• What's the difference between a food, a dietary supplement, and a drug?

I assume that what you mean is what is the legal difference between these products. Obviously, the physical impact of consumable substance upon a human or animal body does not depend upon its classification. Vitamin A doesn’t affect you any differently whether you consume it from a cereal, a vitamin pill or as part of a prescription drug.

The legal difference between these three categories is dependent on how they are marketed. The FDA does not pre-review or pre-approve the marketing of food products. However, foods must be composed of ingredients that are GRAS (Generally Recognized as Safe) and any health claims are strictly limited to those permitted by FDA regulation. On the other hand, drugs (both OTC and prescription) cannot be marketed without prior FDA approval. In the case of OTC drugs, the FDA has a series of monographs (essentially standards of identity) which allow any drugs meeting the standards in those monographs (e.g. aspirin) to be marketed after receiving routine FDA approval. Of course, new drug therapies are rigorously tested for efficacy and safety prior to being approved.

Dietary supplements fall in a category that is between food and drugs. At one time the FDA classified what we now call dietary supplements as food. Because of the limitations placed upon the ingredients that can be used in food products and the limitations on health claims that can be made for those products, the Dietary Supplement Health and Education Act of 1994 created a separate category for supplements.

Unlike food, supplements can contain non-GRAS ingredients. Unlike drugs, supplements do not need prior FDA approval to be marketed although manufacturers of new supplement products may have to submit literature to the FDA demonstrating the supplement’s safety. As is true of any claim on any product, all supplement health claims have to be factually sustainable

Because supplements cannot be marketed as either food or drugs, their advertising is limited to “structure function” claims. For example, supplements cannot be advertised with descriptive terms commonly associated with food such as like “delicious,” “refreshing,” or “great as a salad dressing.” After all, the stuff is supposed to be medicinal. On the other hand, supplements cannot be advertised as drugs either. Therefore words like “cures” or “treats” cannot be used while terms such as “maintains” can be used. As our supplement clients know, despite hundreds of pages of commentary pertaining to the FDA’s supplement regulations, the demarcation lines between food/supplement marketing and between supplement/drug marketing can be very unclear.

 

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