• Home
  • Has Your Product Been Posted as a "Suspected" Cause of an Adverse Event?

Have you ever had a customer complain right to the FDA about a quality or safety aspect of your product? Have there been any “adverse events” suspected of being related to your product reported to FDA? Do you even know if there have? Whether you do or not, it will now be public information, broadcast across the Internet. So get ready to have to protect your reputation in a whole new way. Last week, FDA announced that it will be posting data from the CFSAN Adverse Event Reporting System (CAERS) on a quarterly basis. What is most important to understand is that CAERS captures any adverse events or complaints related to foods or cosmetics – “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.” While these include minor to major medical events, they also may be complaints about off-taste or color of a product, defective packaging, or other non-medical issues – as submitted primarily by consumers and healthcare providers. The first public posting of the CAERS report, published December 6, includes data from January 1, 2004, through September 30, 2016, with 26,840 adverse events reported for conventional food. Although FDA does not validate the basis of the reports, CFSAN clinical reviewers do evaluate every report submitted and has initiated follow-up on hundreds of complaints to investigate potential safety signals. If a potential safety concern is identified, further evaluation is performed, and ,if deemed applicable, FDA may take regulatory action, communicate new safety information to the public, or even remove a product from the market. FDA’s stated purpose in publicizing the data is to increase transparency and improve access to government data for consumers, health care providers, researchers and academics, anticipating that it will help spur the submission of more detailed and complete reports. Previously the reports were only available through Freedom of Information Act (FOIA) requests, but the data can now be downloaded in .csv format or through OpenFDA.gov as an API by anyone with Internet access. And FDA is working to make it even simpler for the public to submit and to access reports. To make this database even more interesting. it is essentially searchable. So a consumer or reporter can search for a specific brand and look at all the complaints related to that brand. While this may all seem to be a good thing in relation to FDA’s new risk-based, preventive approach to food safety, there are some distinct downsides for industry, based particularly on the tendency of all-too-many consumers (and media) to believe and repost anything read on the Internet without delving further than the “headline” or main text. Thus, a consumer report to FDA stating that a child was hospitalized for vomiting, diarrhea and dehydration after consuming Brand XYZ baby food could very easily cause a social media blitz and consumer boycott of the product – even with no validation of the food as to the cause, no FDA investigation into the report, and what appears to be no process to even ensure the report is legitimate. FDA openly admits that it does not necessarily investigate submitted reports before releasing them to the public and that the reports “vary in the quality and reliability of the information provided.” This means that there is no certainty that the product listed as suspected actually caused a reaction, especially because FDA encourages healthcare practitioners, firms, agencies, consumers, and others to report suspected reactions, although the event may actually have been related to another condition, activity or product, or even occurred simply by chance. Additionally, FDA states that not all reports include all relevant data (such as medical condition or other products or medications consumed or used) and some may not enable follow-up due to inaccurate or incomplete contact information or lack of participation by the reporting person. Thus, while branded products are being posted for public viewing as “suspected” of causing an adverse event, in actuality, FDA states that the listing “does not constitute an admission that a product caused or contributed to an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate incidence (occurrence rate) or to estimate risk.” To look for some positive angle on this new initiative, one could wish  that the increased transparency as FDA has said “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.” But the fact that anyone can report a safety or quality issue with food or cosmetic, and that report becomes public information without any validation, is a distinct “red flag” for industry that may be difficult to combat. So what should you do moving forward to address this new and potentially damaging FDA initiative? In my view, this is one more opportunity for your reputation to be damaged and you should pay some serious attention to tracking what is being posted. At the very least, know what FDA is making public about your company or your brands. Second, develop a strategy to be able to address any enquiries you may get from consumers, media, etc. regarding any posted data. Third, ramp up your social media scanning so you can get on top of anything that is created from the database and actively manage the reputational risk. Fourth, make it easy for a customer to contact you and be responsive when they do with a complaint. I am sure that, at some level in FDA, the Agency believes this will help protect public health. Given what appears to be the total lack of validation of the information I feel that this new initiative will result in new costs for the industry, potentially lead to brand-damaging scandals, and is not likely to have a dramatic positive impact on public health. Oh well – one more thing for the food safety professional in a company to worry about. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

Has Your Product Been Posted as a "Suspected" Cause of an Adverse Event?