01.05.16
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 misinterpretations of new science by the consumer media covering those studies. This was the message Dr. Richard Kingston, PharmD, delivered to about 50 congressional staffers, industry executives and public affairs professionals in December.
As a result of misinterpretations of science, consumers are misinformed about the safety of supplement products and misled to believe they are less safe than they actually are, he argued.
Dr. Kingston spoke at the Dec. 9 Dietary Supplement Caucus briefing. He 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 published in the New England Journal of Medicine that projected more than 23,000 annual dietary supplement-related emergency room (ER) 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% 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. 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% 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% of the overall visits were from excessive doses.
Even more important, Dr. Kingston said these ER visits must be considered in context, noting that more than 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 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, according to 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 supplement products they take, saying, “Anything [the industry] can do to help educate people to follow the label instructions increases safety.”
As a result of misinterpretations of science, consumers are misinformed about the safety of supplement products and misled to believe they are less safe than they actually are, he argued.
Dr. Kingston spoke at the Dec. 9 Dietary Supplement Caucus briefing. He 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 published in the New England Journal of Medicine that projected more than 23,000 annual dietary supplement-related emergency room (ER) 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% 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. 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% 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% of the overall visits were from excessive doses.
Even more important, Dr. Kingston said these ER visits must be considered in context, noting that more than 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 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, according to 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 supplement products they take, saying, “Anything [the industry] can do to help educate people to follow the label instructions increases safety.”
