Food science innovations such as ingredients, processing, safety, and technology affect more people daily than almost any other industry—but have you ever counted the number of agencies and departments regulating food? There are over a dozen, just at the federal level! The messy alphabet soup of regulating bodies includes FDA, CFSAN, USDA, FSIS, ARS, CDC, TTB, FTC, CBP, BATFE, APHIS, AMS, FNS, EPA, NMFS, GIPSA, FAS, and CVM, not to mention various state agencies and other, minor actors that regulate food and beverages under at least 30 different laws. In the author's opinion, these agencies have created a madness of regulations affecting an industry worth more than $1.5 trillion dollars—over one-fifth of the U.S. economy.

Even if industry professionals are savvy to the multitude of agencies, consumers do not understand how this regulatory scheme creates inconsistency, lack of information, and safety risks. It also means that some food is under-regulated and under-inspected, and regulations are under-enforced because of disparate funding and priorities. It is time to clean up this food mess!

Historical Considerations

Interestingly, the early days of food and beverage regulation were much more coherent and straightforward than today. The original Pure Food and Drug Act of 1906 tasked the Secretary of Agriculture with regulating food and drink. Within the U.S. Department of Agriculture (USDA), the Bureau of Chemistry and the Bureau of Animal Industry were assigned to enforce the Pure Food and Drug Act, the Federal Meat Inspection Act (FMIA), and the Federal Poultry Products Inspection Act (FPPIA), although the Department of the Treasury and the Department of Commerce and Labor also had oversight over imports. The Pure Food and Drug Act dictated that all "…articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound" were to be regulated such that it was "…unlawful for any person to manufacture… any article of food… which [was] adulterated or misbranded." It was a short and sweet mandate, particularly when compared to today's mess.

However, in 1927, the USDA Bureau of Chemistry was reorganized and named the Food, Drug, and Insecticide Administration. Then in 1930, it was renamed the Food and Drug Administration (FDA). With a presidential reorganization in 1940, FDA was moved to the newly created Federal Security Agency (which later became the Department of Health, Education, and Welfare and is currently called the Department of Health and Human Services). FDA's relocation was intended to prevent conflicts between producer interests and consumer interests. Also, moving the Agency's regulatory oversight was thought to better coincide with public health, education, and social security goals. These premises were unfounded.

While FDA's primary mission has always been consumer protection, the 1940s and 1950s saw a sharp rise in the chemical and pharmaceutical industries, the public health system, hospitals, and insurance companies. The rapid inventions of novel drugs, such as insulin, antibiotics, and cancer treatments, as well as medical devices, such as new X-ray machines, were celebrated. Food began to take a backseat to other healthcare considerations. However, a few new food rules mirrored those supporting the burgeoning healthcare industry, such as regulations banning food additives that cause cancer, limits on harmful pesticide residues on raw agricultural products, and laws regarding the import of potentially radioactive food.

Unfortunately, this shift from consumer and marketplace protection to healthcare created many of today's food and beverage regulatory problems. Although food and health are inextricably linked, FDA's move from the Department of Agriculture has left FDA-regulated food as the underfunded step-sibling compared to drugs and medical devices for the last 80 years.

The Current Regulatory Mess

It was not just public awareness of helpful or harmful chemicals that led to the current mess; it was also political predilections. Meat and poultry products remained regulated by USDA. This is because they were not specifically included in the new Food, Drug, and Cosmetic Act (FD&C) of 1938, nor were the existing meat and poultry statutes modified so that meat and poultry could be regulated by the new Federal Security Agency. However, that bifurcation led to the multiplication of bodies regulating food. This led to vastly different treatments based on the commodity involved.

Of course, the classic example of the inexplicable difference in regulatory supervision is that a cheese or vegetable pizza is regulated by FDA. In contrast, a pizza with meat toppings is overseen by USDA. However, if that manufacturer decides to innovate and use toppings of exotic meat, such as buffalo, venison, rabbit, muskrat, or alligator, then regulation of that pizza moves back under FDA authority.

Furthermore, while FDA regulates bottled water, the Environmental Protection Agency (EPA) regulates public tap water. Use that tap water as an ingredient in a meat stew, however, and then you add a dash of USDA regulation along with your FDA safety-regulated salt and pepper. Even crazier is that if the tap water is used in a fish stew, both FDA and the National Marine Fisheries Service (NMFS) under the National Oceanic and Atmospheric Administration (NOAA) regulate it, but with the bizarre exception that if the fish stew is made using catfish, then USDA regulates it.

