The
U.S. Food and Drug Administration today announced that Brownwood
Acres Foods Inc., Cherry Capital Services Inc. (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.
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 they make for their products and to certify that they have
omitted all violative claims.
"The FDA will not tolerate unsubstantiated health claims that
may mislead consumers," said 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 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.
The companies have a history of promoting unapproved claims on their
product labels, brochures, and Web sites, stating 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.
The FDA 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 FDA regulations.
The companies are also required to pay $1,000 per violation per
day in the event they fail to comply with the consent decree.
The decree was signed by Judge Paul Maloney on Feb. 19 in the U.S.
District Court for the Western District of Michigan. |
