At first, that deadline seemed a long time away. But it now looms large, and many companies are scrambling to collect the information needed to register their cosmetics facilities and/or list their cosmetic products (and ingredients) to meet the deadline.
MoCRA contains a number of new requirements for companies involved in the manufacture, processing, packing, distribution, and sale of cosmetic products in the United States. When it comes to facility registration and product listing, it is critical to understand the importance of these requirements (and exemptions), common misconceptions about the registration and/or listing process, the person (or persons) responsible for compliance, and the legal risks for companies that come up short.
MoCRA Applies to Me: Where Do I Start?
MoCRA compliance begins with facility registration—linking the physical production environment to every cosmetic product for sale on the US market. Among the information required to list a cosmetic product with the FDA is the facility registration number for each facility where a cosmetic product is manufactured or processed. This means a cosmetic product cannot be listed with the FDA until the facility that manufactures or processes the product is registered. Facility registration is critical for the FDA to track the origin of products and ensure that manufacturing and processing facilities meet applicable health and safety standards.
Common Misconception: FEI Numbers
A common misunderstanding among manufacturers is the role of the FDA Establishment Identifier (FEI) number. The FEI number, also known as the Firm or Facility Establishment Identifier, is a unique identifier assigned by the FDA. Many companies mistakenly assume that if you have an FEI number, you are registered under MoCRA. Not so. Obtaining an FEI number is part of the registration process —it is not the only step. The process for facility registration also requires submitting detailed information about facility operations and the types of products manufactured or packed, and demonstrating compliance with applicable regulatory requirements, as per FDA guidance.
Common Misconception: Foreign Facilities
Another common misunderstanding among manufacturers located outside of the United States is that MoCRA’s facility registration requirements do not apply to them. This obligation applies to all facilities that manufacture or process cosmetics sold in the United States, regardless of where the facility is located. Indeed, foreign facilities face additional requirements, one of which is to designate a US agent. This agent acts as a communication bridge between the foreign facility and the FDA, ensuring that the facility (1) adheres to US regulations, and (2) addresses any concerns from the FDA. This role is critical in facilitating effective compliance oversight by the FDA for international operations.
Once the facility is registered, all cosmetic products sold in the United States must be listed with the FDA. Under MoCRA, the responsibility for product listing falls on the “Responsible Person” (i.e., the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label). Identifying the Responsible Person at the outset is critical, and, to date, there has been some confusion among stakeholders (e.g., brand owners and contract manufacturers) as to who ultimately should handle listing cosmetic products and their ingredients. Clarifying responsibility when more than one company is involved in manufacturing, distributing, and selling a product is an important step in ensuring MoCRA compliance.
Common Misconception: “Assuming” Responsible Person Status
A common misunderstanding among cosmetics companies is that there is a choice as to whether to assume the role of Responsible Person. The Responsible Person is dictated by statute — if the company manufactures, packs, or distributes the cosmetic product, and its name is on the product label, the company is the Responsible Person. Although there is no express prohibition against delegating some of the obligations imposed by MoCRA, the legal risk of noncompliance stops and starts with the company that falls under the statutory definition.
I Have Unregistered Facilities and/or Unlisted Products: What Is My Risk?
For companies that manufacture, process, package, distribute, or sell cosmetics in the United States, meticulous MoCRA compliance is not optional. And it is important to keep in mind the potential consequences of noncompliance.
Criminal and Civil Penalties. Failing to register a facility or submit listing information to the FDA is a prohibited act under the Federal Food, Drug, and Cosmetic Act (FDCA), as is selling or distributing a cosmetic product in the United States that has been manufactured or processed at a facility with a suspended registration. Prohibited acts under the FDCA are subject to criminal and/or civil penalties.
Seizures and Injunctions. Any cosmetic product not properly listed or manufactured at an unregistered facility is also considered “misbranded” and may be seized (or if imported, refused admission into the United States). Cosmetic companies (or their brands) can also be restrained from further distribution. This not only disrupts the supply chain but can halt production and sales completely, leading to significant financial losses.
Regulatory Action. MoCRA provides the FDA with significant new enforcement authority when it comes to violative products. In addition to issuing import alerts and warning letters, the FDA can issue a mandatory recall if it determines that there is a reasonable probability that a cosmetic product is misbranded and use of, or exposure to, it will cause serious adverse health consequences or death, and the company refuses to do so voluntarily.
Litigation Risk. Failure to comply with the product listing and facility registration requirements increases the litigation risk for everyone in the supply and distribution chain. The FDCA does not provide for a private right of action, but failing to accurately list all cosmetic ingredients has been fertile ground for litigation for some time. Now that facility registration and product listing are mandatory, any cosmetics company cited (or suspended) by the FDA for noncompliance may be subject to consumer lawsuits alleging that the ingredient(s) the company failed to disclose has caused injury.
Reputational Damage. Legal issues stemming from noncompliance can severely damage the reputation of cosmetic products and the companies associated with them. It can lead to a loss of consumer confidence and brand loyalty, negative media coverage, and harm to the public’s perception of the brand that lasts long after any legal issues have been resolved.
By ensuring that all cosmetic facilities are properly registered and all cosmetic products are properly listed, companies are not only complying with the law but also reinforcing their commitment to transparency and consumer safety. Moving forward, cosmetic companies must stay informed and take proactive steps to navigate compliance with an ever-evolving regulatory landscape. This commitment helps to maintain public trust, and serves to benefit not only consumers but the companies themselves.
Rachel Raphael is a partner at Morgan, Lewis & Bockius LLP. Rachel regularly defends clients against claims for unfair business practices and false advertising. She also advises consumer products, personal care, and cosmetics companies on the many issues that arise over the product lifecycle. As a litigator and regulatory counselor, Rachel offers valuable insights on how to successfully mitigate the legal risks associated with MoCRA compliance.
Marcha Isabelle Chaudry is the founder of the Equity and Wellness Collaborative (EWC), which specializes in comprehensive compliance management, offering tailored solutions that ensure brands meet regulatory requirements efficiently. By focusing on areas such as facility registration, product listing, adverse event reporting, label compliance, and safety assessments, EWC equips businesses with the tools and knowledge needed for seamless MoCRA compliance.
Original published By Rachel Raphael, Esq., Morgan, Lewis & Bockius LLP and Marcha Isabelle Chaudry, Esq., The Equity and Wellness Collaborative
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