AVOID FDA ACTION AGAINST ILLEGAL GLYCEMIC LABEL CLAIMS

FDA TAKES ACTION AGAINST ILLEGAL CLAIMS ON NUTRITION LABELS

FDA Acts on Nutrition Labels Health Claim Abuse

On February 22, 2008, FDA announced enforcement action against particular companies and executives that have a history of abusing nutrition labels health claim regulations.

 

The companies and executives have signed a consent decree of permanent injunction whereby they agree to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain abusive 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. 

 

Per the consent decree, FDA can order the companies to stop manufacturing and distributing any product if the companies fail to comply with any provision of the consent decree, the Food, Drug and Cosmetic Act or FDA regulations. 

 

The companies can also be fined $1000 per violation per day.

 

Also in FDA's announcement of the injunction the Agency states it will not tolerate unsubstantiated health claims and will pursue necessary legal action to make sure companies manufacture and distribute safe, truthfully labeled products to consumers.

 

FEBRUARY 22, 2008 

 

FDA Announces Permanent Injunction against Food Companies, and Executives 

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ILLEGAL DIABETES CLAIMS & UNPROVEN STATEMENTS

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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.