BIGFORK, MONT. — The US Food and Drug Administration (FDA) will likely pay more attention to chemical risks, allergen thresholds and implementation of the Food Safety Modernization Act (FSMA) in 2024.
A forecast for this year’s key regulatory trends comes from David Acheson, MD, founder of The Acheson Group and former associate commissioner for foods at the FDA.
“I predict that we will see more focus on chemical hazards than we have historically,” Acheson said in an interview with Food Business Newsa sister publication of Pet Food Processing.
He pointed to the FDA’s recent concerns about “extremely high” levels of lead found in some applesauce products as a driving factor behind the focus on chemical risks.
“There’s nothing like a crisis to drive regulatory attention,” Acheson said. “Perhaps this will put some pressure on the agency to respond more quickly to cries for stronger regulations around heavy metals.”
States lead
California’s ban on ingredients in Red No. 3, brominated vegetable oil, potassium bromate and propylparaben in October further prompted the FDA’s attention to chemical additives. The agency proposed removing the food additive authorization for brominated vegetable oil less than a month after signing the California bill, citing the potential for toxic effects on the thyroid.
“As soon as Governor Newsom signed it into law, the FDA jumped right on the bandwagon and said, ‘Yeah, we’re going to ban one of those (ingredients), too,'” Acheson said. “I think the concern around chemical residues will continue to resonate, and the FDA will continue to focus on that more than it has ever been.”
Beyond the ingredients themselves, California paving the way for such a ban could be a sign of bigger things to come, he said. Illinois has already proposed a similar piece of legislation, and Acheson believes the actions could be a sign that states will become the stewards of regulatory efforts as the FDA follows suit, reversing the historical trend.
“I was surprised to see (California’s ban) happen, I have to say, and it certainly set a precedent,” he said. “I think it also gives the states confidence that they can do it, and the FDA won’t stop them.”
Acheson suggested that such a future could create extensive compliance difficulties for manufacturers if states were to implement disparate food and beverage regulations.
FSMA
Another of the FDA’s regulatory priorities is the continued enforcement of FSMA. Particular points of emphasis are traceability compliance, as companies prepare ahead of the implementation of traceability requirements in 2026, and violations of Good Manufacturing Practices (GMP).
“What offends people is the fundamentals of GMPs,” Acheson said. “GMPs fail because the training isn’t there, because the food safety culture isn’t there. And part of that is because of the rapid turnover of personnel, and the industry can’t do anything about that.
Allergen thresholds
The FDA has traditionally been hesitant to introduce thresholds for the nine major allergens, other than gluten, but 2024 may be the year the agency begins to seriously consider expanding its use of thresholds. The change in attitude is a result of the addition of sesame to the major allergen list in 2023, Acheson explained.
Instead of reducing the risk of sesame exposure for consumers, the inclusion of sesame has led some manufacturers to add sesame to their previously sesame-free formulations. The process, known as ingredient harmonization, allows producers to include sesame on the label and avoid the additional burdens of avoiding cross-contamination and potential recalls.
“I think the bakery industry doesn’t really appreciate the challenges they face to make sesame seeds clean,” Acheson said. “The sesame situation, almost call it a debacle, to be honest, it really didn’t go the way anybody intended.”
The unexpected increase in sesame inclusion may lead the FDA to consider implementing a threshold, rather than strict zero tolerance rules, to prevent future disasters.
“We’ve seen in the real world where a black and white regulatory decision has unintended consequences, and I think this will open the door to conversations about how you can assess risk,” said said Acheson. “The FDA is a little shy about starting a threshold conversation, but I think in 2024, they’re more likely to have those conversations.”
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