These overly complex types of delineations are often the product of lobbying efforts by various groups. For example, moving catfish regulation to USDA under the Farm Bill was largely due to pressure from the Indianola, Mississippi-based Catfish Farmers of America, a lobbying group for catfish farmers in the Gulf Coast States, primarily Alabama, Arkansas, Georgia, Louisiana, and Mississippi. This group's efforts were based on the erroneous assumption that continuous inspection under the oversight of USDA's Food Safety and Inspection Service (USDA-FSIS) would somehow shift market share from overseas catfish producers back to the U.S. The end result was that USDA, which had never inspected fish, was forced to divert resources from meat and poultry inspections to this new regulatory area and establish new protocols. It was wasteful, to say the least.

“Another problematic aspect is the disparate funding for these disjunct regulatory bodies. This leads to a lack of uniform vision and inconsistencies in oversight, inspections, and enforcement.”

Alcoholic beverages were also under the control of USDA under the 1906 Pure Food and Drug Act. (In fact, the very first enforcement action under the new 1906 law found that adding sugar to wine to increase alcohol concentration was an act of adulteration.) However, after Prohibition ended, the Federal Alcohol Administration Act (FAAA) of 1935 was enacted, and the Department of the Treasury was tasked with regulatory control of alcohol to ensure a national uniform permitting system for manufacturers. Under the law, the Treasury was also granted discretion to require labels so that consumers were informed of what was in the bottle. This conflicted with the FD&C Act, which allowed FDA to regulate labels for "food and drink for man and animal."

For many years, both FDA and the newly formed Federal Alcohol Administration (FAA)—now named the Alcohol and Tobacco Tax and Trade Bureau (TTB)—recognized this concurrent jurisdiction. Finally, after numerous challenges, a memorandum of understanding (MOU) was signed. The MOU specifies that TTB regulates alcoholic beverage labels but defers to FDA regarding health and safety concerns and claims. It also recognizes that TTB and FDA will work together on recalls and enforcement.

However, despite MOUs, alcoholic beverage labeling regulations give one a headache not unlike a hangover. Why is a malted beverage that contains both malted barley and hops regulated by TTB, while a beverage that is malted barley but that contains no hops regulated by FDA? For example, a lime margarita-flavored malt beverage without hops requires nutritional and allergen labeling under FDA authority. In contrast, an adjoining product on the shelf, a lime-flavored beer with malted barley and hops, does not require nutritional labeling or an allergen warning under TTB authority. This creates a conundrum for consumers and difficulties for manufacturers. Frankly, there is no rationale to support the difference. All labeling on alcohol-containing beverages should be identical. Most importantly, consumers deserve accurate and thorough information, and the food and beverage industry should be required to be consistent.

The chaos continues in other areas. While animals are grown on farms that are scientifically and often financially supported by USDA, once those animals enter a mode of transportation, they are regulated by FDA. Once an animal enters a processing plant, it is again regulated by USDA. However, when using that meat or poultry in a product, FDA controls the safety of the food additives as well as the safety of all food contact substances, from the packaging to the processing line and cleaning materials. Additionally, the antibiotics in livestock feed that are used to increase weight gain in animals are also regulated for safety by FDA's Center for Veterinary Medicine (CVM). The ping-pong nature of regulatory oversight is exhausting to follow and difficult to maneuver when bringing a new product to the marketplace.

Disparate Funding Compared to Oversight

Another problematic aspect is the disparate funding for these disjunct regulatory bodies. This leads to a lack of uniform vision and inconsistencies in oversight, inspections, and enforcement.

USDA was established in 1862 as the "People's Department" and was designed to collect and disseminate information related to agriculture, aquaculture, rural development, and human nutrition to the populace. It has since grown to encompass scientific research and policy for agriculture and climate, natural resource protection and management, and rural development. Today, it also provides a much-needed nutritional safety net for needy citizens. To effectuate these goals, USDA receives $390 billion in funding.

That said, departments and agencies that regulate food, food safety, farms, and research are spread across many departments within USDA, making it difficult to determine the total dollars spent on food and nutrition. The best estimates from 2023 are that USDA used $9.1 billion in commodity programs to maintain a farm safety net, $4 billion for research education and economics to advance the competitiveness of U.S. agriculture, and $1.2 billion for FSIS safety personnel. USDA-FSIS funds used for food safety cover more than 6,000 inspection locations, three laboratories, 122 ports of entry, and more than 100,000 commercial entities in the stream of commerce. Estimates indicate that meat, poultry, and eggs equate to 10–20 percent of the food supply. FSIS is also the only regulatory body that conducts consistent, contemporaneous inspections of the food it oversees (Figure 1). The impact and reach of USDA are staggering, albeit difficult to measure.

