State chemical bans, FSMA compliance on FDA’s regulatory radar in 2024

BIGFORK, MONT. — The US Food and Drug Administration (FDA) is likely to pay more attention to chemical risks, allergen thresholds and enforcement of the Food Safety Modernization Act (FSMA) in 2024.

The forecast for this year’s major regulatory trends comes from David Acheson, MD, founder of The Acheson Group and former associate commissioner for foods at the FDA.

“I’m predicting that we’ll see more focus on chemical risks than we have historically,” Acheson said in an interview with Food Business News, a sister publication of Pet Food Processing.

He pointed to the FDA’s recent concerns about “extremely high” levels of lead found in certain applesauce products as a driving factor behind the focus on chemical risks.

“There’s nothing like a crisis to drive regulatory attention,” Acheson said. “It probably will put some pressure on the agency to respond more quickly to the cries for stronger regulations around heavy metals.”

 

States take the lead

California’s ingredients ban on Red No. 3, brominated vegetable oil, potassium bromate and propylparaben in October has further spurred the FDA’s attention to chemical additives. The agency proposed removing food additive authorization for brominated vegetable oil less than a month after the California bill was signed, citing potential for toxic effects on the thyroid.

“No sooner had Governor Newsom signed it into law than the FDA jumped right on the bandwagon and said, ‘Yep, we’re going to ban one of those (ingredients), too,’” Acheson said. “I think the concern around chemical residues is going to continue to resonate, and the FDA is going to continue to focus on that more so than it has traditionally.”

Beyond the ingredients themselves, California paving the way for such a ban may be a sign of bigger things to come, he said. Illinois already has proposed a similar piece of legislation, and Acheson believes the actions may be a signal that states will become the ones to take charge on regulatory efforts while the FDA follows, flipping the historical trend.

“I was surprised when I saw (California’s ban) happen, I have to say, and it set a precedent most definitely,” he said. “I think it’s also given states the confidence that they can do it, and the FDA cannot stop them.”

Acheson suggested that such a future could create extensive compliance difficulties for manufacturers should states implement differing food and beverage regulations.

 

FSMA

Another of the FDA’s regulatory priorities will be continued enforcement of the FSMA. Particular points of emphasis will be traceability compliance, as companies prepare ahead of the 2026 traceability requirements implementation, and violations of Good Manufacturing Practices (GMP).

“What’s hurting people are the fundamentals of GMPs,” Acheson said. “The GMPs fail because training isn’t there, because 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 traditionally has been hesitant to introduce thresholds for the nine major allergens, save for gluten, but 2024 may be the year the agency begins to seriously consider expanding its use of thresholds. The change in attitude is the result of sesame being added to the major allergen list in 2023, Acheson explained.

Rather than decrease the risk of sesame exposure for consumers, sesame’s inclusion 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 added burdens of cross-contamination prevention and potential recalls.

“I think the bakery industry didn’t really appreciate the challenges they were going to face to make sesame plants cleanable,” Acheson said. “The sesame situation, almost call it a debacle, frankly, absolutely did not go the way that anyone intended it to go.”

The unforeseen uptick in sesame inclusion may lead the FDA to consider implementing a threshold, rather than strict zero tolerance policies, in order to avoid future mishaps.

“We’ve seen in the real world where a black and white regulatory decision is having unintended consequences, and I think it will open the door to conversations about how do you assess the risk,” Acheson said. “The FDA has sort of shied away from embarking on a threshold conversation, but I think in 2024, they’re more likely to have those conversations.”

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