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.
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