This rule classifies nonprescription sunglasses as general devices designed to protect eyes from sunlight, not for vision correction. They can be sold over-the-counter and do not need to go through premarket approval.
Requirements
Sunglasses must have frames or clips with protective lenses.
They cannot provide vision correction.
They can be sold without premarket notification.
They are classified as a Class I device, meaning minimal regulation.
Why it matters
Understanding this classification helps sellers navigate regulatory requirements and avoid unnecessary approval processes.
All TikTok Shop sellers listing nonprescription sunglasses.
This FDA guidance provides rules for nonprescription sunglasses, explaining how they should be marketed and what safety standards they must meet. It ensures that sunglasses sold without a prescription protect consumers' eyes properly.
Requirements
Sunglasses must meet FDA safety and labeling standards.
They should not be marketed with unapproved medical claims.
Proper labeling about UV protection and usage must be included.
Why it matters
Following these rules helps avoid regulatory issues and ensures customer trust in your sunglass products.
Manufacturers and sellers of nonprescription sunglasses
This is an FDA guidance document for nonprescription sunglasses issued in 1998. However, the policy text and specific requirements are not included in your submission — only navigation menus and document headers are present.
Requirements
Unable to determine — the actual policy requirements are not included in the text provided. You have only shared the document cover page and navigation elements.
Why it matters
FDA compliance is essential for legally selling optical devices, but the specific requirements cannot be extracted from the text provided.
Anyone interested in the FDA's guidance on nonprescription sunglasses, including sellers, manufacturers, and the public.
This policy explains that anyone can send comments or suggestions about the FDA's guidance on nonprescription sunglasses at any time. However, the FDA will only consider these comments when they update or revise the guidance document. If you have questions about the guidance, you can contact a specific FDA representative.
Requirements
You may submit comments or suggestions anytime to the FDA's Division of Ophthalmic Devices.
Comments will only be reviewed when the guidance document is next updated.
For questions about the guidance, contact Everette Beers, Ph.D., at the provided phone number or email.
Why it matters
Understanding this process helps sellers know how to provide feedback or get clarification on FDA rules that might affect their sunglass products.
Sellers and manufacturers of nonprescription sunglasses seeking FDA guidance
This policy explains how to obtain additional copies of the FDA guidance document for nonprescription sunglasses. You can download it online or request a copy by email using the document number 2208. It also provides contact information for questions or to submit comments.
Requirements
You can get additional copies from the internet.
Email [email protected] with document number 2208 to request a copy.
Submit comments or questions to the provided contacts for consideration or clarification.
Why it matters
Having access to the official FDA guidance helps ensure your products comply with regulatory expectations and reduces risk of non-compliance.
All manufacturers, importers, distributors, and sellers of nonprescription sunglasses in the United States.
In the U.S., nonprescription sunglasses are regulated by the FDA as low-risk medical devices but do not require premarket notification. However, they must still meet general safety and labeling requirements. Certain limitations apply to their exemption from some regulations.
Requirements
Nonprescription sunglasses are classified as Class I medical devices.
Premarket notification (510(k)) is not required unless the device poses significant health risks.
Sunglasses must comply with general controls applicable to Class I devices, including impact resistance and labeling requirements.
Limitations on exemption must be followed to avoid regulatory violations.
Why it matters
Understanding these rules helps sellers ensure compliance and avoid enforcement actions while marketing nonprescription sunglasses.
Manufacturers, distributors, importers, and sellers of Class I nonprescription sunglasses, including clip-ons, marketed as over-the-counter devices for casual or recreational use.
This FDA guidance explains the rules for nonprescription sunglasses, which are over-the-counter sunglasses worn for fashion or general recreation. It clarifies which types of eyewear are covered and which are not, and reminds sellers and manufacturers to comply with all relevant laws. The guidance helps ensure these sunglasses meet FDA standards.
Requirements
Applies only to Class I nonprescription sunglasses and clip-ons.
