Sweeping new US cosmetics act raises the make-up bar
Hogan Lovells lawyers David Horowitz, Heidi Gertner and Sally Gu break down the key aspects of the new legislation
In the last few days of 2022, US President Biden signed into law legislation requiring new standards for cosmetics. From luxury brands sold at high-end beauty counters to those sold at salons and spas, the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) significantly expands the US Food and Drug Administration’s (FDA) authority to regulate cosmetics.
Broad in scope, the new legislation covers not only traditional make-up products like lipstick, foundation, blush, body washes and shampoos, but also perfumes and high-end skin care products. Without question, luxury beauty companies should start planning now to comply with the sweeping new provisions focused on safety substantiation, labelling, adverse event reporting, good manufacturing practices and more.
In our view, it will likely take FDA several years to implement and enforce the new law, for several reasons. First, the effective date for the provisions to enforce the new requirements is deferred for one year (two years for certain labelling requirements). Second, the good manufacturing practice (GMP) requirements will likely not come into effect for several years because they require a rulemaking proceeding that will be technical and complicated by numerous constraints on the authority granted to FDA. And third, the legislation does not come with any additional user fee funding, which will limit FDA’s ability to develop the regulations and guidance documents that will be necessary for implementation.
Although MOCRA includes authorisation of appropriations for cosmetic regulation, it does not include any actual appropriations, which FDA will need to obtain through the annual appropriations process to expand its cosmetic programme and fund MOCRA implementation. Obtaining new funds for FDA regulation in a divided Congress will not be easy.
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Some of the highlights for luxury brands to note, include:
First, the new law requires “safety substantiation”, establishing a reasonable certainty that each cosmetic product is non-injurious. This safety substantiation must consist of rigorous scientific information considered appropriate to meet this standard by scientific experts. We recommend beginning the process of obtaining and documenting the evidence for each product as soon as possible.
Next, the law will require adverse event reporting within 15 business days for “serious adverse events" which includes significant disfigurement, such as persistent or significant alteration of appearance. There are also record-keeping, follow-up reporting and labelling requirements for adverse event reporting. We recommend evaluating your current policies and procedures for adverse event reporting and establishing processes to comply with the new provisions.
The new law also requires cosmetic companies to register manufacturing establishments and list the products, including their ingredients (absent a few exceptions), they sell in the United States. Here, we anticipate FDA will be issuing draft guidance within the next several months that will require prompt attention.
Other important provisions cover GMP for cosmetic products. FDA is required under the law to initiate a rulemaking process to establish new regulations for GMP. Although this may take some time, it is not too early to begin planning for development of appropriate manufacturing controls that will be required in the future. When these requirements come into effect, they are likely to require substantial resources to maintain compliance.
A new express preemption provision in the law also prohibits states or localities from imposing requirements on cosmetic products that are different than the federal requirements. However, states can still prohibit the use of, and can limit the amount of, an ingredient in a cosmetic. Further, the law carves out state product liability lawsuits from federal preemption – allowing them to proceed under state law.
A more detailed analysis of MOCRA from Hogan Lovells is available here. Partners Heidi Gertner and David Horowitz are members of Hogan Lovells' FDA Practice Group and can be reached at email@example.com and firstname.lastname@example.org. They are available to discuss the new law and answer questions about what it means for luxury companies. Sally Gu is a senior associate with the firm and can be reached at email@example.com.
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