regulatory action and removal of listings.
All TikTok Shop sellers listing dietary supplements making structure/function or health claims
If you make structure/function claims about your dietary supplements (claims about how the product affects the body's structure or function), you must follow specific FDA rules. This includes notifying the FDA, using exact disclaimer text, placing the disclaimer properly, and using the correct font size. Qualified health claims require special disclaimers and may need FDA authorization.
Requirements
Notify the FDA using the required form before marketing products with structure/function claims.
Include the FDA-approved disclaimer text on your product label.
Place the disclaimer prominently and use the specified font size.
Use agency-approved disclaimers for qualified health claims, especially if not FDA authorized.
Why it matters
Failure to comply can lead to regulatory action, product listing removal, or loss of consumer trust.
All TikTok Shop sellers listing dietary supplements who want to use nutrient content claims on their product labels.
A nutrient content claim is a statement on a dietary supplement label that describes the amount of a nutrient in the product. To use these claims, the supplement must meet specific nutrient level requirements. These requirements are detailed in Appendix D of the FDA's labeling guide.
Requirements
You can only make nutrient content claims if your product meets the nutrient levels specified in Appendix D of the FDA guide.
Claims must clearly characterize the level of a nutrient in the supplement.
Do not imply nutrient levels that are not supported by your product's content.
Why it matters
Using nutrient content claims without meeting FDA requirements can lead to regulatory issues and affect your product's credibility.
All TikTok Shop sellers listing dietary supplements who make nutrient content claims
If you make a nutrient content claim on a dietary supplement label, the claim's font size cannot be more than twice as large as the product name and must not stand out more than the product name. Also, you must include a "Supplement Facts" panel when making such claims.
Requirements
Nutrient content claims must be no larger than twice the font size of the product name.
Claims must not be more prominent in style than the product name.
A "Supplement Facts" panel is required when making nutrient content claims.
Why it matters
Following these rules helps avoid regulatory issues and ensures your product labeling is compliant with FDA requirements.
All TikTok Shop sellers listing dietary supplements who make nutrient content claims
If you make a nutrient content claim about a dietary supplement, you must include a "Supplement Facts" panel on the label. The nutrient claim text cannot be larger than twice the size of the product name and must not stand out more than the product name. This helps consumers understand the nutritional information clearly.
Requirements
You must include a "Supplement Facts" panel when making nutrient content claims.
Nutrient content claims must be no larger than twice the font size of the product name.
Nutrient content claims must not be more prominent in style than the product name.
Why it matters
Failing to include the required panel or misusing claim sizes can lead to regulatory issues and listing removal.
All TikTok Shop sellers listing dietary supplements who make nutrient content claims
If you make a nutrient content claim about a dietary supplement, you must include a "Supplement Facts" panel and a disclosure statement that points out other nutrient information consumers should know. This helps consumers understand the full nutritional context of the supplement.
Requirements
You must include a "Supplement Facts" panel on the product label.
You must provide a disclosure statement calling attention to other nutrients besides the one claimed (e.g., "See nutrition information for fat content").
The disclosure statement is required whenever you make a nutrient content claim.
Why it matters
Failing to include required disclosures can lead to regulatory action and removal of your listings.
All TikTok Shop sellers listing foods or dietary supplements that make nutrient content claims
If you make a nutrient content claim about your food or dietary supplement, and it contains fat, saturated fat, cholesterol, or sodium above certain levels, you must include a disclosure statement on the label. This helps consumers understand when a product has high levels of these nutrients.
Requirements
You must include a disclosure statement if your product contains:
More than 13 grams of fat per serving
More than 4 grams of saturated fat per serving
More than 60 milligrams of cholesterol per serving
More than 480 milligrams of sodium per serving
Why it matters
Including required disclosure statements helps you comply with FDA rules and avoid enforcement actions or listing removals.
All TikTok Shop sellers listing dietary supplements with disclosure statements on their labels.
If you include a disclosure statement on your dietary supplement label, it must be easy to read and stand out clearly from other text or images. The font must be bold and the size must meet specific minimum requirements similar to those for the net quantity statement.
Requirements
Disclosure statements must be in boldface print or type.
They must have a clear contrast from other printed or graphic matter.
The font size must be at least as large as the net quantity of contents statement, unless the claim is very small.
Why it matters
Properly formatted disclosure statements help you comply with FDA labeling rules and avoid enforcement actions or listing removals.
All TikTok Shop sellers listing dietary supplements with claims
If you make a claim on a dietary supplement label, you must put the required disclosure statement right next to that claim without anything in between, except for the product name or other required info. The size of the disclosure text must follow specific size rules based on the size of the claim text, ensuring it is readable.
Requirements
Place the disclosure statement immediately next to the claim with no intervening images or text except required info.
The disclosure text size must be at least half the size of the claim text if the claim is small, but never smaller than 1/16 inch.
If the package is very small, a smaller disclaimer size of 1/32 inch is allowed.
Why it matters
Proper placement and sizing of disclosure statements help you comply with FDA rules and avoid your listings being removed or penalized.
All TikTok Shop sellers listing dietary supplements with nutrient content claims on product labels.
If you make multiple nutrient content claims on the same label panel, you only need to include one disclosure statement per panel. This statement must be placed next to the claim with the largest text on that panel. You can skip the disclosure on the nutrition facts panel if the same claim appears on multiple panels.
Requirements
Include only one disclosure statement per label panel with multiple claims.
Place the disclosure next to the largest claim on that panel.
Omit the disclosure on the nutrition facts panel if the claim is repeated on other panels.
Why it matters
Proper disclosure helps avoid regulatory issues and ensures your product claims comply with FDA labeling rules.
All TikTok Shop sellers listing dietary supplements that are specially processed to alter nutrient content.
If your dietary supplement is specially processed to reduce or remove a nutrient that is normally present, you can label it as "low" or "free" of that nutrient. However, these claims are considered nutrient content claims and must include any required disclosure statements.
Requirements
You may make "low" or "free" nutrient claims if your supplement is specially processed to reduce or remove that nutrient.
These claims are nutrient content claims.
You must include any required disclosure statements with these claims.
Why it matters
Making these claims correctly helps avoid regulatory issues and ensures your product labeling is compliant.
All TikTok Shop sellers listing dietary supplements
You can only claim your dietary supplement is "low" or "free" of a nutrient if similar products normally contain that nutrient and your product has been specially changed to reduce or remove it. You cannot make such claims just because the product is naturally low or free of that nutrient unless you clarify the claim applies to all products of that type.
Requirements
You may not claim "low" or "free" if the product is naturally low or free of the nutrient without a disclaimer.
You can claim "low" or "free" only if similar supplements normally contain the nutrient and your product is specially processed to reduce or remove it.
If making a claim about all products of that type, you must clearly indicate this in your labeling.
Why it matters
Incorrect claims can lead to regulatory issues and removal of your product listings.
All TikTok Shop sellers listing dietary supplements or food products making sugar or similar content claims.
Claims that a product has "no sugar" are considered nutrient content claims and must follow specific regulatory requirements. However, statements like "100 percent milk free" or "contains no preservatives" are not nutrient content claims if they are not implying nutritional content. Sellers must be careful how they phrase these claims to comply with FDA rules.
Requirements
"No sugar" claims must meet nutrient content claim regulations.
Claims like "100 percent milk free" or "contains no preservatives" are not nutrient content claims if not implying nutrition.
Avoid using non-nutrient claims in a way that implies nutrient content.
Follow 21 CFR 101.60(c)(1) and related regulations for labeling claims.
