New FDA Rules Can Weed Out Drugs Masquerading as Cosmetics

Federal regulation of cosmetics is getting a makeover. The Food and Drug Administration issued draft guidance in August on new facility registration and listing requirements for manufacturers of cosmetic products.

The guidance comes shortly after Congress, for the first time, granted the FDA statutory authority to require registration and listing for such products. Previously, the agency operated a Voluntary Cosmetics Registration Program, but didn’t have statutory authority to compel registration and listing information from cosmetics manufacturers.

The new requirements clearly expand regulation of cosmetics, which the FDA says is “a milestone” in its “continued efforts to protect the public health.”

Manufacturers of cosmetic products must take care to remain compliant in all operations, including development, manufacturing, and promotion—given the FDA’s heightened focus in this space.

New Requirements

Manufacturers of cosmetic products will be required to register their manufacturing facilities and list their products with the FDA. The Food, Drug, and Cosmetic Act defines “cosmetics” by their intended use, as “articles intended ... for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

Under the facility registration requirement, every person who owns or operates a facility that manufactures or processes a cosmetic product for distribution in the US must register the manufacturing facility with the FDA.

Under the product listing requirement, the manufacturer, packer, or distributor whose name appears on a product label must submit a product listing for each cosmetic product it markets.

A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

Manufacturers of currently marketed cosmetic products must comply with the new requirements by Dec. 29. For new cosmetic products manufactured or marketed after December, a facility registration must be submitted within 60 days of engaging in the manufacturing process, and a product listing must be submitted within 120 days of marketing the product in the US.

The FDA plans to roll out a portal this fall for electronic submission of facility registration and cosmetic product listing.

Exceptions

There are two relevant exceptions to the facility registration and product listing requirement for cosmetic products.

First, responsible persons who meet the FDCA definition of “small business” are exempt from the facility registration and product listing requirement.

Second, if a product is regulated as both a cosmetic product and a device or drug product, and a facility registration and device listing has already been submitted for the product under FDA registration and listing requirements for drugs or devices, the facility registration and device listing doesn’t need to be submitted again under FDA registration and listing requirements for cosmetics.

Broader Context

This statutory authority and registration and listing requirements represent a new era in the agency’s regulation of cosmetic products.

The FDA has always exercised its authority to conduct post-market surveillance and issue warning letters, recalls, and other enforcement actions for cosmetic products, but the new registration and listing requirements will significantly enhance this ability by furnishing the FDA with the information to efficiently execute its regulatory authority.

The newly available registration and listing information will especially facilitate FDA oversight of advertising and promotion—an established focus area for the agency with respect to cosmetic products.

Over the past decade, the FDA has been quick to correct manufacturers that sell products marketed as cosmetics but that make drug claims in the product labeling. Unlike drug products, cosmetics products aren’t required to obtain FDA approval before they can be marketed.

Therefore, when a manufacturer markets a product as a “cosmetic,” but the product labeling makes a drug claim such as diagnosing, curing, mitigating, or preventing a disease, the product is effectively being sold as a drug.

That product should either comply with drug-specific requirements, including pre-market approval, or limit its function claims to cleansing, beautifying, promoting attractiveness, or altering the appearance.

The FDA’s growing concern over the safety and efficacy of cosmetic products, including claims about the functionality of cosmetic products, is reflected in the recent guidance and anticipated rulemaking on facility registration and product listing, and in some of its recent enforcement actions.

In August, the agency issued a slew of warning letters to foreign manufacturers of over-the-counter products, including manufacturers that produce primarily cosmetic products, for failure to comply with the FDA’s good manufacturing processes and labeling regulations.

Manufacturers of cosmetic products have the opportunity to participate in the conversation by submitting comments on the new requirements to FDA through Sept. 6.

Ultimately, cosmetics manufacturers should heed the FDA’s increased focus on cosmetics, limit product claims appropriately, and keep a close eye on rulemaking and enforcement actions to ensure compliance.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Dominick DiSabatino is a partner in Sheppard Mullin’s Governmental Practice Group and FDA Regulatory Team.

Audrey Crowell is an associate in Sheppard Mullin’s Governmental Practice Group and FDA Regulatory Team.