by Steven Shapiro, Esq.
On Dec. 4, 2009, quite out of the blue, FDA announced the availability of a new draft guidance, “Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.”
FDA had not previously discussed issuing such guidance, nor was it a particular focus or expectation of industry. There has always been a somewhat uncertain line as to what constitutes a so-called “functional food” in conventional form and what constitutes a dietary supplement that is similar to a conventional food in composition and form. In its draft guidance, however, FDA is attempting to draw a distinct line in a number of ways that could radically change the scope of what types of products that physically resemble conventional beverages could continue to be labeled and marketed as dietary supplements. For example, there could be significant future repercussions for liquid dietary supplements being marketed in any container larger than a dropper bottle or even potentially for any powder that is intended to be added to water or other liquid. As stated in the guidance, FDA’s first concern is the “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.” FDA intends to use new determining factors set forth in the guidance to address this concern.
The agency’s second concern is the “growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.” FDA noted, “some of these ingredients have not previously been used in conventional foods and may be unapproved food additives.” FDA also raised the issue of ingredients that have been present in the food supply for long periods of time “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.” Could this be a veiled reference to the energy supplement/energy drink market? According to FDA, if products contain ingredients at higher levels or under new conditions of use, such ingredients could be unapproved food additives. Could the agency be referring to caffeine and other typical energy product ingredients?
A draft guidance, when finalized, represents FDA’s “current thinking” on a topic. It does not bind FDA or the public, and arguably a company can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. This does not mean, however, any FDA guidance should be ignored.
FDA accepts comments on any guidance at any time. In this case, to ensure comments will be considered prior to FDA working on a final version, they should be submitted by Feb. 2, 2010. All potentially affected companies should review the guidance carefully in order to determine how FDA’s positions may affect current and future products and to consider filing appropriate comments.
As to FDA’s first concern, product representations, pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA), a dietary supplement does not include a product represented “for use as a conventional food or as a sole item of a meal or the diet.” [21 U.S.C. 321(ff)(2)(B)]. On Nov. 8, 2001, Christine Taylor, Ph.D., then director of FDA’s Office of Nutritional Products, Labeling and Dietary Supplements, wrote to Anthony Young, general counsel to the American Herbal Products Association (AHPA): “FDA does not object to a dietary supplement being marketed with the physical attributes that are essentially the same as a conventional food as long as the dietary supplement is accurately labeled and not represented for use as a conventional food” (emphasis added). The letter continued, “a product may be ‘represented for use as a conventional food’ in part by statements and/or vignettes that appear on the label that suggest the product is or can substitute for a conventional food.”
Her letter then cites a number of representations that suggest a product even labeled as a dietary supplement would actually be a conventional food. These representations include standardized food names (e.g., spring water or orange juice) and the use of traditional food terms such as “drinks, beverages, cereals, spreads, soups and breakfast drinks.” Essentially, this has been FDA’s position at least since 2001, and possibly earlier. The new guidance stated, “product or brand names that use conventional food terms such as ‘beverage,’ ‘drink,’ ‘water,’ ‘juice’ or similar terms represent the product as a conventional food;” this is consistent with current FDA policy.
Unfortunately, this is not where the new guidance ends. There are several new positions taken by FDA that could severely limit the scope of acceptable liquid dietary supplements.