As 2009 draws to a close FDA continues their ramped up enforcement activities based upon new guidance documents and letters to industry. A draft guidance document published on December 7, 2009 lets us know that FDA is eyeing functional beverages and liquid dietary supplements for future enforcement activity.
The full title of the draft guidance document is, “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” and can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm
FDA made some very interesting statements in this document. First, the agency notes that there has been a growth in the marketing of dietary supplements that are packaged and labeled as beverages. Beverages are considered ‘conventional foods’ and by definition are not dietary supplement products. Second, the agency notes increased marketing of “beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.” Many of our clients have been dismayed when we have informed them that certain ingredients, that can be found in blockbuster, name brand products, are not permitted for use in their products. The new guidance document tells us that those products’ days are numbered.
The guidance document outlines factors the agency looks at to determine whether a liquid product is a conventional beverage or a dietary supplement.
- Packaging – if it looks like a conventional beverage package, it may be a beverage
- Serving size or the volume in which they are intended to be consumed. A standard beverage serving size is one cup (8 oz) or 240 ml
- Product or brand name, terms such as “beverage,” “drink,” “water,” ‘juice,” or similar terms represent the product as a conventional beverage
- Recommended conditions of use. Products to quench thirst or to refresh would certainly be considered beverages but the agency did not elaborate on other uses that they consider related to conventional beverages.
- Statements about the product in labeling or advertising.
The agency has asked for comments within 60 days of the December 7th proposed guidance. You may submit comments to http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a62af4 . If you would like to submit your comments anonymously, please send them to Bioscience Translation & Application and we will submit them in a consolidated document.
