The Food and Drug Administration (FDA), the agency that regulates the drug industry in the US, put out a press release yesterday warning “Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The press release reports:

“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”

The FDA therefore recognizes that this is a serious problem, and that is good. They also acknowledge that the problem of “bogus cancer cures” is a longstanding one, not a new or recent problem, but the reason they are taking action now is because the internet is significantly increasing the reach of these fake cures.

In the US the FDA regulates as drugs only those products that are already designated as a drug or for which disease claims are made. Everything else, in the context of regulation, is a supplement and is regulated under DSHEA – the Dietary Supplement Health and Education Act. For these substances sellers can make so-called “structure function” claims (that a product improves or supports a structure or function of the body) but cannot make claims that their product cures or alleviates a specific disease. In practice this is a fine line, but this is the line the FDA is now defending.

Essentially, the FDA is going after cancer supplement sellers who are stepping over the line and making claims that their product (which is not approved by the FDA) can cure cancer. They list the suspect claims as follows:

  • “Treats all forms of cancer”
  • “Causes cancer cells to commit suicide!”
  • “80% more effective than the world’s number one cancer drug”
  • “Skin cancers disappear”
  • “Target cancer cells while leaving healthy cells alone”
  • “Shrinks malignant tumors”
  • “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments”

What is more, the effort is part of a larger initiative to protect the public from such false treatments. The FDA sent 23 warning letters to US companies urging them to cease their fraudulent activity. In addition they state:

The Warning Letters are part of the FDA’s ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico–United States–Canada Health Fraud Working Group. Earlier this year, FTC sent Warning Letters to 112 Web sites falsely promoting cancer “treatments” and referred several others to foreign authorities.

In the US The FTC picks up where the FDA leaves off. Even if a company is not violating FDA regulations they still cannot lie to consumers or market a fraudulent or harmful product. Therefore it is necessary with such widespread abuse that the agencies work together. In addition, the internet means that increasingly fraudulent treatments are multi-national – a foreign-run website may be selling products to American or Canadian citizens. Therefore the FDA must increasingly cooperate with foreign regulatory agencies, like they are now with Mexico and Canada.

Even more encouraging is that the FDA is publishing warnings for consumers about health fraud in general. In this consumer update they warn about the signs of health fraud:

  • Statements that the product is a quick and effective cure-all or a diagnostic tool for a wide variety of ailments.
  • Suggestions that a product can treat or cure serious or incurable diseases.
  • Claims such as “scientific breakthrough,” “miraculous cure,” “secret ingredient,” and “ancient remedy.”
  • Impressive-sounding terms, such as “hunger stimulation point” and “thermogenesis” for a weight loss product.
  • Claims that the product is safe because it is “natural.”
  • Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
  • Claims of limited availability and advance payment requirements.
  • Promises of no-risk, money-back guarantees.
  • Promises of an “easy” fix for problems like excess weight, hair loss, or impotency.

In the same document they further warn of the types of harm that fraudulent therapies can cause, including: direct harm from side effect, delaying appropriate and effective treatment, and interfering with effective treatment. I would add to these items: adding an unnecessary financial burden to a patient and family that is likely already burdened by illness, the emotional and psychological harm caused by giving false hope to the desperate, and the indirect harm done by fostering anti-scientific attitudes and beliefs.

While I applaud this new initiative, it also feels as if the FDA is coming a little late to this party – but better late than never. In the last 20-30 years fraudulent health care has been on the rise and has been increasing bypassing regulatory mechanisms designed to protect the public from fraud by hiding under more pleasing labels and rhetoric, such as “health care freedom,” alternative medicine,” and “natural cures.” These labels have been very success as marketing strategies, but they are all ultimately about selling treatments that do not meet reasonable standards of scientific plausibility and evidence.

The FDA now seems to recognize the problem, or (more likely) has gathered the political will to admit the problem exists and face it head on. This is only one of many fronts on which science-based medicine needs to be defended – but it is a critical one and it is heartening to see the FDA recognizing much of what we have been advocating on this blog.

Let’s hope their crack down on fake cancer cures metastasizes to all other fraudulent cures.


Posted by Steven Novella

Founder and currently Executive Editor of Science-Based Medicine Steven Novella, MD is an academic clinical neurologist at the Yale University School of Medicine. He is also the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe, and the author of the NeuroLogicaBlog, a daily blog that covers news and issues in neuroscience, but also general science, scientific skepticism, philosophy of science, critical thinking, and the intersection of science with the media and society. Dr. Novella also has produced two courses with The Great Courses, and published a book on critical thinking - also called The Skeptics Guide to the Universe.