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, an FDA compliance attorney. Let’s talk about structure/function claims — the most commonly used type of claim on dietary supplement labels, and one that gets a lot of brands into compliance trouble when it’s not done right.
A structure/function claim describes the role of a dietary ingredient in maintaining the normal structure or function of the human body. Examples include: “calcium builds strong bones,” “antioxidants maintain cell integrity,” or “fiber maintains bowel regularity.”
Here’s what makes structure/function claims different from health claims: you don’t need FDA pre-authorization to use them. But that doesn’t mean you can say whatever you want.
Three rules apply to every structure/function claim you make. First, the claim must be truthful and not misleading. Second, you must have substantiation — competent and reliable scientific evidence that supports the claim. Third, you must include the required disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The disclaimer must appear on the label and in all promotional materials.
You also must notify the FDA within 30 days of first marketing the supplement with the structure/function claim.
Here’s the line you cannot cross: if your claim implies that your supplement treats, cures, or prevents a disease, it’s no longer a structure/function claim — it’s a drug claim. And making a drug claim on a supplement is a serious violation.
Review your claims carefully. We help supplement brands structure compliant claims and substantiate them properly. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.