Did you know, according to the latest statistics from the Center for Disease Control (CDC), approximately 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne illness*.

New FDA authority impacts recalls

In 2011, the Food Safety Modernization Act (FSMA) was enacted to proactively combat these alarming numbers and give the FDA, which regulates 80% of the nation’s food supply, a greater level of oversight. This law was the first major overhaul of our nation’s food safety practices since 1938. It included new regulations for farms that grow fresh produce (fruits and vegetables), facilities that process food for human consumption, food transportation providers, and imported foods. The law mandated more inspections and much tougher anti-contamination standards for everything from peaches to imported pesto sauce.

FSMA was created to protect our nation’s food supply from production to consumption. The objective was to develop a more proactive verses reactive approach to food safety through three fundamental strategies: prevention, increased surveillance, and more rapid response and recovery.

For the first time in history, this gave the FDA the authority to mandate a recall if needed, or shut down a company that was involved in a product recall or foodborne illness incident. The first use of this authority was in April 2018 when the FDA issued the mandatory recall of all food products containing powdered Kratom manufactured by Triangle Pharmanaturals LLC. In a November 6, 2018 FDA News article, the FDA Commissioner stated, “the FDA will not be shy about flexing its recall muscles.”

Important implications of the FSMA

  • Food facilities now required to have a written preventative control plan that spells out the possible problems that could affect the safety of their products
  • Increased frequency of FDA inspections
  • Established system to enhance the FDA’s ability to track and trace both domestic and imported foods

Combined power from the CDC

Along with the FDA’s new authority, it can access the knowledge-base of its sister company, the Center for Disease Control (CDC), to gain the evidence needed to issue recalls. This shared database of whole genome sequencing (mapping of particular strains of pathogens) is extremely valuable. As the FDA tests food and hospitals diagnose foodborne illnesses with enhanced technology, the information is shared between the agencies. This partnership strengthens the FDA’s ability to foresee and validate necessary recalls.

FSMA inefficiencies and loopholes add to recalls

While the FSMA aided the implementation of new rules, the overall intent has not reached its full potential due to the divided food safety system. The law failed to update safety standards for meat and poultry monitored by the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS). Also, the delay of health-based standards for water used on all produce makes it more likely for contaminated food to continue to reach store shelves. In 2019 alone, high-profile recalls and foodborne illness outbreaks linked to flourchicken strips, and romaine lettuce revealed that more action is necessary to protect the public health.

Other pressures to complicate matters

Along with increased pressure from the FSMA, there have been other sources to complicate matters, including:

  1. COVID-19 aftermath. While 2020 Q1 recalls declined due to the relaxed regulatory actions during the pandemic, product recalls are predicted to surge when “business-as-normal” resides. This is especially true for companies forced to make supply chain adjustments and/or switch product lines to accommodate the increased demand during the pandemic. 
  2. Advocacy organizations are more vocal. In their mission to protect consumers, they can easily turn a small incident into a wide-spread campaign.
  3. Improved technology. Enhanced testing and traceability help to more accurately and quickly determine the cause and source of foodborne outbreaks.
  4. Social media implications. Ten years ago, businesses feared regulators. Today, public expression on social media has a greater capacity to quickly destroy a brand.


* Centers for Disease Control and Prevention (CDC)

Jamie Ducharme, “You’re Not Imaging It: Food Recalls Are Getting More Common. Here’s Why”, Time, Jan. 17, 2019, https://time.com/5504355/food-recalls-more-common/

Disclaimer: Berkley Global Product Recall is pleased to share this material with its customers. Please note, however, that nothing in this document should be construed as legal advice or the provision of professional consulting services. This material is for general informational purposes only, and while reasonable care has been utilized in compiling this information, no warranty or representation is made as to accuracy or completeness.