Industry asserts VMS safety during annual Dietary Supplement Caucus meeting

WASHINGTON — During the Dietary Supplement Caucus briefing last week with industry executives and congressional staffers, Safety Call International’s regulatory and scientific affairs president, Richard Kingston, charged that research in the New England Journal of Medicine published earlier questioning the safety of dietary supplements was taken out of context and led to some erroneous media reports. 

 

The study projected that there were some 23,000 annual emergency room visits attributed to dietary supplements. According to Kingston, the study had many shortfalls, including the fact that not all of the tracked emergency room visits were attributed to actual dietary supplements.

 

“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,” Kingston said. The article gave examples of products contained in the analysis which included various drugs, dimethyl sulfoxide, topical herbal products and what Kingston called “snake oil” —  all of which were listed as miscellaneous complementary health products, but which are outside of the class of FDA regulated dietary supplements.

 

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, 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, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.

 

Kingston said that 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 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 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.”