Adverse event reporting
A responsible person must report serious adverse events associated with using the cosmetic product in the US to the FDA within 15 business days. They must include the label on or within the retail packaging.
If the responsible person receives medical or other information about the adverse event within one year of the initial report to the FDA, they must submit this new information to the agency within 15 business days. The FDA can access adverse event reports during an inspection.
Facility registration
Manufacturers and processors must register their facilities with the FDA and renew registration every two years.
The FDA can suspend a facility’s registration if it:
- Determines that a cosmetic product, manufactured or processed by the registered facility and distributed in the US, has a reasonable probability of causing serious adverse health consequences or death
- Reasonably believes other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility
If a facility’s registration is suspended, it cannot distribute or sell (or otherwise introduce or deliver into commerce) in the US cosmetic products from the facility.
Product listing
A responsible person must list each marketed cosmetic product to the FDA, including its ingredients, and provide updates annually.
Safety substantiation
Organizations and individuals manufacturing or marketing cosmetics must ensure product safety. Neither the law nor FDA regulations require specific tests to demonstrate product or ingredient safety.
A reasonable person must ensure and maintain records supporting adequate safety substantiation of their products. Manufacturers can use relevant safety data already available to support this. Animal testing is not a requirement for marketing a cosmetic product. All data used to support safety claims must be from scientifically robust methods.
