The FDA is currently accepting comments on its newest draft guidance, “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” A copy of this guidance is available here.1,2
Some key statements made in the draft guidance are as follows:
The Food and Drug Administration (FDA) has observed and become concerned about two trends in the marketing of beverages.1 First, 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….Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts….FDA is concerned that some of the novel ingredients that are being added to beverages and other conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS [generally recognized as safe] for their intended use. In addition, some ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these higher levels and other new conditions of use are safe.
There are some experts in the dietary supplement and natural products industry who have stated that this guidance from the FDA is possibly a “veiled reference to the energy supplement/energy drink market,” as stated in a recent article by industry attorney Steven Shapiro in Natural Products Insider.3
Shapiro further points out that there is a food additive regulation stating that caffeine is GRAS when used in “cola-type beverages” and the set tolerance level is approximately 47 mg of caffeine per 8 ounces and 70 mg per 12 ounces. “Obviously the vast majority of currently marketed energy drinks are not ‘cola-types’ and many have significantly more than the aforementioned caffeine tolerances. Thus, these products may be prohibited if FDA were to actively enforce this guidance,” writes Shapiro. “This could be potentially devastating to the liquid energy supplement/energy drink market.”
The FDA encourages those who want their comments considered to submit them by February 2, 2010.2 Submitted comments can be found at www.regulations.gov.
—Kelly E. Lindner
References
1. Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods. Food and Drug Administration website. Available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm. Accessed December 9, 2009.
2. Draft Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods. Federal Register Volume 74, No. 232, Docket No. 0542. Washington, DC: Food and Drug Administration. December 4, 2009.
3. Shapiro S. Differentiating Liquid Supplements and Beverages. Natural Products Insider. December 16, 2009. Available at http://www.naturalproductsinsider.com/articles/2009/12/differentiating-liquid-supplements-and-beverages.aspx. Accessed December 17, 2009.
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