Understanding the regulatory landscape is crucial for companies operating in the U.S. cosmetic industry. This article provides an overview of the federal regulations, the role of the FDA, the definition of cosmetic products, and the recent changes brought about by the Modernization of Cosmetics Regulation Act (MoCRA). We also highlight the importance of facility registration, product listing, and the services offered by REACH24H to support compliance in this sector.
Regulatory Background
The US legislation for cosmetics consists of Federal regulations and state-specific regulations. The two most important Federal laws applicable to cosmetic products in the USA are the Federal Food, Drug and Cosmetic Act (FD&C Act), which prescribes the minimum regulatory standards for cosmetics and applies across all 50 states, and the Fair Packaging and Labeling Act (FPLA).
The legal authority that regulates cosmetics in the USA is the US Food and Drug Administration (FDA) under the FD&C Act and FPLA. The products that are already on the market or when cosmetic products are imported into the country must be compliant with the legislation, including the ingredients, labelling and claim requirements. On top of the Federal legislation, States are allowed to pass their own acts on cosmetic products and set specific requirements that products must be compliant with.
Definition of Cosmetic Products in the U.S.
Articles intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.
Cosmetic Product Categories
| 1. Baby Products | 2. Bath Preparations | 3. Eye Makeup Preparations (other than children’s eye makeup preparations) | 4. Children’s eye makeup preparations |
| 5. Fragrance Preparations | 6. Hair Preparations (non-coloring) | 7. Hair Coloring Preparations | 8. Makeup Preparations (not eye, other than makeup preparations for children) |
| 9. Makeup preparations for children (not eye) | 10. Manicuring Preparations | 11. Oral Hygiene Products | 12. Personal Cleanliness |
| 13. Shaving Preparations | 14. Skin Care Preparations (Creams, Lotions, Powders, and Sprays) | 15. Suntan Preparations | 16. Tattoo preparations |
| 17. Other preparations |
It is important to note, that certain products meet the definitions of cosmetics and over-the-counter (OTC), such as anti-dandruff shampoo, anti-caries toothpaste, antiperspirant, and sunscreen. Certain products are regulated as OTC drugs and cosmetics and must meet the requirements both of OTC and cosmetics.
Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Enacted on December 29, 2022, as part of the 2023 omnibus bill (H.R.2617), the Modernization of Cosmetics Regulation Act (MoCRA) is the first major overhaul of the FD&C Act for cosmetics regulation since the FD&C Act was passed in 1938.
MoCRA includes new provisions for cosmetic products, such as facility registration, product listing, mandatory adverse event reporting and record keeping, safety substantiation, good manufacturing practice (GMP) regulations for cosmetics, fragrance allergen labelling. MoCRA also requires a few changes to existing labelling requirements (including the requirements for professional-use products). Besides, the FDA is required to issue regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products and a public report no later than three years after the enactment of MoCRA to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, and the scientific evidence regarding the safety of such use in these products.
The new provisions and the statutory dates are outlined below：
| MoCRA | Statutory Dates |
| Facility Registration
(Biennially Renew） |
See the details below: “Facility Registration” |
| Product Listing
(Annually Renew） |
See the details below: “Product Listing” |
| Adverse Event Reporting | 2023-12-29 |
| Safety Substantiation | 2023-12-29 |
| Labeling-Professional Use | 2023-12-29 |
| Labeling-Contact Information | 2024-12-29 |
| Labelling of Fragrance Allergens | Proposed rule 2024-06-29
Final rule 180 days after the close of the comment period |
| Good Manufacturing Practice（GMP） | Proposed rule 2024-12-29
Final rule 2025-12-29 |
| Mandatory Recall Authority | 2023-12-29 |
| Testing Method for Asbestos in Talc-Containing Cosmetics | Proposed rule 2023-12-29
Final rule 180 days after the close of the comment period |
| PFAS in Cosmetics | No later than 2025-12-29 |
