On Dec. 4, 2009, quite out of the blue, FDA announced the availability of a new draft guidance, Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for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 In its draft guidance, however, FDA is attempting to draw a distinct line in a number of ways that could radically change the scope of what types of products that physically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, FDAs 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 agencys 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A draft guidance, when finalized, represents FDAs current thinking on a topic.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 FDAs positions may affect current and future products and to consider filing appropriate comments.
As to FDAs 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 FDAs 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 FDAs 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.
In 2001, as noted above, FDA stated a dietary supplement could have physical attributes that are essentially the same as a conventional food. With the new guidance, it is obvious FDA has changed its collective mind. Under the guidance, a liquid dietary supplement could no longer have the physical attributes of a conventional food. Specifically, the guidance states:
Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement. Liquid products can be represented as conventional foods as a result of factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising. For example, the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food.
The first concern is FDAs statement about packaging. If a liquid dietary supplement cannot be packaged in a bottle or can that is similar to a single serve or multiple serve soda, bottled water, fruit juice or iced tea package, what packages are conceivably left besides very small containers and dropper bottles? Are there any liquid packages larger than six or eight ounces that would not fall within the FDAs description of a package representing a conventional food beverage? Will industry be able to develop a new container for liquid dietary supplements that does not resemble a packagebottle or canused for water, juice or iced tea? This provision seems to indicate FDA will no longer accept a product packaged in an 8, 12 or larger fluid ounce package as a dietary supplementa major shift in FDAs thinking.
FDA has also, apparently for the first time, taken a position on the amount of liquid that would be acceptable as a single or daily serving of a dietary supplement. According to FDA, based on data from the 2005-2006 National Health and Nutrition Examination Survey on daily intake of drinking water and other beverages in the United States, FDA estimated the average total daily drinking fluid intake per person to be about 1.2 liters (1,200 ml).
The total of 1.2 liters is slightly more than 40 fluid ounces. It is easily conceivable FDA is intending to take the position under the guidance that a liquid dietary supplement that constitutes a significant portion of the 40 fluid ounces of fluid per day that a person is expected to consume is not actually a dietary supplement, but a conventional food due solely to the amount of fluid consumed per serving or per cumulative daily servings, regardless of what representations are made on the label. It is not possible, however, based on the guidance to determine at what amount of liquid per serving or per day for multiple servings FDA will draw the line between a dietary supplement and a conventional beverage. Clearly, by way of this guidance, FDA is attempting to take the position that the only acceptable liquid dietary supplements are those consumed in small amounts.
But, following FDAs logic, why stop there? How many powder products are currently being marketed as dietary supplements that are intended to be mixed with water or other liquid and consumed? Is FDA planning to object to dietary supplements in powder form if they must be consumed with a significant amount of liquid, noting that we currently have no idea as to what amount of liquid FDA may find objectionable? Clearly, this seems to be a potentially open issue requiring industry comment.
Issues related to the physical characteristics of the packaging and the amount of liquid are critical because if FDA questions a product based on the ingredient issues, there will be very little flexibility to address FDAs concerns.
This issue of ingredients used in conventional beverages and dietary ingredients used in liquid dietary supplements is FDAs second concern. According to the agency, many ingredients intentionally added to beverages are food additives. Food additives require pre-market approval by FDA based on safety data submitted in a food additive petition. Based on the data, FDA will promulgate a regulation specifying the conditions under which the additive has been demonstrated to be safe and, therefore, may be lawfully used.
Alternatively, an ingredient can be exempt from the definition of a food additive if it has been shown to be GRAS (generally recognized as safe) by qualified experts under the conditions of intended use. For a substance to be GRAS for a particular use there must be evidence of safety and a basis to conclude the evidence is generally known and accepted by qualified experts.
On the other hand, DSHEA expressly exempts from the food additive definition dietary ingredients, which are generally those ingredients identified within the Supplement Facts box of a dietary supplement. Thus, dietary ingredients do not need to be GRAS, although they do need to meet the DSHEA safety standardnot pose a significant or unreasonable risk of harmand be the subject of a New Dietary Ingredient notification (NDIN) when required. Thus, for example, the botanical stevia was a dietary ingredient in dietary supplements, but could not be used as an ingredient in conventional beverages until companies were able to establish their stevia ingredient was GRAS.
This question of the status of ingredients is a concern companies must address when making determinations as to whether a product should be marketed as a dietary supplement or as a conventional beverage. For example, until recently, any product that included stevia as an ingredient was required to be labeled as a dietary supplement because stevia was not GRAS. Now that a number of companies have achieved GRAS status for the ingredient, it can be used as a sweetener in conventional beverages.
Under the guidance, however, other herbs that are not currently GRAS could not be similarly marketed in a liquid dietary supplement as stevia was, because such products would be prohibited by FDA based on the size of the package or the amount of liquid that would be ingested. Is FDA attempting to prohibit the addition of what it refers to as novel ingredients (those which are not GRAS) in dietary supplement products that physically resemble beverages? Almost certainly, the answer is yes. As stated in the guidance, FDA is concerned that some of the novel ingredients that are being added to beverages and other conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use.
Finally, a specific group of products is undoubtedly a target of the guidancethose marketed as energy supplements or energy drinks. In the guidance, FDA stated:
In addition, some ingredients that have been present in the food supply for many years are 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. This trend raises questions regarding whether these higher levels and other new conditions of use are safe.
One ingredient that immediately comes to mind is caffeine. There is a food additive regulation stating caffeine is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice and the set tolerance level is 0.02% [21 CFR §182.1180].
Note the regulation limits the addition of caffeine to cola-type beverages and the tolerance is limited by weight to approximately 47 mg of caffeine per eight ounces and 70 mg per 12 ounces. Obviously, the vast majority of currently marketed energy drinks are not cola-types and many have significantly more than the aforementioned caffeine tolerances. Thus, these products may be prohibited if FDA were to actively enforce the guidance. Moreover, if liquid supplements could not physically resemble beverages, there would no longer be any liquid energy supplements, except perhaps the smaller shots. This could be potentially devastating to the liquid energy supplement/energy drink market. Obviously, this is another area of concern where industry comment is warranted.
Steven Shapiro, Esq. is a partner in the New York-based law firm of Ullman, Shapiro & Ullman, LLP , which specializes in legal issues affecting the dietary supplement and natural products industries.