As the July 1 deadline for the registration and listing of cosmetic product facilities and products under MoCRA rapidly approaches, it is crucial for manufacturers and suppliers in the cosmetics and personal care industry to be well-prepared. The U.S. Food and Drug Administration (FDA) has outlined essential requirements and provided guidelines to ensure compliance.
We reviewed FDA’s recently published Cosmetics Constituent Update and spoke with industry attorney Rachel Raphael, Partner at Morgan Lewis, to compile our key takeaways that every stakeholder needs to know in advance of next week’s deadline:
Mandatory registration & listings
FDA requires all facilities involved in the manufacturing, packaging, and distribution of cosmetic products in the United States to register and list their products, including domestic and foreign establishments. Failure to comply with these regulations could result in enforcement actions, including but not limited to product seizures, injunctions, and other legal penalties, according to FDA.
Raphael emphasized the gravity of non-compliance: “Failing to properly register a cosmetics manufacturing or processing facility or submit product listing information to the FDA are ‘prohibited acts’ under the Federal Food, Drug, and Cosmetic Act, and can lead to criminal and/or civil penalties,” she said.
“Other possible consequences can include seizures, injunctions, and product recalls,” she added, and “failing to comply with the facility registration and product listing requirements also increases litigation risk, and in turn, potential harm to a brand’s reputation.”
Therefore, she advised that “partnering with trusted industry consultants and legal counsel can also help to streamline the compliance process, both with respect to facility registration and product listing, and with respect to MoCRA more generally.”
Accurate & complete information
As explained in FDA’s recent Cosmetic Constituent Update, when registering, facilities must provide accurate and up-to-date information, including:
- Facility name and address
- Contact details
- A comprehensive list of products manufactured, packed, or distributed at the facility
It is essential to ensure that all information is complete and truthful to avoid potential compliance issues.
Product ingredient disclosure
Manufacturers must disclose all ingredients used in their products. This requirement aims to enhance transparency and ensure consumer safety, and FDA will use this information to monitor the safety of cosmetic products and take necessary actions if harmful ingredients are identified.
Electronic submission portal & verification of submissions
Regarding the electronic submission portal, Raphael advised that “it is critical that all companies—whether they are simply supplying information for facility registration and product listing, or they are actually submitting that information through Cosmetics Direct—have systems in place (with checks and double-checks) to make sure the information they are supplying, receiving, and/or submitting (whether the source is internal or external) is accurate.”
Common pitfalls to avoid
While FDA has worked to streamline the registration and listing processes as much as possible, “one source of confusion is the ‘Responsible Person’ designation,” Raphael noted.
“Some in the industry have the mistaken impression that companies have a choice as to whether they assume the role and responsibilities of the Responsible Person (or not),” she explained, and clarified that “to the contrary, the Responsible Person is dictated by statute as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.”
“Notably, however,” she concluded, “there is nothing that prohibits a company from delegating some of its obligation under MoCRA – but it is important to remember that at the end of the day, the Responsible Person still bears the legal risk of noncompliance.”
Key steps to ensure compliance
Raphael summarized the following steps to ensure cosmetics and personal care product manufactures and suppliers meet the upcoming July 1, 2024 registration and listing requirements deadline:
- Familiarize themselves with the FDA’s guidance on facility registration and product listing.
- Obtain the necessary information, which can be time-consuming depending on product volume.
- Collaborate with third parties to collect required information promptly.
- Obtain an FDA Establishment Identifier (FEI) and ensure third-party manufacturers and processors provide their FEIs as well.
With the July 1 deadline just days away, it is imperative for all cosmetics and personal care product manufacturers and suppliers to ensure they have completed the necessary registration and listing processes. By adhering to these requirements, companies can avoid legal repercussions and foster a trustworthy relationship with consumers, ultimately benefiting their business in the long run.
