As the July 1 deadline for registering and listing cosmetic facilities and products under the MoCRA rapidly approaches, it is important that manufacturers and suppliers in the cosmetics and personal care industries be well prepared. The U.S. Food and Drug Administration (FDA) has outlined mandatory requirements, GuidelinesTo ensure compliance.
We reviewed the FDA’s recently released Cosmetic Ingredients Update and spoke with industry lawyer and Morgan Lewis partner Rachel Raphael to summarize the key takeaways all stakeholders need to know before next week’s deadline.
Mandatory registration and listing
The FDA requires all facilities involved in the manufacturing, packaging, or distribution of cosmetic products in the United States, including domestic and foreign facilities, to register and list their products. According to the FDA, failure to comply with these regulations may result in enforcement actions, including, but not limited to, product seizure, injunctions, and other legal penalties.
Raphael emphasized the seriousness of non-compliance, saying, “Failure to properly register a cosmetic manufacturing or processing facility or to submit product listing information to FDA is a ‘prohibited act’ under the Federal Food, Drug, and Cosmetic Act and may result in criminal and/or civil penalties.”
“Other possible consequences include seizure, injunctions and product recalls,” she added, saying, “Failure to comply with facility registration and product listing requirements may increase litigation risk and, in turn, have a negative impact on your brand’s reputation.”
As such, she advised, “Partnering with trusted industry consultants and legal counsel can help streamline the compliance process, both with regard to facility registration and product listings, and with regard to MoCRA in general.”
Accurate and complete information
As explained in the FDA’s recent Cosmetic Ingredients Update, when registering, facilities must provide accurate and up-to-date information, including:
- Facility name and address
- contact address
- A comprehensive list of products manufactured, packaged, and distributed at the facility
To avoid potential compliance issues, it is important to ensure all information is complete and truthful.
Product Ingredient Disclosure
Manufacturers must disclose all ingredients used in their products. This requirement aims to increase transparency and ensure consumer safety, and the FDA uses this information to monitor the safety of cosmetic products and take necessary action if harmful ingredients are identified.
Electronic application portal and verification of application contents
Regarding the e-application portal, Raphael advised, “It is important that all companies have access to the e-application portal, whether they are simply providing information for facility registration or product listing, or whether they are actually submitting that information.” Cosmetics Direct— have systems in place (including checks and double-checks) to ensure that the information they provide, receive and/or transmit (whether from internal or external sources) is accurate.”
Common pitfalls to avoid
While the FDA has tried to streamline the registration and listing process as much as possible, “one source of confusion is the designation of the ‘responsible party,'” Raphael noted.
“Some in the industry have the mistaken impression that companies can choose whether to assume the role and responsibilities of a responsible party,” she explained, clarifying that “to the contrary, the manufacturer, packer or distributor of the cosmetic product whose name appears on the label is established by law as the responsible party.”
“However, it is important to note that there is nothing prohibiting companies from delegating some of their obligations under the MoCRA. But at the end of the day, it is important to remember that responsible parties still bear the legal risk of non-compliance,” she concluded.
Important steps to ensure compliance
Rafael outlined next steps for manufacturers and suppliers of cosmetics and personal care products to ensure they meet the July 1, 2024 deadline for registration and listing requirements.
- Become familiar with FDA guidance on facility registration and product listing.
- We will get the information you need, which may take some time depending on the amount of products.
- We will work with third parties to quickly gather the information you need.
- get FDA Facility Identifier Establish a Federal Industry Expense Inventory (FEI) and require third-party manufacturers and processors to also provide an FEI.
With the July 1st deadline just days away, all cosmetic and personal care product manufacturers and suppliers must complete the required registration and listing processes. Complying with these requirements will help companies avoid legal repercussions, build trust with consumers, and ultimately benefit their business in the long term.