In contrast to meat, poultry, and eggs regulated by USDA, the alcohol industry in the U.S. is estimated at $260 billion, generating $20.3 billion in excise and other revenues collected by TTB. Despite being part of the Treasury, the largest revenue-collecting body in the U.S. government, TTB was only allocated $175 million in 2024. Of this total, $80,847,000 was allocated to collecting revenue, and $74,757,000 was allocated to protecting the public. With more than 8.1 billion gallons of alcohol consumed, it is obvious that the regulatory oversight is minuscule compared to the volume of alcohol produced. With only 500 employees, however, TTB pales in comparison to the 100,000 employees at USDA and the 18,000 employees at FDA.

Contrast the above statistics with the Department of Health and Human Services' $2.8-trillion budget. Of this, the entire FDA receives only $7.2 billion. Looking closer, only 18 percent of that $7.2 billion is used to regulate food. This equates to roughly $1.3 billion. Surprisingly, FDA self-reports that it regulates a whopping 78 percent of food! (However, as this percentage does not seem to include alcoholic beverages, 78 percent is likely over-reported.) Regardless, to regulate the vast majority of food with such a seemingly small budget is unconscionable. In contrast, FDA departments that regulate human drugs and medical devices garner 34 percent of the FDA budget, or $2.4 billion. It certainly appears that the "F" in FDA is practically silent.

Moreover, despite the mandatory safety inspection requirements under the 2011 Food Safety Modernization Act (FSMA), which required FDA to register and inspect high-risk facilities at least once every three years and non-high-risk facilities at least once every five years, data shows that the number of domestic inspections has fallen dramatically. In 2010, FDA claimed it inspected 10,000 facilities. That number fell to under 3,000 facilities in 2022. Similarly, while FDA conducted approximately 2,000 foreign facility inspections in 2010, the number dropped to a mere 55 in 2022. Although the 2022 numbers may have been somewhat impacted by the COVID-19 pandemic, FDA's inspection rates appear to be trending in the wrong direction. Compared to USDA's continuous inspection of each and every carcass before it enters the stream of commerce, the difference is quite conspicuous.

“The current system fails the two common goals of an effective food regulatory system: safe food with accurate, informative labels and a protected, coherent, fair marketplace that encourages innovation.”

Time For a New U.S. 'FAD'

In 2022, FDA Commissioner Dr. Robert Califf requested that the Reagan-Udall Foundation complete a review of the Agency, including the culture, structure, resources, and leadership of its Human Foods Program. The subsequent report noted that despite its motivated employees, FDA-regulated food represented a significant risk of harm, extreme medical costs, and loss of productivity due to foodborne illness and chronic diseases. The report recommended a reorganization focused on scientific evidence, culture change, and communication. In the author's opinion, even if the changes come to fruition, they will not be enough to combat the current mess of food regulation.

Without a systemic, larger reorganization, regulatory oversight will continue to be split into 17-plus agencies with wasteful, duplicitous, disproportionately funded efforts. The current system fails the two common goals of an effective food regulatory system: safe food with accurate, informative labels and a protected, coherent, fair marketplace that encourages innovation. It is time to work past the jurisdictional food fight and get to a place where all "food and drink" regulation is within a common department. It is time for a massive new "FAD." Enter the U.S. "Food and Agriculture Department," or U.S. FAD.

This change would require a true congressional champion and strong industry support for consolidation and coordination. It would also require recognizing that the current system is broken and developing a vision of how the existing players could work together for a common goal. This large change may even need a sanctioned presidential reorganization to avoid political posturing and "fiefdoms" similar to the action that moved FDA away from USDA so long ago. Although Congress has not authorized a reorganization since the Reagan administration, reorganizations have been previously authorized 16 times since 1932. Ultimately, this new and improved FAD would take food regulation back to its original order.

This is not to say that the current agencies, departments, sub-departments, and teams would cease to exist. This major change needs to take place at a very high level. The core goals do not change, and for the most part, consolidation would not lead to fewer employees. The most important part would be to afford the collaboration and coordination of regulation and policy, including innovation. Putting all food and drink together would avoid duplication of efforts, reduce governmental waste, and create cohesive regulatory oversight. Monies previously used for coordination efforts could be allocated to enhance food safety and uniformity.

