FDA Getting Tough on Food Claims; Agency Enters Into Consent Decree of Permanent Injunction With Two Food Companies Over Unauthorized Drug ClaimsFebruary 27, 2008
Last week, FDA announced a consent decree of permanent injunction had been entered into with two food companies – Brownwood Acres Foods, Inc. and Cherry Capital Services, Inc. (doing business as Flavonoid Services) – and their top executives, prohibiting them from making unauthorized drug and health claims about their products. The Consent Decree of Permanent Injunction, which was signed by Judge Paul Maloney on February 19th in the U.S. District Court for the Western District of Michigan, might signal FDA’s intent to police food claims more vigorously. (A copy of the Complaint for Permanent Injunction is available here.) Violations of the consent decree, which can be enforced by the court, may result in an order to stop manufacturing and distributing any product and a $1,000 per violation/per day penalty.
Although the companies make a variety of food and dietary supplement products, including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules, the complaint and injunction focus primarily on the companies’ claims made for fruits. In the consent decree of permanent injunction, FDA alleges that the companies made unauthorized drug and health claims in violation of the Federal Food, Drug and Cosmetic Act (“FDC Act”), such as “wild blueberry compounds may inhibit cancer,” “[p]urple grape juice seems to have the same effect as red wine in reducing the risk of heart disease,” “[a] new study . . . found that drinking pomegranate juice can fight prostate cancer,” and “tart cherries . . . may help gout, arthritis, and inflammation sufferers.” The companies have previously faced enforcement for their claims about similar products. For example, in 2005, FDA sent Brownwood Acres a Warning Letter claiming that the company made unauthorized drug claims about the company’s cherry juice concentrate, blueberry juice concentrate, pomegranate concentrate, and cherry flex soft gel capsule products.
The consent decree of permanent injunction, signed by both companies and their executives, was entered into in response to the companies’ continuing to make unauthorized drug and health claims, such as “Chemicals found in Cherries may help fight diabetes.” The companies are permanently prohibited from delivering any product into interstate commerce unless and until FDA approves a drug marketing application (i.e., an NDA or ANDA), or there is an effective IND, or the product’s claims comport with an authorized health claim, or FDA issues a letter of enforcement discretion for a qualified health claim for a particular product, or until the companies remove all unauthorized drug and health claims from their websites, labels, labeling, and promotional material. The companies have also agreed to hire an independent expert to review all claims and certify that they have removed the claims objected to by FDA.
FDA’s Associate Commissioner for Regulatory Affairs, Margaret O’K. Glavin, states in the Agency’s announcement that the “FDA will not tolerate unsubstantiated health claims that may mislead consumers. The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers.” It remains to be seen whether this will be an isolated instance of FDA enforcing the FDC Act against food companies or whether this begins an increased effort by FDA to monitor the claims being made for foods.