FDA released data submitted by consumers, medical professionals and industry from 2004 through September 2016 for conventional foods and dietary supplements, and cosmetics. The data, which is available HERE , will be updated quarterly, said Susan Mayne, PhD, director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Katherine Vierk, MPH, director of the Division of Public Health Informatics and Analytics at CFSAN.
“Examples of how adverse event data has been used to support multiple actions by FDA include recalls of HydroxyCut and OxyElite Pro dietary supplements, and investigations of cosmetic products, such as EOS lip balm and Brazilian BlowOut hair smoothing treatment,” they wrote.
Mayne and Vierk added a couple of caveats about data from CFSAN’s Adverse Event Reporting System (CAERS): “The data from the reports is what was reported to the agency. FDA has not necessarily determined that the events reported were actually caused by the product in question. And there often are gaps in the information provided, which should ideally include the product name, symptoms, outcome, consumer’s sex and age, and the date the adverse event was experienced.”
“This is like the FBI publishing a list of anyone ever questioned in connection with a crime…”
Dr Rick Kingston, President, Regulatory and Scientific Affairs, SafetyCall International and Clinical Professor of Pharmacy, University of Minnesota, told us that the limited details provided in the data download make it near impossible for even trained pharmacovigilance experts to draw any conclusions.
“The supplement adverse event reporting system was designed to be a sensitive surveillance system meaning any allegation of product use resulting in an adverse effect, no matter how outrageous or credible, gets thrown into a single data file. This is like the FBI publishing a list of anyone ever questioned in connection with a crime and what they were potentially accused of or suspected to be involved in without any effort to exonerate those that were subsequently found to have nothing to do with the crime,” said Dr Kingston.
“The FDA acknowledges that they have not necessarily concluded any given report constitutes a cause and effect relationship between the product use and the reported event but most people probably won’t read or care about that disclaimer.
“This new endeavor will undoubted have significant implications for manufacturers whose company name and products will appear in the database along with the reports of adverse effects suspected to be associated with product use. Given the limited accompanying data it will be difficult to determine what, if any, role the products may have played in the reported event. That kind of determination requires much more in-depth analysis of the events and all supporting documentation. It remains to be seen how releasing the data in this format will impact safety surveillance for these products,” added Dr Kingston.
The term “adverse event” is an umbrella term for a number of poor outcomes, including bad reactions, illnesses or deaths. The goal of CAERS is to provide indications, or “signals” of potential hazards.
“We’re hoping that this increased transparency will result in more detailed and complete reports that will help us to more rapidly identify red flags about a possible safety issue with products we regulate,” wrote Mayne and Vierk.
A commitment to transparency, but…
The Council for Responsible Nutrition (CRN) welcomed making the data public and said that it demonstrates the agency’s commitment to transparency, “as consumers expect and deserve transparency”. However, the association said that the move also increases the potential for public misinterpretation of adverse event reports.
“We advise the public to be cautious when reviewing these reports and to consider the fuller picture,” said Duffy MacKay, ND, senior vice president, scientific & regulatory affairs, CRN. “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 noted that the dietary supplement companies are legally required to report serious adverse events to FDA no later than fifteen business days after the company receives the report.
Monitoring how the information is interpreted
Dan Fabricant, PhD, Executive Director and CEO of NPA, welcomed the data release but added a note of caution: “We will be monitoring closely how this information is interpreted and used and will speak out if the system is abused at the cost of small businesses. 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.”