SILVER SPRING, Md. (December 11, 2015)--Dr. Richard Kingston told an audience of almost 50 congressional staffers, industry executives and public affairs professionals that research purporting to raise significant questions regarding the safety of dietary supplements often lacks context and appropriate data to draw meaningful conclusions, which contributes to the misinterpretations of the new science by the consumer media covering those studies. As a result, consumers are misinformed about the safety of these products and misled to believe they are less safe than they actually are. Kingston, PharmD, spoke at the Dec. 9 Dietary Supplement Caucus briefing and is co-founder and president, regulatory and scientific affairs for SafetyCall International; clinical professor, University of Minnesota, College of Pharmacy; and adjunct professor, National Center for Natural Product Research, University of Mississippi.
Dr. Kingston gave examples of studies that have been misrepresented by the consumer media, including the October 2015 study in the New England Journal of Medicine that projected over 23,000 annual dietary supplement-related emergency room visits. The study had many shortfalls, including the fact that "not all emergency room visits are created equal in terms of level of severity or seriousness," according to Dr. Kingston, who observed that "in almost 90 percent of the heart-related ER visits, the patients were discharged from the ER and sent home." He also questioned the accuracy of the report because consumer health products that do not fall under the regulatory definition of dietary supplements were included in the researchers' projections for dietary supplements, and this was overlooked in the 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," said Dr. Kingston. The article gave examples of products contained in the analysis which included various drugs, dimethyl sulfoxide, topical herbal products and "snake oil", all of which were listed as miscellaneous complementary health products but are products and substances clearly outside of the class of FDA regulated dietary supplements.
Dr. Kingston also pointed out that 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 require no treatment and result in no adverse effects despite the child being evaluated in an emergency department." He further noted that among older adults, pill-induced swallowing problems led to more than one-third of the ER visits, which is something that the industry can help evaluate and address. Another 10 percent of the overall visits were from excessive doses. Even more important, Dr. Kingston said these ER visits must be considered in the context noting that over 166 million Americans use dietary supplements, "so that's a pretty large denominator to consider when evaluating these numbers.
The educational event was sponsored by the bipartisan Congressional Dietary Supplement Caucus and co-hosted by the leading trade associations representing the dietary supplement industry-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).
Consumer safety is of great importance to the dietary supplement industry, and the industry stands in support of FDA taking enforcement action against misbranded and adulterated products. Although the Dietary Supplement Health and Education Act (DSHEA) gives FDA authority to take such action against illegal products and the companies that manufacture and distribute them, the agency lacks the resources to fully enforce the law, assessed Dr. Kingston. Thus, he supports additional resources for FDA to enforce the existing laws and the industry's efforts to help educate the public to be vigilant about the supplement products they take, saying, "Anything [the industry] can do to help educate people to follow the label instructions increases safety."
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal and botanical products industry. AHPA is comprised of more than 300 domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org.
The Consumer Healthcare Products Association (CHPA) is the 129-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and dietary supplements. Information on the association can be found at www.chpa-info.org.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 100+ dietary supplement manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN's Code of Ethics. Visit www.crnusa.org.
The Natural Products Association (NPA), founded in 1936, is the largest and oldest non-profit organization dedicated to the natural products industry. NPA represents over 1,900 members accounting for more than more than 10,000 retailers, manufacturers, wholesalers, and distributors of natural products, including foods, dietary supplements, and health/beauty aids. As the leading voice of the natural products industry, the NPA's mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products. Visit www.NPAInfo.org.
The United Natural Products Alliance (UNPA) is an association representing many leading dietary supplement, functional food and analytical companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in regulatory issues and industry best practices. You may visit our website at www.unpa.com.