The food safety landscape has seen many new developments over the past few years. Among the most impactful includes the establishment of the U.S. Food and Drug Administration's (FDA's) Human Foods Program and the changing U.S. Department of Agriculture (USDA) stance on Salmonella as an adulterant in various raw poultry products.

Food Safety Insights wanted to find out more about your opinions on these developments and how they may impact your food safety programs in 2025 and beyond. We conducted a survey of approximately 150 food processors from 35 countries to get their opinions on these issues and how they are preparing for the changes.

A point about the survey results: these two issues related to FDA and USDA will undoubtedly have a higher impact on U.S. and Canadian food processors; however, with the global nature of the food supply chain, these changes will have an impact on many suppliers around the world. Nonetheless, it is important to mention that approximately 100 of the responses came from the U.S. and Canada, meaning that a significant portion of the responses came from the companies most impacted by these changes, thus making them very relevant for the topics we wanted to discuss.

This relevance can be seen in the responses to our first question: “Are you regulated by FDA or USDA?” For those respondents in the U.S. and Canada, more than two-thirds (Figure 1) produce products that are regulated by FDA, USDA, or both. For those outside of the U.S./Canada, on the other hand, nearly four out of five were neither FDA- nor USDA-regulated. For our review of the responses, we focused more closely on the opinions and comments of those who produced either FDA- and/or USDA-regulated products.

Opinions on FDA's Human Foods Program

From its proposal in 2023 to its establishment in 2024, there was a great deal of debate within the food safety sector of whether the establishment of the Human Foods Program was a good idea. Would it be able to break free of other FDA operations to be a standalone division? Will it be sufficiently funded and sufficiently autonomous to complete its mission? Should USDA's Food Safety and Inspection Service (FSIS) have been included in the Human Foods Program?

This led to our second question: "Will the Human Foods Program be successful?" Seventy percent (Figure 2) of the respondents believed that the Human Foods Program will indeed be successful. Many opined that the new Human Foods Program is a positive step for food safety, as food and drugs are very different and, therefore, should be regulated differently. Many respondents mentioned that the expertise needed to understand, inspect, and regulate food production is very different from that needed to regulate pharmaceuticals and other drugs, making the creation of the Human Foods Program a natural—and overdue—move.

One baked goods food safety specialist said, "I believe it will be successful with the right staffing. Separating the programs will allow specified trainings for their staff and [allow them to] focus solely on one area of business."

Another food safety specialist from a fruit and vegetable company—a dual FDA-/USDA-regulated facility—cited their own personal experience and agreed, saying, "Yes, this program will be successful. Coming from both a pharma and food background, I have been able to see the great differences as well as the similarities these programs hold."

Eighteen percent of the responses answered the question by saying "maybe" and indicated some doubt about the probability that the department is equipped to be successful. Many of these responses agreed with the philosophy of a separate Human Foods Program, but their doubts emanated from their skepticism that FDA and/or the federal government in general will resource the program sufficiently to be successful.

One respondent captured this attitude well with the comment, "Theoretically, yes. Actually, no. Congress will not fund the food side appropriately." Another respondent echoed this sentiment, saying, "It can only be successful if it receives the funding and leadership it deserves."

A minority—12 percent—were far more pessimistic about the prospects for the Human Foods Program's success. A plant manager at a baked goods company said, "I think the program will give food its own seat at the table, but be mostly unsuccessful. Food, drugs, agriculture, and environmental protection are all deeply intertwined. It's a new silo in a forest of silos, and will be no more capable against the many interests arrayed against it from both industry and politicians." Another quality control manager from a beverage company said, "I don't think so. It just looks like shuffling the chairs around."

Ideas on a Single Food Regulatory Agency

Another topic that received considerable debate was the concept of a single, unified U.S. food regulatory agency. Put more simply—why was the USDA-FSIS program not made part of the Human Foods Program to make a single, all-encompassing food regulatory agency?

Roughly two-thirds (Figure 3) of all the respondents indicated they thought USDA-FSIS should have been included in a combined Human Foods Program.