Does not apply to industrial, prescription, reading, or sport protective eyewear.
Sellers must comply with FDA regulations and other applicable federal laws.
Nonprescription sunglasses and sunglasses are treated as the same under this guidance.
Why it matters
Following this guidance helps avoid regulatory issues and ensures products meet FDA safety and labeling standards.
Manufacturers, distributors, importers, and sellers of nonprescription sunglasses and related ophthalmic devices.
This section defines key terms related to nonprescription sunglasses, such as manufacturers, distributors, and device classifications. It clarifies what nonprescription sunglasses are and how they are regulated under FDA rules. These definitions help sellers and creators understand the regulatory framework for these products.
Requirements
Nonprescription sunglasses are defined as eyewear that reduces sunlight but does not correct vision.
Manufacturers include anyone who designs or assembles the finished device.
Wholesale distributors and initial importers have specific roles in the supply chain.
Nonprescription sunglasses are Class I devices subject to general FDA controls but may be exempt from premarket notification.
Why it matters
Understanding these definitions helps sellers comply with FDA regulations and correctly classify their products to avoid enforcement issues.
Manufacturers and sellers of nonprescription sunglasses in the United States.
If you manufacture or sell nonprescription sunglasses, the FDA requires that your products meet certain safety and quality standards. This includes using impact-resistant lenses, nonflammable and biocompatible materials, and ensuring the optical properties match what you advertise. Following recognized standards like ANSI and ISO helps ensure compliance.
Requirements
Sunglasses must have impact-resistant lenses compliant with FDA regulations (21 CFR 801.410).
Materials used should be nonflammable according to federal standards.
Materials must be non-toxic, non-irritating, and unlikely to cause allergic reactions.
Optical properties (e.g., UV blocking, polarization) must match product labeling and advertising.
Why it matters
Complying with these requirements helps avoid regulatory action and ensures product safety and consumer trust.
All TikTok Shop sellers listing nonprescription sunglasses
This rule says that nonprescription sunglasses should meet certain recognized standards for optical properties like light transmission and impact resistance. These standards help ensure the sunglasses are safe and effective, including for color-deficient users. Following these standards is considered good manufacturing practice.
Requirements
Must conform to recognized standards such as ANSI Z80.3 and ISO 14889 for optical properties and impact resistance.
Standards cover light transmittance, refractive properties, and traffic signal recognition.
Impact resistance must meet ANSI Z80.3 Section 5.1 requirements.
Flammability requirements also apply as per ANSI standards.
Why it matters
Meeting these standards helps ensure product safety and compliance, reducing risk of enforcement or customer complaints.
All sellers and manufacturers of nonprescription sunglasses in the United States.
This rule explains that the "label" refers to the information physically on the nonprescription sunglasses themselves, while "labeling" includes the label plus any accompanying informational materials. It outlines that nonprescription sunglasses are regulated as medical devices by the FDA and must follow specific labeling requirements.
Requirements
Labels must be on the device itself.
Labeling includes all descriptive and informational literature accompanying the device.
Nonprescription sunglasses are regulated as medical devices by the FDA's CDRH.
Labeling must comply with FDA guidance specific to nonprescription sunglasses.
Why it matters
Proper labeling ensures compliance with FDA regulations, helping avoid enforcement actions and ensuring product legitimacy.
All TikTok Shop sellers listing nonprescription sunglasses
This rule explains that the label on nonprescription sunglasses is the information physically on the product, while labeling includes all related information like brochures or displays. It requires that labels and labeling clearly state the product's name, place of business, intended use, proper usage instructions, and avoid false or misleading statements. Important labeling statements must be prominent and easy to see.
Requirements
Labels must include the product name and place of business.
Labels and labeling must clearly state the intended uses.
Provide adequate directions for use.
Avoid false or misleading statements.
Important labeling statements must be prominent and easy to read.
Why it matters
Proper labeling ensures compliance with FDA rules and helps avoid product misrepresentation or listing removal.
