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Critics say testing used arbitrary standards and ignored federal regulations.
By: Sean Moloughney
November 1, 2019
Consumers Reports (CR) has published a report that criticized the dietary supplement for being “largely unregulated” and asserted that products like turmeric and Echinacea have not been supported by science or don’t meet label claims. However, industry representatives pointed to arbitrary analytical standards for testing methods CR carried out and noted supplements are regulated by 25-year old federal legislation that established standards, practices, and definitions. Of the 16 echinacea and 13 turmeric products CR tested, it claimed to identify “concerns” with more than a third of them, “including elevated levels of lead and bacteria, as well as low levels of key active compounds.” However, the American Herbal Products Association said CR relied on “arbitrary or internal standards for its analysis, apparently in order to support its preconceived view of herbal supplements.” For all but one specific product, the “concerns” identified are related to factors on which CR assigned analytical targets that “ignore federal labeling regulations and quality standards developed by AHPA and other authoritative organizations.” Andrea Wong, PhD, senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition, concurred, noting: “Legitimate, science-based testing standards are widely accepted and used by our industry—and others—to ensure safe and quality products come to market. Well-respected, independent certification bodies routinely evaluate both manufacturing practices and the contents of finished products to provide consumers with added assurance. The industry’s vast adherence to these standards is one of the many factors that has contributed to dietary supplements’ wide-margin of safety. As a scientist, I am disappointed that a consumer publication would disregard these best practices that responsible companies take seriously and essentially establish its own arbitrary standards that are neither grounded in science nor relevant to consumer safety.” Calling the coverage “the kind of snake oil the magazine so hypocritically rails against,” the CRN noted the article did not discuss adulterated products marketed as dietary supplements, which has been one of the most significant industry safety issues. “If Consumer Reports’ intention is to expose threats and warn consumers, then the publication utterly failed. Today, consumers are actually at risk from adulterated products, and while this threat exists only at the fringes of the industry, it is one that can and must be eradicated,” said Steve Mister, president & CEO, CRN. “There is no better time than now to improve the industry and increase consumer safety. For once, we must establish a clear picture of the dietary supplement marketplace for the government agencies who regulate the industry and one common sense way to achieve that is by creating a mandatory product listing.” A mandatory product registry, for which CRN is currently lobbying on Capitol Hill, would allow FDA to see the breadth and extent of the supplement marketplace, Mister said. It would also allow FDA to determine who is using a particular ingredient, what claims are being made on the label, and whether the contact information for reporting an adverse event is properly provided. “Responsible actors have nothing to fear from a mandatory product registry,” said Mister. “Of course, some disreputable actors will ignore the registry requirements, but this law would make it easier for FDA to identify their failure to file and to prosecute them.” Mister noted there will always be low levels of lead found in products naturally sourced from plants grown in soil, “whether it’s an herbal extract or the produce found at a farmer’s market—and the law permits these levels because they are not unsafe.”
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