Since the enactment of FSMA, prevention has become an industry buzzword for proactive food safety. But recent FDA initiatives are making preventive action even more important for brand protection that is related not only to food safety, but to food quality and general consumer perception as well. This is particularly true of FDA’s December announcement that it would begin publicly posting adverse event report data online.
What exactly does that mean?
As of December 6, 2016, any consumer product complaints, healthcare practitioner medical events, and mandatory industry filings reported to FDA since 2004 became available online to anyone for any reason. Additionally, beginning with the February 2017 quarterly update, all data voluntarily reported by industry is included as well.
The data comes from the reports in the CFSAN Adverse Event Reporting System (CAERS) which captures any adverse events or complaints related to foods or cosmetics, and can, as FDA states “include minor to major medical events, but also complaints about off-taste or color of a product, defective packaging, and other non-medical issues.”
The purpose of the quarterly report publication, according to FDA is “to increase transparency and improve access to government data for consumers, health care providers, researchers and academics.” The transparency this imparts is certainly in keeping with the current trend toward traceability and consumer desire for transparency, however there is a downside to the CAERS that is unlikely to be given a lot of notice by a web-troller who happens across the information or a blogger with an agenda.
UNVALIDATED DATA. That is — a critical aspect that needs to be understood about the system is that the information in the database is exactly as reported to the FDA. The agency has not necessarily determined if the product(s) in question were the actual cause of the events reported.
This means you could find your product publicly “implicated” and showing up on someone’s social media page
- … if a consumer gets sick and, thinking it might have been your product he or she ate, reports that to the doctor or submits a report directly to FDA.
- … if a consumer takes a package out of the pantry and sees it’s not completely sealed or it seems to be the wrong color and reports this to FDA instead of to the manufacturer.
- … or if anywhere along the supply chain a violation is self-reported “out of an abundance of caution.”
The web page distinctly and in all capital letters states: “PLEASE OPEN AND REVIEW THE READ ME FILE PRIOR TO DOWNLOADING ANY DATA FILES.” That Read Me file includes caveats, repeatedly stating in various ways that the system only reflects information as reported; submitted reports vary in the quality and reliability of the information; and the information has not been scientifically or otherwise verified.
Unfortunately, not only is it likely that many who download the data never take the time to read the Read Me file, it also is likely that a secondary reader of the data will take it as fact even if the originating author includes the caveats.
A number of recent studies have shown that articles are often shared in social media without ever having been read, so if a blogger picks up a line of data that associates your product as “suspect” in an illness, or worse, a death, and uses that as the headline, you could have a viral brand issue even if there’s no validity in the report. And even if the author includes the caveats in the article, 59% of re-posters never read that, according to the study by Columbia University and the French National Institute.
FDA also states that it “anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers, and other members of the public. Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny.”
We can only hope that it does spur more “detailed and complete” (i.e., accurate) reports and not just “more” reports, particularly if the agency does, indeed, intend to use them to choose products “for further scrutiny.”
And let’s not leave out USDA-regulated plants. In July 2016, USDA announced that it would begin online sharing of “new levels of food safety data” of slaughter and processing facilities. The data includes information on the processes used at each facility, results for Listeria monocytogenes, Salmonella, Shiga Toxin-producing Escherichia coli (STEC) and Campylobacter in various products; routine chemical residue testing data; and advanced meat recovery testing data.
While a key difference between the FDA and USDA data sets is that the USDA’s is agency generated based on its inspections and daily collection of information by on-site regulators, both are publicly available and both can be easily re-disseminated — and misinterpreted by those who read only the headlines.
From all this, I think you can readily understand why I stated in the opening paragraph that preventive action is becoming increasingly important for brand protection in areas other than food safety. Whether adverse event data is truth or “suspect”; whether a pathogen detected by an environmental swab contaminates finished product or not; whether a customer complaint is based on manufacturer error or home storage — your product, and thereby your brand, is at risk every day. Are you assigning preventive controls to protect yourself as well as your consumers?