The CFSAN Adverse Event Reporting System (CAERS) is one of the post-market surveillance tools the FDA uses to monitor the safety of foods and cosmetic products. Adverse event reports related to conventional foods, dietary supplements, and cosmetics come primarily from consumers and healthcare providers; of these products, only dietary supplement manufacturers have a legal obligation to report adverse events to the agency.
The FDA uses adverse event reports as part of its overall strategy to help monitor the safety of foods and cosmetics. The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, healthcare providers and other members of the public. The agency said complete and detailed reports are immensely helpful when identifying safety signals and choosing particular products for further scrutiny.
CAERS captures any adverse events or complaints related to foods or cosmetics. These can include minor to major medical events, but also complaints about off-taste or color of a product, defective packaging, and other non-medical issues. However, it’s also important to understand the information in the database is exactly as reported to the FDA, and the agency has not necessarily determined if the products(s) in question were the actual cause of the events reported.
From Jan. 1, 2004 through Sep. 30, 2016, the FDA received 56,574 adverse event reports. Of these, 26,840 adverse events were reported for conventional food; 25,412 were reported for dietary supplements; and 4,322 were reported for cosmetic products. FDA staff reviewed f these reports and, collectively, initiated follow-up on hundreds of complaints to investigate potential safety signals.
The FDA is currently modernizing CAERS, improving the process for consumers, healthcare providers, and other members of the public to provide information to the agency, and expects to have a more user-friendly platform in one to two years. The move to post these data now is an important first step in increasing public access to such information, and the public can expect improved access to even better data in the future, the agency said.
The Council for Responsible Nutrition (CRN), Washington, D.C., embraced FDA's decision to make data public, calling it a demonstration of the agency’s commitment to transparency. CRN noted, however, that publishing these reports online increases the potential for public misinterpretation of adverse event reports, and stressed 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 reminded the dietary supplement industry that under the law, supplement companies are required to report serious adverse events to FDA no later than 15 business days after the company receives the report. CRN urged the industry to follow the law.