The Modernization of Cosmetics Regulation Act (MoCRA) significantly changed the regulatory landscape for cosmetics. Below are answers to the questions our cosmetics clients ask most frequently.
How does MoCRA affect my cosmetics business?
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, gave the FDA substantially expanded authority over cosmetics for the first time in decades. Key MoCRA requirements include: facility registration (due by July 1, 2024 for most businesses), product listing with the FDA, substantiation of product safety, serious adverse event reporting within 15 business days, and compliance with FDA-issued Good Manufacturing Practice regulations. Small businesses with less than $1 million in average annual gross sales have modified compliance timelines.
Do cosmetics need FDA approval before going to market?
With the limited exception of color additives, cosmetic products and ingredients do not require FDA pre-market approval. However, cosmetics must be safe for their intended use when used as directed, properly labeled in accordance with 21 CFR Parts 701 and 740, and free from prohibited or restricted ingredients. MoCRA now additionally requires FDA registration and product listing, which are mandatory compliance steps before marketing.
What must be included on a cosmetic label under FDA regulations?
FDA cosmetic labeling regulations require the following information: (1) the product identity (what it is); (2) net quantity of contents; (3) name and place of business of the manufacturer, packer, or distributor; (4) an ingredient declaration listing all ingredients in descending order of predominance; and (5) any required warnings. Color additives must be declared using their FDA-approved names. Labeling that is false or misleading in any way renders the product misbranded under the FD&C Act.
Can a cosmetic product also be regulated as a drug?
Yes — and this is one of the most misunderstood areas of FDA compliance. Products intended to affect the structure or function of the body are regulated as drugs, not just cosmetics. Common examples include: sunscreens (SPF products), anti-dandruff shampoos, antiperspirant deodorants, anti-acne moisturizers, and teeth-whitening products. These “combination products” must comply with both FDA cosmetic labeling requirements AND OTC drug requirements, including Drug Facts panel labeling under 21 CFR 201.66.
What documentation does Amazon require to sell cosmetics on its platform?
Amazon requires cosmetics sellers to provide compliance documentation demonstrating that their products meet all applicable federal regulations. This typically includes proof of FDA facility registration and product listing (required under MoCRA), ingredient safety documentation, a Certificate of Analysis, and confirmation that labeling complies with FDA requirements. Capote Law Firm prepares the legal documentation and compliance certifications businesses need to list cosmetics on Amazon and other major retail platforms.
Have more questions about FDA cosmetics compliance? Capote Law Firm provides personalized regulatory guidance for businesses at every stage. Contact us today or call (786) 207-1174 to schedule a consultation.