Why it matters
Non-compliance with nutrient content claim rules can lead to enforcement actions and listing removals.
All TikTok Shop sellers listing dietary supplements
You can only use the claim "no added sugar" on dietary supplements that normally would have added sugars but do not in your product. This prevents misleading customers about the sugar content. Also, dietary supplements with a "sugar free" claim do not have to be labeled as "low calorie."
Requirements
You may use " no added sugar" only if the supplement normally contains added sugars but yours does not.
"Sugar free" claims do not require a "low calorie" label.
Sugar content claims must follow nutrient content claim rules under 21 CFR 101.60.
Why it matters
Using these claims incorrectly can mislead customers and may lead to enforcement actions or listing removal.
All TikTok Shop sellers listing dietary supplements
If you label a dietary supplement as "sugar free," you do not have to also label it as "low calorie." However, you cannot make a "low calorie" claim unless your supplement replaces another similar supplement that normally has more calories. Also, only use "no added sugar" if your supplement normally would have added sugars but doesn't.
Requirements
You may label a supplement "sugar free" without labeling it "low calorie".
You cannot claim "low calorie" unless your supplement substitutes a similar product that usually exceeds the low calorie definition.
Use " no added sugar" only for supplements that normally contain added sugars but do not in your product.
Why it matters
Making unsupported "low calorie" claims can mislead customers and may lead to regulatory issues or listing removal.
All TikTok Shop sellers listing dietary supplements with antioxidant claims
This rule defines antioxidant claims as statements about the amount of antioxidant nutrients in a dietary supplement. To make such claims, the nutrient must have a recognized daily intake value (RDI), with some exceptions. This ensures that antioxidant claims are based on established nutritional standards.
Requirements
You can only make antioxidant nutrient content claims if the nutrient has an established RDI.
The claim must specifically characterize the level of one or more antioxidant nutrients in the supplement.
Exceptions to the RDI requirement may apply as noted in specific regulatory guidance.
Why it matters
Making antioxidant claims without meeting these requirements can lead to regulatory issues and listing removal.
All TikTok Shop sellers listing dietary supplements with antioxidant claims
If you want to make an antioxidant claim on a dietary supplement, the nutrient or ingredient must have a recognized daily intake value (RDI) and proven antioxidant activity. This means you can only claim antioxidant benefits for nutrients officially recognized for that purpose.
Requirements
The nutrient or dietary ingredient must have an established RDI.
The nutrient must have recognized antioxidant activity.
Antioxidant claims must characterize the level of one or more antioxidant nutrients present.
Why it matters
Making antioxidant claims without meeting these requirements can lead to regulatory issues and listing removal.
All TikTok Shop sellers listing dietary supplements with antioxidant claims
If you want to claim your product has antioxidant benefits, the nutrients you mention must be scientifically proven antioxidants. Also, your product must contain enough of these nutrients to meet specific levels defined by FDA rules, like being "high" or a "good source" of that nutrient.
Requirements
The nutrient must have recognized antioxidant activity supported by scientific evidence.
The product must contain enough of the nutrient to qualify for "high," "good source," or "more" claims as defined by FDA regulations.
For example, to claim "high in antioxidant vitamin C," the product must have at least 20% of the recommended daily intake (RDI) of vitamin C.
Why it matters
Making antioxidant claims without meeting these requirements can lead to regulatory issues and removal of your listing.
All TikTok Shop sellers listing dietary supplements containing beta-carotene
You can make antioxidant claims about beta-carotene in your product if the amount of vitamin A from beta-carotene meets or exceeds 10% of the recommended daily intake (RDI). This means you can say your product is a "good source of antioxidant beta-carotene" only when this vitamin A level is present. Antioxidant claims must be based on scientific evidence that the substance helps neutralize free radicals in the body.
Requirements
You may claim beta-carotene as an antioxidant only if the vitamin A from beta-carotene is at least 10% of the RDI.
Claims must be supported by recognized scientific evidence of antioxidant activity.
Beta-carotene itself does not have an RDI, but the vitamin A it provides does.
Why it matters
Making unsupported antioxidant claims can lead to regulatory issues and affect your product's credibility.
All TikTok Shop sellers listing dietary supplements with antioxidant nutrient content claims.
If you make a claim that your product is high in antioxidants, you must clearly list all the antioxidant nutrients included in the claim on your label. You can either name them directly in the claim or use a symbol that refers to a list elsewhere on the label. Also, you can claim beta-carotene as an antioxidant if it provides at least 10% of the recommended daily intake of vitamin A.
Requirements
You must include the names of all antioxidant nutrients mentioned in the claim.
You can use a symbol (like an asterisk) linking the word "antioxidants" to a list of nutrients on the same label panel.
The nutrient names in the list must be at least 1/16 inch tall or half the size of the largest nutrient claim text.
You may claim "good source of antioxidant beta-carotene" if beta-carotene provides 10% or more of the vitamin A RDI.
Why it matters
Accurate labeling prevents regulatory issues and builds consumer trust in your product claims.
All TikTok Shop sellers listing dietary supplements with antioxidant properties
You can make claims about how your dietary supplement's ingredients act as antioxidants, as long as these claims are truthful and not misleading. Such claims must follow specific FDA rules about nutritional support statements. For example, saying an ingredient is "involved in antioxidant processes" is allowed if it meets these conditions.
Requirements
Claims must be truthful and not misleading
Claims must comply with section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act
Claims can describe how ingredients participate in antioxidant processes
Claims cannot reference a Recommended Dietary Intake (RDI) if none exists
Why it matters
Making false or misleading claims can lead to enforcement actions and removal of your listings.
All TikTok Shop sellers listing dietary supplements containing vitamins or minerals
You can label a dietary supplement as "high potency" if it contains individual vitamins or minerals at 100% or more of the Recommended Daily Intake (RDI) per serving. This applies even if the product combines botanicals with vitamins. The term "high potency" must accurately reflect the nutrient content based on standard serving sizes.
Requirements
You may use "high potency" only for individual vitamins or minerals at 100% or more of the RDI per serving.
This applies to both single nutrients and combination products like botanicals with vitamins.
The reference amount must be the customary serving size for the product.
Why it matters
Using "high potency" incorrectly can lead to regulatory issues and affect your product's credibility and sales.
All TikTok Shop sellers listing dietary supplements with vitamins or minerals, including combination products like botanicals with vitamins.
You can label a dietary supplement as "high potency" if it contains individual vitamins or minerals at 100% or more of the recommended daily intake (RDI). If your product has multiple ingredients, you must clearly specify which vitamin or mineral is "high potency."
Requirements
You may use "high potency" only for vitamins or minerals at 100% or more of the RDI per serving.
If the product contains multiple nutrients, clearly identify which vitamin or mineral is "high potency" (e.g., "Botanical X with high potency vitamin E").
Why it matters
Accurate use of "high potency" claims helps avoid misleading customers and potential regulatory issues.
All TikTok Shop sellers listing multinutrient dietary supplements
You can label a multinutrient supplement as "high potency" if at least two-thirds of its vitamins and minerals meet or exceed 100% of the recommended daily intake. If you call out a single vitamin or mineral as "high potency" in a product with multiple nutrients, you must clearly specify which one it is.
Requirements
At least two-thirds of vitamins and minerals present at 2% or more of the RDI must be at 100% or more of the RDI to use "high potency" for the whole product.
If using "high potency" for individual nutrients, clearly identify which vitamin or mineral is being described.
Why it matters
Using "high potency" correctly helps avoid misleading claims and potential regulatory issues.
