Research publications raising questions about the safety of dietary supplements often lack context and appropriate data to draw meaningful conclusions, and the studies are often misrepresented in media coverage. This was the message delivered by Rick Kingston, PharmaD, co-founder and president of SafetyCall International, during his address to attendees at the Dietary Supplement Caucus Briefing held Dec. 9 in the Rayburn House Office Building on Capitol Hill. Kingston, who is also a clinical professor in the College of Pharmacy at the University of Minnesota and an adjunct professor in the National Center for Natural Product Research at University of Mississippi, explained such misinterpretations by the media misinform consumers about the safety of these products, misleading them to think the products are less safe than they actually are.
Among the examples he provided was the October 2015 publication in the New England Journal of Medicine (373:1531-1540) that projected more than 23,000 annual dietary supplement-related emergency room visits, a statistic Kingston questioned due to the study’s many shortfalls. He noted the projections included numerous products that do not fall under the regulatory definition of dietary supplements, a fact absent from media coverage. “If you’re going to raise questions regarding the safety of an entire class of products, it’s important to know what actually is a dietary supplement and what’s not," he said, noting products in the analysis included drugs, topical herbal products and so-called snake oil.
Further, he said all emergency room visits are not equal in terms of seriousness or severity, noting, “In almost 90 percent of the heart-related ER visits, the patients were discharged from the ER and sent home." In fact, he pointed out more than 20 percent of ER visits cited in the article involved “unsupervised ingestion by children, and although a concern, supplement ingestions by children often requite no treatment and result in no adverse effects despite the child being evaluated in an emergency department." Among older adults, pill-induced swallowing problems led to more than one-third of the ER visits, he explained, adding this is an area the industry can help evaluate and address. Another 10 percent of the overall visits were from excessive doses, he said. Putting these ER visits into context, he said more than 166 million Americans use dietary supplements, “so that’s a pretty large denominator to consider when evaluating these numbers."
The bipartisan Congressional Dietary Supplement Caucus sponsored the event, which was co-hosted by several leading dietary supplement industry trade associations including the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA).
Kingston highlighted the supplement industry’s commitment to consumer safety and its support of FDA action against misbranded and adulterated products. He noted FDA has ample authority under DSHEA (The Dietary Supplement Health and Education Act) to take action against such products and the companies that make and/or market them, but the agency is slowed by a lack of resources to fully enforce DSHEA. To this end, he backed calls for additional resources from Congress to help FDA enforce existing law. Industry’s ongoing efforts to help educate the public to be vigilant about the supplement products they take is equally important, according to Kingston, who said, “Anything [the industry] can do to help educate people to follow the label instructions increases safety."