An Injunction With a Cherry on Top

WASHINGTON—Cherry products makers Brownwood Acres Foods and Cherry Capital Services (dba Flavonoid Sciences) and two of their top executives signed a consent decree of injunction on Feb. 19 in U.S. District Court, effectively prohibiting them from manufacturing and distributing any products with label claims to cure, treat, mitigate or prevent diseases. FDA went after the defendants for making unapproved drug claims and unauthorized health claims about their products, such as "Chemicals found in cherries may help fight diabetes." Under this injunction, the companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products' label and labeling comply with the law.

Under the terms of the consent decree, the companies have agreed to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain such claims. They have also agreed to hire an independent expert to review the claims made for their products and to certify that they have omitted all drug claims.

"The FDA will not tolerate unsubstantiated health claims that may mislead consumers," said Margaret O’K. Glavin, associate commissioner for regulatory affairs, FDA. "The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."

Brownwood Acres Foods Inc. and Cherry Capital Services Inc. manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine and salmon oil capsules. According to FDA, the companies have a history of promoting unapproved claims on their product labels, brochures and Web sites, including statements that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies' Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres' president and contained similar unproven statements claiming benefits for their products.

FDA further noted it can order the companies to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act or other FDA regulations. In the event the companies fail to comply with the consent decree, they will be required to pay $1,000 per violation per day.