All TikTok Shop sellers listing dietary supplements
You can make percentage claims about dietary ingredients in your supplements even if there is no established daily intake value for those ingredients. However, these claims must include any required disclosure statements as specified by FDA regulations.
Requirements
You may state the percentage level of a dietary ingredient without an established RDI or DRV.
You must include any disclosure statements required under 21 CFR 101.13(h) when making these claims.
Percentage claims can be simple or comparative.
Why it matters
Including required disclosures helps you comply with FDA rules and avoid regulatory issues or listing removal.
All TikTok Shop sellers listing dietary supplements with ingredients lacking established RDIs or DRVs.
You can state the percentage of a dietary ingredient in your supplement if there is no established daily intake value for it. However, you must also include the actual amount of that ingredient per serving next to the percentage. These claims must follow any required disclosure statements.
Requirements
You may make percentage claims for ingredients without established RDI or DRV.
You must declare the actual amount of the ingredient per serving next to the percentage claim (e.g., '40 percent omega-3 fatty acids, 10 mg per capsule').
Include any required disclosure statements as per 21 CFR 101.13(h).
Why it matters
Accurate labeling helps avoid regulatory issues and builds trust with customers.
All TikTok Shop sellers listing dietary supplements with comparative percentage claims
If you make a claim comparing the percentage of a dietary ingredient in your supplement to that in another food, you must clearly identify the reference food, the amounts in both products, and the actual amount of the ingredient in your product. This applies to ingredients without established daily values, like omega-3s or amino acids.
Requirements
You must clearly identify the reference food used for comparison.
You must state the amount of the dietary ingredient in both your supplement and the reference food.
You must include the actual amount of the dietary ingredient per serving next to the percentage claim.
This applies only to ingredients without established RDI or DRV values.
Why it matters
Accurate and clear claims help avoid regulatory issues and build consumer trust.
All TikTok Shop sellers listing dietary supplements who want to use health claims on their product labels or promotions.
You can only use additional health claims on dietary supplements if the FDA has approved them through a formal petition process. Sometimes, these claims must include a disclaimer explaining the scientific evidence behind them. Without FDA approval or an authorized disclaimer, you cannot legally make these health claims.
Requirements
Submit a health claim petition to the FDA following 21 CFR 101.70.
Use additional health claims only after FDA issues an authorizing regulation or enforcement discretion letter.
Include an FDA-approved disclaimer if required to disclose the level of scientific evidence.
Why it matters
Using unapproved health claims can lead to enforcement actions and removal of your listings, harming your business reputation and sales.
All TikTok Shop sellers listing dietary supplements
You can make certain claims about dietary supplements that describe how a nutrient or ingredient supports the body's structure or function, or how it helps prevent nutrient deficiency diseases common in the U.S. You can also claim general well-being benefits from consuming the nutrient or ingredient. These claims must be truthful and based on documented roles or mechanisms.
Requirements
You may claim benefits related to classical nutrient deficiency diseases and must disclose how common the disease is in the U.S.
You may describe how a nutrient or dietary ingredient affects the body's structure or function.
You may explain the documented mechanism by which the nutrient or ingredient maintains structure or function.
You may claim general well-being benefits from consuming the nutrient or ingredient.
Why it matters
Making allowed claims helps you market supplements effectively while complying with FDA rules, avoiding enforcement actions or listing removals.
All TikTok Shop sellers listing dietary supplements making structure/function claims
If you make structure/function claims about your dietary supplement (claims about how it affects the body's structure or function), you must ensure these claims are truthful and not misleading. You also need to include a specific FDA disclaimer on your product label and notify the FDA within 30 days of first marketing the product with these claims.
Requirements
You must have evidence that your structure/function claims are truthful and not misleading.
You must include the FDA-required disclaimer on your product labeling.
You must notify the FDA within 30 days after first marketing the product with these claims.
Why it matters
Failing to comply can lead to regulatory action and removal of your product listings.
All TikTok Shop sellers listing dietary supplements with health claims
If you make health-related claims about dietary supplements, you must include a specific FDA disclaimer stating that the claims have not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. You must use the exact wording provided by the FDA without any changes.
Requirements
You must include the FDA disclaimer text exactly as provided.
Use the singular disclaimer if referring to one statement.
Use the plural disclaimer if referring to multiple statements.
Do not modify or alter the disclaimer wording in any way.
Why it matters
Including the correct FDA disclaimer helps you comply with legal requirements and avoid enforcement actions or listing removals.
All TikTok Shop sellers listing dietary supplements with health claims
If you make a health-related claim on a dietary supplement label, you must include a specific disclaimer either right next to the claim or elsewhere on the same label panel. If the disclaimer is not next to the claim, it must be in a box and connected to the claim by matching symbols like asterisks. You cannot change the wording of these disclaimers.
Requirements
Include the required disclaimer immediately next to the claim with no space in between, or
Place the disclaimer elsewhere on the same label panel in a box linked by matching symbols (e.g., asterisks)
Do not alter the wording of the disclaimer
Why it matters
Proper disclaimer placement is legally required and helps avoid regulatory issues or listing removal.
All TikTok Shop sellers listing dietary supplements with claims requiring disclaimers
If you include a required disclaimer with a dietary supplement claim, it must be in bold type and at least 1/16 inch tall. The disclaimer should be placed right next to the claim or elsewhere on the same panel/page in a box, linked by a symbol like an asterisk. This ensures the disclaimer is clear and connected to the claim.
Requirements
Use boldface type for disclaimers
Type size must be at least 1/16 inch tall
Place disclaimer immediately next to the claim or elsewhere on the same panel/page
If not adjacent, put disclaimer in a box and link it to the claim with matching symbols (e.g., asterisks)
Why it matters
Proper disclaimer placement and formatting helps avoid regulatory issues and builds consumer trust.
All TikTok Shop sellers listing dietary supplements with structure/function claims
If you make structure/function claims about a dietary supplement, you must notify the FDA with specific details. This includes who makes or distributes the supplement, the exact claim text, the ingredient involved, and the product name. This ensures transparency and compliance with labeling rules.
Requirements
Include the name and address of the manufacturer, packer, or distributor of the supplement
Include the exact text of the structure/function claim
Include the name of the dietary ingredient or supplement the claim is about
Include the name and brand of the dietary supplement on whose label the claim appears
Why it matters
Failure to provide this information can lead to regulatory action and removal of your product listings.
All TikTok Shop sellers listing dietary supplements with structure/function claims
If you make structure/function claims about a dietary supplement, you must notify the FDA with specific information. This includes details about the product, the claim, and the company responsible. This ensures transparency and compliance with labeling rules.
Requirements
Include the name and address of the manufacturer, packer, or distributor.
Include the exact text of the structure/function claim.
Include the name of the dietary ingredient or supplement the claim is about.
Include the name and brand of the dietary supplement on whose label the claim appears.
Why it matters
Failure to provide this information can lead to regulatory action and removal of your product listings.
All TikTok Shop sellers listing dietary supplements with structure/function claims on their product labeling.
If you sell dietary supplements and make structure/function claims on your product labels (claims about the role of a nutrient or ingredient in the body), you must notify the FDA within 30 days of first marketing the product with that claim. This notification is required by law to ensure transparency about the claims made on supplements.
Requirements
You must notify the FDA within 30 days after first marketing a dietary supplement with a structure/function claim.
The claims covered are those that describe the role of a nutrient or dietary ingredient in affecting the structure or function of the body.
This notification is mandatory under the Federal Food, Drug, and Cosmetic Act.
