Consumer Health Digest #19-21
Your Weekly Update of News and Reviews
May 26, 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.
FDA toughens regulation of compounded drugs. In February, the U.S. Food and Drug Administration (FDA) issued a final rule that establishes what bulk drug substances can be used in drug compounding, the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. FDA's new criteria for evaluating substances are:
- the physical and chemical characterization of the substance
- any safety issues raised by the use of the substance in compounded drug products
- the evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists
- historical use of the substance in compounded drug products, including information about the medical condition(s) for which it has been used and any references in peer-reviewed medical literature
Jann Bellamy has noted that various ingredients in compounded drugs prescribed and/or administered by naturopaths have not made it through the approval process and are unlikely to be approved. Thus, the American Association of Naturopathic Physicians has initiated a misleading campaign to undermine FDA's effort to protect consumers. [Bellamy J. New FDA rule cracks down on compounded drug ingredients. Science-Based Medicine. Apr 11, 2019]
Companies prohibited from further drug compounding. Consent decrees of permanent injunction have been entered in federal courts prohibiting Pharm D Solutions, LLC and PharMedium Services, LLC from further production of sterile compounded drug products until corrective actions are taken. Both companies allegedly:
- manufactured and distributed drugs intended to be sterile that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements
- produced or distributed drugs that were unapproved or were misbranded because their labeling did not bear adequate directions for use
- had failed to take corrective action after the FDA warned them about manufacturing violations
Pharm D Solutions also allegedly produced products that were adulterated because they had strengths different from what they were represented to possess. The FDA sent a warning letter to Pharm D Solutions in 2016. Follow-up inspections in 2018 led to a recall of unexpired drugs intended to be sterile and to the FDA alerting health care professionals and patients not to use those products. Pharm D Solutions resumed compounding in January 2019 despite FDA's warnings. [Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions. FDA news release. May 22, 2019]
The FDA sent warning letters to PharMedium in 2007 and 2014. [Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities. FDA news release. May 22, 2019]
FDA warns five homeopathic companies about unsterile products. The FDA has posted warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC doing business as WePackItAll, which jointly manufacture and package Puriton Eye Relief Drops labeled as homeopathic. The letters describe failures to conform to current good manufacturing practice requirements (CGMP) due to improper methods, facilities, or controls for manufacturing, processing, and packing. The FDA tested multiple samples and found these eye drops were non-sterile, which could lead to an eye infection, and had a high pH level, which could lead to eye injuries such as glaucoma, corneal scarring, and loss of vision. Kadesh issued a voluntary recall in November 2018 due to non-sterile production conditions at the manufacturing facility.
A warning letter was also issued to Newton Laboratories for human drug CGMP and misbranding violations, as well as unapproved new animal drug violations. [FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards. FDA news release. May 14, 2019] Lack of proper controls when manufacturing products with ingredients such as nux vomica, belladonna, aconitum napellus, and gelsemium sempervirents could lead to poisoning of consumers. Some of the products are labeled for use in treating infants and children.
Walmart sued for misrepresenting its homeopathic products. The Center for Inquiry (CFI) is alleging in a lawsuit filed in the District of Columbia that Walmart is committing wide-scale consumer fraud and endangering the health of its retail consumers through its marketing of homeopathic products. CFI asserts the company is deceiving its customers by making no meaningful distinction between real medicine and useless homeopathic products on its shelves and in its online store. [Walmart sued for fraud: Nation's largest retailer deceives and endangers consumers with homeopathic fake medicine. CFI press release. May 20, 2019]
Quebec pharmacies provide disclaimers about homeopathic products. The Quebec Association of Pharmacy Chains has distributed signs for pharmacists to place next to homeopathic products to warn customers that the effectiveness of homeopathic products is generally not supported by scientific evidence. The signs also invite consumers to consult the pharmacist for details. The association also asked Health Canada to revise the authorization of homeopathic products. [Jarry J. Quebec pharmacies show signs of progress on homeopathy. McGill Office for Science and Society. May 17, 2019]
This page was posted on May 27, 2019.