Recently, the FDA released a long-awaited final version of its guidance regarding the differences between beverages and liquid dietary supplements. The “Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages” had been promised over the course of the last two years as part of the ongoing dialogue between certain U.S. Senators and Congressmen and the FDA. So, now that it is out, what does it mean?
Of course, it is always important to remember that FDA guidances are not the law, but instead, reflect the FDA’s current thinking on the subject. That being said, while guidances aren’t law, they are instructive on how the FDA is likely to act regarding the topic and it is generally advisable to follow the guidance if a company does not want to run afoul of the FDA.
Supplements Represented as Conventional Foods
In my opinion, the FDA did not substantially change its position regarding the distinction between beverages and liquid dietary supplements from its previous position set forth in the 2009 draft guidance. Perhaps the biggest concern to some companies was whether the new guidance would contain any “bright-line” determinations or thresholds distinguishing beverages from liquid supplements. Other than potentially the use of “beverage,” “drink,” or other names traditionally associated with conventional foods and beverages, no one factor is likely to make a product labeled as a dietary supplement to be considered “represented as a conventional food.” The FDA is still going to evaluate products on a case-by-case basis and look at the entire context of advertising, labeling, and marketing to make a determination. That being said, the revised and finalized guidance is instructive in that it provides some more specific examples of circumstances that could cause a product to be “represented as a conventional food.”
The FDA reiterated that one of the key aspects of a product that the agency will look at is the name of the product or the way in which it is referenced. While the previous guidance did reference this, it is clear from the warning letters that the FDA has issued in this area that references to the product as a “beverage” or “drink” are probably the #1 factor that could cause a product to be “represented as a conventional food.” The FDA identified other examples such as “bottled water,” “orange juice,” “iced tea,” and “coffee,” although it did indicate that teas would not likely be deemed a beverage on the basis of the name alone since there is some history of use as dietary supplements.
In my opinion, this is the most important factor for companies to consider. You must be consistent in your messaging. If you intend to sell a dietary supplement, it is a supplement product in all labeling, advertising, and marketing, not an “energy drink” or “after-dinner beverage.”
One of the aspects that I thought was of particular interest was the comment that statements like “refresh” or “rehydrate” used on the labeling of a dietary supplement could cause the product to be deemed “represented as a conventional food” because refreshing and rehydrating are uses associated with beverages. This is certainly an item to keep an eye on for marketers of dietary supplement products.
While I think it is important to review all of the factors, I don’t think the guidance will have a significant impact on companies making energy shots or other supplements in small serving sizes. In my opinion, companies marketing and selling dietary supplement shots start out with an advantage because a 2-fl-oz or 4-fl-oz shot does not resemble a traditional beverage. Accordingly, issues with product packaging, serving size, and recommended daily intake do not come into play as much because the products do not resemble beverages in those respects. Companies selling shots still must be cognizant of some of the other points identified in the guidance, but they have less to worry about in this area.
Beverage’s Structure-Function Claims
While most of the guidance focuses on the FDA’s review of supplement products to see whether they are being represented as conventional foods, there was one aspect of the final guidance that I find important for beverage companies—the FDA’s position regarding structure-function statements. While structure-function statements are specifically provided for dietary supplements pursuant to the Section 6 of DSHEA (Dietary Supplement Health And Education Act of 1994), the FDA’s position with respect to conventional food and beverages is that such statements must relate to aroma, taste, or nutritive value. This position regarding structure-function statements for conventional food and beverages is not new; however, the FDA, historically, has rarely made the distinction and taken action against a company because a structure-function statement was not related to aroma, taste, or nutritive value.
While most of the guidance is directed towards determining if a product is a beverage instead of a dietary supplement, this aspect should be of interest and possibly concern to those companies marketing beverages or looking to “flip the switch” from supplement to beverage. If the FDA does start enforcing this aspect, it would narrow the range of claims available to beverage companies.
Overall, the key message is that companies have to be consistent in the marketing and advertising of their products. If the intent is to sell a product as a dietary supplement, the marketing and advertising may not reference it as a “beverage” or “drink” or otherwise promote it in ways which would suggest it is a beverage or conventional food instead of a dietary supplement. When the previous draft guidance was issued in 2009, the FDA took little action in line with the guidance for almost two years. We will be watching with great interest to see whether the FDA acts quicker now that the guidance is final.
Justin J. Prochnow
Greenberg Traurig, LLP