Regulation of Cosmetics in the United States.
Level 5 - mechanism / opinion, no new human data
Narrative review and descriptive regulatory overview without empirical human data
PubMed 35750414 · doi:10.1016/j.det.2022.02.006
What was done
This narrative review outlines the legal and administrative framework governing cosmetic products in the United States under the Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. It details Food and Drug Administration (FDA) regulatory programs—including the Voluntary Cosmetic Registration Program, Good Manufacturing Practice guidance, the Adverse Event Reporting System, and product recall mechanisms—alongside international cosmetic harmonization efforts.
What was found
The abstract reports no quantitative data. It summarizes the regulatory status: cosmetic ingredients are not subject to mandatory FDA premarket approval (with the exception of color additives), though finished products and ingredients are legally prohibited from being adulterated or misbranded.
Why it matters
It summarizes the statutory authority, monitoring tools, and regulatory boundaries the FDA uses to oversee cosmetic product safety and labeling in the United States.
Limits
This is a descriptive regulatory review without empirical clinical data, systematic search criteria, or quantitative evaluations of safety surveillance outcomes.
Cited by
- supports Chemical ingredients under the labels 'perfume' or 'fragrance' in personal care and cleaning products are not legally required to be tested for safety or toxicity before being sold.