Tart Cherry Disease Claims Spur FDA Warning Letter

DETROITFour tart cherry products produced by Michelles Miracle Inc., a Leland, MI-based dietary supplement producer, are misbranded, according to a warning letter FDA's Detroit District Office Director Glenn T. Bass sent the company on June 8, 2012. The products are promoted for conditions that cause the products to be drugs per the Federal Food, Drug and Cosmetic Act, FDA said.  

Bass told Michelle White, president, Michelles Miracle Inc., that the products Michelles Miracle® Joint Formula Tart Cherry Concentrate Dietary Supplement, Michelles Miracle® Original Tart Montmorency Cherry Concentrate Dietary Supplement, Michelles Miracle® Sleep Formula Tart Cherry Concentrate Dietary Supplement and Michelles Miracle® Tart Cherry CherriMax Dietary Supplement are considered drugs because claims say they are used in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.

FDA noted therapeutic claims observed on the company's website , including that the products help relieve gout, arthritis and joint pain. The company websites also said anthocyanins, antioxidants in cherries, may reduce inflammation and risk factors for heart disease. Michelle's Miracle also compared tart cherries to aspirin. Calling out specific diseases lands these product claims into the drug category, according to FDA.

FDA said the company site also includes links to other websites that describe the use of tart cherries and tart cherry juice to prevent and treat various diseases, such as a link to the National College of Natural Medicines Tart Cherries Summary of Current Scientific Literature," which contains statements about the use of tart cherry products in preventing and treating cancer and cardiovascular disease. As FDA have previously noted in other warning letters, the agency evaluates information that comes from third-party links the same as information that comes from the brand owner.

Further, FDA said the tart cherry juice concentrate products are also misbranded because the website states they are, Always fresh from the farm to the bottle;" however, else where on the website, it says the products are flash-pasteurized to preserve the rich flavor and potency of the cherries," indicating the products have been preserved via thermal processing. FDA said the term "fresh" means the food is in its raw state and has not been frozen or subjected to any form of thermal processing or other form of preservation.

In addition, FDA said an inspection of the manufacturer of the company's tart cherry juice concentrate products, Triple D Orchard Inc., revealed these products are made from frozen tart cherry concentrate, despite the labels saying they are concentrates.

FDA also called out inappropriate nutrient content claims on the website, such as  "Montmorency tart cherries are a rich source of antioxidants" and "Nutraceutical Loaded with Antioxidant Activity . . ." FDA said nutrient content claims using the term antioxidant" must the name of the nutrient, and that nutrient must have an established reference daily intake (RDI). In this case, Michelles Miracle did not provide what type of antioxidant it referred to.

INSIDER's Take:

A dietary supplement company should carefully evaluate its website claims before it publishes them. Here, FDA  showed that disease claims made by the company or through a third party link cause dietary supplements to be misbranded. Also, this letter shows nutrient content claims must follow the law.

Lastly, FDA shows it is willing to use information from an inspection of a brand owner's contract manufacturer to evaluate marketing claims.