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. Let’s talk about the Supplement Facts panel — the most important labeling element on your dietary supplement, and one of the most common sources of compliance issues.
The Supplement Facts panel is required on all dietary supplements sold in the United States. It’s governed by 21 CFR Part 101, specifically Section 101.36. Getting the format and content right is non-negotiable.
Here are the key elements. First, serving size — as I mentioned in another video, this must reflect the amount customarily consumed and must be clearly stated in both the unit and the common household measure where applicable.
Second, servings per container. Third, the list of dietary ingredients — each ingredient must be listed with the quantity per serving. Dietary ingredients with established daily values must show the percentage of the daily value. Those without established daily values get an asterisk and the footnote “Daily Value not established.”
Fourth, formatting matters. The FDA has specific requirements for the visual format of the panel — the type size, the bold headings, the hairlines separating sections. A panel that has the right information but the wrong format is still non-compliant.
Fifth, other ingredients. Any ingredient that isn’t a dietary ingredient — binders, fillers, coatings, flavors — must be declared in an “Other Ingredients” section below the Supplement Facts panel.
Getting your Supplement Facts panel reviewed by a regulatory attorney before your label goes to print is one of the best investments you can make. We can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.