FDA Sends Warning To Smucker Beverages

WASHINGTON--In a letter dated June 8, the Food and Drug Administration (FDA) warned Chico, Calif.-based Smucker Quality Beverages Inc. that its label and Web site bore inappropriate health claims for one of its beverages, Visionade. FDA alleged that Visionade, which is marketed under the R.W. Knudsen Family brand (www.knudsenjuices.com), was being promoted as a product intended "to prevent, treat cure or mitigate disease."

In a letter addressed to Smucker president Julia Sabin, FDA (www.fda.gov) expressed concern that statements such as "Lutein . is added to protect against retinal degeneration" and "Bilberry extract . teams up with the antioxidant vitamin C to help protect the eyes against cataracts" made the seem drug-like, especially since there is no scientific evidence that Visionade is generally recognized as safe (GRAS). "Therefore, it may not be legally marketed in the United States without an approved New Drug Application," wrote John Foret, director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA and the letter's author.

The agency also stated that these "added" ingredients were also not prior sanctioned, nor were they used in accordance with a food additive regulation. As a result, FDA stated that such a food (as Visionade) could be viewed as an adulterated food that "cannot be legally marketed in the United States." In addition, the company must include the basis for concluding that lutein, bilberry extract and ginkgo are prior sanctioned or GRAS. Visionade contains blueberry and cranberry juice, in addition to vitamin C, selenium, bilberry extract, lutein, taurine, zinc and ginkgo biloba.

Smucker has 15 working days to rectify the label and Web site violations found by FDA. The agency noted that if changes are not implemented, product might be seized or given an injunction. Calls to Smucker had not been returned by press time.