FDA’s implementation of the Modernization of Cosmetics Regulation Act (MoCRA) passed by Congress on December 29, 2022, affects all businesses manufacturing and selling “cosmetic” products, including those in the spa and wellness industries. While MoCRA should not change the day-to-day activities of most spa and wellness providers, it is important that the products your company sells comply with MoCRA to avoid potential FDA interference and penalties. Since these compliance activities can be costly, MoCRA needs to be taken into account before it affects your company’s bottom line.
Key MoCRA Requirements
Facility and Product Registration
Spa and wellness businesses that sell cosmetic products manufactured by the business or privately labeled from a third party contract manufacturer need to understand MoCRA. Unless subject to a special exception, MoCRA places special duties on those businesses to ensure that the manufacturing facility is registered with FDA and a list of all applicable products is submitted, including a list of ingredients. The original deadline to get in compliance with these requirements was July 1, 2024. These exceptions include many spas and wellness centers that fall within the following categories:
Small businesses (average sales of less than $1 million/yr. over the past three years);
Businesses that compound and sell products directly to customers;
Retailers; and
Establishments that only label, relabel, package, repackage, hold or distribute cosmetics products.
Labeling and Adverse Event Reports
Regardless of whether the business must register its facility or products, any spa or wellness businesses selling products under its name qualifies as a “responsible person” under MoCRA and will be subject to MoCRA’s labeling and adverse event recordkeeping requirements, requiring a review, and likely revision, of the product labels and company policies.
Under MoCRA, a “responsible person” (i.e., responsible company) must include on its product labels information sufficient for a customer to contact the “responsible person,” should the customer experience an adverse event they believe is due to use of the product. The “responsible person” or company must also maintain records of all such adverse events reported and provide reports of any serious adverse events (e.g., death, permanent injury, hospitalization and serious or persistent rashes) to FDA within fifteen days of the company learning of the issue.
MoCRA also requires that the product label identify any potential fragrance “allergen” that could cause harm to an individual taking the products.
These requirements need to be addressed as soon as possible, as they went into effect on December 29, 2023.
Adequate Safety Substantiation
In addition to the adverse event reports noted above, the “responsible person” must also maintain records establishing that the company’s cosmetic products are safe for their intended use as of December 29, 2023. MoCRA states that this new requirement refers to “tests or studies, research, analyses, or other evidence or information,” that an expert in the field would find adequately substantiates the product’s safety. This means that companies either: (1) need to undertake safety testing through a reputable contract laboratory for products they manufacture or sell under private label, or (2) obtain such safety information from the products’ contract manufacturer.
Notably, FDA can seek this safety submission information during any inspection of your facility.
Preemption
Unlike many federal laws, MoCRA does not preempt state laws that cover the use of certain cosmetic ingredients and govern the labeling of cosmetics, such as Proposition 65 in California (requiring businesses to provide warnings when exposing California residents to chemicals known to cause cancer, birth defects, or reproductive harm) and state bans and limits on ingredients in New York, Illinois and California. Companies will therefore need to be aware of and comply with both FDA’s requirements under MoCRA as well as applicable state laws. While making your company and products MoCRA-compliant can be time-consuming and expensive, state requirements will likely add to future costs for doing business.
Don’t Wait to Get in Compliance
While FDA has taken its time implementing rules and guidance for MoCRA, no one wants to be caught without its paperwork and policies in order. Buchanan has a team of experienced regulatory and legal specialists who can assist your business with getting MoCRA-compliant before any potential action by FDA.