Biosimilar drugs

FDA Warns Companies Selling Fraudulent Cancer Treatments

The U.S. Food and Drug Administration (FDA) has issued 14 warning letters and four online advisory letters addressed to U.S.-based companies illegally selling products that fraudulently claim to prevent, diagnose, treat or cure cancer. More than 65 products were found to be in violation.

Since 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 companies will need to respond to the FDA stating how the violations will be corrected. Failure to do so may result in legal action, such as product seizure, injunction, and/or criminal prosecution.

According to the agency, the illegally sold products include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics (such as thermography devices). The products are marketed for use by humans or pets and make unproven cancer claims, such as preventing, reversing, or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. The letters detail the specific violations of each company and cite examples of claims that establish the intended use of the product to diagnose, cure, mitigate, treat or prevent disease.

The products—marketed and sold without FDA approval—are most commonly found by consumers on websites and social media platforms, such as Facebook and Instagram. They may also be found in retail stores or flea markets, swap meets, and even trade shows.

The FDA action is nothing new. The agency has issued more than 90 warning letters in the last ten years to companies marketing products that make fraudulent claims to minimize the potential dangers to consumers. While many of the companies stop selling their products or stop making fraudulent claims, some companies continue to market their products by changing their names or creating new websites. For this reason, the FDA continues to monitor the companies engaged in promoting fraudulent cancer treatments.

Unproven and possibly unsafe

The FDA is responsible for approving drugs and devices intended to treat cancer for safety and efficacy before they are marketed and sold. While fraudulent products are marketed as natural or non-toxic alternatives to cancer treatments, they are not without risks. They may not only be ineffective, but they may cause actual harm. In January, FDA researchers found the bacteria Variovorax paradosux in a sample of PNC-27, an unapproved product marketed as a treatment for cancer. Then, in March, researchers found the bacteria Ralstonia insidious in another sample of PNC-27.

Beyond being ineffective or causing direct harm, the use of such products may delay or interfere with life-saving care. “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,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs in a press statement. “We encourage people to remain vigilant whether online or in a store and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis, and treatment of cancer.”

The FDA Consumer Updates page lists red flags a consumer can look for to identify fraudulent products. Language such as “new discovery,” “scientific breakthrough” or “secret ingredient” or any other claims touting the product as a miracle cure should be questioned. Also questionable, conspiracy theories claiming the pharmaceutical industry and government are keeping the cure a secret.  Another popular tactic may be to include personal testimonials in lieu of scientific evidence. Consumers should be checking with their health care provider before taking any supplemental or alternative product.

Health care professionals and consumers are encouraged to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

Date: 05/04/2017

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