Growing Pains: The Challenges of FSMA Implementation

Editor's Note: This article originally appeared in the January/February 2026 print edition of QA magazine under the headline “Growing Pains.”

During the development of the Food Safety Modernization Act (FSMA), a pressing concern of the U.S. Food and Drug Administration (FDA) was how to balance education and enforcement. Roberta Wagner recalls that tension well. Now senior vice president for regulatory and scientific affairs at the International Dairy Foods Association, she spent 29 years at the FDA until 2016, including serving as associate commissioner of FSMA implementation.

“Because it was such a monumental change in philosophy, we knew we couldn’t just walk in and start enforcing against the new standards,” she said. “We had to think about how we were going to do that through education and not with a strong regulatory arm.”

Fifteen years later, Wagner sees clear evidence that the education worked. “The industry has embraced FSMA completely and totally,” she said.

Part of that, she explained, is thanks to the new regulatory requirement that companies have a trained Qualified Individual develop their risk-based food safety plans and programs and ensure they are implemented.

Also key is the continual improvement undertone embedded in FSMA: “The fact that you have to routinely monitor and verify preventive controls are working as intended and, if something goes awry, figure out why that happened and enhance or put better controls in place, is one of the main differences between before and after FSMA,” said Wagner.

From the consulting side, the picture looks more mixed. Jennifer McEntire, founder of consulting firm Food Safety Strategy, agreed that mandatory training has had a positive impact, but added: “None of the rules require ongoing training or to demonstrate understanding or implementation. It’s likely that many people take those trainings to check the box without really using that information to improve systems.”

A lack of ongoing training is partly responsible for the slow adoption of FSMA standards by produce growers, she said.

“When I was going to school, no one talked about produce safety,” said McEntire. “The industry was successful. Bringing those skills into the produce industry has taken time. You can’t expect people who have done things a certain way all their lives to change after one day of training. I think we’re getting there, but capacity is still an issue. You don’t create thousands of food safety professionals overnight.”

Overall, McEntire sees the industry stuck between HACCP terminology and risk-based thinking.

“FSMA implementation has fallen short in this shift,” she said. “We don’t have alignment across the industry on how to approach food safety in a risk-based way. Fifteen years later, I still see a lot of remnants of HACCP. It seems that people think preventive controls are GMPs [Good Manufacturing Practices], not the critical programs necessary for food safety. Audits and their language and requirements perpetuate this.”

The inspection gap.

This focus on GMPs shows up even more starkly on the enforcement side.

“Right now, inspections are still focused on GMPs, such as hygiene and cleanliness,” said Brian Ronholm, director of food policy at Consumer Reports. “That’s better than nothing, but if we want a food safety system to be more prevention-based, regulatory oversight should include reviews of hazard analysis and food safety plans, monitoring records, including environmental monitoring results, root cause investigations and responses to system near-misses, recalls and outbreaks, and trends in consumer complaints. We’re not seeing enough of that, and following FSMA, changes in regulatory oversight are happening far more deliberately and gradually than expected.”

Steve Mandernach, executive director at the Association of Food and Drug Officials (AFDO), sees the same pattern.

“We’re still less focused on systems and more on what we can observe quickly during inspections — floors, walls and ceilings. Once in a while, these may create the situation for an illness, but often, you have to really get into the process to understand that. Both state and federal inspectors are clearly moving in that direction, but we’re not there yet.”

Wagner is even more blunt about this: “Regulatory oversight has been FSMA’s big fail. I don’t think the FDA has changed its inspection models since the late 1990s when I joined. GMP inspections, now referred to as ‘limited PC inspections,’ are still the norm. Working for the industry, I’ve had many food companies tell me nobody has ever come to take a look at their food safety plan, although they would love to know if they got it right, from the FDA specifically. Fifteen years in, that’s really not acceptable.”

Why change stalled.

Part of the issue is that inspections have once again reverted to a numbers game, Wagner said.

“The only way for FDA and state inspectors to meet minimum inspection frequency mandates is to quickly check GMPs rather than doing full preventive controls inspections,” she said. “But even with little time available, it would be more effective to review records and actions taken in response to, for example, environmental monitoring programs.”

Wagner attributes the current approach to resource shortages.

“Right now, the FDA has the lowest number of food inspectors ever, and both the states and FDA are having a very hard time recruiting and keeping them,” she said. “Being an inspector is not glamorous work. You have to travel. Sometimes, you’re going out to big facilities in the middle of nowhere with messy operations.”

Mandernach agreed that high turnover is a problem, but he pointed to a deeper issue.

“FSMA is more a public health law than a regulatory law, because it’s all about preventing illness,” he said. “But this hasn’t necessarily taken hold within the FDA, where we still have this constant struggle: Are we a regulatory or a public health agency? As a regulatory agency, you want far more information, because that’s a legal process. As a public health agency, you may make a decision based on imperfect information. For a regulatory agency, it’s hard to move away from ‘floors, walls and ceilings’ inspections. A public health agency gets into the process to prevent issues. I’d like to see the FDA as more public health than regulatory. I think that’s what’s best for consumers.”

Wagner sees the agency’s role differently.

“The Federal Food, Drug and Cosmetic Act makes it very clear that the FDA is a regulatory agency,” she said. “You put out standards, assure that the industry is complying with them and take enforcement action when they’re not. This has been FDA’s mandate forever.”

