FDA Sends Warning to Smucker Beverages 30951

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. FDA alleged that the beverageVisionade, 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 JuliaSabin, 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 beverage 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 JohnForet, 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 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.

"We are confident that the ingredients of Visionade are all safe and appropriate for use in this product," the company stated in early July. "Our products are not meant to mitigate, treat or cure disease, and any suggestion to the contrary on any label would be against company policy." Smucker added that it would "immediately" change label claims to be in compliance with both the company's and FDA's requirements.