Planning to import sunglasses and other non-prescription eyewear to the United States? In this article, we explain what you must know about FDA regulations, labeling requirements, lab testing, and much more.
- Children’s sunglasses
- Safety spectacles
- Welding shields
- Laser safety goggles
21 CFR (FDA): Sunglasses
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are categorized as medical devices by the FDA in the US, thus those products manufactured, imported and sold in the US market should comply with the applicable FDA (Food and Drug Administration) regulations.
According to the FDA, eyewear products importers should adhere to the following requirements:
a. Manufacturers and importers must register their establishment with the FDA. This process is known as establishment registration 21 CFR 807
b. Foreign companies must register their establishment with FDA and name a United States Agent
c. Manufacturers must list their devices with FDA
d. Manufacturers must meet the Quality System (QS) requirements set forth in 21 CFR 820
e. The lens for spectacles and/or sunglasses must be certified as impact resistant under 21 CFR Part 801.410
Also, sunglasses, spectacle frames, spectacle lens, and magnifying spectacles may be exempt from 510K Premarket Notification.
Also, the FDA requires that importers of sunglasses and other eyewear must list all the product categories and devices produced by the company.
Manufacturers should submit the device listing to the FDA with the following information:
- Classification Name
- Classification Product Code
- Title 21 CFR
|Classification Name||Classification Product Code||Title 21 CFR|
Quality System Requirements
FDA may require certain types of eyewear products manufactured in or imported to the US comply with the Quality System Regulation, which covers the aspect of designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.
The American National Standards Institute (ANSI) oversees the development of voluntary consensus standards for products, services in the US. ANSI harmonize U.S. standards with international standards in order to facilitate the circulation of American products worldwide.
ANSI Z80.3-2018 mandates that sunglasses manufactured, imported and sold in the US must perform UV and visible light transmittance lab-tests.
Unique Device Identification (UDI)
By order of the FDA, any pair of frames, pair of sunglasses, OTC reader, or other Class I medical device, label, or package must bear a unique UDI (Unique Device Identification) so that regulators can identify each model and monitor its distribution and usage.
UDI consists of numeric and alphabetic combinations. Each device, label, and package requires its own Unique Device Identification. You can also learn more about UDI here.
Companies such as QIMA offer lab testing services for sunglasses and other eyewear products, helping you confirm if your products are compliant with all mandatory product standards and regulations. We recommend that you book lab testing prior to import the products to the USA.
Third-party 21 CFR testing generally starts from around $400 to $500 per sunglass SKU or other eyewear products. Note that the testing cost also depends on the type of eyewear and its usage.
Sunglasses manufactured outside the United States, for example in China and other Asian countries, are not by default designed to comply with FDA requirements. It’s therefore important to carefully select suppliers that have a verified track record manufacturing sunglasses and other eyewear for the US market.
Also, note that non-compliant sunglasses are frequently sold on dropshipping and other cross-border e-commerce websites. Do not assume that all sunglasses and eyewear available for delivery to the United States are ‘FDA compliant’.
OSHA Regulations: Safety Glasses
The Occupational Safety and Health Act (OSH Act) mandates that employers must provide their workers with a safe working environment that does not pose serious threats to them and ensure the affected personnel’s physical safety at worksite by providing the necessary protective equipment such as safety spectacles, goggles, masks, gloves, or earplugs, to prevent the harms brought by chemical exposure, falls or any other hazards from using dangerous devices.
If you are importing eyewear for protection purposes to the US market, then your products are subject to the OSHA regulation.
OSHA recommends that employers take steps to prevent injuries from the following articles befalling their workers:
- Flying particles
- Molten metal
- Liquid chemicals
- Chemical vapors
- Injurious light radiation
According to OSHA, employers are obligated to provide different types of protective eyewear and other equipment based on the nature of the danger to which they expose their employees. The following factors should serve as parameters that determine the selection of protective eyewear equipment for employees in the worksite:
- Ability to protect against workplace hazards
- Fit properly
- Do not restrict movement and vision
- Be durable and cleanable
- Allow unrestricted functioning of any other required PPE
Several types of PPE for eyes suggested by OSHA:
- Safety spectacles
- Welding shields
- Laser safety goggles
- Face shields
The Occupational Safety and Health Administration requires that protective eye and face devices must comply with the ANSI/ISEA Z87.1 Standard: Occupational and Educational Personal Eye and Face Protection Devices
In most contexts, ASTM standards are not legal obligations but optional guidelines that can help you to design a safer product.
In addition to the standards themselves, ASTM publishes detailed descriptions of testing methodology to guide you in ascertaining that your goods are as safe to use as possible.
Note: Adhering to ASTM standards benefits your business by helping to avoid forced recalls, which may occur even in the absence of a violation of mandatory safety standards should your product prove unsafe in practice.
- ASTM F803: Standard Specification for Eye Protectors for Selected Sports
- ASTM F659: Standard Specification for Ski and Snowboard Goggles
See this page for more information about ASTM standards and rules.
Importers can hire a third-party lab-testing company such as SGS, Intertek, QIMA to give their products an assessment report on ASTM compliance.
