Supplement or Beverage? FDA Releases Guidance

WASHINGTONFDA has released a new guidance to help manufacturers determine if a liquid product can be labeled as a dietary supplement, as opposed to a beverage/food. Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods is a response to an increase in the marketing of beverages as dietary supplements, despite packaging and labeling that represents the products as conventional foods, and an increase in beverages and other conventional foods that contain novel ingredients, such as added botanical extracts.

While not a rule, but merely the agencys current thoughts, the guidelines note liquid dietary supplements whose packaging and labeling represent them as beverages do not fit the definition of dietary supplement under section 201(ff) of the Federal Food Drug and Cosmetic Act (FFDCA, 21 U.S.C. 321(ff)). In fact, the volume in which a liquid product is intended to be consumed, the product or brand name, and statements about the product in labeling or advertising all can cause the product to be a conventional beverage and subject to conventional food regulations, not those for supplements.

For example, the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food, the guidance states.

As for beverages with novel ingredients, FDA said some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. The guidance reads, In addition, 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 ingredients are unapproved food additives when used at higher levels or under other new conditions of use.  Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA. The agency seems concerned that some such novel ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use.

The guidance also provides some in-depth details on the use of health claims for beverages, including some online resources that can help marketers and manufacturers determine what can and can not be claimed, depending on whether the product would be considered by FDA as a supplement or food.

The full guidance is posted on the FDA Web site.