Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.
Society for Science-Based Medicine
Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century
All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)
Alternative medicine is ascendant in Canada. From the dubious remedies that are now stocked by nearly every pharmacy, to the questionable “integrative” medicine at universities, there’s a serious move to embrace treatments and practices that are not backed by credible evidence. Canada’s support for alternative medicine, and for its “integration” into conventional health care is arguably is worse than many other countries. Canada’s drugs regulator, Health Canada, has approved hundreds of varieties of sugar pills and declared them to be “safe and effective” homeopathic remedies. Some provinces are even moving to regulate homeopaths as health professionals, just like physicians, nurses and pharmacists. Given the regulatory and legislative “veneer of legitimacy” that homeopathy is being granted, you can see how consumers might be led to believe that homeopathic remedies are effective, or that homeopaths are capable of providing a form of health care. The reality is far uglier, and the consequences may be tragic. Canadian homeopaths are putting the most vulnerable in society at risk by selling sugar pills to consumers, while telling them that they’re getting protection from communicable diseases. (more…)
If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”
We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:
…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.
In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.