FDA Works To Clarify Supplement/Food Distinction In Durbin Response

03 Sep 2012

Assistant Commissioner Ireland says FDA is preparing a final guidance on distinguishing liquid supplements from conventional beverages, and a guidance on differences between supplements and foods in general could follow. She cites the challenges of distinguishing the categories in a letter responding to Senator Durbin’s questions about regulation of energy drinks.

FDA conducts a complex evaluation on a case-by-case basis to determine whether a liquid product is labeled appropriately as a dietary supplement or is “represented” as a conventional food, and will publish a guidance to help its staff and manufacturers distinguish between the two.

That document could lead to a broader guidance for navigating the conventional food/supplement line in general.