Trial News

Late last year, Congress took its first major step since 1938 to update cosmetics safety. The Modernization of Cosmetics Regulation Act of 2022 (MOCRA), signed into law by President Biden as part of the omnibus spending bill on Dec. 29, 2022, mandates new registration, reporting, and product labeling requirements for cosmetics manufacturers and greatly increases the FDA’s regulatory authority. The new law also requires the FDA to address asbestos-containing talc products, as well as PFAS in cosmetics. (Pub. L. No. 117-328, §§3501-3508 (2022).)

MOCRA establishes new registration requirements for owners and operators of cosmetics manufacturing and processing facilities. Facilities must renew their registrations biennially and notify the FDA of any changes to their information within 60 days. The act also authorizes the FDA to suspend a facility’s registration—during which time cosmetics manufactured or processed at the facility may not be introduced into interstate commerce. After a suspension, facilities also must submit a corrective action plan to the FDA.

The act also requires the FDA to establish, through rulemaking, good manufacturing practices for facilities. The rules must aim to protect public health and ensure cosmetics are not adulterated. The agency is directed to issue a proposed rule within two years of MOCRA’s enactment and a final rule within three years.

In addition, MOCRA requires that cosmetics manufacturers, packers, and distributors include the name and contact information of a “responsible person” on product labels to whom consumers can report adverse events. The responsible person is required to maintain adverse report records for six years and report to the FDA any “serious” adverse event—defined as death, inpatient hospitalization, congenital anomaly or birth defect, or significant disability or incapacity—within 15 days. The responsible person also must submit to the FDA a “product listing” that includes a list of ingredients and information on where the product was manufactured or processed.

In addition, if the FDA determines there is “reasonable probability” that a product is misbranded or adulterated and could cause serious health consequences, the agency must give the responsible person an opportunity to voluntarily recall the product. If no voluntary recall is made, the act authorizes the FDA to order distribution of the product to cease immediately.
MOCRA also addresses a few specific cosmetic ingredient safety concerns. It requires the FDA to engage in rulemaking to establish a standardized testing method for asbestos in talc-based cosmetic products. The agency must propose a rule within one year of MOCRA’s enactment and finalize the rule after a comment period of no more than 180 days. The FDA also must assess the safety and risks of PFAS in cosmetics and issue a report of its findings in no more than three years.

MOCRA preempts some state and local laws regarding registration, listing, recall, good manufacturing, recordkeeping, and adverse event reporting. It does not, however, preempt states from barring or limiting the amount of an ingredient in cosmetics products. It also does not preempt states from continuing reporting requirements that were in effect when MOCRA was enacted. And importantly, the law does not “modify, preempt, or displace any action for damages or the liability of any person” under state law, “whether statutory or based in common law.”

Jared M. Placitella, of Red Bank, N.J., who represents plaintiffs in talc litigation, said “in mandating that cosmetic product manufacturers list all ingredients in their products and arming the FDA with the ability to monitor and enforce product safety, MOCRA will protect public health while preserving the constitutional right for those harmed to hold wrongful actors accountable.”

“Any unregulated product introduced into the marketplace has a high potential to cause harm and seriously injure the consuming public,” said Rockville, Md., attorney Michelle Parfitt, who also handles talc claims. “For decades, cosmetics have been one of those unregulated industry products directly impacting consumer safety,” she added, and “this new law addresses the need for mandatory safety obligations and consumer protection by the cosmetic industry.”

Parfitt said this new regulatory process “is designed to establish industry safeguards, oversight, reporting requirements, and an enforcement mechanism to protect consumers who place their trust and faith in the cosmetic industry’s representation that their products are safe for use. These regulations are just the beginning of any meaningful reform of a multibillion-dollar industry that has put profits ahead of consumer health.”

Montgomery, Ala., attorney Leigh O’Dell, who also represents talc plaintiffs, said “after decades of deceptive practices by the cosmetics industry and its lobbyists, this is an important and long overdue effort to protect consumers and align the responsibilities of cosmetic manufacturers with those imposed on the makers of other consumer products, pharmaceuticals, and medical devices. It’s revealing and shocking that this is the first enhancement to the FDA’s authority to regulate cosmetics since the 1930s.”

O’Dell added that “while the act is a significant and substantial step to promote consumer safety, we will need to diligently follow the implementation process to ensure that the goals of this legislation are not watered down or diminished. For example, the FDA should safeguard against companies hiding behind a trade secret designation to avoid full disclosure of product ingredients, and it should require standardized, comprehensive testing to detect and report carcinogenic asbestos and talc fibers in talc-containing cosmetics. The enactment of this legislation is a positive and encouraging first step in a multi-step process.”