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At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals today seized the dietary supplements, Forticel and Forticel Mix, from Jean’s Greens in Norway, N.Y. After an investigation of this company and its marketing practices FDA has determined that Jean’s Greens is making unapproved medical claims for these herbal products. Specifically, the products claim to treat and cure various life-threatening and serious illnesses such as cancer, although there is no scientific evidence to support these claims.
The seizure included 385 bottles and 78 mix packages worth more than $4,000.
“FDA is committed to rooting out modern purveyors of snake oil," said FDA Commissioner Mark McClellan, M.D., Ph.D. "These unscrupulous merchants not only cheat unsuspecting consumers, but they also endanger patients by encouraging them to substitute their bogus products for legitimate and proven remedies. Consumers must have accurate and truthful information so they can make informed choices, and FDA will continue its aggressive enforcement efforts against companies that make misleading claims about their products.”
Under the Federal Food, Drug and Cosmetic Act, products labeled as dietary supplements cannot make any claims that the products will cure, mitigate, treat, or prevent disease. Such claims on a dietary supplement would render the product a drug and subject to FDA approval before marketing. Moreover, the labeling must be truthful and not misleading.
Because the Forticel and Forticel Mix products make disease claims, FDA considers these products to be unapproved new drugs. Before a new drug product is approved for marketing, it must be shown to be safe and effective. Furthermore, drug product labeling must also include adequate directions for their intended use, which the seized products' labeling did not provide.
After its investigation of the firm’s marketing practices, FDA advised the firm that its products were making disease claims and are subject to be regulated as drugs. Despite the FDA’s warnings, the firm failed to comply.
Today’s action continues FDA’s stepped-up enforcement actions against dietary supplements that falsely claim they can treat life-threatening diseases. This year alone, the agency has taken the following actions against firms making false and misleading claims about its dietary supplements:
To date FDA has received no reports of illnesses associated with taking the
products that were seized today.
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