Also, a lot of the manufacturers in Asia do not have the proper assessment tools to conduct ASTM compliance tests.
FDA regulates the labeling requirements for non-prescription glasses. The following are related policies importers should pay attention to:
21 CFR Part 801
21 CFR Part 801 requires that the general labeling contents for nonprescription sunglasses should include the following:
- Name and Place of Business
- Intended Uses
- Adequate Directions for Use
- False and Misleading Statements
- The prominence of Labeling Statements
Section 501 Adulteration Laws
Section 501of the Adulteration Laws specifically states “a device is adulterated if its quality falls below that which it purports or is represented to possess.”
For example, if a label for nonsubscription glasses claims that the lenses are able to block 100% UVA, UVB & UVC, but in fact, it is an untrue statement, importers/manufacturers then violate the Adulteration Laws.
Section 502 Misbranding Laws
The following behaviors or statement could lead to violations of Misbranding Laws:
- Unsubstantiated claims of therapeutic value
- Ambiguity, half-truths, and trade puffery
- Failure to reveal a material fact
- Inadequate, incomplete, or inaccurate statements
- Deceptive pictorial matter
Children’s Eyewear: CPSIA
All children’s products, including sunglasses and eyewear, sold in the United States must comply with the Consumer Product Safety Improvement Act (CPSIA).
Here’s a summary of the CPSIA requirements:
- Third-party lab testing required
- Children’s Product Certificate (CPC)
- Tracking label
- Periodic testing plan
- Product Registration Card
Note that the CPSIA doesn’t replace other product safety standards and labeling requirements in this article. For example, sunglasses must comply with relevant FDA rules and ANSI standards, in addition to CPSIA.
Country of Origin
16 Code of Federal Regulations mandates that any product imported to the US from foreign or domestic manufacturers must be labeled with the correct Country of Origin (COO) mark.
The C/O must appear on the front side of the label and be placed in a conspicuous location of the product.
- Made in the USA
- Made in China
- Made in Vietnam
- Made in India
- Made in Thailand
The Federal government and the state government have special regulations concerning the content of product labels in the US. Therefore, importers should also treat the content on the label with extra care to avoid misleading information.
We suggest importers create a specific folder to keep track of all the relevant and necessary information for the product label, better if using an s. We recommend that you use .ai or .eps formats for your file.
California Proposition 65
California’s Proposition 65 aims at regulating the concentration of hazardous substances in the products manufactured, imported and sold in California.
California Proposition 65 currently includes more than 910 kinds of toxic or dangerous chemicals, and the list is still expanding every year.
When importing eyewear products to the US, importers should be concerned about the compliance issue of their products with California Proposition 65.
Examples of restricted substances
- Phthalates (BBP, DBP, DEHP, DIDP, DINP, and DNHP)
- Bisphenol A
California Proposition 65 Lab testing
Eyewear products importers should hire a third-party lab-testing company for product compliance tests before mass import, which is the only way to confirm the compliance of the products.
Most of the eyewear manufacturers in China and Southeast Asia are not able to provide the California Proposition 65 Lab test reports. We suggest you importers choose internationally-recognized lab-testing companies such as SGS, QIMA, Bureau Veritas, or similar companies.
The bare minimum cost of California Proposition 65 third-party lab testing is approximately $200, but it increases with the number of products, materials, and colored dyes that need testing.
For a large number of complex products, the total cost may be orders of magnitude higher.
Click here to find out about specific companies that provide California Proposition 65 lab testing services.
In some cases, instead of subjecting your product to California Proposition 65 third-party testing, it is permissible to attach a warning label to the product or its packaging.
When applicable, this is the only acceptable alternative to third-party testing.
Some plastics, coatings, paints and hardware parts (e.g. hinges) used to manufacture sunglasses may contain excessive amounts of restricted chemicals and heavy metals. It’s therefore important to submit your product for third-party lab testing.
Further, many suppliers in the eyewear industry don’t have access to ‘compliant materials’. As such, limit your supplier selection to eyewear manufacturers with a proven track record (e.g. existing lab test reports) exporting products to the United States, and other developed markets.
In addition to ensuring the compliance of your sunglasses, importers and manufacturers should also pay attention to the product packaging compliance issue and also conduct the corresponding lab-test for safety reasons. Here is an example of the main package regulations :
Heavy Metals Restrictions
Each state in the US sets its own limits on the levels of lead, cadmium, mercury, and other heavy metals that packaging materials, dyes, and printing inks can legally contain.
Bureau Veritas, SGS, TUV, QIMA, and other certified third-party testing companies offer testing of inks, dyes, and packaging materials for compliance with the regulations of each state.
Importers may also be required that the packaging conspicuously demonstrate any applicable compliance marks and/or country of origin along with other labels.
Bag Suffocation Warning
Bag suffocation warning label texts are mandatory for all Amazon sellers and in certain US states. In this article, we explain what you must know about creating warning label files, risks, and non-compliance penalties.
Warning: To avoid the danger of suffocation, keep this plastic bag away from babies and children. Do not use this bag in cribs, beds, carriages, or playpens. This bag is not a toy.