Moreover, this change would allow consistent labeling, including nutrition and health claims. This is important because consumers are becoming savvier about their food choices with the advent of social media. Labeling could and should be consistent. This is not to say that there should not be policy differences for different commodities. For example, it might not be prudent to require nutrition facts labeling on alcoholic beverages, lest consumers think they are a source of nutrients and, therefore, "healthy." It is important to consistently list ingredients and allergens for all food and drinks.

Furthermore, rather than each agency determining definitions for its own labeling regulations, the rules for various claims such as "natural" and "healthy" could be consistent without each regulatory body adding its own "flavor" to the mix. This leads to both consumer awareness and understanding. Similarly, with the current explosion of lawsuits plaguing the food industry, a "label approval" system for all foods would ensure that products making a particular marketing claim would not be false or misleading.

In terms of food safety and inspections and enforcement, a common FAD could lead to greater consistency and oversight. The shared number of employees and budget could offer the means to better assure safe food. While the standards and analysis are already under the authority of FDA, the commonality could lead to an overarching culture change focusing on safety. Although it may be ultimately unachievable, a strong leader could bring food and drink back to its original mission—protecting both consumers and the marketplace. The true "farm-to-fork" approach would increase consumer confidence and allow for consistent traceability.

Furthermore, inspections and enforcement could be unified. The food industry could realize enormous benefits from a single regulatory body. No company turning out pizza with different toppings needs two different regulators conducting inspections on its products depending on the toppings of the day. Even industry members that churn out single products may benefit from shared or common inspection and enforcement best practices, because foodborne illness is not limited to regulatory bodies (e.g., Listeria is not only found in products regulated by USDA). Industry members who are hesitant to venture into new products under a different regulatory scheme may also see a single regulatory body as a means to innovation. In the end, both consumers and industry would benefit.

“Each step in the 'rings of defense' must be used consciously and with proper consideration, as it may be obvious what caused the noncompliance, and its resolution may be straightforward, simple, and not costly.”

Takeaway

The fad of moving agencies in the 1930s and 1940s has resulted in an unpalatable food regulatory mess. Ultimately, the most important part of food and beverage regulation is ensuring that consumers have safe food with informative labels. There is no conflict of interest between consumers and industry as proffered when FDA was split off from USDA in 1940. Truthful, informative products that offer consumer protection and fair marketplaces that foster innovation are common goals for both sides. The best way to accomplish these goals is by rearranging the federal agencies in the current alphabet soup. Cleaning up the mess is going to require a new ‘FAD.’

