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There are two kinds of health claims that can be made about foods other than dietary supplements: structure/function claims and disease claims. Structure/function claims are claims that do not suggest that the food can diagnose, treat, or prevent any particular disease, but that it can, for example, maintain, regulate, or promote normal healthy bodily functions. Where such claims are made, foods are generally required to carry a disclaimer on their label indicating that the claim has not been evaluated by the FDA.
Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; however, they are subject to the FDA regulations regarding adulteration and misbranding. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products.
Be aware that promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body may cause the product to be considered a drug. FDA has an Import Alert in effect for cosmetics labeled with drug claims. If a product is an over-the-counter (OTC) drug as well as a cosmetic, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling.
The CheckFDA team understands the challenges manufacturers face with navigating the FDA product compliance and online landscape. We work to ensure your products, and websites are in full compliance. Our team will provide you with a detailed report on your claims and any potential compliance infractions.
What you need to know about our services.
Our team will review your sites homepage and the claims on it.
Web banners and any other marketing materials should be reviewed for FDA Compliance.
We will review your labels for any potential compliance issues.
The CheckFDA.com can review your product descriptions for potential compliance issues.