Why it matters
Failing to notify the FDA as required can lead to regulatory action and affect your ability to sell supplements legally.
Dietary supplement sellers and marketers making structure/function claims, general well-being claims, or classical nutrient deficiency disease claims on product labels
If you market a dietary supplement with certain types of health-related claims (like structure/function claims, general well-being claims, or nutrient deficiency claims), you must notify the FDA within 30 days of first selling the product with that claim. Your label must include a specific FDA disclaimer and have proof that your claim is truthful and not misleading.
Requirements
Submit FDA notification within 30 days of first marketing with the claim
Include the required FDA disclaimer in bold: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
Have substantiation that your claim is truthful and not misleading
Do not claim the product diagnoses, treats, cures, or prevents any specific disease
Why it matters
Failure to notify FDA on time or include the required disclaimer can result in regulatory action, product delisting, or legal penalties for non-compliance with federal dietary supplement requirements.
All TikTok Shop sellers listing dietary supplements with structure/function claims
If you make structure/function claims about dietary supplements (claims about how the product affects the body's structure or function), you must notify the FDA within 30 days of marketing the product with that claim. The FDA provides an online portal (COSM) to submit these notifications electronically, which helps speed up processing and gives you confirmation and status updates.
Requirements
You must not claim to diagnose, treat, cure, or prevent diseases.
Submit a notification with the exact claim text and required info to the FDA within 30 days of first marketing.
Use the FDA's COSM online portal for electronic submission to get faster processing and confirmation.
Keep your COSM account for future submissions.
Why it matters
Failing to notify the FDA or making prohibited disease claims can lead to regulatory action and removal of your listings.
All manufacturers, packers, or distributors of dietary supplements making structure/function claims on their product labels or labeling.
If you make structure/function claims on dietary supplement labels, you must notify the FDA with specific information about your product and the claim. You can submit this notification either in writing or electronically through the FDA's COSM portal, which is recommended for faster processing and confirmation.
Requirements
Include the name and address of the manufacturer, packer, or distributor.
Provide the exact text of the claim being made.
State the name of the dietary ingredient or supplement related to the claim.
Include the name (including brand name) of the dietary supplement bearing the claim.
Have a responsible individual sign the notification certifying the information is complete, accurate, and substantiated.
Why it matters
Proper notification helps ensure compliance with FDA rules and avoids potential enforcement actions or delays in product marketing.
All TikTok Shop sellers listing dietary supplements with structure/function, general well-being, or classical nutrient deficiency disease claims.
If you make structure/function, general well-being, or classical nutrient deficiency disease claims on dietary supplement labels, you must notify the FDA before marketing. This notification must list all products and brands using the claim. The FDA reviews these notifications and may object if claims imply disease treatment or are otherwise inappropriate.
Requirements
You must submit a notification to the FDA for structure/function, general well-being, or classical nutrient deficiency disease claims.
List every product and brand name using the claim in the notification; generic phrases like "other products" are not allowed.
Claims like "vegan" or "non-GMO" do not require FDA notification but must be truthful and not misleading.
FDA may object to claims that suggest disease treatment or if the product is not a dietary supplement.
Why it matters
Failure to notify the FDA or making unauthorized claims can lead to FDA objections, risking product listing removal or enforcement actions.
All TikTok Shop sellers listing dietary supplements with structure/function claims
If you make structure/function claims about dietary supplements, you can notify the FDA but are not required to respond if you receive a courtesy letter from them. Any response you send will be made public, and the FDA may send additional letters if they still object to your claims. The FDA publicly posts these notifications and related correspondence.
Requirements
You may notify the FDA about your structure/function claims as required under section 403(r)(6) of the FD&C Act.
You are not required to respond if you receive a courtesy letter from the FDA.
If you respond, your response will be publicly posted.
The FDA may send additional courtesy letters if they continue to object to your claims.
Why it matters
Understanding this process helps you manage compliance risks and public visibility of your supplement claims.
All TikTok Shop sellers listing dietary supplements with structure/function claims
If you want to make structure/function claims (claims about how a dietary supplement affects the body's structure or function) on your product labels, you must notify the FDA as required by law. This guide helps small businesses understand how to comply with these notification requirements.
Requirements
You must notify the FDA about any structure/function claims made on your dietary supplement labels as required under section 403(r)(6) of the FD&C Act.
You can contact the FDA via email at [email protected] for questions about these notifications.
Refer to the Small Entity Compliance Guide for detailed instructions on labeling and claims.
Why it matters
Failure to notify the FDA about structure/function claims can lead to regulatory action and affect your ability to sell dietary supplements legally.
All TikTok Shop sellers listing dietary supplements
This FDA guide explains the legal rules for making structure/function claims on dietary supplement labels in simple language. It helps small businesses understand what they can say about how their supplements affect the body. The guide is effective immediately and aims to ensure compliance with labeling regulations.
Requirements
You must only make structure/function claims that are truthful and not misleading.
Claims must describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in the body.
You cannot claim to diagnose, treat, cure, or prevent any disease.
Labels must include a disclaimer that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.
Why it matters
Non-compliance can lead to enforcement actions and removal of listings, affecting your ability to sell supplements on TikTok Shop.
Dietary supplement manufacturers and sellers making labeling claims
This is the FDA's plain-language guide to the legal requirements for structure/function claims on dietary supplement labels. It explains how the regulations work and what claims you're allowed to make, though the actual regulations (not this guide) are what have legal force.
Requirements
Structure/function claims must comply with FDA regulations on dietary supplement labeling
This is a guidance document restating legal requirements in plain language
Alternative approaches to compliance are permitted if they meet the underlying statute and regulations
The regulations themselves—not this guide—are legally binding
Why it matters
Non-compliant labeling claims can trigger FDA enforcement action against your product.
All TikTok Shop sellers listing dietary supplements
This FDA rule explains that dietary supplement labels can include statements about how the supplement affects the body's structure or function without needing FDA approval first. However, any claims that say the supplement can diagnose, treat, cure, or prevent diseases require FDA approval and are only allowed for approved drugs or certain foods. The rule helps sellers understand what types of claims are allowed on supplement labels.
Requirements
You may use structure/function claims describing effects on body structure or function without prior FDA review.
You cannot make disease claims (diagnose, cure, mitigate, treat, prevent disease) without FDA approval.
Disease claims are only allowed for FDA-approved drugs or foods with approved health claims.
Follow other FDA labeling and packaging regulations for dietary supplements as applicable.
Why it matters
Making unapproved disease claims can lead to regulatory action and removal of your listings.
All TikTok Shop sellers listing dietary supplements making structure/function claims
This rule explains that dietary supplements can make certain claims about how their ingredients affect the body's structure or function, but they cannot claim to treat or prevent diseases unless authorized. Sellers must have proof that their claims are truthful, notify the FDA within 30 days of marketing, and include a specific disclaimer on their labels.
Requirements
You can make claims about how a nutrient affects body structure or function but not disease claims.
You must have evidence that your claims are truthful and not misleading before using them.
You must notify the FDA within 30 days of first marketing your product with these claims.
You must include the FDA-mandated disclaimer statement on your product labeling.
Why it matters
Failing to follow these rules can result in your product being regulated as a drug, which has stricter requirements and could lead to enforcement actions.
All TikTok Shop sellers listing dietary supplements making health-related claims
This rule explains that a disease claim is any statement that says a product affects a disease or its symptoms, like cancer or arthritis. Claims about signs or symptoms closely linked to a disease are also considered disease claims. Nutrient deficiency diseases like scurvy are excluded from this definition.
