Consider the FDA’s New Food Safety Blueprint a Warning
After months of COVID-19-related delays, the FDA has just released its “New Era of Smarter Food Safety: Blueprint for the Future.” Part of that blueprint focuses on recall modernization – a process that actually has been ongoing even without FDA’s close attention. But now that it is top priority for the agency, you can expect your regulatory obligations to change.
As part of the agency’s focus on “Smarter Tools and Approaches for Prevention and Outbreak Response,” the FDA highlights four major initiatives it sees as driving factors to modernize the recall process. They are listed below. Each is followed by our analysis and recommendations based on decades of experience managing recalls of food, consumer products, medical devices, and pharmaceuticals.
- Explore mechanisms to harmonize how FDA and USDA communicate recall information to consumers. We agree that this is important, but the effort must go beyond the federal agencies and nationwide recalls. It must include activities at the state and local level because right now there is no single consumer-friendly place to go for food recall information. To the extent consumers are watching the recall pages on FDA.gov or USDA.gov, they could be missing important announcements about recall events that impacted only their local store. This step makes information easier for consumers to obtain and understand, while lessening the chance for consumer confusion over what’s being recalled by any company.
- Develop best practices guidance on various consumer notification processes ranging from web and social media postings, text messages, email, alerts, and digital scan prompts to ensure that consumers know if they purchased recalled product. Smart companies are already doing this. But if yours still doesn’t have a product-recall plan, we recommend you develop one right away. We help companies implement consumer notification best practices during recall planning and active recalls to ensure they don’t just check the boxes, but go above and beyond what is expected. The penalties for failing to keep pace are more severe and damaging to brands than ever.
- Explore the use of a broad spectrum of technologies to enhance external communications and the effectiveness of recalls Specifically, the FDA suggests two initiatives:
Enhance connectivity of data from Reportable Food Registry submissions and food recalls. In our experience, regardless of industry, the ability to collect and analyze all available data about a product and the potential safety risk is critical to recall effectiveness. So while connectivity of RFR and food recall data is important, it likely doesn’t go far enough. Foodborne illness reports filed with state health departments and CDC, as well as food safety complaints filed by consumers, food retailers and food service operators must also be connected and accessible.
- Create a United States Government (USG) app for alerting consumers about food recalls and advisories to empower them with actionable information in real time. Apps are great in theory, but in cases like these they too often fail in execution. We see two significant challenges. The first is convincing consumers to download the app. The second is ensuring they always see value in the information it provides once they opt-in. Consumers are inundated with information, and push notifications on their phones are a major contributor. If alerts come too often or are irrelevant to their buying habits, expect consumers to turn off the notifications or delete the app entirely. At this point, the app has failed in its primary objective. Far more effective would be push notifications from retailers that notify you about recalls based on your actual purchase history.
- Explore the ability to create and incentivize the widespread use of protocols and standards to enable register lockdown capabilities to prevent sales of recalled food products. To a large extent, this is already happening. We know many retailers that can stop the sale of products at the register. This does become more challenging, however, when selling produce or other products that don’t have unique barcodes. Consider how fresh apples, cilantro or lettuce are sold. Locking down registers in these cases can quickly create situations where an entire product category is impacted instead of products from just one producer or supplier. We’ll need careful consideration of this challenge to ensure that one recall doesn’t result in blocked sales of all products in the category.
From our perspective, it comes down to this: There is little innovative or groundbreaking thinking in the FDA’s blueprint when it comes to recall modernization. Much more is already happening inside the companies we work with.
But if any of these concepts are new to you, it’s time to get up to speed. It’s always easier to start implementing changes now before FDA starts setting a deadlines.