Products can't claim effectiveness against diseases, FDA says
ROCKVILLE, Md. The Food and Drug Administration on Friday announced that Brownwood Acres Foods, Cherry Capital Services—doing business as Flavonoid Sciences—and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.
The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as “Chemicals found in Cherries may help fight diabetes.” 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, the FDA stated.
“The FDA will not tolerate unsubstantiated health claims that may mislead consumers,” stated Margaret O’K. Glavin, associate commissioner for regulatory affairs. “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 and Cherry Capital Services manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine and salmon oil capsules.
The decree was signed by Judge Paul Maloney on Feb. 19 in the U.S. District Court for the Western District of Michigan.