Drug-Tainted Product Warning Letter
FDA will test “sketchy” products
I’m sometimes asked what types of herbal products are safe and good to purchase. A first step is to ensure the company is not making extreme disease claims about its products, as this can signal deeper non-compliance.
In this warning letter, the company made extreme claims, which seemed to prompt FDA to purchase and test its products. FDA then discovered NSAIDs and other contaminants in the products, which, combined with the medical claims, led to the warning letter.
From warning letter.
- “100% natural herbal to relief gout, joint, arthritis body aches [sic].”
- “Ganoderma Huo Luo Dan for relief of Rheumatism, Gout, Arthritis, Stiff Joints, Back Pains.”
- “helps to lower blood glucose and cholesterol. Prevents diabetic complications by lowering blood glucose. Lowers cholesterol to prevent cardiovascular disease.”
The company also recently issued a drug-tainted recall for another product, which likely shows a culture of non-compliance. Scary!
From warning letter: “Your xxx product is not the first product found by FDA to contain hidden ingredients. You previously sold the product “Vail-Bon Jie Yang Wan,” which FDA laboratory testing identified as containing undeclared dexamethasone and chlorpheniramine.
The moral of the story here is that if products seem “too good to be true” or “sketchy,” it is better to avoid them. Thanks FDA for helping us get rid of these potentially dangerous products.
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