A sample of products considered making fraudulent cancer claims (FDA.gov/Flickr)
25 April 2017. The Food and Drug Administration sent warning letters to 14 companies in the U.S. that the agency says are selling products fraudulently claiming to prevent, diagnose, treat, or cure cancer. The letters from FDA alert the companies marketing 65 products to the public that they violate federal law and request responses indicating actions taken to correct the violations.
Under the Federal Food, Drug and Cosmetic Act, companies need to first demonstrate to FDA that products that claim to diagnose, prevent, or treat diseases are safe and effective if used as labeled or advertised. The agency says none of the companies have approval from FDA for these products, most of which are marketed on web sites or through social media.
The sanctioned companies offer pills, ointments, drops, syrups, and teas to treat cancer, as well as diagnostic systems to detect tumors. The products, says FDA, claim to prevent cancer, kill cancer cells, reverse cancer progression, or cure cancer entirely. “Consumers should not use these or similar unproven products,” says Douglas Stern, FDA’s director of enforcement and import operations in an agency statement, “because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment.”
One of the companies sent a warning letter is Hawk Dok Natural Salve LLC in Wenden, Arizona. FDA specifically highlights several of the company’s products sold on its web site or through Amazon.com, including Booster Cleansing Tablets, Genital Wart Remover & Relief, Skin Cancer Treatment, and Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores as those making cancer treatment claims. Hawk Dok’s Skin Cancer Treatment, for example, claims to contain herbs that “pull out the virus and cancer,” and clean “cancer out of the body.”
Another company cited by FDA is Nature’s Treasures Inc. in Glendale, California that also offers products for treating cancer in humans and pets, such as KR22 Oxicell. FDA cites Nature’s Treasures claims, “If you (or your pet) are suffering from liver problems, cancer, arthritis, kidney disease or other inflammatory conditions, this product can really help.” The company also offers a type of green tea that claims to fight cancer.
In addition, Nature’s Treasures markets a device called a thermographic camera for detection of breast cancer, for which the company never sought approval, according to FDA. The agency cites claims by Nature’s Treasures that its thermographic camera can detect breast cancer on its own, making it a class 3 medical device, requiring FDA approval before marketing. Nature’s Treasures web site also compares its thermographic diagnostics to mammography.
FDA gives the companies 15 working days to respond to the warning letters, indicating the actions taken to correct the cited violations. Natures Treasures, however, was asked to immediately stop the misbranding of its thermographic camera.
In a blog post on the the agency’s web site, FDA consumer safety officer Nicole Kornspan notes that, “Anyone who suffers from cancer, or knows someone who does, understands the fear and desperation that can set in. There can be a great temptation to jump at anything that appears to offer a chance for a cure.”
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- Report: More Biotech Regulations Needed, and Soon
- FDA Begins Cancer Product Review Center
- Targeted Leukemia Drugs Sharply Raising Costs of Care
- Hundreds of U.S. Clinics Found Selling Stem Cell Services
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