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. Here’s a question I get all the time: “Is my cosmetic product also a drug?”
The answer depends on what your product is intended to do. Under FDA law, a product is a drug if it’s intended to affect the structure or function of the body, or to diagnose, cure, treat, mitigate, or prevent a disease or condition.
Some products fall into both categories — they’re regulated as both a cosmetic and a drug. We call these combination products. Classic examples include sunscreens with SPF, anti-dandruff shampoos, antiperspirant deodorants, and anti-acne moisturizers.
If your product is a combination cosmetic-drug, you need to comply with the requirements for both. That means your label needs to include a Drug Facts panel in addition to meeting cosmetic labeling requirements.
The way you market and advertise your product matters too. Even if the formulation is purely cosmetic, if you make a claim that your product treats a condition, you’ve created a drug under the FDA’s eyes.
If you’re not sure how your product is classified, get a regulatory review before you go to market. It’s much easier to fix a classification issue before launch than after. Reach out — we can help.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.