Consumer Health Digest #18-36
Your Weekly Update of News and Reviews
September 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.
Goop settles lawsuit over three products. Gwyneth Paltrow's lifestyle company Goop has settled a lawsuit brought by the district attorneys of ten California counties who alleged that the company had made unsubstantiated medical claims for three products. Goop had advertised:
- Jade Egg and Rose Quartz Egg, which were designed to be inserted vaginally and left in for various lengths of time, could balance hormones, regulate menstrual cycles, prevent uterine prolapse, and increase bladder control
- Inner Judge Flower Essence Blend, a blend of essential oils meant to be taken orally or added to bathwater, could help prevent depression.
Goop has offered to refund the full purchase price to consumers who purchased any of these products on or between January 12, 2017 and August 31, 2017. Requests for refunds can be made by emailing or calling Goop customer service at email@example.com or 1-844-WTF-GOOP. [Goop, Inc. settles consumer protection lawsuit over three wellness products. County of Santa Clara Office of the District Attorney news release. Sept 4, 2018] Under the terms of the Final Judgment Pursuant to Stipulation, Goop also agreed to pay $145,000 in civil penalties and is prohibited for five years from:
- representing that goods or services have sponsorship, approval, characteristics, ingredients, uses or benefits which they do not have
- advertising that any nutritional supplement or medical device has any effect in any of the conditions, disorders, or diseases listed in California Health and Safety Code section 110403
- making and/or disseminating any statement regarding any nutritional supplement or medical device that is false or misleading in any particular, or has the tendency or capacity to deceive or mislead
- representing that any nutritional supplement or medical device can diagnose, mitigate, treat, cure, or prevent any disease unless the representation is non-misleading and has appropriate Federal Food and Drug Administration recognition as a drug product or medical device
- making and/or disseminating any claim or representation about the nature, attributes, effects, efficacy, benefits, results or safety of any nutritional supplement or medical device, unless, at the time of making and/or disseminating such claim or representation, it is true, not misleading, and Goop already has in its possession and relies upon competent and reliable scientific evidence to substantiate the claim or representation
- making and/or disseminating any claim or representation, either directly or indirectly, that misrepresents the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research
- making and/or disseminating in the form of an endorsement in violation of specified federal regulations
The lawsuit against Goop followed a complaint filed last year by advertising watchdog truthinadvertising.org to the California Food, Drug, and Medical Device Task Force about more than 50 unsubstantiated health claims in Goop's marketing. [California regulators crack down on Goop after TINA.org complaint. Sept 5, 2018]
Banned sports stimulant found in supplements. Higenamine is a stimulant that occurs naturally in a variety of traditional plant remedies. It has not been FDA-approved for any purpose, but is sold as an ingredient in supplement products. In 2016, researchers made online purchases of 24 supplement products with higenamine as a labeled ingredient. Eleven of the products were marketed for weight loss, eleven were marketed as sports/energy supplements, and two were not labeled with a specific reason for use. Laboratory analyses revealed that the quantity of higenamine in the products ranged from trace amounts to 62 milligrams per serving with a margin of error of 6.0 milligrams. Of the five products that listed a specific amount of higenamine on the label, none were accurate; the higenamine contents ranged from less than 0.01% to three times the quantity listed on the label. Clinical evidence regarding the safety and effectiveness of higenamine is lacking. Adverse effects such as difficulty in breathing, palpitations, and chest tightness have been reported. In January 2017, the World Anti-Doping Agency banned higenamine in sports competitions, but some higenamine-containing supplements remain on the market. [Cohen P. and others. The stimulant higenamine in weight loss and sports supplements. Clinical Toxicology, Sept 6, 2018]
More online networks warned about illegal opioid marketing. The U.S. Food and Drug Administration (FDA) has expanded its campaign to stop Internet sales of potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol, which is required to carry a boxed warning of a significant risk of serious and even life-threatening adverse effects. In August, the agency sent letters to CoinRX, MedInc.biz, PharmacyAffiliates.org, and PharmaMedics, which operate a total of 21 sites, warning that failing to correct the violations may trigger enforcement action. [FDA takes action against 21 websites marketing unapproved opioids as part of agency's effort to target illegal online sales. FDA News Release, Aug. 28, 2018] In June, the FDA sent similar warnings to nine networks that operated a total of 53 Web sites. [FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales. FDA news release, June 5, 2018]
Notorious blood-testing company to shut down. Theranos, Inc. has announced that it will formally dissolve and seek to pay unsecured creditors its remaining cash in coming months. The company, based in Palo Alto, California, misled doctors, patients, and investors by falsely claiming to have developed technologies that revolutionized blood testing by requiring only a finger stick to draw blood. Investors in the company have lost nearly $1 billion. [Carreyrou J. Blood-testing firm Theranos to dissolve. The Wall Street Journal, Sept 5, 2018] The company's founder, Elizabeth A. Holmes, has been the subject of regulatory actions by the Centers for Medicare and Medicaid Services and the Securities and Exchange Commission. In June, she and former chief operating officer Ramesh "Sunny" Balwani were indicted for allegedly defrauding investors, doctors, and patients.
This page was posted on September 9, 2018.