In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm breaks down avoiding harmful ingredients: a guide to fda compliance for cosmetics. Watch the video below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. Today we’re talking about cosmetic ingredients — specifically, the ones you need to avoid. The FDA has authority under the Modernization of Cosmetics Regulation Act, or MoCRA, to prohibit or restrict cosmetic ingredients that pose safety concerns. While cosmetics don’t require pre-market approval, that doesn’t mean you can use whatever you want. Certain ingredients are outright prohibited — meaning they cannot be used in cosmetics sold in the U.S. under any circumstances. Others are restricted, meaning they’re only allowed in specific concentrations or for specific uses. Beyond the prohibited list, you also need to substantiate the safety of every ingredient in your product. Under MoCRA, you’re responsible for documenting that your cosmetic is safe for its intended use. Color additives are in a separate category — they require specific FDA approval before use, and you need to make sure the color additives you’re using are approved for the specific application, whether that’s rinse-off, leave-on, or near the eye area. Bottom line: your formulation choices have real regulatory consequences. If you’re developing or reformulating a product, get your ingredient list reviewed. We can help. See you in the next video.
Have questions about FDA compliance? Contact Capote Law Firm or call (786) 207-1174 to speak with an FDA compliance attorney.