The Food and Drug Administration's draft guidance distinguishing liquid dietary supplements from conventional beverages could have major impact on the supplements industry should the FDA begin enforcing it,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 But in the draft guidance, the FDA listed factors such as packaging type, serving size and use of terms like drink and beverage as qualifications that could confuse consumers.
"In the draft guidance, for the first time, the FDA talked about the packaging—which is not discussed in DSHEA and is the exact opposite of statements made previously," said Steven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."
It's important to note that the draft guidance is not law, but rather the FDA's expressed intention of how it will interpret a law, followed by an open public comment period designed to solicit consumer and industry opinion, as well as institutional research. However, it still carries impact: "The FDA has already cited the draft guidance in courtesy letters it has sent to one or two companies," Wasserman said.
"We understand that this is a draft guidance," Shapiro said. "This means the FDA either can take steps to finalize it, withdraw it—admitting that what they've said goes beyond what's allowed in DSHEA—or do nothing and leave it out there in limbo. But even if it's left out there, it still exists. And the longer a guidance exists, the more backing it could get. The FDA could build upon this in the future."
And building upon it could mean using it as a precedent for other supplement categories that might be mistaken for food products. "This is also a slippery slope into an argument against bars," Wasserman said. "There are a lot of supplement bars out there that otherwise look like general health bars. The FDA could use the same arguments, and certain supplement products could become illegal unless you reformulate them. You'd have to either repackage into smaller serving sizes or reformulate."
Shapiro agrees: "If the FDA says a product can't be a supplement if it comes in a can or bottle, it could also end up meaning a dietary supplement bar can't resemble a Milky Way," he said.
In the meantime, it's not too late for manufacturers, trade associations, retailers and consumers to chime in, Shapiro said, even though the FDA had wanted all comments submitted by February 2010. "Whenever the FDA issues guidances, the affected industry should be prepared to comment," he said. "There's a reason why comments are required for guidances and regulations. Even now, up until the FDA takes further action, there's still a value in submitting."
Jason Sapsin, head of Denver-based law firm Polsinelli Shughart's national FDA/food/dietary supplement/cosmetic/drug/device practice, and former associate chief counsel for the FDA, agrees: "I almost always recommend engaging with the FDA," he said. "It's much easier for the agency to respond to industry and consumer needs if there are reliable, committed people in the marketplace willing to converse and contribute in good faith their experience and research."
However, ensuring an effective dialogue requires some give-and-take from both sides and an understanding of the other camp, Sapsin said. "On the industry's side, this means recognizing that the FDA is going to be relatively conservative because of its focus is on public health and safety," he said. "On the FDA's side, it means recognizing that the natural products industry is genuinely interested in enhancing consumers' quality of life and invested in learning about new products and ideas for healthier living."
And even though this draft guidance's future and significance is yet to be determined, retailers should be aware of its existence, Sapsin said. "There are two reasons why this is very important for retailers," he said. "First is the issue of perception. Retailers don't want to be found promoting products that are ultimately questioned because of labeling or formulation. Fairly or unfairly, these situations undermine consumer confidence in the retailer and in the industry. Secondly, and perhaps more importantly, one of the greatest areas of differentiation among retailers is the customer service and support they provide—this is a key strength of the natural products retailing community. A retailer that really pays attention to customer education and uses its food and supplements knowledge to offer safe and easy-to-understand products is helping to create a healthy, loyal community around it."