CRN Urges Caution in Interpreting New Study Results, Citing Lack of Context about Exposures and Misunderstanding of Supplement Regulation

Washington, D.C., July 24, 2017In response to a study from the Journal of Medical Toxicology, “An Increase in Dietary Supplement Exposures Reported to US Poison Control Centers,” published online on Monday, July 24, 2017, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:

Statement by Steve Mister, president & CEO, CRN:

“Consumer safety is the top priority for the dietary supplement industry, and, overwhelmingly, the majority of dietary supplement products are safe. More than 170 million Americans take dietary supplements each year, and the responsible industry is invested in bringing safe and quality products to meet this demand. We recommend that consumers store dietary supplement products in safe places, out of a child’s reach. In addition, we recommend that consumers talk with their doctor or pediatrician about their family’s supplement use.

However, it’s also very important to put the results of this new study in context when reporting and interpreting those study results.

  • The study completely misunderstands the difference between an “exposure” as reported by the poison control centers and an actual adverse event associated with a dietary supplement that might be a reason for concern.
  • The study suggests that exposures have increased between 2000 and 2012, but fails to account for the fact that dietary supplement usage among Americans has mushroomed during that time. In fact, according to the Nutrition Business Journal, the industry grew from about $18 billion to over $32 billion annually during that time, and CRN’s own consumer usage data tracks a similar increase in usage. When considered in light of that 77 percent increase in sales, the increase of about 47 percent in exposures is actually a positive indication.
  • The authors appear to have little grasp of the federal regulations for dietary supplements, as illustrated by the fact that they included homeopathic medicines in the study (homeopathic products are not dietary supplements and they are regulated quite differently by FDA). They state that some supplements can be ‘intended for therapeutic use, such as treating or preventing disease’—by law, dietary supplements are prohibited from making any claims to treat, cure, prevent or mitigate disease.
  • Lastly, several obvious biases are apparent in the presentation of the data by suggesting that, for example, yohimbe, a product with relatively little sales and an even smaller percentage of ‘exposures’ (about 0.7 percent of all exposures, according to the authors) constitutes a high risk substance, and the highly selective use of statistics to inflate the levels of concern about particular ingredients when those proportions do not reflect the percentage of all supplements in the study, (e.g., the study reported that 30 percent of yohimbe exposures resulted in ‘moderate or major effects’ while also acknowledging that yohimbe exposures accounted for only 0.7 percent of all supplement exposures—viewed in the larger context of 274,998 exposures, the cause of alarm is greatly diminished). In comparison to same poison control center data for over-the-counter (OTC) medicines during that same period, all ‘exposures’ related to dietary supplements amount to a small fraction of exposures for those OTC medicines, in spite of the fact that the authors characterize supplement regulation as ‘inadequate.’"

 

Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food 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 and food 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. Follow us on Twitter @CRN_Supplements and LinkedIn.