All TikTok Shop sellers listing nonprescription sunglasses
This rule requires that nonprescription sunglasses have clear and accurate labeling on their packaging. The label must show the product identity, the amount inside, and must not include false or misleading information. Directions for use should be clear unless the product has commonly known uses exempting it from detailed instructions.
Requirements
Labels must include a clear statement of the product identity.
Labels must declare the net quantity of the product.
Labels must not contain false or misleading statements.
Directions for use must be adequate unless exempted due to commonly known uses.
Why it matters
Proper labeling ensures compliance with FDA rules, helping avoid product removal or penalties and building customer trust.
All TikTok Shop sellers listing eyeglasses and sunglasses products.
This rule requires that eyeglasses and sunglasses use impact-resistant lenses to ensure safety and quality. It also defines when a device is considered adulterated if it does not meet quality standards. Sellers must provide clear product identity and net quantity information.
Requirements
Eyeglasses and sunglasses must have impact-resistant lenses.
Products must include a clear statement of identity.
Products must declare net quantity.
Products failing to meet quality standards are considered adulterated and not allowed.
Why it matters
Non-compliance can lead to product removal, legal issues, and harm to customers, affecting your business reputation and sales.
All TikTok Shop sellers listing nonprescription sunglasses
This rule means that sunglasses sold must meet the quality and safety claims made about them. If a sunglass product claims to block certain UV rays or meet impact resistance standards but does not, it is considered adulterated and violates the law. Sellers must ensure their products honestly represent their features and comply with relevant regulations.
Requirements
Sunglasses must meet all quality and safety claims made on their labeling.
Products claiming impact resistance must comply with impact resistant lens regulations.
Sunglasses claiming to block 100% UVA, UVB, and UVC must actually do so.
Sellers must not make false or misleading claims about their sunglasses' features.
Why it matters
Non-compliance can lead to legal violations and removal of listings, harming your business reputation and sales.
All TikTok Shop sellers listing nonprescription sunglasses
This rule says that nonprescription sunglasses must not have false or misleading labels or advertising. Claims about the sunglasses must be truthful, complete, and not create a false impression. Also, the sunglasses must meet quality standards, such as using impact-resistant lenses if claimed.
Requirements
Do not make unsubstantiated therapeutic or performance claims.
Avoid ambiguous, incomplete, or deceptive labeling or advertising.
Disclose all material facts about the product.
Ensure sunglasses meet quality standards, including impact resistance if claimed.
Why it matters
Violating these rules can lead to legal issues and removal of your listings for misbranding or adulteration.
All TikTok Shop sellers listing nonprescription sunglasses
Sunglasses must be labeled accurately based on their ability to block UV light, reduce glare, and meet safety standards. Claims about UV protection, glare reduction, impact resistance, and suitability for driving must be supported by recognized standards or testing. Unsubstantiated or false claims can lead to FDA warnings or enforcement.
Requirements
You must label sunglasses with accurate UV protection claims if they meet ANSI Z80.3 standards.
You may claim glare reduction if lenses have appropriate properties.
Impact resistance claims must state compliance but clarify they are not shatterproof.
Sunglasses not meeting driving safety standards must carry a caution label stating "not for use while driving."
Why it matters
Making unsubstantiated claims can lead to FDA warnings and removal of your listings, harming your business reputation and sales.
Manufacturers and sellers of OTC nonprescription sunglasses
Sunglasses sold over-the-counter don't legally require detailed directions for use because most people know how to use them, but manufacturers can optionally include guidance on selection, fit, and usage warnings. If sunglasses don't meet driving safety standards, they must be clearly labeled "CAUTION: not for use while driving."
Requirements
Directions for use are not mandatory but are permitted
Sunglasses must meet federal impact resistance requirements and be labeled accordingly (not shatterproof)
Sunglasses unsafe for driving (failing ISO-14889 section 4.5 or ANSI Z80.3-1996 section 4.6.3) must include "CAUTION: not for use while driving" label
Optional warnings should address risks like night driving, high-impact sports, industrial use, and direct sun exposure
Why it matters
Proper labeling protects your customers from injury, reduces liability risk, and ensures compliance with FDA regulations for sunglasses safety.
