Consumer Health Digest #18-49
Your Weekly Update of News and Reviews
December 9, 2018
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.
Routine vitamin and mineral supplements not recommended for chronic disease prevention. The Academy of Nutrition and Dietetics has issued a position paper that addresses: (a) the regulatory framework of dietary supplements; (b) the prevalence and motivations for using dietary supplements; (c) nutrient and food recommendations from the Food and Nutrition Board of the National Academies of Science, Engineering, and Medicine and the 2015 Dietary Guidelines of Americans; (d) how micronutrient (essential vitamin and mineral) supplements can fill dietary gaps, but also result in excessive intake; (e) the lack of evidence that such supplementation prevents chronic disease; (f) reasons to consider and also to avoid supplementation; and (g) evidence-based resources for information related to dietary supplements. [Position of the Academy of Nutrition and Dietetics: micronutrient supplementation. Journal of the Academy of Nutrition and Dietetics. 118(1):2162-2173, 2018] The Academy's concise position statement is:
It is the position of the Acadeny oif Nutrition and Dietetics that micronutrient supplements are warranted when requirements are not being met through the diet alone. Those with increased requirements secondary to growth, chronic disease, medication use, malabsorption, pregnancy and lactation, and aging may be at particular risk for inadequate dietary intakes. However, the routine and indiscriminate use of micronutrient supplements for the prevention of chronic disease is not recommended, given the lack of available scientific evidence.
Nobetes Corporation banned from selling diabetes products. Nobetes Corporation and its two officers, Marvin Silver and Jeffrey Fleitman, have settled a complaint by the Federal Trade Commission (FTC) that, between 2015 and 2018, they made false or unsubstantiated advertising claims on television, radio, Facebook, and YouTube for Nobetes, a concoction of vitamins, minerals, and plant extracts. According to the complaint:
- The defendants made unsubstantiated health claims, misled consumers about the terms of "free trial" offers, billed consumers without their consent, and improperly used "expert" endorsements and consumer testimonials. The price of a 30-tablet bottle of Nobetes ranged from $29.95, plus shipping and handling, to $50.60.
- The defendants falsely claimed, even after the U.S. Food and Drug Administration and the FTC warned them not to do so in 2016, that Nobetes treats diabetes, keeps blood sugar within normal levels, and reduces or eliminates the need for medications such as insulin.
- One of their television ads began with an announcer asking, "Is your diabetes out of control? Are your numbers ranging from 150 to 550 or more? . . . Are your blood sugar numbers dangerously high?" The announcer then stated, "You need to try the all-natural supplement called Nobetes. . . Just listen to what other diabetics are saying," and introduced consumer testimonials reporting large reductions in blood sugar levels and, in some instances, asserting that they were able to reduce their use of insulin.
- Another television ad featured Mitch Darnell, who stated that Nobetes (a) "helps control blood sugar within normal levels," (b) contains 35 supplements that can "fill the nutritional shortages that diabetes cause," and (c) is the miracle product that diabetics have been waiting for. Although promotional materials implied that Darnell was a qualified scientific or medical expert, he is actually an actor who was paid to promote the product.
The stipulated order for permanent injunction and monetary judgment prohibits the company and its officers from undertaking future deceptive practices, including making unsubstantiated health claims, misleading consumers about the terms of "free trial" offers, billing consumers without their consent, and other practices related to the use of "expert" endorsements and consumer testimonials. They must also pay $182,000. ["Nobetes" dietary supplement marketers settle FTC complaint alleging unsubstantiated health claims, illegal billing practices, and deceptive endorsements. FTC News Release. Dec 4, 2018]
Implantable medical devices investigated. The International Consortium of Investigative Journalists (ICIJ) has created an "Implant Files" Web page with links to articles and videos revealing safety problems arising out of inadequate regulation of implantable medical devices. An article about ICIJ's project states:
Bringing together more than 250 reporters from 36 countries and 59 news organizations—including the BBC, NBC News, the AP, Le Monde, and Süddeutsche Zeitung—the group has started to unveil massive problems plaguing the global medical devices industry. ICIJ and its partners flagged more than 1.7 million injuries and 83,000 deaths linked to implants such as pacemakers, breast implants, and spinal cord stimulators, which manufacturers move around the world as regulators flounder and patients and doctors are left in the dark. [Allsop J. Global collaboration is a success story for journalism, whatever its impact. Columbia Journalism Review. Nov 27, 2018]
StemGenex warned about purported stem cell product. The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, CA, its owner/manager Rita F. Alexander, and its laboratory and medical director Jenny R. Galloway, M.D. about: (a) marketing a purported stem cell product without FDA approval and (b) significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination that endangers patients. The product, derived from body fat, has been intended for administration intravenously, by inhalation, and directly into the spinal canal to treat Alzheimer's disease, Crohn's disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson's disease, peripheral neuropathy, rheumatoid arthritis, and other serious diseases. [FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk. FDA News Release. Nov 13, 2018]
This page was posted on September 9, 2018.