In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. Cosmetic labeling is an area where I see a lot of brands make preventable mistakes — mistakes that can result in their product being considered misbranded under FDA law. Let’s go through the most important requirements.
First, the principal display panel must include the product identity — what the product is — and the net quantity of contents, accurately stated in both metric and U.S. customary units.
Second, the information panel must include the name and address of the manufacturer, packer, or distributor, and the ingredient declaration. The ingredient declaration must list all cosmetic ingredients in descending order of predominance — from the ingredient present in the greatest amount to the least. Each ingredient must be identified by its INCI name.
Third, required warnings. Certain cosmetic products require specific warning statements — for example, products that could be hazardous if misused, aerosol products, and certain other categories have mandatory label warnings.
Fourth, under MoCRA, you’re also now required to include a responsible person — a domestic U.S. contact — on your label. This is a newer requirement that many brands, especially international ones, are still catching up on.
Fifth, the label cannot be false or misleading in any way. This includes not just explicit false statements but also omissions that make the label deceptive.
Get your labels reviewed before production. One label error can trigger a recall or regulatory action. We help cosmetic brands build compliant labels from the start. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.