Beauty brands and industry advocates, including trade associations, have been lobbying for years for increased federal authority to regulate cosmetic products in order to increase consumer safety and transparency in cosmetic formulations. Long awaited, the Food, Drug, and Cosmetic (FD&C) Act is being updated for the first time in 85 years and will have a global impact on the cosmetics industry.

Buried within the 4,155 pages of the Consolidated Appropriations Act, a mere 36-page law, called the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), redefines the standards within the US beauty industry. Signed and passed into legislation by President Biden on December 29, 2022, MoCRA grants the US Food and Drug Administration (FDA) greater control over standards and regulations of the cosmetics industry, an overhaul that will ripple throughout the cosmetic supply chain and apply to all cosmetics marketed in the US, including those imported from other countries.

Jaclyn Bellomo, Registrar Corp’s Director of Cosmetic Services and Software, explained, “Some of MoCRA’s main objectives are to know where cosmetics are being made, what cosmetics are being made, and who’s responsible for those cosmetics. That is at the forefront of what the FDA is trying to accomplish. When that information is available, it’s easier to enforce regulations because there’s transparency about where the products are coming from. Enforcement cannot happen without the clarity of who, what, and where.”

The Deadline Looms

As part of the rollout of MoCRA, the FDA has announced its new electronic submissions portal, Cosmetics Direct, where cosmetic registration and listing data must be submitted electronically using the same format as used by the FDA for the submission of drug products—Structured Product Labeling (SPL). The portal helps users organize their information in a standard electronic format, including the required registration and listing submission information. Cosmetics Direct will also provide users access to prior registrations and listing submissions.

Bellomo emphasized the need for companies to act quickly to develop a strategy for tackling MoCRA’s requirements: “Gather information you might need for your product listings and come up with a game plan on how your company will take on MoCRA.”

The registration portal will open in October 2023, and the deadline for registration and product listings is December 29, 2023. For international companies registering their cosmetic facilities with the FDA, a US Agent designation is also required. Businesses will have a relatively short window to comply with the new MoCRA requirements, which will undoubtedly create a rush for third-party assistance with registration and listings. Don't wait to identify resources and secure these relationships, because capacity issues will likely become problematic.

Who Is Affected by MoCRA?

The most extensive reform in FDA cosmetic regulations in history will have different implications for different entities but any business that touches a cosmetic product distributed or marketed in the US needs to be aware of MoCRA and its potential impact on them.

• Manufacturers will be responsible for facility registrations, GMPs, record access, and inspections. 
• Brands will be accountable for product listings, adverse event reporting, and recordkeeping. 
• Raw-material suppliers will be significantly impacted because safety extends to the raw-material level, requiring companies to acquire specific ingredient data. 
• Brokers, importers, and retailers will be affected by mandatory recalls if a product has been misbranded or adulterated.

Labeling Requirements: Under MoCRA, the FDA has also adjusted how labeling is handled in the cosmetics industry. For example, a key change put forth is that all professional cosmetics must identify on the label that they are for sole use by licensed professionals.

Product Safety Substantiation: Substantiating the safety of your cosmetics is now required under MoCRA. All products must be registered along with safety substantiation for all ingredients and formulas. Cosmetics may be “adequately” substantiated through documented research and analysis. Tests, studies, and any other evidence that an expert can qualify to support the product’s safety is also admissible.

Fragrance Allergens Disclosures: Gone are the days of simply listing fragrance as an ingredient rather than listing each ingredient contained in the fragrance. MoCRA now requires that any ingredient deemed an allergen by the FDA must be listed and fully disclosed on the label.

Good Manufacturing Practices (GMP): GMP is also no longer implied for cosmetic companies but is mandated under MoCRA; however, guidance has yet to be established. The FDA is required to supply GMP guidance within two years of enactment and final guidance within three years. Once the FDA enacts these new regulations, they will be the first federal regulations to require cosmetic companies to install and adhere to GMP.

For smaller organizations, the FDA is also required to supply simplified requirements ensuring the new GMP guidelines are not causing undue economic hardship. They may even grant a longer compliance window for qualifying entities.

How Will MoCRA Be Enforced? 

The new MoCRA legislation empowers the FDA with three new enforcement powers to help regulate the cosmetics industry; these powers supersede state and local laws governing cosmetic product safety.

1. Full Preemption: MoCRA will now preempt any and all state or local laws that differ from FDA on product listings, adverse event reporting, facility registrations, records, GMP, recalls, or safety substantiation.
2. Mandatory Recall Authority: Under the new regulations, MoCRA now authorizes the FDA to enforce a mandatory recall on any products they deem misbranded, adulterated, or pose public health risks. If a manufacturer fails to comply or execute the recall within the time frame set by the FDA, the agency may order the manufacturer to cease distribution of the cosmetic product at issue immediately. In conducting a recall, the FDA will notify the public through press releases and public notices, as appropriate.
3. Facility Suspensions: MoCRA gives the FDA the authority to suspend a manufacturer’s registration if the agency reasonably believes a cosmetic product made by the manufacturer could cause serious adverse health consequences; other products manufactured by the facility may be similarly affected. Once a facility gets suspended, the FDA will not allow the introduction of any cosmetic products into US commerce until the registration becomes reinstated.

Addressing Potential Challenges 

Independent beauty brands that use contract manufacturers to make their products need to understand what needs to be done to comply with MoCRA. These brands are considered responsible persons and must understand how their manufacturing partners will handle registration.

“Smaller, less technical companies that have limited staff for regulatory purposes and have not had any experience with FDA compliance will face a big challenge,” Bellomo said. “They may struggle to either add staff or to understand the regulations, and most likely will need to contract with third parties that can bridge that knowledge gap.”

One regulation that may prove particularly challenging is the adequate safety substantiation requirement, which requires companies to provide evidence or information sufficient to support a reasonable certainty that a cosmetic product is safe.

“The definition is slightly vague at this time,” Bellomo explained. “Understanding which tests and studies are sufficient and how these will be viewed could be a gray area, so people might rush out to get as many tests as possible, which could be burdensome.”

Compliance is not optional, so companies must begin preparing to ensure product labeling, safety, and GMP standards are followed before and as the new rules become finalized. Registrar Corp has spent the last 20 years helping companies navigate the complexities of US FDA compliance. If you need regulatory assistance, Registrar Corp makes both MoCRA and your cosmetics R&D compliance quick and easy.