Adverse Event Reporting Tells the Story of Dietary Supplement Safety

Adverse Event Reporting Tells the Story of Dietary Supplement Safety

FDA AER data often lacks fields that may prevent misinterpretation, including FDA’s assessment of causation

Published: Tuesday, March 3, 2020

Washington, D.C. — 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).

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The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal and botanical products industry. AHPA is comprised of more than 300 domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org .

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products. Visit www.chpa.org .

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 www.crnusa.org . Follow us on Twitter @CRN_Supplements and LinkedIn.

The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents over 700 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Visit www.npanational.org and follow NPA on Twitter and Instagram @NPAnational and LinkedIn.

The United Natural Products Alliance (UNPA) is an international trade association representing nearly 120 leading natural products, dietary supplement, functional food, scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in legislative and regulatory issues and industry best practices. Visit www.unpa.com . Follow us on twitter @UNPANational and LinkedIn.

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