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The Food and Drug Administration (FDA) has issued a long-awaited and much anticipated, revised and now, final Guidance for Industry entitled, “Distinguishing Liquid Dietary Supplements from Beverages.” The FDA had previously issued a Draft Guidance for Industry entitled, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” in December 2009 and the FDA had indicated recently on numerous occasions that a revised guidance would be forthcoming.
In the new guidance, the FDA focuses on the first prong of the previous guidance, the factors distinguishing liquid dietary supplements from beverages. As background to the guidance, the FDA states that there has been an increase in the marketing of liquid products with a wide array of ingredients and uses. Some are marketed as dietary supplements, some as beverages, and the FDA believes that some products may be misbranded because the labeling and representations are inconsistent within the product category they are claiming.
Accordingly, the FDA identifies a number of factors that it may consider in determining whether a product is represented as a conventional food and therefore, prohibited from being marketed as a dietary supplement. Although, there are some circumstances in which a single factor may be enough for the FDA to deem a product to be represented as a conventional food, in most cases, the FDA will review a combination of factors and the overall context to make a determination. Some of those factors that the FDA may review include the following:
• Product Name. Product or brand names that use conventional food terms such as “beverage,” “drink,” “water” or “soda” are viewed by the FDA as representations of the product as a conventional food or beverage. In some instances, the FDA asserts that use of one of the terms alone may be sufficient to establish a product as a conventional food. In other instances, use of the term will be viewed in context with other factors.
• Labeling and Advertising. The FDA may consider statements and graphics on labels, labeling and advertising, including websites and social media, like Facebook or Twitter. The use of words like “refresh” or “rehydrate,” which the FDA asserts represents the product for use as a beverage, may cause the FDA to deem a product labeled as a dietary supplement to be a beverage, as well as graphics depicting a use associated with a conventional food.
• Recommendations and Directions for Use.Recommendations or directions to use a dietary supplement product like a beverage, such as for quenching thirst, may represent the product as a conventional food. Conversely, directions to use a liquid product as to supplement the diet in a manner similar to other dietary supplements may be a factor in favor of a determination that the product is not being represented as a conventional food.
• Marketing Practices. This factor was not present in the previous version of the guidance. Marketing practices identified by the FDA that may represent a product as a conventional food include comparing the product to a category of beverages (e.g., energy drinks), using metatags such as “beverage” or “drink,” and paying for a product to be displayed in the beverage section of retail stores.
• Other Representations. Other representations which might cause the FDA to determine that a product is represented as a conventional food include statements made in public filings with government agencies like the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
In addition to identifying some of the factors that the FDA may review in making a determination about the identity of a product, the FDA also reiterated the regulatory requirements for ingredients in beverages and liquid dietary supplements and the labeling requirements. While health claims and nutrient content claims are regulated the same for beverages and liquid dietary supplements, the FDA took special care to note the differences in the regulation of structure/function claims for beverages and dietary supplements. Statements made regarding the role of a particular nutrient or dietary ingredient intended to affect the structure of function of the body are specifically allowed for dietary supplements pursuant to section 403(r)(6) of the Federal Food, Drug and Cosmetic Act and 21 CFR 101.93. While structure/function claims are allowed for beverages as well, the FDA asserts that such claims must be made with respect to a food’s taste, aroma or nutritive value or such claims may cause the product to be a drug.
The FDA also clarified that powdered premix products and liquid concentrates may be marketed as dietary supplements as long as they are properly labeled as a dietary supplement and are not represented for beverage use or as alternatives to beverages.
Coinciding with the issuance of this guidance, the FDA issued another Guidance for Industry entitled, “Considerations Regarding Substances Added to Foods, including Beverages and Dietary Supplements.” That guidance contains some of the language that was in the previous version of the guidance entitled, “Distinguishing Liquid Dietary Supplements from Beverages” and addresses some of the FDA’s concerns over the use of novel substances in beverages and conventional foods.
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