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. |