Requirements
Do not make claims that your product treats, prevents, or affects diseases or disease classes.
Avoid claims about signs or symptoms that are characteristic of diseases.
Claims about nutrient deficiency diseases (like scurvy) are not considered disease claims.
Use medical references to check if a claim implies disease treatment or prevention.
Why it matters
Making disease claims without FDA approval can lead to regulatory action and removal of your listings.
Anyone interested in providing feedback on FDA guidance for dietary supplements, including TikTok Shop sellers and creators dealing with such products.
This policy explains that anyone can submit comments on FDA guidance documents about dietary supplements at any time, either online or by mail. It provides the mailing address for written comments if online submission is not possible.
Requirements
You can submit comments online anytime.
If you cannot submit online, mail written comments to the FDA's Dockets Management at the provided address.
All written comments should clearly identify the relevant document or guidance.
Why it matters
Submitting comments can influence FDA guidance, which affects how you market and label dietary supplements on TikTok Shop.
Anyone submitting written comments on the FDA's guidance for dietary supplement claims.
This rule explains how to submit written comments about the FDA's guidance on structure/function claims for dietary supplements. If you cannot submit comments online, you must mail them to the FDA's Dockets Management office and include the specific docket number.
Requirements
Include the docket number FDA-1998-N-0071 on all written comments.
If unable to submit online, mail comments to the FDA Dockets Management at 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.
Why it matters
Properly submitting comments ensures your feedback is officially received and considered by the FDA.
All TikTok Shop sellers listing dietary supplements or conventional foods making structure/function claims.
Structure/function claims describe the role of a dietary supplement or food in supporting the body's structure or function but do not claim to treat or prevent diseases. The FDA regulates these claims differently for supplements compared to drugs, requiring specific labeling and disclaimers. Sellers must follow these rules to legally market their products.
Requirements
You may make structure/function claims that describe how a product supports body functions.
You cannot claim the product treats, cures, or prevents diseases.
You must include a disclaimer that the FDA has not evaluated the claim.
Labels must comply with DSHEA requirements for supplements.
Why it matters
Non-compliance can lead to enforcement actions, product removal, or legal issues affecting your business.
Sellers and creators marketing dietary supplements and conventional foods with label claims about how products work
Structure/function claims describe how a dietary supplement or food affects normal structure or function of the body, and are allowed on labels under special FDA rules established by DSHEA (1994). These claims are distinct from disease claims, which turn a product into a drug and require different approval. The FDA regulates structure/function claims differently than drug claims, with specific requirements for how they're worded and supported.
Requirements
Structure/function claims are permitted on supplement and food labels under DSHEA
Claims must describe normal structure or function—not disease treatment or prevention
Claims on supplements and conventional foods are regulated differently than drug claims
Specific regulatory procedures and requirements apply (full details referenced in FDA guidance)
Why it matters
Using the wrong type of claim can cause your product to be classified as a drug, triggering FDA enforcement action and removal from shelves.
All TikTok Shop sellers listing dietary supplements and conventional foods making structure/function claims.
Structure/function claims describe the role of a dietary supplement or conventional food in supporting normal body functions but cannot claim to diagnose, treat, cure, or prevent diseases. These claims are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which sets specific rules for how such claims can be made.
Requirements
You may make structure/function claims that describe how a product supports normal body functions.
You cannot make claims that the product diagnoses, treats, cures, or prevents any disease.
Claims must comply with DSHEA regulatory requirements and procedures.
Labels must not mislead consumers about the product's effects.
Why it matters
Non-compliance can lead to enforcement actions, removal of listings, or legal issues affecting your business.
All TikTok Shop sellers listing dietary supplements
If you sell dietary supplements on TikTok Shop, you can make structure/function claims that describe how a nutrient affects the body's normal functions, like "calcium builds strong bones." However, you cannot claim your product diagnoses, treats, cures, or prevents diseases. You must notify the FDA about these claims within 30 days of marketing and include a disclaimer that the FDA has not evaluated the claim.
Requirements
You may make structure/function claims about how a nutrient affects normal body functions.
You must notify the FDA within 30 days after marketing the product with such claims.
You must include a disclaimer stating the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.
You cannot make disease claims unless they meet strict FDA criteria.
Why it matters
Non-compliance can lead to regulatory action and removal of your listings.
All TikTok Shop sellers listing dietary supplements making structure/function claims
This rule explains that structure/function claims describe how a nutrient or dietary ingredient affects the body, such as supporting general well-being or addressing nutrient deficiencies. These claims are regulated differently for dietary supplements compared to drugs. Sellers must follow specific FDA requirements when making these claims on supplement labels.
Requirements
Structure/function claims must comply with the Dietary Supplement Health and Education Act (DSHEA) regulations.
Claims can describe the role of a nutrient or ingredient in the body but cannot claim to diagnose, treat, cure, or prevent diseases.
Labels must include a disclaimer that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.
Why it matters
Non-compliance can lead to regulatory action and removal of listings, impacting sales and reputation.
All TikTok Shop sellers listing conventional foods and dietary supplements
For conventional foods, structure/function claims must relate to the food's nutritional value, while dietary supplements can claim effects from both nutritional and non-nutritional components. The FDA treats these claims similarly for both types but does not require notification or disclaimers for conventional foods. Dietary supplements have different notification requirements.
Requirements
Structure/function claims for conventional foods must focus on nutritive effects only.
Dietary supplements can make structure/function claims about nutritive and non-nutritive effects.
No FDA notification or disclaimers are required for structure/function claims on conventional foods.
Dietary supplements have separate notification rules not covered here.
Why it matters
Understanding these rules helps sellers avoid making unapproved claims that could lead to enforcement actions or listing removals.
All TikTok Shop sellers listing dietary supplements and conventional foods making structure/function claims.
Structure/function claims describe the role of a dietary supplement or conventional food in supporting normal body functions but cannot claim to treat or prevent diseases. The Dietary Supplement Health and Education Act (DSHEA) sets specific rules for making these claims on supplement labels. These claims must follow regulatory guidelines to be legally used.
Requirements
You must only make claims about how a product supports normal body functions, not about curing or preventing diseases.
Claims must comply with DSHEA regulations.
Labels must clearly distinguish structure/function claims from drug claims.
Why it matters
Incorrect claims can lead to regulatory action and removal of listings, impacting your business credibility and sales.
All TikTok Shop sellers and creators promoting dietary supplements or health products.
This FDA warning letter addresses Crystal Clear Supplements for making unapproved health claims on social media. It means sellers cannot claim their supplements treat or prevent diseases without FDA approval. Such claims can lead to regulatory action.
Requirements
Do not make claims that your supplement can diagnose, treat, cure, or prevent any disease.
Ensure all health claims are supported by FDA approval or scientific evidence.
Avoid misleading or unsubstantiated health statements in your content.
Why it matters
Violating these rules can result in warnings, removal of listings, or legal action, harming your business reputation and sales.
Supplement sellers and manufacturers promoting products on social media or other channels
This is an FDA warning letter to Crystal Clear Supplements regarding unauthorized health claims made on social media. The company made disease treatment or prevention claims that are not permitted for dietary supplements without FDA approval.
Requirements
Do not claim your supplement treats, prevents, mitigates, or cures any disease or health condition
Do not make drug-like claims on social media or marketing materials
Only make structure-function claims (e.g., "supports joint health") that are truthful and not misleading
Maintain substantiation for any health-related claims you do make
Why it matters
Violating FDA rules on supplement claims can result in warning letters, product seizure, and legal action against your company.
