Medical Foods Governance A Slippery Proposition

A precise characterization of the regulatory category “medical foods” remains elusive to many because it represents a category that is “neither fish nor fowl”. That is, medical foods are not drugs (although they once were), nor are medical foods necessarily, a nutritionally adequate food for the general population. The difficulty in adequately describing this category and that the category is exempt from certain requirements for other foods, could have led to a number of abuses.  For example, the Nutrition Labeling and Education Act exempted medical foods from (1) nutrition labeling, (2) pre-market approval of efficacy claims and, (3) nutrient content claim requirements applicable to conventional foods.  As a result, this category was once contemplated by some as a means to add dietary supplements ingredients to foods because supplements were ordinarily prohibited for addition to food by the Dietary Supplement Health and Education Act nor did many dietary supplement ingredients meet the court’s definition of a food ingredient, by contributing “taste, aroma or nutritive [or technical] effect” to food. Further, because the “books were closed” by the 1970’s on what was considered a nutrient, this left an opening for manufacturers to respond to a public that wanted “something extra” in their food to support continued vitality. Therefore, the medical foods category was becoming a conduit to supplement nutritionally adequate diets, rather than provide s