This bill amends the Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients. Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities.
If the FDA determines that a cosmetic has a reasonable probability of causing serious adverse health consequences, it may prohibit the cosmetic's distribution by suspending the cosmetic ingredient statement. If other cosmetics from the same facility may be affected, the FDA may prohibit distribution from the facility by suspending the facility's registration.
The FDA must review the safety of at least five cosmetic ingredients each year, and it may establish conditions for safe use of an ingredient, including a limit on the amount of the ingredient or a requirement for a warning label. A cosmetic cannot be sold if it contains an ingredient that is not safe, not safe under the recommended conditions of use, or not safe in the amount present in the cosmetic.
Cosmetics companies are required to report to the FDA any serious adverse health event associated with their cosmetics.
The FDA must: