The warning letters are a primary compliance tool that the FDA uses to address violations of the Federal Food, Drug and Cosmetic Act, the authors explain.
The warning letter to Aie Pharmaceuticals notes claims on various webpages that the product ImmunPro is "proven to still be effective against cancer." Other claims for nutritional compands include the claim that "grape seed extract may inhibit tumors." The warning letter to Amazing Sour Sop Inc highlights the company's promotional literature, titled "Miracle Unleashed," for its Sour Sop capsules, tea bags, and tea leaves.
The company claims that the active ingredient of Graviola leaves "has proven to be an immensely potent cancer killer in 20 independent laboratory tests" and that "[O]ne chemical in Graviola was found to selectively kill colon cancer cells at 10,000 times the potency of [the commonly used chemotherapy drug] Adriamycin." The warning letter to Hawk Dok Natural Salve LLC notes that the product, which contains sheep sorrel and blood root, is being promoted for use in skin cancer with claims that "the herbs pull out the virus and cancer....
It cleans cancer out of the body." The warning letter to BioStar Technology International LLC concerns various products, including Angiostop, which is "used in the treatment of certain cancers and stomach ulcers" and "cuts off the blood supply to cancer cells." "Hoping to skirt the law on a technicality, some sellers made false claims and in small print provided a disclaimer that their products are not intended to diagnose, treat, cure or prevent any disease," the FDA officials write.
The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics (such as thermography devices).