Dietary supplement industry officials say that the study’s conclusions are incomplete, and that the vast majority of calls placed did not involve any adverse events related to dietary supplements, but were simply inquiries.
A study published earlier this week in the Journal of Medical Toxicology1 found an increase in calls related to dietary supplements placed to poison control centers from 2002 to 2012; specifically, the authors state that calls to poison control centers increased by 46.1% between 2000 and 2002, decreased by 8% between 2002-2005, and then increased again by 49.3% from 2005-2012. Dietary supplement industry officials, however, say that the study’s conclusions are incomplete, and that the vast majority of calls placed did not involve any adverse events, but were simply inquiries.
In a statement from the Natural Products Association (NPA; Washington, DC), Daniel Fabricant, PhD, president and CEO, NPA, commented on the overall safety of dietary supplements, and pushed back on the idea that the industry is not regulated: “Adverse events from supplements are extremely low given their widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors. Supplements are safe, which is why millions of Americans use them every day. The laws that regulate supplements require official reporting of adverse events so that the regulators, the healthcare community and others can review the data and make informed public policy decisions.”
Further, NPA said, poison center data “does not automatically imply causality between ingestion of the ingredient in the product and appearance of symptom and clinical signs.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), told Nutritional Outlook that just because a call is made to a poison control center, “that doesn’t mean there was any harm from the product.” The study, he said, includes all calls made to a poison control center, which are considered “exposures,” regardless of whether an adverse event occurred. “So, for instance, if a mother turns her back, and her child gets into her gummy vitamins, and she…sees the kid with the gummy vitamins in front of them and calls the poison control center to say, ‘Do I need to be worried?’ That counts as an exposure. That doesn’t mean that there was any harm from the product.”
Both NPA and CRN pointed out the high number of calls to poison control centers placed regarding adverse events related to medications and food-related events. NPA cites data from Clinical Toxicology showing that every 21 seconds, someone places a call to poison control centers because of a medication error, and points to CDC data indicating that hospitalizations and deaths related to foodborne illnesses affect roughly 1 in 6 Americans. Ultimately, both NPA and CRN say they believe that the study ignores the “superior safety record” of supplements when compared to other FDA-regulated products.
While the study took aim at supplements writ large, it specifically called out yohimbe, energy products, ephedra (Ma Huang), and homeopathics. To this point, Mister told Nutritional Outlook that the inclusion of homeopathic medicine in the study data is misleading. “To throw in the homeopathic products into the study tells me that these people don’t know the difference,” he said, noting that homeopathic products and supplements are “two very distinct categories that are regulated differently by FDA.”
Mister expressed concern for the seeming lack of knowledge about the supplements industry that he said the study demonstrates. “I’m disturbed by the way these numbers are presented-with what I believe is a very strong agenda-to try to demonstrate some sort of harm from dietary supplements when I think the data actually do just the opposite.”
Mainstream media coverage of the study findings also focused on the issue of child safety packaging and whether or not [any of the poison control center reports were related to packaging deficiencies], given that the study notes that the majority of reported dietary supplement exposures (70.0%) occurred among children younger than six years old. NPA noted that the law requires that products such as iron supplements containing 250 mg or more of iron, which could be hazardous to children under the age of six, must be packaged in child-resistant packaging. NPA said that it is unclear how children under the age of six included in the study’s findings gained access to the childproof products but noted that, ultimately, it is up to the user to properly seal and store the product.
Though many media reports in the consumer press are framing the study results as a cautionary tale, Mister said, the data fail to acknowledge the impressive growth of the supplements industry, and the low incidence of exposures as compared to other FDA-regulated products. “The data…fails to appreciate that the dietary supplements industry grew by 77% over that 10-year period. It went from about 18 billion to about 32 billion. So, they raised the fact that there was a 47% increase in exposures, when the industry actually increased by 77%.”
Mister continued: “I don’t see this study as a reason for alarm, but if you want to declare that there’s a problem, you can mine this to try to find it.”