How Do You Solve a Problem Like the FDA?

If there is one thing that really bugs me (these days) is how big and worthless government is.  Take, for example the FDA (aka Food and Drug administration).  

The FDA is a regulatory agency within the Department of Health and Human Services (HHS).  Historically, its job is/was to protect public health by ensuring that many products Americans use every day are safe, effective, and properly labeled.

Officially, the FDA regulates:

• Prescription and over-the-counter drugs (human and veterinary).

• Biologics (vaccines, blood products, gene therapies).

• Medical devices (from pacemakers to tongue depressors).

• Food safety (except most meat, poultry, and some egg products, which are regulated by USDA).

• Cosmetics (ensuring products are safe and not mislabeled).

• Tobacco products (authority granted in 2009).

• Radiation-emitting products (like X-ray machines and microwaves).

The problem is that it's not doing a very good job of any of this.

When this is brought up, proponents of the FDA always point to the fact that they are underfunded and understaffed.  The problem is that no matter how much more money is budgeted or how many more people are hired, they always say that.  

In point of fact, for fiscal year 2025, the FDA's budget is/was a whopping $7.2 BILLION.  If the IRS can hire tens of thousands of employees, bringing its total workforce to over 100,000, then certainly the FDA can loosen the purse strings and get a few dozen more employees on its payroll.

I'm just sayin.

So, who actually runs the FDA?  Well,...... 

Congress created the FDA’s legal authority through statutes (mainly the Food, Drug, and Cosmetic Act of 1938 and its amendments).

The President / Executive Branch appoints the FDA Commissioner (who leads the agency), with Senate confirmation.

Finally, Federal Courts can review FDA decisions if challenged (e.g., whether FDA exceeded its statutory authority, or if its actions were arbitrary or capricious under the Administrative Procedure Act).

So, in summary, the FDA is not independent; it’s an Executive Branch agency under HHS. Congress writes the laws that give FDA power.  The President (through HHS) appoints its leadership and shapes its policy direction and Courts can step in if FDA overreaches. 

Got all that? 

So, what's the problem with the FDA?  Mostly, the argument is that the FDA is too cozy with the industries it regulates and, consequently, fails to regulate food and drug safely.  While RFK, Jr. is working to change all this, it's still business as usual.

Um, so why is this important?

Well, all this coziness can lead to public health risks like unsafe drugs or contaminated food. In fact, the FDA's response to food safety crises is often too slow, and concerns exist about the use of unsafe agricultural chemicals, food additives, and processing techniques.  

So, wait, too slow?  How does this play out in real life?

Peanut Corporation of America Salmonella Outbreak (2008–2009)

• What happened: Salmonella-contaminated peanut products caused over 700 illnesses and at least 9 deaths across 46 states.
• FDA'sCriticism: The FDA had been aware of previous contamination problems at the plant but failed to act aggressively before the outbreak spread. Critics said inspections were too infrequent and reactive rather than preventive.

Listeria in Cantaloupes (Jensen Farms, 2011)

• What happened: A deadly listeria outbreak linked to cantaloupes sickened 147 people and killed 33 across 28 states.
• FDA's Criticism: The FDA only ramped up produce-safety rules after this crisis, even though experts had long warned about weak oversight of fresh produce. Stronger standards didn’t come until the Food Safety Modernization Act (FSMA) was implemented later.

Spinach E. coli Outbreak (2006)

• What happened: Bagged spinach contaminated with E. coli O157:H7 caused 199 illnesses and at least 3 deaths in 26 states.
• Criticism: The FDA had known leafy greens were high-risk but hadn’t mandated stricter safety practices before the outbreak. Afterward, it issued only voluntary guidelines for leafy greens until FSMA gave it stronger authority years later.

Salmonella in Eggs (2010)

• What happened: Half a billion eggs were recalled after Salmonella contamination at two Iowa farms, sickening more than 1,900 people.
• Criticism: The FDA had finalized egg safety rules in 2009 but had not begun routine inspections before the outbreak occurred. The slow rollout left the public vulnerable.

Infant Formula Shortage & Cronobacter Contamination (Abbott, 2021–2022)

• What happened: Abbott’s Michigan plant, a major U.S. producer of baby formula, was linked to Cronobacter contamination after several infants became ill and at least two died.
• Criticism: A whistleblower had alerted the FDA months before the crisis, but the agency took four months to inspect and act on the complaint. By the time it shut down the plant, the U.S. faced a nationwide infant formula shortage.

2023–2025 Raw Milk Salmonella Outbreak Reporting Delay

• Incident: From September 2023 to March 2024, at least 171 people across five states fell ill from a Salmonella outbreak linked to raw (unpasteurized) milk.
• Criticism: The outbreak was not publicly reported until July 2025, long after illnesses occurred—raising concerns about delayed disclosure and its impact on consumer awareness and safety.

2024 Boar’s Head Listeriosis Outbreak (Listeria in Deli Meats)

• Incident: A widespread listeria outbreak tied to Boar’s Head liverwurst and deli meats affected individuals between May and November 2024, resulting in 60 hospitalizations and 10 deaths. The implicated plant had documented 69 violations, including mold, insects, and unsanitary conditions.
• Criticism: Experts and media questioned why regulatory authorities, including the FDA, allowed the plant to continue operations amid persistent safety failures.

2024 McDonald’s E. coli Outbreak (Contaminated Onions)

• Incident: From September to October 2024, 104 confirmed E. coli O157:H7 cases (including one death) were linked to slivered onions on McDonald’s Quarter Pounders in 14 states.
• Criticism: The FDA’s public warning only came October 22, over a month into the outbreak, and traceback investigations took time to isolate the source at supplier level—with criticism over delayed disclosure and slow root-cause identification.

Suspension of Food Emergency Response Network (FERN) Testing Program (2025)

• Issue: In early 2025, the FDA temporarily suspended its FERN Proficiency Testing Program, a critical system ensuring lab readiness for detecting contaminants in dairy and other products. 
• Criticism: While the agency said safety tests continued at state and federal levels, experts expressed concern that suspending this program—without a clear timeline for resumption—undermines confidence in emergency response readiness.

Delaying Enforcement of Food Traceability Rule (FSMA Section 204)

• Issue: The Food Traceability Rule—part of the Food Safety Modernization Act—had been in development for 14 years and was set to take effect in January 2026. In March 2025, the FDA announced a 30-month delay, pushing enforcement back significantly.
• Criticism: This postponement delays critical traceability infrastructure meant to speed outbreak investigations and recalls, creating concern that potentially dangerous food items will remain more difficult to track when contamination occurs.

While some of these are active outbreaks and others are regulatory shifts or resource challenges, collectively they underscore a disturbing pattern - the FDA is unable to handle detecting, response, or preventing food (and other) safety threats.

So, how do you solve a problem like the FDA?  I don't know - I just report the stuff.  

Maybe, though, it's time to re-shuffle the deck and bring in some fresh talent.  Oh, wait, didn't they do that back in November 2024?  

It will certainly be interesting to see if the FDA can get it's act together now under new management.