VMS industry supports published AERs, but cautions to not take at face value

WASHINGTON — The Council for Responsible Nutrition earlier this week embraced the Food and Drug Administration's decision to make public data from FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System, calling it a demonstration of the agency’s commitment to transparency.



“We’re encouraged by FDA’s move to make this information public as consumers expect and deserve transparency,” stated Duffy MacKay, SVP 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," he said. "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.”

“The Natural Products Association shares the FDA’s commitment to promoting safety and transparency for the millions of Americans who use natural products,” added Dan Fabricant, executive director and CEO of the Natural Products Association. “While this data has the potential to be another tool in the many the government has at its disposal to hold bad actors accountable and to protect consumers, it is important to remember this type of data often tells only part of the story," he said.



“We will be monitoring closely how this information is interpreted and used and will speak out if the system is abused at the costof small businesses,” Fabricant added. “We have to be certain this is a tool for consumers, and not for the Plaintiff's bar to file frivolous and irresponsible lawsuits, given that the vast majority of these AERs are not causal.”



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,” MacKay said. “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.”