FDA Cosmetic Requirements and Regulations
FDA Cosmetics Requirements
FDA defines a cosmetic as an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance of the body. The definition excludes “soap” so technically, FDA does not regulate soap. However, FDA has a very narrow definition for soap, and most products marketed as “soap” do not actually fall under that definition and are regulated by FDA as cosmetics.
A common misconception is that FDA does not regulate cosmetics. While FDA does not have premarket approval requirements for cosmetics and cosmetic ingredients (except that there are premarket approval requirements for color additive ingredients), FDA does in fact regulate cosmetics to ensure the products are not adulterated (i.e. contaminated) or misbranded (e.g. mislabeled.)
FDA can take regulatory actions against adulterated or misbranded cosmetics and the companies that market those products. For example, FDA currently has over ten import alerts for cosmetic products. If you market cosmetic products in the United States, below are requirements you must meet to avoid such regulatory actions.
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Cosmetic Facility Registration
- Registration of cosmetic manufacturers and processors under an FDA Establishment Identifier (FEI) which FDA now requires under the Modernization of Cosmetics Regulation Act (MoCRA).
Cosmetic Listing
- Submit listing of cosmetic product (intended for human use) to FDA which FDA now requires under the MoCRA for the manufacturer, packer, or distributor declared on the product label.
Label Review
- Report detailing all changes that must be made to bring the label into compliance with U.S. federal regulations. Includes ingredient review.
APHIS VS Permit Application (VS 16-3)
- APHIS may require this permit for importing products that contain ingredients derived from animal material.
Regulatory Review
- Report explaining the federal regulatory requirements for your product, identifying any potential problems for marketing it in the US, and advising how to resolve or prevent those problems.
FDA Cosmetic Requirements
FDA Cosmetics Requirements
Cosmetic Facility Registration
The Modernization of Cosmetics Regulation Act (“MoCRA”) amended the Federal Food Drug and Cosmetic Act to require that cosmetic manufacturers and processors register with the FDA as cosmetic facilities!
Some cosmetic facilities are exempt from the cosmetic registration requirement. A cosmetic facility is exempt from the registration requirement if its average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000. However, these exemptions do not apply if the facility manufactures or processes cosmetics that:
- regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- are injected.
- are intended for internal use.
- are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Also, if the facility manufactures products that are subject to both cosmetic and drug regulations and no other cosmetics, then the facility only needs to register as a drug establishment and not as a cosmetic facility. For example, if the facility only manufactures makeup marketed with sun-protection claims, then it should register as a drug establishment and not as a cosmetic facility. However, if that facility also manufactures cosmetics that are not subject to drug regulation (such as makeup with no sun-protection or other drug claims), then it must register as both a drug establishment and as a cosmetic facility.
If the cosmetic facility manufactures or processes other FDA-regulated products such as medical devices or foods, then it must register for each type of regulated commodity that it manufactures. For example, if the company manufactures both cosmetics and medical devices, it must register separately as a cosmetic facility and as a medical device establishment.
FDA requires that the registrations be renewed every two years. Foreign registrants must have a US Agent.
Note: Registration of cosmetic manufacturers and processors was previously voluntary, and submissions could be made through FDA’s Voluntary Cosmetic Registration Program (VCRP). As this registration is now mandatory, FDA has discontinued the VCRP. Any companies that registered through the VCRP must register again under FDA’s mandatory registration requirements.
Click here for a brief video explaining FDA’s registration requirements for cosmetic facilities.
Cosmetic Product Listing
Note: Information in any Cosmetic Product Ingredient Statements (CPIS) filed through FDA’s voluntary program will not be transferred to the mandatory listings.
Cosmetic products subject to drug regulations may be exempt from the cosmetic listing requirement. For example, a product that FDA regulates as both a cosmetic and as a drug (such as a makeup marketed with sun-protection claims) must be listed as a drug but does not need to be listed as a cosmetic.
Also, if the responsible person meets the criteria for a small business described above, the person (company) is exempt from the listing requirement.
Click here for a brief video explaining FDA’s listing requirements for cosmetic products.
Cosmetic Ingredient Safety
Also, each batch of certifiable color additives used in the product must be FDA-certified.
- For products containing animal-derived ingredients, determine whether the Animal and Plant Health Inspection Service (APHIS) allows those ingredients to be imported and whether the shipment must be accompanied by a Veterinary Services permit. The permit requirements depend on the animal source of the ingredient, the country of origin, and other factors.
- Determine whether the product contains any ingredients subject to Bovine Spongiform Encephalopathy (BSE) restrictions.
FDA Cosmetics Labeled as Organic
Any organic labeling must meet USDA’s organic labeling and certification requirements.
California Proposition 65 (“Prop 65”)
For products marketed in California, Prop 65 requires warnings to the consumers about any substances in the products (including packaging) that California believes may cause cancer or reproductive harm including birth defects. California lists these substances in its “Prop 65 list” ( https://oehha.ca.gov/proposition-65/proposition-65-list). If the products contain any of those substances, Prop 65 requirements can usually be met by placing the appropriate warning statement on the product’s label.
CITES Permit
Know if any of the product’s ingredients are prohibited by the US Fish and Wildlife Service (FWS) due to being derived from an endangered species or if any ingredients require a Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) permit for importing an endangered species.
FDA Label Requirements
Ensure the product label complies with all federal labeling requirements such as having a properly declared statement of identity, net quantity of contents (net weight), ingredient list with names of each ingredient properly declared, business name and address (manufacturer, distributor, or packer), country of origin, any required warning/caution statements, and other labeling requirements.
Manufacturing Conditions
Cosmetics must not be manufactured under conditions that may lead to adulteration (i.e. contamination) of the products. The MoCRA requires FDA to publish mandatory Good Manufacturing Practices (GMPs) for cosmetics to ensure that cosmetics are not adulterated. However, FDA has not yet published these GMPs. FDA currently provides cosmetic manufacturing guidelines which can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices.
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