All TikTok Shop sellers listing nonprescription sunglasses
This rule explains that nonprescription sunglasses must comply with various federal laws and regulations, including impact resistance standards, labeling, and manufacturing practices. Sunglasses lenses must meet impact resistance requirements but are not shatterproof. It also warns consumers not to stare directly at the sun or an eclipse, even when wearing sunglasses.
Requirements
Sunglasses lenses must meet federal impact resistance standards.
Sunglasses are not shatterproof and should not be used to stare directly at the sun or an eclipse.
Products must comply with labeling, registration, and manufacturing regulations under the FD&C Act and related laws.
Flammability requirements and other safety standards apply as specified in federal regulations.
Why it matters
Noncompliance can lead to product recalls, legal penalties, and harm to customers, affecting your business reputation and sales.
All TikTok Shop sellers listing nonprescription sunglasses and fashion eyewear.
This policy outlines voluntary national and international standards for nonprescription sunglasses, including safety, optical quality, and labeling requirements. It references specific standards for lens performance, flammability, medical device regulations, and country of origin marking. Sellers should ensure their sunglasses meet these standards to comply with FDA guidance.
Requirements
Follow ANSI Z80.3-1996 for nonprescription sunglasses and fashion eyewear requirements.
Comply with ISO standards 8980-3, 14889, and 10993 for lens quality and safety.
Adhere to flammability requirements under the Federal Hazardous Substances Act (15 USC Sections 1261 and 1263).
Include country of origin marking as required by the Tariff Act of 1930 (19 USC Section 1304).
Why it matters
Meeting these standards helps avoid regulatory issues and ensures product safety and consumer trust.
Manufacturers, sellers, and stakeholders involved with nonprescription sunglasses and fashion eyewear.
This rule explains that anyone can submit comments on the FDA guidance for nonprescription sunglasses at any time, either online or by mail. It also references specific standards related to sunglasses and eyewear that are relevant to the guidance. If you cannot submit comments online, you can send them by mail.
Requirements
You may submit comments on the FDA guidance online or in writing at any time.
If unable to submit online, mail written comments to the specified address.
The guidance references standards like ANSI Z 80.3-1996 and ISO standards related to sunglasses and lenses.
Why it matters
Submitting comments can influence FDA guidance, which affects product compliance and market access.
Anyone submitting written comments on the FDA guidance for nonprescription sunglasses who cannot submit online.
If you want to submit written comments about the FDA guidance on nonprescription sunglasses and cannot do so online, you must mail them to the FDA's Dockets Management office. All mailed comments must include the docket number FDA-2020-D-0957 to be properly identified.
Requirements
If unable to submit comments online, mail them to the FDA Dockets Management at 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.
Include the docket number FDA-2020-D-0957 on all written comments.
Why it matters
Properly submitting comments ensures your feedback is considered by the FDA regarding nonprescription sunglasses guidance.
TikTok Shop sellers offering medical devices and medical supplies, including items in Baby & Maternity, Beauty & Personal Care, Sports & Outdoor, and Health categories.
To sell medical devices and medical supplies on TikTok Shop, you must submit documentation for qualification review. Different requirements apply depending on your role (manufacturer, importer, repacker, or reseller). Some products are prohibited entirely, while others are only available to approved sellers.
Requirements
Submit documentation through the Qualification Center for review before listing
Class III medical devices and prescription-only products are prohibited
Some devices (glucose monitors, blood pressure monitors, fertility tests, pregnancy tests) are only available to invite-only sellers
Comply with both Medical Devices requirements and the Restricted Products Policy
Why it matters
Failure to qualify or selling prohibited items will result in delisting and potential account suspension; qualification approval determines whether you can legally sell these products.
