By Lori Hardaway, Director of AVERTURE
That the beverage industry has been an area of rapid growth is no surprise to anyone. Beginning about 20 years ago with the introduction of Red Bull, the market has seen the onslaught of products touting increased energy, promoting relaxation, and a host of other health benefits. These products usually claim to be dietary supplements, but the Food and Drug Administration (FDA) does not agree. Hence, the blurry line.
In 2009, the FDA issued a Draft Guidance Document with respect to these products. Although the Guidance is still in draft stage and has not been finalized, it represents the Agency’s current thinking on the topic. In addition to releasing the Draft Guidance, the agency released 3 Warning Letters to manufacturers shortly after releasing this Guidance.
The FDA’s Draft Guidance enumerated two issues that cause concern regarding these products. First is the incorrect categorization of the product as a dietary supplement rather than as a beverage. This shift in categorization is not just a linguistic game for attorneys and bureaucrats. How a product is categorized dictates how it is regulated. The shift of a product from dietary supplement to beverage brings the product under the umbrella of food regulation rather than dietary supplement regulation. Second is the inclusion of a host of new ingredients including botanicals and extracts that may be unapproved food additives.
Dietary Supplements vs. Beverages
Dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act (DSHEA). Under DSHEA, manufacturers do not need to obtain FDA pre-approval before production or sale of a dietary supplement. Instead, manufacturers have the burden of determining whether a product is safe prior to marketing. FDA may take action against a product on the market if the Agency determines that the product or an ingredient is unsafe. Because of this shift in regulatory status for dietary supplements, being classified as a supplement rather than a food, beverage or drug is highly desirable. The definition of dietary supplements is lengthy but for purposes of this article, the pertinent part is the exception that dietary supplements cannot be represented as food. Foods include beverages such as water, tea, juices and energy drinks– even if labeled as a dietary supplement.
According to the Guidance Document, the factors that go into determining whether a liquid product is a traditional beverage or a dietary supplement include its packaging, the volume in which it is intended to be consumed, its product or brand name, and statements about the product in labeling or advertising.
“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.”
“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 in the U.S., are represented as beverages.” The FDA estimates the average total daily drinking fluid intake per person to be about 1.2 liters. Product volume and recommended daily intake or serving sizes of a product in relation to the total daily fluid intake are considered in determining whether a product is a beverage or a dietary supplement.
Product or brand name
“The name of a product can represent the product as a conventional food. Product or brand names that use conventional food terms such as “beverage,” “drink,” “water,” “juice” or similar terms represents the product as a conventional food.”
Beverages must comply with pertinent food regulations regarding labeling, including nutritional information, health claims and nutrient claims. Beverages may not display the disclaimer required on dietary supplements that have structure/function claims. In addition, beverage ingredients are subject to regulations pertaining to food additives which circles back to FDA’s second concern regarding these liquid products.
Ingredients intentionally added to beverages (and other foods) are food additives. Food additives require pre-market approval unless exempted for some other reason. Pre-market approval of a food additive is gained through successful submission of a food additive petition to the FDA.
One of the exceptions to the requirement of a food additive petition is if a substance is Generally Recognized as Safe or GRAS for the conditions of intended use. To be considered GRAS there must be evidence of safety and a basis to conclude that this evidence is generally known and accepted by qualified experts. The requirement of safety evidence is that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. This data must be generally available and there must be a basis to conclude that there is a consensus among qualified experts about the safety of the substance for its intended use.
If a substance is not GRAS, is not the subject of an approved food additive petition or does not meet any other exceptions, the use of the substance in a food, causes the food to be adulterated. Adulterated foods cannot be legally imported or marketed in the United States.
Novel ingredients such as botanicals and extracts are being added to beverages without becoming GRAS for their intended use. In addition, some of these herbal and botanical ingredients are being added to beverages in amounts exceeding their traditional or conventional amounts. These new ingredients, along with their ever escalating amounts, raise significant questions about the safety of these beverages.
The energy and health drinks that are now ubiquitous in the beverage distribution chain are being treated as beverages despite the claims on many to be dietary supplements. These beverages are regulated by the FDA as a conventional food, including regulations pertaining to the addition of safe ingredients, statement of identity, and required nutrition labeling. For this reason, many of these products are likely candidates for future FDA enforcement action including warning letters and seizure.
But FDA is not the only worry. Although FDA regulates the labeling of a food product, the Federal Trade Commission and the state Attorneys General have enforcement responsibilities for federal and state statutes that regulate false or misleading labeling or advertising. Further, consumer class actions typically follow close behind governmental actions, leading to a storm of litigation that may threaten the life of a company.
Manufacturers have the responsibility of determining their product classification and complying with all applicable regulations pertaining to their product. It is unlikely that placing the moniker “dietary supplement” on a product will keep the FDA away.
 Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Conventional Foods, December 2009. http://www.fda.gov/food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm
 21 U.S.C. §321 (ff)
The term “dietary supplement”
(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
(2) means a product that – (A)(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title; or (ii) complies with section 350(c)(1)(B)(ii) of this title; (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement; and
(3) does -(A) include an article that is approved as a new drug under section 355 of this title or licensed as a biologic under section 262 of title 42 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this title; and (B) not include – (i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter. Except for purposes of paragraph (g), a dietary supplement shall be deemed to be a food within the meaning of this chapter.
 21 U.S.C. §321(ff)(2)(B)
 21 U.S.C. §321(f). The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
 Based on National Health and Nutrition Examination Survey on daily intake of drinking water and other beverages in the United States, 2005-2006.
 See generally, 21 C.F.R. §§101
 21 U.S.C. §343(r)(6)(A). The disclaimer is “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” 21 C.F.R. §101.93(c)(1).
 21 C.F.R. §§170
 21 C.F.R. §§171
 21 U.S.C. §321(s) and 21 C.F.R. §170.30
 21 U.S.C. §342(a)(2)(C)