It’s budgeting time again for the federal government, and FDA has set out its request for increased monies to fund its “ever growing and more complex” responsibilities. While the medical side of FDA still takes a larger chunk of the pie, the agency’s budget authority increase request allocates just over a third for the funding of food safety and nutrition programs. Of the increase request of $372 million for fiscal year 2024, FDA would allocate $128 million to food safety and nutrition.
The key areas for which the increased monies are planned – and TAG’s take on each – include:
- $64M: “Healthy and Safe Food for All” Program. With the increase providing a total of $87 million for the activities of this program, the resources will support the modernization of infant formula oversight, addition of staff, and refining of laboratory methods for detecting bacteria in products. It also will continue to support FDA’s Closer to Zero plan for reducing and eliminating toxic elements in infant and toddler foods and improve its approach to assessing chemicals and food ingredients including post-market reassessment of previously approved food chemicals.
- TAG’s Take: Infant formula, and the continued drive toward zero for heavy metals have been a primary focus for FDA since the massive infant formula recall and shortages of 2022. TAG has long predicted that the impacts will go well beyond infant formula, and the massive $64M increase request for these initiatives appears to prove that out. As FDA uses the funding to improve “its approach to assessing chemicals and food ingredients,” it is unlikely that it would limit such progress to a single industry segment.
- $5M: Emerging Chemical and Toxicological Issues. With the increase bringing the budget to $20 million, the focus will be on modernizing the regulatory framework for products or ingredients that pose potential risks to human health. That is, advancing the identification and evaluation of emerging ingredients in dietary supplements, conducting post-market safety reviews, and conducting scientific assessment of chemicals that enter the food supply through contamination (e.g., PFAS) to inform risk management policies for reducing dietary exposure.
- TAG’s Take: The consumer concern of PFAS leaching into food products has caused PFAS to leach far into the regulatory and media conscious as well. While there is certainly concern should high chemical levels be detected, we can only hope that FDA’s scientific assessment is thorough, so that hazard times exposure is taken into consideration to determine risk and inform any new policies. It is evident from other federal agencies, such as the EPA, as well as activities in Europe, that these chemicals will be an increasing area of focus in the coming years.
- $12M: Nutrition and Food Labeling. This new funding will support further nutrition and food labeling modernization efforts as set forth in the White House National Strategy on Hunger, Nutrition, and Health, building on the Nutrition Facts Label by developing symbols, claims, and front-of-pack labeling. FDA also will develop a standardized labeling system to help consumers easily identify foods that are part of a healthy eating pattern, and employ resources for tools, authorities, and staff to empower consumers with information and facilitate industry innovation toward healthier foods.
- TAG’s Take: It as a positive sign that new funding is being requested in the area of nutrition. We see nutrition as an area that has been somewhat neglected and should have a greater focus by the agency whose duty it is to oversee it. Indications are that, at least to some extent, this will focus on labeling and messaging to consumers.
- $37M: Smarter Food Safety. With a total budget of $41M, FDA will expand GenomeTrakr network, strengthen preparedness and food inspection efforts, and advance animal food safety coordination. These investments will allow the agency to leverage new tools, approaches, and technologies to build upon the benefits of the FSMA’s prevention-oriented framework.
- TAG’s Take: Whole genome sequencing has proven to be of significant value in linking foodborne illness across space and time, thereby linking outbreaks to detected pathogens in facilities present or past. So the expansion of the GenomeTrakr network should further enhance that ability and aid in earlier detection to help prevent foodborne illness. This funding also indicates the importance of looking at both human and animal health and pathogens collectively.
- $5.2M: Animal Food Safety Lifecycle. The budget, which totals $27M, will be used to increase staff to support pre-market animal food ingredient reviews and invest in animal food risk models to promote advancements in food safety based on risk and identified food safety gaps, with an overarching goal of keeping pace with newly emerging animal food ingredients while addressing foundational gaps in the oversight of the animal food industry.
- TAG’s Take: With FSMA having significantly expanded what had previously been very limited powers of FDA regulatory oversight for animal foods, continuing effort in this area is likely a good investment – both focused on foundational gaps which are almost to be expected in the first decade of enactment, and in newly emerging ingredients.
- $5M: Food Supply Chain Continuity. This new funding will focus on food supply chain continuity efforts, including resources for the 21 Forward tool, which helped track supply chain shortages during the COVID-19 pandemic and inform ongoing work to track and anticipate supply disruptions across the infant formula supply chain. Funding will support additional staff, strengthen the agency’s capabilities to assess the health of supply chains, and inform efforts to respond to shortages of critical foods.
- TAG’s Take: COVID-19 carried with it numerous challenges for the food industry, but the lessons learned and initiatives developed to deal with those challenges will benefit the industry well into our future – if we continue to learn from, focus on, and build out capabilities not only to better deal with a future pandemic but to inform the daily, ongoing challenges of the industry.
With FDA dealing with numerous challenges of its own – not the least of which are its structural issues, any new funding and focused efforts toward the enhancement of food safety and nutrition are a positive step. If the agency is able to focus its resources on all the areas intended by its funding requests (along with those planned by its priority guidance list published last month), we should be able to see some significant forward movement this year. We can only wait and see how it all pans out. But in the meantime, keep in mind that the FDA is under pressure from many angles and we are seeing this translate into more pressure on the food industry. Thus the mantra of being inspection-ready and on top of regulatory requirements is more important than ever.