The distinction between whether a product is a food or a dietary supplement is important because of what can go into and what can be said about the product. For a variety of reasons, a number of products have been introduced into the marketplace in recent years that have hybrid properties and that have run afoul of the FDA. This has been especially problematic in the liquid dietary supplement and beverage sectors of the market. Since compliance with regulation of such products requires an understanding of the lines of demarcation utilized by the FDA in its enforcement decisions, a new guidance has been published that provides insight into the factors FDA uses to determine whether a product is a beverage or a liquid dietary supplement (Table 1).
Table 1: Factors that Indicate That a Product is a Beverage
The guidance notes that products are evaluated on a case-by-case basis and that in some cases, a single factor may be sufficient to identify a product as a beverage. In other cases, it is the totality of the information provided by the manufacturer that will cause a product to be considered either a beverage or liquid dietary supplement.
The Weinberg Group has decades of experience in working with the FDA and the FTC on these issues. Clients with questions are encouraged to call us to assist.
Posted by Carrie Rabe, Ph.D., Senior Consultant. For more information, please contact Carrie at email@example.com.