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, an FDA compliance attorney. Today I’m walking through the most common FDA compliance mistakes I see cosmetic brands make — and how to avoid them.
Mistake number one: drug-like claims on cosmetic labels. If your label, website, or social media says your product treats, cures, or prevents any condition, you may have turned your cosmetic into a drug. Review every single claim you make.
Mistake number two: non-compliant ingredient labeling. Under 21 CFR Part 701, cosmetic ingredients must be listed in descending order of predominance. Many brands either skip ingredients, list them in the wrong order, or use incorrect names. Every ingredient must appear using its INCI name.
Mistake number three: color additives that aren’t approved. This is a big one. Not all color additives used internationally are approved for use in U.S. cosmetics. Always verify your colorants against the FDA’s approved list.
Mistake number four: failing to meet MoCRA requirements. Since the Modernization of Cosmetics Regulation Act took effect, cosmetic facilities must be registered and products must be listed with the FDA. Many brands, especially small ones, don’t realize this now applies to them.
Mistake number five: no safety substantiation. Under MoCRA, you must have adequate substantiation that your product is safe. “It’s natural” is not substantiation. Get your products properly tested and documented.
Avoid these five mistakes and you’ll be in significantly better compliance shape. We can help you conduct a full compliance review. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.