Are Nutritional Supplements Regulated in a Different Way from Food and Drugs?

The justified answer is ‘YES’, though nutritional supplements are regulated by the FDA as foods, they are regulating in a different way from other foods and drugs. Most of the time, categorization as a nutritional supplement is defined by the information that the producer provides on the product’s label or in supplementary literature, even though many foods and nutritional supplementary product’s labels do not include this kind of information. Whether a product is categorized as a nutritional supplement, usual food or drug is based on its intended use.

How the intended use of a product is established?

According to the statement tagged on the product labeling, in advertising, on the Internet, or in other promotional supplies. There are certain claims which may cause a product to be considered as a drug or medicine, even if the product is marketed as if it were a cosmetic or usual product. Those types of claims establish the product as a drug or medicine because the intended usage is to treat or prevent diseases or affect the formation or functions of our human body. The label tagged on a nutritional supplement or food product may include one of three types of claims: 

1. Health Claim: Illustrates an affiliation between a food/food component or nutritional supplement component and reducing the risk of disease or health related condition.
2. Nutrient Content Claim: Illustrates the related amount of a nutrient or food material in a product.
3. Function/Structure Claim: It is a statement describing how a product may affect the systems of our body and it cannot explain any exact disease. (E.g. glucosamine helps to hold up healthy joints). Function claims do not need FDA approval but the producer must provide FDA with the copy of the claim within 30 days of putting the product on the market Product labels holding such claims have to comprise a disclaimer that reads, “This statement is not evaluated by the FDA. This product is not intended to treat, diagnose, prevent or cure any disease.” Any other health related claims are habitually about marketing, not about health. Just keep in mind that foods are not drugs! Here are some key regulation differences between Supplements & Cosmetics and Drugs & Medicines.