FDA Publishes New Draft Guidance for Liquid Beverages, Supplements

By Justin J. Prochnow, Greenberg Traurig LLP

FDA published a new Draft Guidance, entitled 'Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods,' on December 3.

FDA ostensibly issued the Draft Guidance to assist dietary supplement and beverage manufacturers in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement. However, it is clear that FDA...s underlying purpose for issuing such a guidance is its growing concern over the types of products marketed as dietary supplements, perhaps signifying that this area may be one in which FDA will increase its enforcement focus in the near future. This concern is evidenced by FDA...s statement in the Draft Guidance that 'we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods.'

The full version of this article will be published in Nutritional Outlook's January/February 2010 issue.