An FDA draft guidance has the potential to make defining a beverage as a dietary supplement much tougher.

In the document posted Dec. 3, FDA appears to narrow its definition of what types of products qualify as supplements - likely with an eye toward energy drinks labeled with long lists of novel ingredients.

Experts speculate the agency eventually could apply the same logic on liquid supplements to other food categories and supplement formats.

The Center for Food Safety and Applied Nutrition says liquid supplements with packaging and labeling representative of conventional beverages do not fit the definition of a dietary supplement under the Food, Drug and Cosmetic Act.

A product's size and shape, phrases such as "drink" and "juice," and other similarities to conventional beverages may invoke food rather than supplement regulations, CFSAN says in the draft, "Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods" (¹ 'The Tan Sheet' Dec. 7, 2009, In Brief).

Packaging of liquid products in bottles or cans similar to those used for beverages including sodas, fruit juices and bottled water "suggests that the liquid product is intended for use as a conventional food," according to the ² guidance.

Keeping GRAS In Field Of Play

The guidance is intended to address the agency's concern that by labeling products as supplements, some firms are circumventing the costly process of proving ingredients generally recognized as safe for use in conventional foods.

"The implications are enormous," according to United Natural Products Alliance Executive Director Loren Israelsen.

Should the position taken in the draft guidance extend to FDA's larger regulation of supplements, structure/function claims and the status of certain ingredients could be at stake, Israelsen said.

While structure/function claims usually are associated exclusively with supplements, the guidance says a conventional food may make such claims relating to its inherent "taste, aroma or nutritive value." Any other claimed physiological effect could make the food an unapproved drug, FDA says.

The Council for Responsible Nutrition acknowledged the draft's potential to make some products now marketed as supplements subject to regulation as a food product, or to be considered an unapproved drug.

In an e-mail, CRN said it hopes FDA will provide "further clarification on the meaning of 'nutritive value'" to help supplement firms maintain compliance with structure/functions claim regulations.

Some beverage supplement providers may attract FDA scrutiny simply because they differentiate their products as liquids.

Andrew Shao, CRN's VP for scientific and regulatory affairs, said, With beverages. firms "have a 'novel' delivery system for supplemental nutrients and other ingredients."

Vexation About Representation

CFSAN notes that in addition to a product's claims, how a product is "represented" affects whether it should be labeled a supplement and not be subject to the food GRAS rule and other regulations.

The limits proposed in the guidance reflect a significant policy shift from what industry has followed since the Dietary Supplement Health and Education Act was passed in 1994.

FDA typically has defined supplement products in the context of their claims, said attorney Ivan Wasserman.

"Does 'represented' mean 'looks like'? Nothing in DSHEA says a dietary supplement can't look like conventional food," said Wasserman, a partner with Manatt, Phelps & Phillips in Washington.

FDA points out liquid products that suggest - "through their serving size, packaging, or recommended daily intake" - they are meant to compose "all or a significant part of" a person's fluid consumption are, by their nature, comprising the diet and not supplementing it.

Such product characteristics are "important determinants" of how FDA says it will classify them, but where the agency might ultimately draw the line is left unstated in the draft guidance.

Wasserman added that beverages may not be the only target of this restrictive regulatory posture.

"FDA could be using this as first foray into other types of supplements in conventional food form, such as bars," he said.

CRN's Shao points out FDA already goes after beverages pitched as supplements in enforcement actions.

The draft shows FDA "is taking a more formal approach, hoping to stop companies from committing this violation in the first place," he said.

CFSAN issued multiple letters Nov. 30 on this issue, including an informational ³ notice to Skinny Nutritional Corp. of Bala Cynwyd, Pa., that its Skinny Water beverages in 16-ounce bottles cannot be dietary supplements as labeled, in light of their packaging and product name.

Another ⁴ letter, to Irish firm Shannon Minerals Ltd., said the agency declined to review a new dietary ingredient submission from the company because the proposed finished beverage product, CoolwaterTrim , does not qualify as a supplement.

Confusion between conventional foods and supplements is not new. In 1998, McNeil switched Benecol from a supplement to a food before launch when FDA said proposed labeling for the plant stanol-ester spread caused the product to be a food (⁵ Also see "Benecol Highlights Unclear Food, Supplement Distinction - McNamara" - Pink Sheet, 16 November, 1998.).

Alternative Energy Labeling

Attorney Antonio Martinez acknowledges FDA has legitimate concerns about the safety of highly caffeinated energy drinks, but he says food and supplement regulation could benefit from more flexibility.

"All that FDA cares about is maintaining black and white distinctions in the law between foods, drugs and supplements," said Martinez, a regulatory affairs consultant based in Washington and Warwick, N.Y.

"That's been a challenge for them because there's overlap, and FDA has never been able to ... ease the tension between the distinctions there."

Martinez said he does not expect FDA's guidance to lead to sizeable market shifts, though it could ultimately affect labeling of energy drink products.

Many top-selling energy drinks are labeled as energy supplements with accompanying "Supplement Facts" information, including Rockstar and Monster energy drinks. More concentrated formulations such as 5-Hour Energy and Red Bull Energy Shots also are marketed as supplements.

Marc Ullman predicts the draft guidance could have a "pretty broad impact" on liquid supplements of all sizes and delivery formats.

He notes FDA's stance may force energy drink companies to re-evaluate GRAS status for all their products' ingredients, including commonly used food additives.

While caffeine is GRAS as an additive to cola, it may not be so at the higher levels found in certain energy drinks, said Ullman, of New York law firm Ullman, Shapiro & Ullman.

"You can't just say, 'I have GRAS caffeine from my supplier,'" he added.

Comments on the draft guidance are due to CFSAN by Feb. 2, 2010.

Stakeholders say they hope firms take the opportunity to weigh in on FDA's thinking.

"There are good reasons FDA is raising this issue, and there are even better reasons why the functional food and [supplement] industries should be very studious in preparing comments to this draft document," Israelsen said in an e-mail.

- Dan Schiff ( ⁶ d.schiff@elsevier.com )

FDA Supplement Beverage Guidance May Open Can Of Regulatory Worms

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