MoCRA Is Here: What Product-Based Beauty Businesses Must Do Now

For most of its history, the beauty industry operated under cosmetics regulations that were largely unchanged since 1938. In December 2022, that changed. The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, was signed into law, giving the FDA significant new authority over cosmetics for the first time in nearly a century.

If you manufacture, package, or sell cosmetic products in the United States, MoCRA applies to you. The law has already begun taking effect, with key deadlines phased in over 2023 and 2024. If you are not yet compliant, you are behind, and the cost of non-compliance is significant.

Here is what you need to understand.

What MoCRA Changed

Before MoCRA, cosmetics were among the least regulated consumer products the FDA oversaw. Companies did not have to register their facilities, did not have to disclose product formulas to the FDA, and were not required to report serious adverse events. The FDA could not order a product recall. It could only request one voluntarily.

MoCRA changed all of that. The law introduced:

• Mandatory facility registration for cosmetic manufacturers and processers
• Product listing requirements with the FDA
• Safety substantiation requirements: you must have evidence your product is safe for its intended use before it goes to market
• Adverse event reporting: serious adverse events must be reported to the FDA within 15 days
• FDA authority to order mandatory recalls of cosmetic products
• Good manufacturing practice (GMP) requirements for cosmetic manufacturers
• Fragrance allergen labeling: certain fragrance allergens must be disclosed on labels
• Professional salon product labeling requirements

This is not a minor update. It is a complete rewrite of the regulatory framework your business operates under.

Who MoCRA Applies To

MoCRA applies to any person or company that manufactures, processes, packages, or holds cosmetics for distribution in the United States. This includes:

• Domestic manufacturers and brand owners
• Foreign manufacturers whose products are imported and distributed in the US
• Private label brands (yes, even if you are not the one doing the manufacturing)
• Small businesses, though those under $1 million in average annual gross sales of cosmetics, and not selling products that regularly come into contact with mucous membranes, may qualify for certain exemptions from facility registration and product listing

Understanding whether you qualify for the small business exemption is important. The exemption has specific criteria, and it does not exempt you from all of MoCRA’s requirements. It only exempts you from facility registration and product listing.

The Registration and Listing Requirements

Facility Registration

Owners and operators of facilities that manufacture or process cosmetics for US distribution must register with the FDA. Registration must be renewed every two years, and any changes to registration information must be updated promptly.

The registration deadline for existing facilities was December 29, 2023, which has already passed. If you have not registered, you are currently out of compliance.

Product Listing

Each cosmetic product distributed in the US must be listed with the FDA. The listing must include:

• The product’s name
• The facility where it is manufactured or processed
• A list of ingredients (using the International Nomenclature of Cosmetic Ingredients, or INCI, names)
• The product category

Product listing must be updated annually and whenever there is a change to the product’s name, formulation, or labeling. The initial listing deadline was December 29, 2023 for products already on the market; new products must be listed within 120 days of entering commerce.

Safety Substantiation: What It Means for Formulators and Brand Owners

MoCRA requires that cosmetic products be “adequately substantiated for safety.” This is not a new concept, as the FDA’s pre-MoCRA guidance already reflected this standard, but MoCRA formalizes the requirement and gives the FDA authority to enforce it.

What does safety substantiation look like in practice? It means having documented evidence (testing data, ingredient safety assessments, stability data, challenge testing for preserved products) that supports the claim that your product is safe when used as intended.

If you are working with a contract manufacturer, your contract should specify who is responsible for maintaining safety substantiation documentation. Do not assume this is being handled. Ask. Get it in writing.

Adverse Event Reporting

If you become aware of a serious adverse event associated with your product, you have 15 days from receiving that information to report it to the FDA. A “serious adverse event” includes events that result in: death, a life-threatening event, inpatient hospitalization, a significant disability, a congenital anomaly or birth defect, or any event that requires medical or surgical intervention to prevent a permanent outcome.

You are also required to maintain records of adverse events, including both serious and non-serious events, for six years.

This means you need a system for tracking customer complaints and adverse reports. If you do not have one, creating it is urgent.

Labeling: What Is Changing

MoCRA introduced new labeling requirements that will affect product packaging. The most significant for most brands is the fragrance allergen disclosure requirement: certain fragrance allergens (as identified by the FDA through rulemaking) must be disclosed on the label when present above specified concentration thresholds.

The FDA is still in the rulemaking process for specific fragrance allergen thresholds, but this is coming, and reformulating packaging takes time. If your products contain fragrance, start planning for this now.

Additionally, MoCRA requires that professional salon products (those intended for use by licensed professionals, not consumers) carry a label statement indicating they are for professional use only.

What You Should Be Doing Right Now

If you have not already taken these steps, they are your immediate priorities:

1. Determine if the small business exemption applies to you, and document that determination.
2. Register your facility with the FDA if you have not done so. If registration was required and you have not filed, consult with regulatory counsel about how to come into compliance.
3. List your products with the FDA. Each SKU that is a distinct formulation or product requires its own listing.
4. Audit your safety substantiation documentation: do you have the testing data to support the safety of each product?
5. Create or review your adverse event tracking process: you need a system for documenting and evaluating consumer complaints.
6. Review your contracts with contract manufacturers: ensure safety substantiation responsibilities are clearly allocated.
7. Watch for FDA rulemaking on fragrance allergen labeling and plan your packaging update cycle accordingly.

MoCRA compliance is not optional, and the FDA has made clear it is taking its new authority seriously. The cost of getting ahead of compliance is far less than the cost of a warning letter, an enforcement action, or a mandatory recall.

If you are not sure where your business stands under MoCRA, working with an attorney who understands both the regulatory landscape and the practical realities of running a beauty brand is a smart starting point.

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This article is for informational purposes only and does not constitute legal advice. For guidance specific to your situation, book a consultation with Antonella Colella, Esq.