Consumer Health Digest #19-45
Your Weekly Update of News and Reviews
November 10, 2019
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.
Comments requested about draft homeopathy regulatory guidance. In October, the Food and Drug Administration (FDA) made its revised draft guidance document for FDA staff and industry titled "Drug Products Labeled as Homeopathic" available for public comment. The revised guidance indicates that FDA intends to prioritize enforcement and regulatory action for unapproved homeopathic drug/biologic products marketed in the United States for which there are:
- reports of injury that, after evaluation, raise potential safety concerns
- ingredients associated with potentially significant safety concerns
- routes of administration other than oral and topica
- intended uses for the prevention or treatment of serious and/or life-threatening diseases or conditions
- intended uses for vulnerable populations including immunocompromised individuals, infants and children, the elderly, and pregnant women.
- significant quality issues
The proposed policy fails to clearly indicate that: (a) homeopathic principles make no sense in light of scientific progress since homeopathy was proposed in the late 1700s, (b) there is no evidence that homeopathic products can prevent or treat any medical condition, and (c) there is no justification for exempting homeopathic products from premarket approval. Comments about the revised draft guidance can be submitted electronically by January 23, 2020.
Classic homeopathy history book updated. Dr. Stephen Barrett has updated and greatly expanded Martin Kaufman's 1971 book on the history of homeopathy in America. During the early 19th century, homeopathic remedies were less dangerous than those of medical orthodoxy and many medical practitioners began using them. As medical science developed, homeopathy's use declined so that by 1970 it appeared headed for extinction. Aggressive promotion, failure of the federal agencies to curb its marketing practices, and increased public interest in "complementary medicine" boosted homeopathy's popularity. But recent research analyses and opposition by skeptical organizations are again threatening its survival. The first half of this 539-page book details: (a) homeopathy's history in the United States, (b) why its basic principles are impossible, (c) what the research shows, (d) how products are deceptively advertised, and (e) how the FDA and FTC have failed to protect the public. The second half of the book includes government policy documents and comments submitted by scientific groups that want stronger government regulation. (People thinking of commenting on the proposed FDA regulations would find these references useful.) The foreword by Dr. Edzard Ernst is a remarkable account of his shift from believer to critic.
Homeopathy in America: The Ups and Downs of Medical Heresy is available to readers within the United States as a Kindle book for only $9.95. Residents of other countries must order it from the Amazon Web site in their own country. A Kindle device is not needed to read it. Free Kindle reader apps are downloadable for iOS, Android, Mac, and PC.
Unauthorized products list updated. Health Canada has updated its list of unauthorized health products promoted for sexual enhancement, weight loss, as a workout aid, or as "poppers," and that are labeled to contain or have been tested and found to contain dangerous ingredients. Unauthorized products have not been assessed for safety, effectiveness, and quality. The possible health dangers may be due to specific ingredients, specific combinations of ingredients, and ingredients not listed on the label. [Unauthorized products may pose serious health risks. Health Canada alert, Nov 6, 2019]
FTC challenges "diabetes cure" publisher. The Federal Trade Commission (FTC) has sued Agora Financial, LLC, alleging that it tricks seniors into buying books, newsletters, and other publications that falsely promise a cure for type 2 diabetes or promote a phony plan to help them cash in on a government-affiliated check program. Agora and some of its affiliates allegedly:
- market publications, including The Doctor's Guide to Reversing Diabetes in 28 Days, primarily to older consumers nationwide, using e-mail distribution lists, online newsletters, affiliate networks, and their own Web sites
- use marketing materials that include-an hour-long video presentation that falsely claims the "hidden cause" of type 2 diabetes is non-ionizing radiation (NIR) exposure from everyday electronic devices like computers, televisions, and cell phones
- tell consumers that the disease can be cured with a combination of hard-to-find natural ingredients called "Himalayan Silk," "Epsom Blue," and "Chromanite," which actually contain widely available supplements, including mulberry, magnesium, and chromium, none of which can cure, treat, or mitigate the disease
- tout a "100 percent success rate"
- baselessly claim there is a "shocking, hidden" cause for type 2 diabetes that cannot be treated with "mainstream" treatments, and that these treatments may even make consumers' diabetes worse
The agency is seeking to halt the challenged conduct and obtain money back for consumers. [FTC sues publisher for targeting seniors with phony diabetes cure and money making schemes. FTC press release, Oct 29, 2019]
Jen Gunter receives JREF award. Dr. Jen Gunter has received an award from the James Randi Educational Foundation (JREF) in recognition for her efforts to provide responsible information on women's health issues and to be a voice of reason against those who promote bogus health and wellness claims. The award is given to the person or organization that best represents the spirit of the foundation by encouraging critical questions and seeking unbiased, fact-based answers. In 2015, the JREF announced its plan to convert itself into a grant making foundation with plans to make a small number of grants totaling approximately $100,000 per year as a pleasant surprise to recipients. Dr. Gunter is the author of The Vagina Bible: The Vulva and the Vagina: Separating the Myth from the Medicine published in 2019. [Gordon M. 'Vagina Bible' tackles health and politics in a guide to female physiology. NPR, Aug 27, 2019]
This page was posted on November 10, 2019.