Passage of the Food Safety Modernization Act (FSMA) gave the U.S. Food and Drug Administration (FDA) broader authority to manage product recalls and request records and information from product manufacturers. Additional funding in 2018 is expected to allow for even more sampling and product/facility inspections, and the number of recalls is likely to rise as well.
If you deal with allergens or possible microbiological and foreign material contamination—the leading causes of Class I recalls—watch out.
Food and safety quality specialist John Ryan explains how to respond to a quality deviation investigation and potential FDA recall in his live webinar for ProfEdOnDemand, “FDA Recalls and Traceability Requirements—2018 Trends and Common Issues.” In addition to overviewing the FDA recall landscape, Ryan examines ISO 22005 traceability standards, product and process liabilities, overlooked transportation issues, and more.
Are Food Recalls Up? You Bet
The FDA has long had the ability to enact food recalls, but the passage of FSMA in 2011 “changed the paradigm of food safety measures,” wrote Megan Poinski for Food Dive. FSMA flipped enforcement from reaction to prevention, with food and beverage manufacturers working to keep contaminated food from ever leaving their facilities.
FSMA may not be responsible for more food recalls: Recalls have been rising in general for more than a decade. But the law could drive further increases.
Food Safety News reported in April that a review of food trends from 2004 to 2013 showed a 125% increase in food recalls over the period. Most recalls came from the FDA, with a smaller number from the U.S. Department of Agriculture’s Food Safety and Inspection Service.
A former FDA director and current industry lawyer, Joseph Levitt, told Food Drive that while FSMA may not be driving a spike in recalls, one is probably coming.
“In terms of food recalls, it follows the principle that the more you look, the more you find,” he said. “And FSMA has companies looking more, particularly manufacturers overseeing their suppliers.”
Earlier in April, the FDA announced its first-ever mandatory recall, which was for all food products containing powdered kratom from a company called Triangle Pharmaceuticals, LLC. The recall centered around salmonella concerns and Triangle’s refusal to voluntarily recall its products.
“Although this is the third time the FDA has started the process of exercising its mandatory recall authority by issuing a Notification of Opportunity to Initiate a Voluntary Recall, it is the first time the Agency has actually ordered a mandatory recall due to a company’s refusal to voluntarily recall after receiving such a notification,” lawyers Gugan Kaur and JP Ellison noted in FDA Law Blog.
Watch For: Undeclared Milk, Eggs, Soy, Nuts—and Other Contaminants
Regardless of the breadth of FSMA’s impact, there are certain constants the industry should be aware of, reported Food Safety Magazine.
In 2017, “undeclared allergens still dominate when it comes to food products needing to be pulled from store shelves,” the magazine found. The most common undeclared food allergens in 2017 were, in order, milk, eggs, soy, almonds, and peanuts.
Other major recalls were for listeria, salmonella, E. coli, and foreign material contamination, which included metal and plastic contamination, followed by lead, antibiotic nitrofurazone, water, and meat casings.
“As consumers continue to trust food companies and government agencies to properly vet our food, it is clear that the processes in place do not always go as planned,” the magazine summarized. “The persistence of unsafe foods making it into the market should serve as a reminder that for those who work in the food industry, safety is everyone’s job. It is not limited to those on the front lines.”
The 2004-2013 trend report found that, regardless of legislation, pathogen and risk detection technology improvements mean more problems are being spotted, and that increasing food volumes mean that recalls may have ever-broader impacts.
“Most of the recalls fell into six food categories: prepared foods and meals, nuts and seeds, baked goods, grains and grain products, candy products, and sauces condiments and dressings,” explained Food Poisoning Bulletin. “The most common reason for the recall, except for nut products, was undeclared allergens.”
To steer clear of recalls and away from negative publicity, warns Ryan, those in the food industry need to be current on best practices like lot identification and ISO 22005 traceability.