Adverse Event Reporting Tells the Story of Dietary Supplement Safety

Washington, D.C., March 3, 2020 — At the initial Congressional Dietary Supplement Caucus briefing of 2020, held last week, Dr. Richard Kingston, president, regulatory and scientific affairs and co-founder of SafetyCall International, educated congressional staffers on the types of evidence used to monitor dietary supplement safety, including adverse event reports, emergency room visits and poison control center data. Dr. Kingston is an expert on clinical toxicology and pharmacology, poison control, product post-market surveillance, and drug and dietary supplement safety.

Emphasizing that media headlines citing safety data on dietary supplements often lack the proper context and overstate potential risk to consumers, Dr. Kingston noted that whether through the development of consumer education campaigns, or advocating for increased resources for FDA to enforce the law, the dietary supplement industry has exhibited a commitment to maintaining a safe marketplace, as the majority of Americans take dietary supplements each year. 

FDA data of reported adverse events can be misconstrued, says Kingston. The Dietary Supplement and Nonprescription Drug Consumer Protection Act, 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.  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.

The bipartisan, bicameral Dietary Supplement Caucus briefing was organized with help from trade associations representing the dietary supplement industry—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA).

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 180+ 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 Follow us on Twitter @CRN_Supplements and LinkedIn.