All TikTok Shop sellers listing supplements or health-related products that make disease-related claims.
The FDA warns that selling products like Tianeptine powders and certain capsules with claims that they diagnose, treat, or prevent diseases makes them unapproved drugs, which is illegal. These products cannot be marketed with health claims unless FDA-approved. Sellers must avoid making drug claims about supplements or similar products unless they have FDA approval.
Requirements
Do not market or sell products as treatments or cures for diseases without FDA approval.
Avoid making claims that your products affect the structure or function of the body in a way that classifies them as drugs.
Ensure your product claims comply with FDA regulations to avoid being considered unapproved new drugs.
Why it matters
Violating these rules can lead to FDA enforcement actions, including product seizures and legal penalties, which can harm your business and reputation.
All TikTok Shop sellers listing supplements or health-related products making medical or therapeutic claims.
You cannot make medical or health claims about supplements that are not approved by the FDA, such as saying they treat depression, anxiety, or other medical conditions. This includes claims made on product packaging, websites, and social media. Products like tianeptine, phenibut, and others mentioned are not FDA-approved drugs and cannot be marketed as such.
Requirements
Do not claim your supplement treats, cures, or prevents any disease or medical condition unless FDA-approved.
Avoid describing your product as an antidepressant, anxiolytic, or similar drug.
Do not promote unapproved substances like tianeptine or phenibut as safe or effective treatments.
Ensure all health claims comply with FDA regulations and TikTok policies.
Why it matters
Making unapproved health claims can lead to enforcement actions, product removal, and damage to your seller reputation.
All TikTok Shop sellers listing supplements and creators promoting health-related products
You cannot make unapproved medical claims about supplements, such as stating they treat depression or anxiety, on social media or product pages. Claims that a supplement acts like a prescription drug or affects brain chemistry must be backed by FDA approval. Sellers must avoid suggesting their products have drug-like effects without authorization.
Requirements
Do not claim supplements treat or cure medical conditions like depression or anxiety.
Avoid stating supplements have drug-like effects or alter brain chemistry unless FDA-approved.
Ensure all health claims comply with FDA regulations and are not misleading.
Why it matters
Making unapproved health claims can lead to enforcement actions, product removal, and damage to your business reputation.
All TikTok Shop sellers and creators who have made drug-related claims on their social media platforms.
Any drug claims made on your social media posts remain accessible to viewers even if they were posted years ago. These claims can still be reviewed and may be subject to regulatory action regardless of when they were originally published.
Requirements
Do not post unapproved drug claims on social media.
Remove or update any past posts that make unapproved drug claims.
Ensure all health-related claims comply with FDA regulations at all times.
Why it matters
Old posts with unapproved drug claims can lead to regulatory warnings or enforcement actions, affecting your business reputation and ability to sell.
All TikTok Shop sellers listing supplements that make health or medical claims, especially for products like Phenibut and PEA capsules.
You cannot make medical or health claims about supplements like Phenibut or PEA that suggest they treat or cure conditions such as anxiety, ADHD, or depression unless these claims are approved by the FDA. Describing these products as having effects on the brain or treating medical conditions is not allowed without proper authorization.
Requirements
Do not claim supplements can treat, cure, or prevent diseases or medical conditions.
Avoid describing supplements as having specific medical benefits without FDA approval.
Remove or avoid unverified health claims in product descriptions and promotions.
Why it matters
Making unauthorized health claims can lead to enforcement actions, including removal of listings or account penalties.
All TikTok Shop sellers and creators promoting supplements with health-related claims on social media.
You cannot make unapproved medical claims about your supplements on social media, such as saying they relieve anxiety or improve sleep, unless these claims are approved by the FDA. This includes statements on product images and descriptions that suggest health benefits without FDA approval.
Requirements
Do not claim your supplement treats or cures medical conditions like anxiety or sleep disorders unless FDA-approved.
Avoid using language that implies your product has therapeutic effects.
Ensure all health claims are supported by FDA authorization before posting.
Remove or correct any existing posts that make unapproved health claims.
Why it matters
Making unapproved health claims can lead to enforcement actions, including warnings or removal of your listings, which can harm your business reputation and sales.
All TikTok Shop sellers listing dietary supplements or health-related products
You cannot make unapproved health claims about supplements on TikTok Shop, such as stating they treat diseases or have specific medical benefits without FDA approval. Claims like fat burning, cognitive enhancement, or treating conditions like Alzheimer's or PTSD are not allowed unless officially authorized. This rule ensures that sellers do not mislead consumers with unsupported medical claims.
Requirements
Do not claim your supplement treats, cures, or prevents any disease.
Avoid stating your product has specific medical benefits like fat burning or cognitive enhancement unless FDA-approved.
Do not promote supplements as treatments for mental health conditions or serious illnesses.
Ensure all health claims comply with FDA regulations and TikTok policies.
Why it matters
Violating this rule can lead to enforcement actions, removal of listings, or account penalties due to misleading or illegal health claims.
All TikTok Shop sellers listing dietary supplements or health-related products
You cannot make unapproved medical or health claims about supplements on TikTok Shop, such as stating they treat or cure diseases like depression, anxiety, or Alzheimer's. Claims must be truthful and comply with FDA regulations. Sellers should avoid suggesting their products have therapeutic effects unless officially approved.
Requirements
Do not claim your supplement treats, cures, or prevents diseases.
Avoid making medical claims about improving symptoms of mental health conditions without FDA approval.
Do not describe your product as a treatment for addiction or neurodegenerative diseases unless authorized.
Ensure all health-related claims are supported by approved scientific evidence and comply with FDA rules.
Why it matters
Making unapproved health claims can lead to enforcement actions, product removal, or account penalties on TikTok Shop.
All TikTok Shop sellers listing supplements or health-related products making disease-related claims
You cannot claim that supplements or similar products can prevent, treat, or cure diseases unless the product is approved by the FDA as a drug. Making unapproved health claims about your products is illegal and can lead to enforcement actions. You must ensure your product claims comply with FDA regulations.
Requirements
Do not claim your product can prevent, treat, or cure diseases unless FDA-approved as a drug.
Avoid making unsubstantiated health claims about your products.
If making health claims, ensure you have FDA approval or scientific evidence as required.
Respond promptly to any FDA warnings or enforcement notices.
Why it matters
Violating these rules can lead to product seizures, injunctions, and other legal enforcement actions that can harm your business.
All TikTok Shop sellers and creators who have made drug claims on their social media platforms.
Any drug claims made on your social media posts remain visible and accessible to visitors, even if the posts were made years ago. This means old posts with unapproved drug claims can still cause compliance issues. Sellers must ensure that all accessible content complies with regulations, regardless of when it was posted.
Requirements
Remove or update any social media posts with unapproved drug claims.
Ensure all accessible content complies with FDA regulations.
Monitor and manage historical posts that remain publicly visible.
Why it matters
Old posts with unapproved drug claims can lead to regulatory action and harm your business reputation.
All TikTok Shop sellers and creators promoting supplements or health products making drug claims.
The FDA reviewed the Umbrella website and found that it directs consumers to other websites making unapproved drug claims about supplements. Such claims are not allowed unless the products are approved by the FDA. Sellers must avoid making drug claims about supplements on their websites or linked sites.
Requirements
Do not make or promote unapproved drug claims about supplements.
Ensure your website and any linked sites do not contain such claims.
Only make claims that are supported and approved by the FDA.
Why it matters
Violating FDA rules can lead to warning letters, legal action, and removal of your listings or accounts.
