CRN Applauds FDA’s Transparency with Adverse Event Reporting, Warns of Potential Misinterpretation by Consumers, Media

Washington, D.C., December 7, 2016

The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, embraces FDA's decision to make public data from FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Adverse Event Reporting System (CAERS), calling it a demonstration of the agency’s commitment to transparency. CRN notes, however, that publishing these reports online increases the potential for public misinterpretation of adverse event reports, and stresses the importance of FDA providing context for its data.

“We’re encouraged by FDA’s move to make this information public as consumers expect and deserve transparency,” said Duffy MacKay, ND, senior vice president, scientific & regulatory affairs, CRN. “When the Dietary Supplement and Nonprescription Drug Consumer Act was introduced, our industry was a strong proponent of its passing and emphasized the benefits it would provide consumers. Since the law’s passage in 2006, the industry’s track record demonstrates a strong safety profile for our industry both in comparison to other FDA-regulated industries and considering that more than 170 million Americans take dietary supplements each year. This law gave the FDA a valuable tool to identify potential safety concerns through patterns and signals. It’s essential to understand, however, that an AER does not demonstrate a causal relationship.”

In its announcement, FDA noted that ‘adverse events about a particular product and the total number of adverse event reports for a product in the CAERS database only reflect the information reported and do not represent any conclusion by FDA about whether the product actually caused the adverse event(s).’

“We advise the public to be cautious when reviewing these reports and to consider the fuller picture,” Dr. MacKay continued. “If consumers are looking to make decisions about safe or unsafe products, they would do best to pay attention to FDA’s consumer advisories rather than looking at individual adverse event reports which, at the end of the day, may not be related to the supplement product.”

CRN reminds the dietary supplement industry that under the law, supplement companies are required to report serious adverse events to FDA no later than fifteen business days after the company receives the report. CRN urges the industry to follow the law. 

About CRN

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ 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 @wannabewell and on Facebook