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. Today I’m focusing on two of the most common mistakes I see on dietary supplement Supplement Facts panels: serving size and daily value.
Serving size on a Supplement Facts panel must reflect the amount of the product that is customarily consumed at one time. This sounds simple, but it gets complicated. You can’t just set any serving size you want to make your nutrient numbers look better — the serving size needs to reflect reasonable consumption patterns.
For dietary supplements, the serving size is typically expressed as the number of units — tablets, capsules, softgels, or scoops — that constitute one serving. And the nutrient amounts listed on the panel must correspond to that serving size.
Daily value percentages are the second common trouble spot. Not all dietary ingredients have established daily values. For those that do, you must list the percentage of the daily value per serving. For those that don’t — and many botanical ingredients fall into this category — you simply list the amount and put an asterisk with a footnote that reads “Daily Value not established.”
Getting serving size and daily value right isn’t just a labeling compliance issue — it also affects the truthfulness and accuracy of the nutrition information you’re providing to consumers. Inaccurate Supplement Facts panels can result in misbranding findings.
If you’re developing a new supplement or reformulating an existing one, get your label reviewed before you go to print. We can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.