Is the cosmetics industry ready for 2023? While there have been years of considering the implications of a more thoroughly regulated industry, 2023 is the year that regulation begins to become a reality. On December 23, 2022, Congress passed the Omnibus Food and Drug Reform Act of 2022 as part of the Consolidated Appropriations Act of 2023, which was signed into law by President Biden on December 29 2022. The Omnibus reform package includes Modernization. of the Cosmetics Regulation Act of 2022 (MOCRA), which aligns cosmetics with other consumer products regulated by the Food and Drug Administration (FDA). Now is the time for the cosmetic industry to prepare to develop pharmacovigilance systems, facility registration and product listing, good manufacturing practices, and the FDA’s new mandatory recall authority.
For the first time, cosmetic companies must report to the FDA any “serious adverse events” associated with the use of a cosmetic product in the United States. Significantly, “serious adverse events” include:
- life threatening experience,
- hospital admission,
- incapacity or persistent or significant incapacity,
- congenital anomaly or birth defect,
- infection, or
- significant disfigurement (including severe and persistent rashes, 2nd or 3rd degree burns, significant hair loss or persistent or significant changes in appearance) other than intended, under normal or usual conditions of use; or
requires, based on reasonable medical judgment, medical or surgical intervention to prevent an outcome described above.
This report must be made no later than 15 working days after the report is received by the “responsible person” (ie the manufacturer, packager or distributor whose name appears on the product label ). Cosmetic companies must also submit to the FDA “material new medical information” related to a serious adverse event report received by the company within one year of the initial report. Product labels must carry a home address, national telephone number, or electronic contact information through which consumers can report adverse events to the company.
As the over-the-counter (OTC) drug and dietary supplement industries know from the passage of the Dietary Supplement and Over-the-Counter Drug Consumer Protection Act of 2006, establishing a robust pharmacovigilance program takes time and resources, especially when a company markets a substantial line. of products through various channels. In particular, social media platforms can be an important forum through which companies become aware of alleged adverse events associated with their products, although obtaining complete and reliable information from these platforms is challenging. Clear and comprehensive pharmacovigilance policies and procedures must be established to implement these new requirements, as well as a robust training program for employees and potentially company agents. The good news is that the OTC and dietary supplement industries had to implement similar requirements in 2006, so there are good roadmaps to lean on. The new law also provides for the maintenance of adverse event records and grants FDA inspection authority over those records. Accordingly, it is important to train employees on the management of FDA pharmacovigilance inspections.
Good Manufacturing Practices
MOCRA requires the FDA to establish good manufacturing practices (GMP) for cosmetic products. Notably, the law mandates that before issuing these regulations, the Secretary of Health and Human Services must “consult with cosmetic manufacturers, including smaller companies, consumer organizations, and other experts.” The FDA has three years from the enactment of this law to develop industry-applicable GMPs, including considerations based on the size and scope of companies that manufacture cosmetics and the flexibility to address different sizes and types of facilities. locations Although the FDA issued a draft GMP guidance document in June 2013 offering its views on the manufacturing practices that cosmetic companies should consider, the new regulations are likely to add rigor, already that product safety concerns supported the cosmetic provisions in MOCRA. It is imperative that cosmetic companies work with the FDA before and during GMP rulemaking to ensure that FDA regulations are necessary and meaningful to the manufacture of a safe, unadulterated cosmetic without being unduly burdensome .
Historically, cosmetic manufacturers have not been subject to GMP. As dietary supplement companies learned when supplement GMPs were first implemented in 2008, establishing GMP practices and procedures is often more difficult and time-consuming than anticipated. It is therefore important that cosmetic manufacturers start preparing now for the GMP regulations, using the 2013 draft guidance as a starting point. This may include procedures, training and third-party assessments to identify potential gaps.
Register of installations and list of products
MOCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. Similarly, cosmetic products must be listed with the FDA. Products marketed on the date of MOCRA’s enactment have one year to list their products with the FDA. Products first marketed after enactment must be listed within 120 days of marketing. The product list must include, among other things, a list of all product ingredients, including fragrances, flavors and colors, and annual updates are required.
Although registration and listing may seem purely administrative, the FDA has the authority to inspect all registered facilities; the law gives FDA the ability to suspend facility registrations in certain limited situations. As with the mandatory over-the-counter drug list, the cosmetic product list will allow FDA easy access to a list of marketed cosmetic products with detailed information about those products. Interestingly, the FDA has been asking Congress for this authority for dietary supplements for years, to no avail, so the cosmetic industry will now provide more information to the FDA about their topically applied products than the FDA currently does. dietary supplement industry for its ingested products.
Although the industry obtained a preemption provision in MOCRA, with some restrictions for state laws such as California’s Proposition 65, MOCRA also includes a number of specific new regulatory obligations, such as requirements for the maintenance of safety justification files and the labeling of fragrance allergens included in a cosmetic product. In connection with the safety justification provisions, Congress has defined the types of studies required and provided a definition of a “safe” cosmetic. Establishing a safety justification policy to address these new requirements before FDA requests documents under these provisions will be essential to avoid compliance issues with the agency. Finally, it is worth noting that MOCRA states “[i]It is the sense of Congress that animal testing should not be used for the purpose of safety testing in cosmetic products” and that such testing should be eliminated “with the exception of appropriate allowances.” It remains to be seen how FDA interprets this provision and how the use of animal testing evolves over time.
The MOCRA provisions cover a wide range of new obligations. Sidley’s Food, Drug and Medical Device Practice Group is available to assist our cosmetic clients with the development of policies, procedures and training to implement these and other important MOCRA obligations.