Consumer Health Digest #17-05

Your Weekly Update of News and Reviews
January 29, 2017


Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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.


FDA finds more belladonna in homeopathic teething tablets. The U.S. Food and Drug Administration has announced that it has found inconsistent amounts of belladonna again in homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and is urging consumers not to use these products. The FDA also noted that it had contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland's homeopathic teething products, regarding a recall of those labeled as containing belladonna, but the company did not agree to conduct a recall. [FDA confirms elevated levels of belladonna in certain homeopathic teething products. FDA news release, Jan 17, 2017] In 2010, under similar circumstances, Standard did recall its homeopathic teething tablets.


Libel suit against supplement critic fails. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, has successfully defended against a suit brought against him by Hi-Tech Pharmaceuticals. In 2015, the journal Drug Testing and Analysis published an article, "An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements," which was co-authored by Cohen and three colleagues. Not long afterward, the FDA issued warning letters to Hi-Tech and other manufacturers whose products contained BMPEA. [Recent FDA action on dietary supplements labeled as containing BMPEA. FDA Web site, April 27, 2015] Hi-Tech's lawsuit charged that the article and subsequent public comments by Cohen included false and defamatory statements about the safety of Hi-Tech products that contain BMPEA. The jury disagreed, ruling in Cohen's favor in less than 3 hours. Stat News has published a comprehensive report on the lawsuit and prior legal troubles of Hi-Tech's president, Jared Wheat. The article stated that Wheat was openly hopeful that the long and costly legal battle (estimated cost between $300,000 and $400,000) "will scare away other academics from investigating the supplement industry." [Robbins R. A supplement maker tried to silence this Harvard doctor—and put academic freedom on trial. Stat News, Jan 10, 2017.]


FDA warns against using PNC-27. The FDA is warning cancer patients not to use PNC-27 products, which are marketed as a treatment for cancer. An FDA laboratory has discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inhalation. Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections, especially if they are young children, elderly, pregnant, or have a weakened immune system. PNC-27 may be available in a nebulized solution, intravenous solution, vaginal suppository, and rectal suppository. The PNC-27 Web site, which was launched in 2013, says PNC-27 is available to doctors, clinic, and hospitals outside of the United States. The site claims that PNC-27 "puts cancer on the defensive, resulting in outcomes that include significant pain reduction and, in many cases, lengthening of life."


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This page was revised on January 30, 2017.