References

1. U.S. Food and Drug Administration (FDA). "Import Alert 99-48: Detention without Physical Examination of Foods Due to Chemical Contamination." March 19, 2024. https://www.accessdata.fda.gov/cms_ia/importalert_1180.html.  
2. California Health and Safety Code § 109000. "Chapter 15. Chemicals of Concern in Food Packaging and Cookware, Article 1. Plant-Based Food Packaging Containing PFAS." January 1, 2022. https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=109000.&lawCode=HSC.  
3. Colorado General Assembly. "House Bill 22-1345: Concerning Measures to Increase Protections From Perfluoroalkyl and Polyfluoroalkyl Chemicals." Regular Session 2022. https://leg.colorado.gov/sites/default/files/2022a_1345_signed.pdf.  
4. New York State Senate. "Senate Bill S8817: Relates to the use of perfluoroalkyl and polyfluoroalkyl substances in food packaging." Regular Session 2019–2020. https://www.nysenate.gov/legislation/bills/2019/S8817.  
5. Maryland General Assembly. Annotated Code of Maryland Environment § 9-1901. 
6.  Hawaii Revised Statue § 321-602. 
7.  Connecticut General Statute § 22a-255i. 
8.  Minnesota Statue § 325F.075. 
9.  Oregon State Legislature. "Senate Bill 543: Relating to prohibitions for certain products." Regular Session 2023. https://olis.oregonlegislature.gov/liz/2023R1/Measures/Overview/SB543.  
10.  Rhode Island "House Bill 7438, H 5861 Substitute A: Toxic Packaging Reduction Act." Regular Session 2022. 
11.  Vermont Statutes, Title 18 § 1671. 
12. Massachusetts [S 143, HB 2197, H 767] (all food packaging; no intentionally added PFAS); Michigan [SB 327] (all food packaging; "A person shall not manufacture, sell, or distribute food packaging that has PFAS intentionally added in any amount greater than an incidental presence"); New Hampshire [HB1630, HB242] (all food packaging; "No person or entity may sell or distribute any packaging containing PFAS substances"); Tennessee [SB 0573, SB 1786] (all food packaging; "A person shall not sell or distribute any packaging designed to include PFAS substances"). 
13. Illinois Senate Bill 0088: "EPA-PFAS Consumer Protection"; New Jersey Assembly Bill A1421: "Protecting Against Forever Chemicals Act." 
14. Vermont House Bill 152: "An act relating to regulating products containing certain chemicals and chemical classes." 
15. Hawaii House Bill 1896: "Relating to Environmental Protection." 
16. New York Assembly Bill 05322: "Enacts the 'packaging reduction and recycling infrastructure act' to require companies selling, offering for sale, or distributing packaging materials and products to register with a packaging reduction organization to develop a packaging reduction and recycling plan." 
17. North Carolina House Bill 279: "Break Free from Plastics & Forever Chemicals"; Pennsylvania House Bill 1122: "An Act amending Title 3 (Agriculture) of the Pennsylvania Consolidated Statutes, in food protection, further providing for penalties and prohibiting certain food packaging." 
18. Keefe, Dennis M., and FDA. "Letter to Manufacturers, Distributors, and Users of Fluorinated Polyethylene Food Contact Articles." August 5, 2021. https://www.fda.gov/media/151326/download.  
19. FDA. "FDA Announces PFAS Used in Grease-Proofing Agents for Food Packaging No Longer Being Sold in the U.S." Feb. 28, 2024. https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-pfas-used-grease-proofing-agents-food-packaging-no-longer-being-sold-us.  
20. Federal Register 88 FR 70516. "Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances." Environmental Protection Agency (EPA). October 11, 2023. https://www.federalregister.gov/documents/2023/10/11/2023-22094/toxic-substances-control-act-reporting-and-recordkeeping-requirements-for-perfluoroalkyl-and.  
21. Inhance Technologies LLC v. United States Environmental Protection Agency. 96 F.4th 888 (5th Circuit 2024). On May 13, 2024, EPA voluntarily dismissed an underlying lawsuit. 
22. Federal Register 88 FR 74360. "Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting." EPA. October 31, 2023. https://www.federalregister.gov/documents/2023/10/31/2023-23413/changes-to-reporting-requirements-for-per--and-polyfluoroalkyl-substances-and-to-supplier.  
23. EPA. "Risk Assessment of Pollutants in Biosolids." Last updated June 4, 2024. https://www.epa.gov/biosolids/risk-assessment-pollutants-biosolids.   
24. Michigan Department of Environment, Great Lakes, and Energy (EGLE). "Interim Strategy—Land Application of Biosolids Containing PFAS (2024)." https://www.michigan.gov/egle/about/organization/water-resources/biosolids/pfas-related.; Maine Legislature. HP 1417, LD 1911: "An Act To Prevent the Further Contamination of the Soils and Waters of the State with So-called Forever Chemicals." April 20, 2022. https://www.mainelegislature.org/legis/bills/getPDF.asp?paper=HP1417&item=8&snum=130.  
25. Federal Register 88 FR 6258. "Effluent Guidelines Program Plan 15." EPA. Jan. 31, 2023. https://www.federalregister.gov/documents/2023/01/31/2023-01413/effluent-guidelines-program-plan-15.  
26. Federal Register 89 FR 39124. "Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances." EPA. May 8, 2024. https://www.federalregister.gov/documents/2024/05/08/2024-08547/designation-of-perfluorooctanoic-acid-pfoa-and-perfluorooctanesulfonic-acid-pfos-as-cercla-hazardous.  
27. Uhlmann, David M. and EPA. "PFAS Enforcement Discretion and Settlement Policy Under CERCLA." April 19, 2024. https://www.epa.gov/system/files/documents/2024-04/pfas-enforcement-discretion-settlement-policy-cercla.pdf.  
28. Federal Register 88 FR 22399. "Addressing PFAS in the Environment." EPA. April 13, 2023. https://www.federalregister.gov/documents/2023/04/13/2023-07535/addressing-pfas-in-the-environment.  
29. Federal Register 89 FR 8606. "Listing of Specific PFAS as Hazardous Constituents." EPA. February 8, 2024. https://www.federalregister.gov/documents/2024/02/08/2024-02324/listing-of-specific-pfas-as-hazardous-constituents.  
30. Federal Register 89 FR 8598. "Definition of Hazardous Waste Applicable to Corrective Action for Releases From Solid Waste Management Units." EPA. Feb. 8, 2024. https://www.federalregister.gov/documents/2024/02/08/2024-02328/definition-of-hazardous-waste-applicable-to-corrective-action-for-releases-from-solid-waste.