Companies and sellers marketing supplements online, particularly those making health or disease claims across multiple websites or sales channels
The FDA reviewed a website making unauthorized drug claims about supplement products and issued a warning letter. The company was directing consumers to multiple websites that appeared to market these products with unsubstantiated health claims.
Requirements
Do not make unsubstantiated drug claims about supplements on your website or marketing materials
Do not direct consumers across multiple websites to amplify product claims
Ensure any health claims about supplements are truthful and not presented as drug treatments
Why it matters
The FDA actively monitors online supplement marketing and will issue warning letters for violations, which can lead to enforcement action, product seizure, or legal penalties.
All TikTok Shop sellers listing dietary supplements or products marketed as supplements, especially those containing active pharmaceutical ingredients.
The FDA found that the product "Alpha Male Plus" contains an undeclared prescription drug ingredient, tadalafil, which is unsafe and illegal to sell as a dietary supplement. Selling products with hidden prescription drugs or unapproved new drugs is against federal law. Sellers must not market supplements that contain undeclared or unapproved drug ingredients.
Requirements
Do not include undeclared prescription drug ingredients in your products.
Do not market unapproved new drugs as dietary supplements.
Ensure all product labeling accurately reflects the ingredients.
Avoid selling products that could pose health risks due to hidden drug ingredients.
Why it matters
Violating these rules can lead to FDA warnings, product seizures, and legal action, harming your business reputation and ability to sell on TikTok Shop.
All TikTok Shop sellers listing dietary supplements containing ingredients that are also approved drugs
You cannot sell dietary supplements that contain ingredients approved as new drugs unless those ingredients were marketed as supplements or food before drug approval. For example, a supplement containing tadalafil (the active ingredient in Cialis) is not allowed unless it was sold as a supplement before being approved as a drug.
Requirements
Do not include any ingredient in a supplement that is an FDA-approved new drug unless it was marketed as a supplement or food before drug approval
Label products accurately and avoid making drug claims for supplements
Ensure your product ingredients comply with FDA regulations for dietary supplements
Why it matters
Violating this rule can lead to FDA enforcement actions and removal of your listings, harming your business reputation and sales.
All TikTok Shop sellers listing dietary supplements, especially those making health-related claims.
Products marketed as dietary supplements cannot make claims that they diagnose, cure, treat, or prevent diseases, or affect the body's structure or function, unless they are approved as drugs. The product "Alpha Male Plus" is considered a drug because it claims to treat erectile dysfunction and other health issues, which is not allowed for supplements without FDA approval.
Requirements
Do not claim your supplement can diagnose, cure, treat, or prevent diseases.
Avoid claims that your product affects the body's structure or function unless FDA-approved as a drug.
Ensure your product is not on the FDA's list of tainted supplements.
Remove or revise any labeling or marketing that makes drug-like claims.
Why it matters
Making unapproved drug claims can lead to FDA enforcement actions and removal of your listings, harming your business reputation and sales.
All TikTok Shop sellers listing male enhancement supplements or similar health products
This rule means you cannot make unapproved drug claims about supplements, such as stating they treat or prevent medical conditions like erectile dysfunction, unless the product is FDA-approved for those claims. Marketing a supplement as a treatment for diseases without FDA approval is prohibited.
Requirements
Do not claim your supplement treats or prevents medical conditions like erectile dysfunction.
Only make claims that are supported and approved by the FDA.
Avoid language that implies your product is a drug or has proven medical benefits without FDA approval.
Why it matters
Making unapproved drug claims can lead to enforcement actions, removal of listings, and damage to your seller reputation.
If you sell kratom products, you cannot make claims that describe them as drugs or treatments for health conditions like erectile dysfunction or prostate issues. The FDA views such claims as evidence that your product is intended to be a drug rather than a dietary supplement, which triggers strict regulatory requirements you likely cannot meet.
Requirements
Do not claim kratom prevents, treats, or cures diseases or medical conditions
Do not claim kratom improves sexual performance or treats erectile dysfunction
Do not claim kratom prevents or slows prostate growth
Marketing that describes health benefits can cause the FDA to classify your product as an unapproved drug
Why it matters
Making drug claims about kratom products can result in FDA warning letters, product seizures, and your business being shut down for selling unapproved drugs.
Sellers offering kratom products, botanical supplements, and herbal products marketed with health or therapeutic claims.
The FDA prohibits marketing kratom and similar botanical products with unsubstantiated disease or health claims, such as treating anxiety, depression, chronic pain, erectile dysfunction, or addiction withdrawal. Products marketed with these types of claims are considered unapproved drugs rather than dietary supplements, which violates federal law.
Requirements
Do not claim kratom or herbal products treat, cure, or alleviate diseases (anxiety, depression, pain, erectile dysfunction, addiction withdrawal, etc.)
Do not claim products provide drug-like therapeutic effects without FDA approval
Do not use language suggesting medical benefits or efficacy even if framed casually ("helps with," "excellent for," etc.)
Why it matters
Unsubstantiated health claims transform your product into an illegal drug under FDA law, triggering warning letters, forced removal from platforms, and potential legal action.
Sellers offering kratom (Mitragyna Speciosa) products online or through e-commerce platforms
You cannot make health claims about kratom products that suggest they treat, manage, or cure medical conditions like pain, opioid withdrawal, or sleep issues. The FDA considers such claims to classify kratom as a drug, which requires regulatory approval. Making these claims without proper FDA authorization violates federal law.
Requirements
Do not claim kratom can treat, manage, or provide relief from pain, sleep disorders, or opioid withdrawal
Do not describe kratom as having drug-like effects (sedative, stimulant, or psychoactive properties)
Do not make medical benefit claims even if preceded by phrases like "is known for" or "is said to"
Remove all therapeutic or medical use language from product listings and websites
Why it matters
Violating these rules can trigger FDA enforcement action including warning letters, product seizure, or legal prosecution, as demonstrated by this actual FDA warning to kratom sellers.
Sellers marketing nootropic products, kratom, and supplement powders on e-commerce sites and social media
You cannot market nootropic or supplement products (like Tianeptine, kratom, or NAC powder) using drug claims that promise to treat, cure, or significantly manage medical conditions like anxiety, depression, stress, pain, sleep disorders, or addiction. The FDA considers these claims proof that your product is an unapproved drug, not a supplement, which violates federal law.
Requirements
Do not claim your product treats, reduces, or cures anxiety, depression, stress, sadness, or other medical conditions
Do not claim immediate or long-term therapeutic effects (e.g., "reduces feelings of stress")
Do not market sedative effects, sleep improvement, pain relief, or addiction treatment benefits
Avoid language like "mood brightener," "wellness," or medical benefit language—stick to general structure/function claims only
Why it matters
FDA warning letters result in product seizure, account suspension, legal action, and permanent reputational damage—companies making drug claims without FDA approval face enforcement action.
Supplement and nootropic sellers marketing products on websites and social media platforms like Instagram
You cannot market dietary supplements or nootropics as treatments, preventatives, or symptom relievers for serious diseases like COVID-19. The FDA has authority to warn and take action against companies that make unproven drug claims about supplements on product pages or social media, even if the claims reference scientific research.
Requirements
Do not claim supplements can "mitigate," "prepare for," "prevent," or reduce symptoms of COVID-19 or other serious diseases
Do not claim supplements offer "defense" against disease-caused damage or viral replication
Do not make therapeutic claims about mood, cognition, or disease effects without proper FDA approval
Avoid marketing language that frames supplements as disease-fighting treatments, even indirectly
Why it matters
Violating these rules can result in FDA warning letters, forced removal of listings, account suspension, and legal liability for making unapproved drug claims.
