Beverage or Supplement? FDA Issues Industry Guidance

The U.S. Food and Drug Administration (FDA) today issued a pair of long-awaited advisory statements that are of particular interest to beverage marketers because they explain how the agency will look at product claims with regard to functional products.

In its “Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages” the FDA updated its 2009 draft guidance, explaining its current thinking on the topic as a way “to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage.”

It has been hotly anticipated due to the proliferation of beverages that have made functional claims in recent years and questions about whether those products should be more properly labeled as dietary supplements. Consumer advocates have worried that products that have a variety of effects and make a variety of at times hard-to-prove claims have been labeled as dietary supplements – an arena where claims are given more room with regard to accuracy – when they are being sold as beverages.

The Council for Responsible Nutrition – a trade association working on behalf of the dietary supplement industry – rushed to applaud the guidance, calling it “an instructive roadmap for both the dietary supplement and the conventional food industries.”

Justin Prochnow

But regulatory attorney Justin Prochnow, a partner with Greenberg Traurig LLP, warned that part of the advisory statement might lead to closer scrutiny of beverage claims.  For many products trying to comply with the 2009 draft guidance, he said, it had made sense to launch or recast themselves as conventional beverages rather than dietary supplements to get their labels in line with the agency’s recommendations. But in doing so, he warned, the products may have decreased their ability to market certain functions as they must be reliant on the flavor, aroma, or nutritive value of the food or beverage itself.

“Until now, [the FDA] hasn’t taken action except for disease claims,” with regard to beverage claims, Prochnow said. Knowing more products will likely base their functional claims on the nutritive value of their ingredients, rather than on supplementation, he added, “Is the FDA going to take a closer look at structure function claims from certain types of beverages? That’s the one kind of flip back the other way – you lose some of the range of claims you can make.”

The agency did not outline any specific single factor that will help it determine whether it will regard specific products as beverages or supplements, instead indicating that “in most circumstances a combination of factors” would assist in the determination on a case-by-case basis.

Nevertheless, it made clear that some factors, like product names that use conventional food terms such as “beverage,” “drink,” “water,” or “soda” would represent the product as a conventional food. Claims that a product would offer certain benefits typically ascribed to a food or beverage — like “refresh” or “rehydrate” or symbols and graphics that show foods – would put it squarely in the food or beverage camp, regardless of supplement claims or labels.

“For example,” the FDA notes, “An ad or a label with a picture of a liquid product being poured on to a green salad would represent the product as a salad dressing.”

Other factors that will weigh into FDA interpretation include:

  • Packaging: typically, the FDA says, if a product is packaged in a container like those typically used by beverages (i.e. a 12 oz. can) it will be regarded as a beverage.
  • Serving Size: a product is regarded as a beverage if its recommended intake is that it be used as a beverage or replace a beverage in the diet.
  • Recommendations and directions for use: following the advertising model, if a product is recommended to be used in the same method or for the same purpose as a beverage,  the FDA said, the product will probably be regarded as a beverage. Recommending that it be used “in a manner consistent with other dietary supplements (e.g. , by taking one tablespoons three times a day) could be a factor in determining that the product is not represented as a conventional food, even if the packaging is similar” to beverage packaging.
  • Marketing practices: both language on labels, online representation as a beverage for web searches, and paying for a product to be placed in stores alongside other beverages will be considered, according to the FDA. The agency also noted that in terms of marketing, “promoting a product as a substitute for a beverage would not always represent the product as a traditional food,” citing the example of a vitamin C supplement as an alternative to drinking orange juice to get vitamin C would likely mean the product was still a supplement.
  • Composition: the FDA announced it intended to ensure that foods supplemented with dietary supplements will be marketed in the proper form to make sure that those products are GRAS or approved for their intended use. Using the example of “adding a botanical such as ginkgo to kool-aid… would not automatically create a product that could be marketed as a ‘ginkgo supplement,’” the FDA made it clear it wasn’t ready to start letting products that aren’t allowed to be added to conventional foods and beverages get added under the auspices of labeling that food as a dietary supplement.
  • Other Representations: the FDA said it would look at public filings, trademarks, and context to determine whether specific products could be defined as a conventional food or beverage.