On February 28, 2023, the Food and Drug Administration announced its removal of cosmetic regulation out of the Centre for Food Safety and Applied Nutrition (CFSAN) and into the Office of the Chief Scientist (OCS). The new move is in response to the December 2022 omnibus bill enacted under the U.S. Federal Food, Drug, and Cosmetic Act which provided the FDA with authority to regulate cosmetics, its manufacturing and implementation of new requirements for manufacturers.
Presently, the FDA does not preapprove or authorize cosmetics except for colour additives. Cosmetic products are not required to be manufactured under good manufacturing practices (GMP’s), and manufacturing facilities are not required to be registered with FDA. In addition to this, manufactured cosmetic products are not required to be listed. As a result, the FDA has faced significant backlash as it regards optimizing its regulatory focus towards the Cosmetic Industry.
The new proposed changes set out to:
- Provide the FDA with regulatory authority to recall a cosmetic product if the label is mis-branded and has ‘reasonable probability’ to cause potentially adverse health effects and death.
- Authorized commercial businesses within the cosmetic industry to follow and abide by good manufacturing practices.
- Require manufacturing facilities including those assigned by contract to register with the FDA.
- Require the listing of existing products on the market and products brought to the market after the bill has been passed alongside mandatory listing by the manufacturer and submission to the FDA and proper labelling.
- Authorize the suspension of any manufacturing facility that agency has reasonable probability to believe is manufacturing or processing cosmetic products that result in adverse health effects and death.
- Authorize the permission of the FDA’s review of manufacturing facilities records and logs if the agency has reasonable probability to believe that a cosmetic product and/or ingredient if being processed/manufactured that causes adverse health effects and death.
- Issue regulations to established and require standardized testing methods to detect asbestos in cosmetics containing talc.
- Thoroughly assess cosmetic products manufactured with and containing perfluoroalkyl and polyfluoroalkyl substances (PFAS).
The FDA is proposing the finalization of the new enactment in the fall of 2023. The new bill highlights the first changes to cosmetic regulation since the 1950’s.
Contact Nexreg if you need assistance preparing your cosmetic labels for sale in the USA.