Supplement sellers and marketers promoting products on social media, websites, or other channels
You cannot claim that dietary supplements prevent, treat, mitigate, or cure COVID-19 or any disease without FDA approval or authorization. Making these claims—whether on product pages, social media, or marketing materials—violates federal law and puts consumers at risk by promoting unproven treatments.
Requirements
Do not claim your supplement prevents, treats, mitigates, diagnoses, or cures COVID-19 or any disease
Do not link supplement use to disease protection or symptom relief (e.g., "protects from COVID-19 symptoms")
Do not make disease claims even if framed as educational or scientific (e.g., "improves defense from COVID-19 induced oxidation")
Be aware that some supplement ingredients (like tianeptine) may be unapproved drugs in the U.S. and subject to FDA enforcement
Why it matters
FDA actively enforces against disease claims for supplements and can issue warning letters, demand corrective action, or pursue legal enforcement, which can result in product seizure and significant business disruption.
Sellers and creators marketing SARM products (including GW-501516, MK-2866, MK-677, RAD-140, S-4 Andarine, and similar compounds) on any platform including websites, Instagram, TikTok, or other social media.
SARMs (Selective Androgen Receptor Modulators) are not approved by the FDA and cannot be legally sold for human use due to serious safety risks including liver toxicity, heart attack, and stroke. Even if you label a SARM product as "research only" or "not for human consumption," the FDA will treat it as an illegal drug if your marketing, website, or social media posts describe health or performance benefits for people.
Requirements
Do not market, sell, or distribute SARMs for human use in any form
Do not make claims that SARMs treat health conditions, build muscle, increase testosterone, or provide any human health benefit
Do not use "research only" or "not for human consumption" disclaimers as a workaround to sell SARMs
Do not promote SARMs on social media or your website, even indirectly through blog posts or educational content that suggests human use benefits
Why it matters
Selling SARMs violates FDA law and exposes your business to warning letters, product seizure, and potential criminal enforcement; platforms like Instagram and TikTok will remove your account and listings for promoting unapproved drugs.
Sellers and creators promoting SARM (selective androgen receptor modulator) products on social media platforms like Facebook and Instagram
You cannot market SARM products (like GW 501516 Cardarine or RAD-140 Testolone) by claiming they affect body structure or function, either directly or through customer testimonials. The FDA treats these products as unapproved drugs when marketed with such claims, regardless of the delivery method (like sublingual absorption).
Requirements
Do not make claims that SARMs affect the structure or function of the human body
Do not endorse or promote customer testimonials that describe SARMs being used to target muscles, bones, or other body systems
Do not include instructional content on how to use SARMs to achieve physiological effects (including sublingual administration techniques)
Do not market specific SARM compounds like GW 501516 or RAD-140 with performance or body-composition claims
Why it matters
Violating this rule can result in FDA warning letters, product seizure, and legal action against you and your business for marketing unapproved drugs.
Supplement sellers, particularly those selling SARMs and research chemicals on social media platforms like Facebook and Instagram
You cannot like, endorse, or promote customer testimonials on social media that describe using supplement products (like SARMs) to change how the body looks or functions. If customers post comments claiming muscle gains or physical transformations from your products, engaging with those posts by liking or promoting them is a violation.
Requirements
Do not like or endorse testimonials claiming products affect body structure or function
Do not promote customer comments describing physical transformations or health benefits
Do not engage with posts that imply products are used for muscle gain, body composition, or other physiological effects
Remove or distance your brand from user-generated content making medical or functional claims about your products
Why it matters
Endorsing testimonials that make drug-like claims about supplements violates FDA regulations and can result in warning letters, forced removal of products, or legal action against your company.
All TikTok Shop sellers and creators promoting supplements or products like SARMs on social media or websites linked to TikTok Shop listings.
This FDA warning letter highlights that promoting SARMs (Selective Androgen Receptor Modulators) and similar substances with claims about muscle growth and energy on social media and websites is not allowed without FDA approval. Such claims can make the products be considered unapproved drugs. Sellers must avoid making drug claims about supplements on TikTok or linked websites.
Requirements
Do not make drug claims about supplements or SARMs, such as muscle growth or energy enhancement.
Avoid directing consumers to websites that promote unapproved drugs.
Ensure product claims comply with FDA regulations and do not imply the product treats or prevents disease.
Remove or correct any promotional content that violates FDA rules.
Why it matters
Violating FDA rules can lead to warning letters, product removal, or legal action, harming your business and reputation.
Sellers and creators promoting or selling SARMs (like mk-677, rad-140, ostarine), kratom products, tianeptine, nootropics, and other compounds not approved by the FDA as safe and effective drugs
The FDA prohibits selling unapproved drugs—including SARMs, kratom products, nootropics, and other compounds that lack FDA safety and effectiveness approval—either directly or through social media. These products cannot be legally sold or promoted unless they have gone through the FDA drug approval process and received explicit authorization.
Requirements
Do not sell, offer for sale, or deliver these unapproved products across state lines (interstate commerce)
Do not make claims that these products treat, cure, or provide therapeutic benefits
Do not use social media posts, testimonials, or transformation claims to promote these products
No approved FDA applications exist for SARMs, kratom marketed for drug uses, or other listed compounds
Why it matters
Selling or promoting unapproved drugs violates federal law and can result in FDA enforcement action, product seizure, account suspension, and legal penalties.
Sellers offering supplements, SARMs, kratom, nootropics, or performance-enhancing products on social media or e-commerce platforms
You cannot sell products containing undeclared pharmaceutical ingredients (like tadalafil or SARMs) or products that require prescription use without FDA approval. Products claiming to treat medical conditions must include proper warnings and cannot be sold as dietary supplements if they actually function as drugs.
Requirements
Do not sell prescription-only drugs or compounds (like SARMs, tadalafil, other PDE-5 inhibitors) without FDA approval and proper licensing
Disclose all active ingredients on product labels, especially pharmaceutical compounds
Include adequate warnings about serious health risks and potential drug interactions
Do not claim products treat conditions that require medical diagnosis and are unsafe for self-treatment
Why it matters
Selling misbranded or unapproved drug products exposes you to FDA enforcement action, product seizure, and legal liability; hidden pharmaceutical ingredients can seriously harm or kill consumers.
Entities or individuals involved in pharmaceutical quality operations or those who received this FDA letter.
This document is a formal communication from the FDA regarding compliance issues related to pharmaceutical quality operations. It provides contact information for further questions about the letter. It does not specify any direct rules or requirements for sellers or creators.
Requirements
Contact the FDA Compliance Officer for any questions regarding the letter.
No specific product or listing requirements are detailed in this excerpt.
No direct instructions for TikTok sellers or creators are provided.
Why it matters
Understanding and responding to FDA communications is important to avoid regulatory actions that could impact your business.
Sellers or creators making health-related claims about COVID-19, especially regarding supplements or drugs.
This FDA warning letter addresses concerns about claims related to COVID-19 and requires the recipient to respond in writing within 15 working days detailing how they will fix the violations and prevent them from happening again. Failure to respond or comply may lead to legal actions such as seizure of products or injunctions.
Requirements
Respond in writing within 15 working days of receiving the letter.
Explain the specific steps taken to correct violations.
Describe measures to prevent future violations.
Provide copies of related documentation.
Why it matters
Ignoring this warning can lead to serious legal consequences including product seizure and injunctions, which can harm your business.
