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. If you’re new to the cosmetics industry or just getting your brand off the ground, this video is your beginner’s guide to FDA cosmetic compliance.
The cosmetics regulatory landscape changed significantly with the passage of the Modernization of Cosmetics Regulation Act — MoCRA — in December 2022. Here’s what every cosmetic brand now needs to know.
First, facility registration. If you manufacture or process cosmetics — or if you contract with someone who does on your behalf — the manufacturing facility must be registered with the FDA. This is now a legal requirement, not optional.
Second, product listing. Every cosmetic product you market in the U.S. must be listed with the FDA. This is done through the FDA’s Cosmetics Direct electronic submission system. You need to list each product, its intended use, and its ingredient list.
Third, safety substantiation. You must have adequate evidence that your product is safe for its intended use before you market it. This typically involves safety testing of the finished product and review of ingredient safety data.
Fourth, labeling compliance. Your labels must comply with FDA cosmetic labeling regulations — proper ingredient declaration, required warnings, net quantity, and responsible person information.
Fifth, adverse event reporting. Serious adverse events related to your cosmetic must be reported to the FDA within 15 business days.
Compliance doesn’t have to be overwhelming if you build it in from the beginning. We help cosmetic startups and growing brands establish their compliance framework. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.