BIGFORK, MONT. โ The 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 yearโs major regulatory trends comes from David Acheson, MD, founder of The Acheson Group and former associate commissioner for foods at the FDA.
โI’m predicting that weโll see more focus on chemical risks than we have historically,โ Acheson said in an interview with Food Business News.
He pointed to the FDAโs recent concerns about โextremely highโ levels of lead found in certain applesauce products as a driving factor behind the focus on chemical risks.
โThere’s nothing like a crisis to drive regulatory attention,โ Acheson said. โIt probably will put some pressure on the agency to respond more quickly to the cries for stronger regulations around heavy metals.โ
States take the lead
Californiaโs ingredients ban on Red No. 3, brominated vegetable oil, potassium bromate and propylparaben in October has further spurred the FDAโs 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.
โNo sooner had Governor Newsom signed it into law than the FDA jumped right on the bandwagon and said, โYep, weโre going to ban one of those (ingredients), too,โโ Acheson said. โI 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.โ
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 states will become the ones to take charge on regulatory efforts while the FDA follows, flipping the historical trend.
โI was surprised when I saw (Californiaโs ban) happen, I have to say, and it set a precedent most definitely,โ he said. โI think itโs also given states the confidence that they can do it, and the FDA cannot stop them.โ
Acheson suggested that such a future could create extensive compliance difficulties for manufacturers should states implement differing food and beverage regulations.
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, sesameโs 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.
โI think the bakery industry didn’t really appreciate the challenges they were going to face to make sesame plants cleanable,โ he said. โThe sesame situation, almost call it a debacle, frankly, absolutely did not go the way that anyone intended it to go.โ
The unforeseen uptick in sesame inclusion may lead the FDA to consider implementing threshold, rather than strict zero tolerance policies, in order to avoid future mishaps.
โWe’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,โ Acheson said. โThe 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.โ
FSMA
Another of the FDAโs 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).
โWhat’s hurting people are the fundamentals of GMPs,โ Acheson said. โThe GMPs fail because training isn’t there, because food safety culture isnโt there. And part of that is because of the rapid turnover of personnel, and the industry can’t do anything about that.โ
