Introduction:
The first major change to cosmetic regulatory law since 1938 has been enacted by Congress and signed by President Biden. The FDA has been given new authority under the FD&C Act which sets significant new requirements for cosmetics manufacturers and brand owners. FDA is mandated to promulgate multiple new regulations over the next couple of years that will create sweeping requirements across the cosmetic industry. The regulations will be enforceable in either 1 or 2 years, depending on the specific requirement. The following is a synopsis of the new requirements.
“Responsible Person” and “Facility”
MOCRA has clarified the roles of brand owner and manufacturer. A “responsible person” is defined as the “manufacturer, packer, or distributor of a cosmetic whose name appears on the label of that product,” while a facility is any establishment (including that of an importer) that manufactures or processes cosmetic products that are distributed in the United States. These definitions make it clear that brand owners are responsible for complying with the law, not just manufacturers. This has always been the case under the FD&C Act, but the role of “responsible person” has been overlooked since there was no requirement for brand owners to register. The responsibility for compliance with adulteration and misbranding requirements was often left to the contract manufacturer to figure out. Now all the requirements are the responsibility of the firm whose name is on the label. To be clear, the contract manufacturer is also responsible for what they do, but only if they actually manufacture or process. MOCRA defines a “facility” as any establishment that manufactures or processes cosmetics distributed in the United States, but specifically excludes establishments that “solely perform” labeling, relabeling, packaging, repackaging, holding, and/or distributing cosmetic products. Several other types of entities are also expressly excluded from the definition of a facility, such as cosmetic retailers and beauty shops/salons and tattoo parlors and permanent makeup facilities (unless they’re engaged in manufacturing).
Definition of “Cosmetic”
The definition of “cosmetic” has not changed. The FD&C Act defines a “cosmetic” broadly and includes all “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Traditional beauty make-up items, perfumes, shampoos, conditioners, and other hair care products, deodorants, mouthwash, body creams, moisturizers are all included. FDA considers tattoo ink used for traditional tattooing and permanent cosmetic tattooing to be cosmetics as well. For some firms that have not previously been directly impacted by FDA oversight the new law will have a big impact.
