Jul 29, 20194 min read

By: Hilary Thesmar, PhD, RD, CFS, Chief Food and Product Safety Officer, Senior Vice President, Food Safety Programs, Food Marketing Institute

Hilary Thesmar Legal ConferenceTwo high profile and market crippling consumer advisories last year from the FDA and CDC for romaine lettuce not only captured the attention of food safety professionals, but captured the attention of individuals outside of food safety. Entire business operations and individuals at all levels-from store associates to CEOs-and most importantly, customers were impacted. FMI’s 2019 Legal, Regulatory and Compliance Conference discussed the investigation process leading to the consumer advisories, as well as the new normal for what to expect with public health alerts.

The food industry is very familiar with food recalls, and retailers and wholesalers execute multiple food recalls each week. This is a normal event and can be viewed as a tool to effectively and efficiently remove products from commerce that may be potentially harmful to public health. Food recalls are typically voluntary actions initiated by a firm. FDA oversees and monitors recalls to ensure that adequate steps are being taken. If FDA determines the firm’s recall to be ineffective or if a firm fails to voluntarily recall a product, FDA has mandatory recall authority. Whether a recall is voluntary or mandatory, the process and procedures for these actions are specific and clearly defined.

The emergence of new tools, like Whole Genome Sequencing (WGS), has greatly changed how outbreak investigations are conducted. WGS analyzes the genetic fingerprint of bacteria and genetic matches can be identified in international databases. More outbreaks are being detected but with fewer illnesses due to the specificity of the data available. More cases of foodborne Illnesses are being linked to one another, over a long period of time, sometimes years. Previously, these outbreaks would have likely gone undetected and the illnesses would have probably been classified as “sporadic” illnesses or more individuals would have gotten sick before being the outbreak was identified.

Resultantly, these advances have greatly sped up the investigative process and in doing so, FDA has increasingly resorted to taking actions to notify the public in the form of a “consumer advisory” or “public health alert.”  In the past, FDA has issued statements in the form of consumer advisory when there is not enough information available about the source of the outbreak (i.e., the specific product that is causing outbreaks).

In both of the 2018 advisories, despite knowing the commodity, FDA was unable to narrow the scope to identify the farms or specific products causing the illnesses. With limited and incomplete information, FDA was unable to take the regulatory action of a recall. Regardless, the industry was faced with removing product from the market with no notice and without a recall. Beyond the impact on public health and consumers, the outbreaks and consumer advisories affected the entire romaine lettuce industry--from growers to retailers--who suffered significant losses due to complete market withdrawals from the market.  

Consumer advisories, unlike recalls, are vague and lack a clearly defined process for when and how the notifications are issued. As a result, when these statements are issued it creates significant confusion and often it is unclear what is expected from the industry and supply chain partners. Because of this, supply chain partners are proactively working together in effort to develop clarity and define what actions should be taken when these advisories are made.

Here are some best practices to consider in you supply chain agreements to prepare for such events in the future.

  • Make the Supplier Responsible for Documenting the Source– The scope of a consumer advisory is often geographically limited. Because the supplier is better positioned than the buyer to document the source of the goods, it can be helpful to require the supplier to document that the product is notwithin the scope of the advisory (rather than having the buyer prove that the product iswithin the scope).
  • Define Key Terms– Even seemingly basic terms such as losses, damages, costs and expenses can further complicate an already stressful situation if not clearly defined ahead of time. For example, without clear terms it might be hard to tell whether these covered handling, freight, warehousing, and other transportation or storage costs.
  • Indemnification– Provisions which indemnify the buyer should accurately reflect the parties’ intentions as to the scope of the protection in order to avoid potential issues.
  • Insurance– Where possible, the Supplier’s guaranty to reimburse in the event of a recall, advisory statement, and/or out-of-specification product should be supported by appropriate insurance policies. 

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