FDA's warning to a firm marketing a melatonin-containing beverage yields early evidence of how the agency intends to enforce provisions of its draft guidance on liquid dietary supplements.

Innovative Beverage Group's drank - labeled as a supplement, according to a spokesman, and marketed as an "extreme relaxation beverage" - drew a Jan. 13 warning letter.

But as its December 2009 draft guidance on liquid products threatened, FDA deemed IBG's beverage a food product rather than a supplement.

The letter posted March 2 says FDA is "not aware of any basis to conclude that melatonin is [generally recognized as safe] for use in conventional foods

Houston-based IBG's spokesman said in an e-mail that the firm's attorneys "are working closely with the FDA to resolve this issue."

In considering drank a conventional food despite its supplement labeling, FDA hews closely to language in its December 2009 draft guidance that drew intense criticism from the supplement and beverage industries (¹ Also see "FDA Should Not Judge A Liquid Supplement By Its Packaging - Stakeholders" - Pink Sheet, 8 February, 2010.).

Drank's 16-ounce cans and prominent use of the word "beverage" give it the appearance of a conventional food under the guidance, which says a product's serving size, packaging and recommended daily intake are all to be considered in delineating a conventional food from a supplement.

However, stakeholders say that there is no recommended intake value for fluids and FDA has not specified at what size a product becomes classified as a food rather than a supplement.

The warning letter explains that concern regarding melatonin stems from animal studies that found the neurohormone to increase spontaneous malignant tumor incidence in mice and demonstrated toxicity in retinal cells of rats. Drank also contains valerian and rose hips, according to the product Web site.

Melatonin is an accepted dietary ingredient often used in supplement form as a natural sleep aid (² Also see "In Economic Storm, Supplements Surface As Affordable Alternatives" - Pink Sheet, 20 October, 2008.).

- Dan Schiff ( ³ d.schiff@elsevier.com )

FDA's Drank Melatonin Warning Echoes Liquid Supplement Draft Guidance

More from Archive

More from Pink Sheet