What Makes a Beverage a Supplement or a Conventional Food?

In January of this year, FDA released its Guidance for Industry, Distinguishing Liquid Dietary Supplements from Beverages.[1]Other than stating the obvious (i.e., offering a supplement as a substitute for a food) or a recitation of settled (or undisputed) regulation (as in “settled law”), the Guidance takes a potentially sinister turn, laying out the ground work for imputing intent, when evidence of intent may only be apparent to the agency.

It is unlikely that anyone disputes the meaning or intent of the law in the definition of a dietary supplement (21 USC 321(ff)) in that a dietary supplement “is not represented for use as a conventional food or as a sole item of a meal or the diet.” Nor, as the guidance states, should the product name, marketing practices or representations violate the spirit of the law, by implying the supplement and its delivery system is represented as a conventional food.  However, when the agency claims that packaging, recommended conditions of use, serving size or composition, et cetera, may be considered in determining intent to market a violative product, this sows the seeds for arbitrary decision making.  That is, the agency is sure to announce that it will take into consideration a constellation of factors to determine if a product is violative, there is nothing in this guidance to prevent taking action on an isolated product attribute.

Examples within the Guidance include language that a product is a conventional food if it bears a statement that the product is intended to “rehydrate”, which everyone can agree this would mean replacement of body water by the food, known as water.  However, as noted in the Guidance, the term, “refresh” as a synonym for rehydrate and therefore characteristic of a food application is a “bridge too far.”  After all, a cold shower, a walk or a few minutes of meditation can all refresh.

The Guidance also cites packaging and implies that a re-sealable package is indicative of a packaging seeking to emulate food, as if the presence of a screw-top cap has the potent