One food safety manager mentioned that this would have been the best solution "…to have a well-rounded program where all information and programs are localized and agreed upon." A few others saw the benefit for dual-regulated facilities, saying, "Dual-regulated sites would benefit from not having two regulatory oversight agencies... [and] save taxpayers' expense of running two agencies."

Another respondent mentioned that this combination might benefit both food inspection programs by combatting an inherent weakness they saw as being present in each, commenting, "Yes, because both USDA and FDA individual food safety programs are seen as lesser, secondary enterprises within their respective agencies."

Some in industry have said—tongue-in-cheek—that it is time to "get the 'F' out of FDA." It appears some may agree it is also time to "get the 'FSIS' out of USDA," too.

Another respondent thought this was maybe a good idea, but that the timing was not right. "Not at this time; current FSIS and FDA regulatory oversight methodologies and regulations are too different," they commented. "Rushing this would cause significant disruptions. It will take many years to work out how this transition would occur and how regulations and inspection methods would be combined."

Regardless of whether USDA-FSIS should or should not have been included in the Human Foods Program, the Program does nonetheless now exist with its current responsibilities. But what should the focus of the program be in its first few years? We asked that, too.

What Does Industry Want from FDA?

We posed this idea as an open-ended question where survey participants could suggest anything they wanted, without prompting or choices offered. What emerged from their answers was a common theme that could be characterized as, "FDA needs to do better, and help us as an industry do better."

The most common answer (Figure 4) was that FDA needs to be more strict, more effective with its inspections and audits, and more strict with its enforcement compliance, especially with repeat offenders. Two comments were typical of this view when suggesting that the FDA should focus on "…making sure facilities are in compliance and are actually following through with their corrective action plans," and "…not waiting a year to send a plant a warning letter."

This concept of better enforcement was also seen in another common answer, where respondents called for a better focus on pathogens. One comment suggested that FDA should focus on environmental monitoring programs. "I am seeing so many foods recalled for pathogens, [and] I know we are never asked about our environmental monitoring and never swabbed randomly. This program should be bolstered," the respondent said.

Another respondent added that there should be more focus on Good Manufacturing Practice (GMP) programs, as the FDA is currently "…driving the cost of goods up, and there is not a significant decrease in illness/death."

Others suggested that FDA should focus on conducting inspections in a manner more similar to USDA. A food safety manager at a pork company mentioned that FDA should implement "…tighter inspections at the plant(s). There is a serious lack of 'at the line' verification from the FDA. Unlike the USDA, who are stationed in the plant(s) and their presence is felt daily, the FDA is only inspecting most plant(s) every three to five years."

Regardless of whether the program should mimic USDA's practices, many cited that FDA should focus on its inspection program. A food safety manager at a baked goods company commented that FDA should be "…ensuring that the program is adequately staffed so that more facilities are inspected."

The second-most common answer was related to the first, but more in line with giving industry the tools and guidance for risk management and prevention and to execute their food safety programs more effectively. A manager at a snack food company commented that FDA should be focusing on "…helping manufacturers develop and implement effective food safety programs, and not penalizing smaller manufacturers… acting like the police isn't working. Provide resources to review and develop processes so everyone can be effective at implementing their rules."

Another major theme in the comments was the need for a focus on traceability and FSMA 204 compliance, with many asking for more support and guidance from FDA on how to implement the regulations—plus having FDA impose tighter controls and better inspections on imported foods.

Many of these same themes emerged when we asked, "If you could ask any question or make a request to Human Foods Deputy Commissioner Jim Jones, what would that be?" While we cannot print all of the questions, we show a few of the more representative questions in Table 1.

Next Time: Your Opinions on USDA

In the next Food Safety Insights column, we will turn our focus to USDA and the opinions of its new Salmonella regulations, what questions should be asked of USDA Deputy Under Secretary for Food Safety Sandra Eskin, and what regulators in general should understand better. We will also examine what items food processors have on their priority lists for their food safety programs in 2025.

Look for those insights in the February/March 2025 issue of Food Safety Magazine.

Bob Ferguson is President of Strategic Consulting Inc. and can be reached at bobferguson9806@gmail.com or on X/Twitter at @SCI_Ferguson.