When information doesn’t flow.

When food safety incidents happen, information sharing between the FDA and states is another pain point, Ronholm said.

“The FDA tends not to be forthcoming with information about outbreaks and recalls with states and consumers,” he said.

This can hamper the recall alert system, Ronholm said, referencing the ByHeart infant formula recall in late 2025: “The FDA had to send strong letters to certain retailers because products were still being found on store shelves,” he said. “Everyone — the FDA, the industry and consumers — acknowledges that that’s an improvement that needs to be made.”

Wagner agreed, noting that FSMA should have included mandates for sharing information from the start.

“During the Jensen Farms cantaloupe outbreak in 2011, we were able to identify contributing factors very quickly,” Wagner said. “As the incident commander, I insisted that the industry should know without delay so other people wouldn’t make the same mistakes. I was able to work with a lawyer in FDA’s Office of Chief Counsel at the time to share likely contributing factors in real time as the investigation continued. But now, the FDA’s lawyers interpret information disclosure like this differently and won’t do that. Sometimes, FDA can’t even share information or details of investigation findings with state regulatory bodies — the very same people they work with every day. And it’s shameful, because if you have the smoking gun, it should be shared with everyone. I wish that FSMA had thought about how to allow that to happen.”

Not all federal-state coordination has faltered, according to Mandernach.

“We’re seeing a lot more coordination and collaboration on whose tools to use,” he said. “Both federal and state governments have enforcement tools, and states often move quicker — suspending or revoking a processing license within a day or freezing products immediately. FDA often has to go to court, which can take years.”

Measuring success.

Part of the reasons for such divergent views on FSMA’s success is that it’s hard to define it.

“When we were delivering on the mandates in FSMA, we spent a lot of time talking about how to measure success,” said Wagner. “I don’t think the agency has done a good job of proving we’ve been successful. People point to more outbreaks and recalls, though they are smaller and more contained. Is that a failure, or does it mean we’re able to detect more problems, and sooner? If today everybody’s still debating this, it’s because that conversation around metrics went into the background.”

Ronholm agreed that measuring success is nearly impossible.

“It’s very difficult to measure the number of illnesses that have been prevented,” he said. “But it’s also difficult to make the claim that food safety has improved for consumers. We haven’t seen a notable decrease in illness rates as a result of FSMA, and all the foods that tend to be higher risk still are.”

The traceability debate.

Much of the current debate around FSMA centers on the traceability rule, which requires operators at all supply chain stages to record key data and provide information to the FDA within 24 hours if requested. The rule came into force in January 2023, with an initial compliance date of January 2026 that was postponed by FDA to July 2028 after industry concerns about readiness.

Ronholm is skeptical about those concerns.

“When you talk to companies that develop traceability systems, their feeling is that many of those concerns are overblown and could be addressed with existing technologies,” he said. “Everyone understands that this is very complicated. But it’s hard to believe some retailers when they use that excuse when you see how companies like Sysco and Walmart were able to push their suppliers to get prepared before the rule even went into effect.”

The risk, for him, is industry sabotage of the rule.

“Some grocery retailers have privately expressed the concern that traceability initiatives within their industry stopped once the delay was announced,” said Ronholm. “It’s certainly possible that those opposed to the rule will use that time to leverage political dynamics and try to undermine it or kill it completely.”

Wagner disagrees with that, emphasizing the massive shift the FSMA rules require of smaller companies who do not have the resources and might not be as technologically advanced as their larger counterparts.

“I really don’t think this is a stall tactic,” she said. “It’s just way more complicated than people thought, especially for the smallest players who are still doing manual record-keeping — and specifically for smaller retailers and restaurants. The purpose of this rule is to trace products that are making people sick faster. Most clusters of illnesses start at restaurants and retail, so it’s important that they are able to comply with the rule and get it right. If that is accomplished, we will impact public health in a positive way.”

Mandernach sees the rule’s scope as both significant and problematic.

“The traceability rule is the only one that gets into the restaurant and grocery store level, virtually covering every restaurant in the country, and that’s a big deal,” he said. “But the rule is really complex — you have no clue what it’s talking about unless you are a supply chain expert, and the FDA has been less transparent on what their expectations are. To this day, very few questions have been answered, particularly for the restaurant level.

“My other concern is that it could easily become a giant unfunded mandate on state and local governments with an expectation that they take care of compliance and enforcement. In the current world, there’s just no appetite to accept any additional federal responsibility without the resources.”

What comes next?

If this is the present of FSMA, experts can agree that the 15-year mark calls for action.

“There’s a real opportunity for a broad group, especially those who were around 15 years ago with that vision of moving from a reactive to a truly risk-based system, to evaluate progresses and gaps, and make a plan for the future — whether that’s a change in the act of Congress, in the language of the regulations or in how they’re interpreted and implemented,” said McEntire.

Mandernach said he’s surprised no revisions have occurred yet.

“One of the things we don’t do a good job of is updating laws and regulations as technology and the world change,” he said. “And the world has changed a lot in those 15 years.”

Ronholm would like to first see what an effectively implemented FSMA looks like before reworking it. But, he added, “If I had to pick one thing to change, it would be providing the FDA with adequate resources and staffing. Considering that they’re responsible for 80% of the food supply, it makes it really difficult to oversee so many products when you’re chronically underfunded.”