Supplement Beverages or Conventional Foods?

The Food and Drug Administration (FDA) released draft guidance on December 4, 2009 for liquid dietary supplements.[1] The purpose of this guidance is to “assist dietary supplement and beverage manufacturers and distributors in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement.” This guidance clearly states that 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.” Furthermore, “the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food.”

In a sense, some of this issue has been the result of FDA’s reasonable accommodation to industry early on in the implementation of Dietary Supplement Health and Education Act (DSHEA) rules. That is, according to the law, the format of a dietary supplement should conform to §411(c)(1)(B)(i) as follows:

…[the dietary supplement] is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or (ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet…[and] ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure…

Because some supplements do not readily lend themselves to such a compact delivery system, FDA did not object when supplements were marketed in snack bar formats or small volume liquid containers. However, it would now appear from the guidance, FDA feels the industry has overshot the mark in terms of delivery size such that now these large delivery formats resemble packaging for conventional food. While the agency will likely not insist the industry revert to “…quantities measured in drops or similar small units of measure,” something smaller than 8 oz. might represent a good compromise position.

Obviously, the leverage the agency intends to use to enforce this change in policy, is to indicate that these larger formats are actually foods and would require the contents to go through the food ingredient approval process. Meeting the food ingredient standard could be an expensive proposition (i.e., establishing the GRAS nature of the substance or going through the Food Additive Petition process), as well as label changes. The label changes could significantly impede claims as unless the structure function claim could be made on the basis of “taste, aroma or nutritive value” of the product, the product could no longer make the claim as it could have in the more compact supplement format.

Reference

[1] The guidance is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm196903.htm