FDA Takes Action Against 'Bogus Cancer Cures'

Zosia Chustecka

April 25, 2017

"Today we are announcing that 14 companies peddling bogus cancer cures have received warning letters," write physicians at the US Food and Drug Administration (FDA) in a blog post.

"A cancer diagnosis often provokes a sense of desperation," they write. "Unfortunately, rogue operations exploiting those fears peddle untested and potentially dangerous products, particularly on the internet."

The FDA is now taking the first step to stamp out such practices. 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.

At the same time, the agency is publicizing its actions against the bogus products with warnings sent to consumers.

The warning letters were sent to 14 US-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer.

Most commonly sold on websites and social media platforms, these products are being marketed with "slick ads, videos, and other sophisticated marketing techniques, including testimonials about miraculous outcomes," the FDA officials comment.

The authors are Donald D. Ashley, MD, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research, and Douglas Stearn, MD, director of the Office of Enforcement and Import Operations in FDA's Office of Regulatory Affairs.

"Often a single product was promoted as a treatment or cure for multiple diseases in humans and animals, " they point out.

A few examples of the claims made for cancer are listed below:

  • 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. "Making such obvious claims and then saying later that you are not doing so might seem clever, but the technique does not comply with federal laws intended to protect public health," they point out.

Warning to Consumers

It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses, the FDA says in a news release.

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). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing, or curing cancer; killing/inhibiting cancer cells or tumors; or similar anticancer claims.

"Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment," Dr Stern commented in a statement.

Frequently advertised as "natural" treatments and often falsely labeled as dietary supplements, such products may appear harmless, but they may cause harm by delaying or interfering with proven, beneficial treatments, and they could contain dangerous ingredients, the FDA warns.

Follow Medscape Oncology on Twitter for more cancer news: @MedscapeOnc

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