In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. This one is specifically for cosmetic brands: are your color additives actually FDA-approved?
Color additives in cosmetics are regulated differently from other cosmetic ingredients. They require pre-market approval from the FDA — unlike most cosmetic ingredients, which don’t need pre-market clearance. Using a non-approved color additive in a cosmetic renders the product adulterated, which means it can be seized, and you can face enforcement action.
The FDA maintains a list of approved color additives for cosmetics, found in 21 CFR Parts 73 and 74. Some are exempt from batch certification — meaning you don’t need FDA to certify each batch. Others are subject to batch certification, meaning the FDA tests and certifies each batch before it can be used.
Important nuance: some color additives are approved for cosmetic use generally but are not approved for use in the area of the eye. If you’re making eye makeup or products applied near the eyes, you need to verify that your colorants are specifically approved for that use.
This is an area where I see a lot of cosmetic brands get tripped up — especially brands importing finished products or ingredients from overseas markets where color additive rules differ. Review your formulations with an attorney before you launch. We can help.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.