Thursday, January 16, 2014

FDA Issues Guidance to Clarify Requirements for Beverages v. Liquid Dietary Suppelments

The FDA published two final guidance documents to help industry determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.

One of the guidances - Distinguishing Liquid Dietary Supplements from Beverages - describes the factors that characterize liquid products that are dietary supplements and those that characterize beverages that are conventional foods.  Such factors include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling and advertising.

The second guidance - Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements - reminds the industry of requirements in the Federal Food, Drug, and Cosmetic Act that apply to substances added to both conventional foods, such as beverages, and to dietary supplements.

Why does it matter whether a food is a beverage or a dietary supplement? 

All ingredients intentionally added to conventional foods or beverages are considered food additives.  Food additives must either be approved by the FDA, deemed generally recognized as safe (GRAS), or otherwise exempted.  A company may self-affirm the GRAS status of a food ingredient in its product(s).  It is not mandatory for the company to submit a self-affirmed GRAS report to the FDA, however, it must be prepared to do so upon the FDA's request.  Further, the costs associated with GRAS determinations can run upwards of $75,000 to $100,00 per ingredient.

Ingredients in a dietary supplement, on the other hand, have different requirements.  For example, if an ingredient meets one of the definitions of dietary ingredient and was used as a dietary ingredient prior to October 1994, no additional proof of safety is required.  Therefore, many companies may have used the dietary supplement route to market their liquid food products to save money.  However, the costs associated with complying with the more stringent good manufacturing practices (GMP) for dietary supplements, as well as their added post-marketing requirements (adverse event reporting and record keeping), can make it more expensive to market a dietary supplement vs. a beverage, in the long run.

Therefore, it is important to consider all the potential costs involved for regulatory compliance when a company decides whether to include a particular ingredient in its next liquid food product.

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