There is a statutory difference between foods and dietary supplements and yet companies often have difficulty determining how to position their products as food versus dietary supplements.

The FDCA defines “food” as “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article” (FD&C Act Sec. 201(f)). According to the FDA, “Conventional foods” are those that are consumed for taste, aroma, and nutritive value. They do not require FDA approval.

Examples of food include fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods, foods with standards of identity, spices and the list goes on and on. (21 CFR Parts 130 –169). It is impractical to list all the substances according to FDA but the above listing should give the reader a pretty good idea of what the food category encompasses.

Sometimes the distinction between the food and dietary supplement classifications is not clear especially in the arena of beverages.

A good example is a 240 ml can of energy drink. Is it a food/Beverage or is it a dietary supplement?   

FDA has a guidance document for dietary supplements that resemble conventional beverages. FDA indicates that “liquid products that suggest through their serving size, packaging, or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the U.S., are represented as beverages.”  This is a key point.

In addition, the name of a product can represent the product as a conventional food in the eyes of the FDA. Product or brand names that use conventional food terms such as “beverage,” “drink,” “water,” ‘juice,” or similar terms represent the product as a conventional food.

In summary, FDA considers a liquid product’s name, packaging, serving size, and recommended conditions of use, as well as other representations about the product, to be important determinants of whether the product is represented as a conventional food and may not be marketed as a dietary supplement.