Drawing the Line

Originally Published NO January/February 2010

Every trip to the grocery market seems to uncover a multitude of new drink choices. Shelves are stacked with soft drinks with herbal ingredients, energy drinks, dietary supplements, and herbal teas-the list goes on. With this recent explosion of drink choices, it is sometimes difficult for the consumer to know what he or she is actually buying. A new Draft Guidance for Industry posted on FDA's Web site on December 3, 2009, reflects some of these consumer concerns. It also provides some insight regarding FDA's regulatory mindset with respect to liquid products being sold as beverages, dietary supplements, or drugs.

The Draft Guidance, titled "Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods," is, in essence, FDA's informal interpretation of Section 201(ff)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Section 201(ff)(2)(B) is the portion of the definition of dietary supplement that states that a supplement is one that "is not represented for use as a conventional food or as a sole item of a meal or the diet."

FDA ostensibly issued the Draft Guidance to assist dietary supplement and beverage manufacturers in determining whether a liquid product may be labeled and marketed as a dietary supplement. However, it is clear that FDA's underlying purpose for issuing such a guidance is its growing concern over the types of products marketed as dietary supplements-perhaps signifying that this area may be one in which FDA will increase its enforcement focus in the near future. This concern is evidenced by FDA's statement in the Draft Guidance that "we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods."

In addition to the issues FDA has regarding "suspect" dietary supplements, the Draft Guidance addresses two other main issues: 1) the inclusion of novel ingredients in conventional foods, and 2) the differences in allowable claims and labeling requirements between conventional foods and dietary supplements.

Beverage or Dietary Supplement?

The first section of the Draft Guidance discussion addresses FDA's concerns about products that are labeled as dietary supplements but, from FDA's position, more closely resemble conventional foods/beverages.

FDA indicates that liquid products labeled as dietary supplements may be considered to be conventional foods, notwithstanding the characterization on the product label, as a result of factors such as packaging, the volume in which the products are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising. While this is not a novel position for FDA and is consistent with previous enforcement action taken by the agency, this reaffirmation in the form of a Draft Guidance likely serves as notice that FDA will be reviewing such products with more scrutiny than ever.

FDA also posits that the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages such as soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food. This should be of particular concern to the growing number of energy drink companies marketing and selling products as "energy supplements."

Additionally, FDA states that liquid products that suggest through their serving size, packaging, or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person are indicative of beverages.

Finally, FDA states that product brand names using conventional food terms such as beverage, drink, water, juice, or similar terms may represent the product as a conventional food. While none of the factors identified above are likely to mandate a specific classification of a product, in and of themselves, FDA reviews all aspects of marketing and labeling of a product to get an overall picture of the intent of a company in selling a product.

Novel Ingredients

Another concern FDA addressed in the Draft Guidance is novel ingredients being added to beverages and other conventional foods that are not approved food additives or generally recognized as safe (GRAS) for their intended use-thereby causing the food to be considered adulterated. The Draft Guidance identifies the basic elements for achieving GRAS status and the repercussions for failing to do so. FDA discusses an additional concern, that some ingredients are being added to beverages and other conventional foods at greater amounts than the traditional levels of use, raising further concerns over safety.

Labeling Claims

The final section of the Draft Guidance is essentially a short refresher on the different types of claims that can be made for beverages and other conventional foods. These types of claims are health claims, nutrient content claims, and structure/function claims. While both conventional foods and dietary supplements may make such claims, FDA's position is that there are differences in the extent to which these claims can be made for the two.

There are some technical labeling differences between beverages sold as conventional foods and dietary supplements as well. These differences can be found in the labeling regulations found in 21 CFR 101.9 (conventional foods) and 21 CFR 101.36 (dietary supplements). Differences include the fact that conventional foods require nutrition information to be displayed in the form of a Nutrition Facts panel, while dietary supplements display information in a Supplement Facts panel. Also, conventional foods must declare all of the ingredients in the product in the ingredients statement, in descending order of predominance by weight. Additionally, beverages and other conventional foods should not be labeled with the disclaimer required for dietary supplements bearing structure/function statements, as this serves to only further confuse the consumer.

Guidances Are Not the Law

The Draft Guidance is informative in that it represents FDA's current thinking on a particular topic, but it is important to remember that it is not the law. Guidances for Industry do not confer any rights on people, and they do not bind FDA or the public.

Furthermore, this Draft Guidance is not the final version of a Guidance for Industry, but merely a draft. FDA posts this Draft Guidance, in part, to solicit comments before the final version is completed. Companies should strongly consider submitting comments to FDA so that industry voices are heard.

While this Draft Guidance does not establish new law, it is a message that FDA is going to pay closer attention in the near future to the labeling and claims for these types of products. It is to the benefit of companies manufacturing, distributing, or selling liquids as beverages, dietary supplements, energy shots, or any one of the number of other forms of products that have appeared on the drink horizon, to be aware of FDA's view on the differences between beverages and dietary supplements. Such knowledge affords companies the best opportunity to market their products successfully while avoiding unwanted enforcement action from FDA.

Justin J. Prochnow is a lawyer in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food and beverage, dietary supplement, and cosmetic industries. He can be reached at 303/572-6562 or at prochnowjj@gtlaw.com.