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The Food and Drug Administration’s draft guidance distinguishing liquid dietary supplements from functional beverages could have major impact on the supplements industry should the agency begin enforcing it, experts say.
The Food and Drug Administration's draft guidance distinguishing liquid dietary supplements from conventional beverages could have major impact on the supplements industry should the FDA begin enforcing it, experts say.
Issued in December 2009, "Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods" outlined what constitutes liquid supplements and beverages--using parameters that some view as contradictory to those established in the Dietary Supplement Health and Education Act of 1994. While DSHEA states that a dietary supplement "may not be represented for use as a conventional food," it doesn't say specifically what factors it considers as "representative." But in the draft guidance, the FDA listed factors such as packaging type, serving size and use of terms like drink and beverage as qualifications that could confuse consumers.
"In the draft guidance, for the first time, the FDA talked about the packaging—which is not discussed in DSHEA and is the exact opposite of statements made previously," said Steven Shapiro, partner at Ullman, Shapiro and Ullman, a New York-based law firm specializing in dietary supplements regulation. "Also, the amount of liquid [as a qualifying beverage characteristic] came totally out of left field."
According to Ivan Wasserman, partner at Mannatt, Phelps and Phillips law firm and expert on regulatory issues surrounding food and supplement labeling and advertising, "I think what happened is that consumers were going down convenience store beverage aisles and seeing beverages and liquid supplements that looked by quick glance to be the same types of products. Only on close inspection would they realize that one product was a conventional beverage and the other a dietary supplement. And that's if they knew the difference between the supplement facts and nutrition facts on a label."
Beyond consumer confusion, the main issue behind whether a product is considered a beverage or a liquid supplement is that beverage ingredients must be approved as food additives and given GRAS (generally recognized as safe) status, while supplement ingredients do not require the same approval. In short, supplement ingredients' structure/function claims do not equate to food and beverage ingredients' nutritional benefits. Some speculate the FDA set forth even stricter differentiating guidelines because drink manufacturers had been skirting the GRAS rules by classifying and marketing their products as supplements.
Still, some experts believe the FDA's action is too broad and restrictive. "If FDA has a direct concern—such as energy drinks—it should deal with that concern directly and not via a guidance that takes broad strokes that go beyond what I believe is entitled by DSHEA," Shapiro said. "If products are marketed and labeled correctly, they should be legal dietary supplements."
Shirapo also stressed that supplements and beverages are indeed different and should be regulated differently. "The reason why DSHEA was set up in the first place was to allow [structure/function] claims on ingredients that don't have nutritive value," Shapiro said. "If the FDA is trying to close the door on liquid dietary supplements and force these products into the category of liquid beverages, many won't fit. If this ends up pertaining to any product that has "significant" amount of liquid—and we don't know exactly how much "significant" means—there could be a whole host of products affected."