The landscape of federal regulation of cosmetics is poised to undergo significant alterations. As of August, the Food and Drug Administration (FDA) has set forth a draft guide detailing new requirements pertaining to facility registration and product listing for all cosmetic product manufacturers. This action marks an evolution in the FDA’s regulatory power, as the agency had previously operated under a Voluntary Cosmetics Registration Program which lacked any statutory authority to enforce producer compliance.
These enhanced regulations indicate an expanded scope for the FDA’s control over cosmetics, aimed at serving the public health better by ensuring compliance in various sectors of operation – from product development and manufacture to marketing and promotion.
Under these new guidelines, cosmetic manufacturers will be required to register their manufacturing facilities and list their products with the FDA. The Food, Drug, and Cosmetic Act defines “cosmetic” products as items intended for usage in beautifying, adorning, and modifying physical appearances. This regulation includes a 60-day window for new facilities to register with the FDA upon commencing the manufacturing process, and a 120-day limit for product listing after being marketed in the United States.
However, a couple of crucial exemptions exist to these directives. Firstly, individuals or entities that fulfill the FDCA definition of a “small business” are exempt from these requirements. Secondly, product registration and listing need not be duplicated for items regulated both as cosmetics and as drugs or devices provided the listing and registration have been completed under FDA directives for drugs or devices.
The implementation of these new authority measures and requirements signifies a dramatic shift in cosmetics regulation, equipping the FDA with vital information to enforce its authority with increased efficiency. Notably, the ability to scrutinize advertising and promotion will greatly aid the agency in its effort to expose products masquerading as cosmetics while being sold as medicinal drugs.
Such products should ideally adhere to drug-specific regulations, including pre-market approval or restrict their functionality claims to cosmetics, i.e., products employed in making aesthetic or appearance-enhancing modifications.
In addition to issuing a multitude of warning letters in August to non-compliant cosmetic product manufacturers, the FDA has indicated the possibility of rolling out a new portal this fall for streamlining electronic submissions of facility registration and cosmetic product listings. Hence, cosmetic manufacturers should take note of the FDA’s growing focus on this sector and curate product claims, while paying apt attention to new rules and enforcement measures, much of which seems to be in the pipeline.