At the first Congressional Dietary Supplement Caucus briefing of 2020, which was held last week, Dr. Richard Kingston, the regulatory and scientific affairs president and co-founder of SafetyCall International, briefed congressional staffers on the types of evidence used to monitor dietary supplement safety.
 
Five major trade groups – The American Herbal Products Association, Consumer Healthcare Products Association, Council For Responsible Nutrition, Natural Products Association, and United Natural Products Alliance – worked in collaboration to organize for the first congressional briefing on the dietary supplement industry held this year.
 
Three key components in monitoring supplements are adverse event reports, emergency room visits, and poison control center data. Kingston, whose experience includes clinical toxicology, pharmacology, poison control, product post-market surveillance, and drug and dietary supplement safety, argued that adverse event reporting conducted by the FDA often misconstrues data.
 
Media headlines citing safety data on dietary supplements often lack the proper context and overstate potential risk to consumers, Kingston argued. He further noted that the dietary supplement industry has demonstrated a by-and-large commitment to maintaining a safe marketplace for the majority of Americans who take dietary supplements each year, through developing consumer education campaigns, and advocating for increased resources allowing FDA to enforce the law.
 
The Dietary Supplement and Nonprescription Drug Consumer Protection Act, which was signed into law in December 2006, requires manufacturers to report to FDA serious adverse events (AERs) associated with dietary supplements whether or not a likely causal connection is established.  
 
Kingston posited that FDA AER data falls short in providing full context in a number of ways. In many cases, FDA AER data also do not include information on underlying medical conditions, concomitant use of medications, and even the exact ingredients involved. Even though FDA makes AER data available, fields that may prevent misinterpretation of the data are omitted, including FDA’s assessment of causation.
 
Similarly, studies analyzing emergency department visits and exposures reported to poison control centers fail to provide proper context by not considering the rarity of events in comparison to the billions of servings used by consumers, Kingston argued.