ARTICLE
13 March 2020

FDA Warning Letters Provide Opportunity For Food-Safety Reminders During Viral And Bacterial Outbreaks

SH
Shook, Hardy & Bacon

Contributor

Shook, Hardy & Bacon has long been recognized as one of the premier litigation firms in the country. For more than a century, the firm has defended companies in their most substantial national and international products liability, mass tort and complex litigation matters.

The firm has leveraged its complex product liability litigation expertise to expand into several other practice areas and advance its mission of “being the best in the world at providing creative and practical solutions at unsurpassed value.” As a result, the firm has built nationally recognized practices in areas such as intellectual property, environmental and toxic tort, employment litigation, commercial litigation, government enforcement and compliance, and public policy.

The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John's Franchise, LLC and its supplier Sprouts Unlimited Inc. regarding food safety practices after the agency traced
United States Food, Drugs, Healthcare, Life Sciences

The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John’s Franchise, LLC and its supplier Sprouts Unlimited Inc. regarding food safety practices after the agency traced an outbreak of E. coli to Jimmy John’s produce, which had previously caused outbreaks of foodborne illnesses. In the letter to Jimmy John’s, FDA focused on the company’s prior sales of adulterated products, its misrepresentations to FDA regarding the sourcing of its sprouts, and the need for Jimmy John’s to demonstrate “long-term, sustainable corrections” that would prevent these outbreaks in the future. It comes as no surprise that letters like these make headlines and risk hurting a food supplier’s reputation.

In light of these warning letters and the concerns raised by potential outbreaks of the new coronavirus COVID-19, food manufacturers must be vigilant about supply chain management, whether at the growing, transporting, processing or handling stages. Oftentimes, the supply chain is where adulteration occurs. This process starts with vetting a company’s national suppliers and its contracts with them. A few considerations: (i) contracts should require each supplier to warrant and guarantee that its products and operations are in full compliance with all applicable food safety laws, including those from FDA; (ii) relationships and contracts with suppliers should allow for suspending or stopping purchases when food safety practices need improvement or FDA alleges they need improvement; (iii) documented supplier verification procedures can be used for a fulsome review of a supplier’s systems for controlling food safety hazards as well as its compliance with applicable food safety laws; and (iv) companies should consider implementing (or revisiting their implementation of) hazard analysis critical control point (HACCP) principles.

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