Researchers behind a study showing that calls to US Poison Control Centers about supplements rose by nearly 50% from 2000-2012 has been accused of “significantly exaggerating” the safety risk of dietary supplement, while playing down supplements’ superior overall safety record.
The study from the Center for Injury Research and Policy and the Central Ohio Poison Center, both at Nationwide Children’s Hospital, shows
The study, published online in the Journal of Medical Toxicology, found the rate of calls regarding dietary supplement exposures increased (46.1%) during 2000 to 2002, decreased (8.8%) during 2002 to 2005 and increased again (49.3%) from 2005 to 2012. The study’s authors speculate that the decrease from 2002 to 2005 probably resulted from the US Food and Drug Administration’s (FDA) ban of the botanical stimulant ma huang previously found in some dietary supplements.
70% of supplement exposure calls occurred among children. Most exposures (97.3%) occurred at home, and in more than 97 percent of the cases, the child swallowed the substance. Serious medical outcomes accounted for 4.5 percent of exposures and the most serious outcomes (95%) occurred among children six years and older.
“Many consumers believe dietary supplements are held to the same safety and efficacy standards as over-the-counter medications,” said Gary Smith, MD, DrPH, senior author of the study and director of the Center for Injury Research and Policy at Nationwide Children’s. “However, dietary supplements are not considered drugs, thus they are not required to undergo clinical trials or obtain approval from the FDA prior to sale, unless the product is labeled as intended for therapeutic use.”
US trade body, the Natural Products Association, criticized the report for “significantly exaggerating the safety risks of dietary supplements and ignores their superior safety record” when compared to other FDA regulated products.
NPA president and CEO, Dan Fabricant, said: “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 health care community and others can review the data and make informed public policy decisions.”