The FDA, Again?!?

You know, it seems just yesterday I was bagging on the FDA.  

In today's blog post, I'm complaining about drugs and why is it the FDA isn't doing a better job of regulating Big Pharma.

In fact, and did you know, that there are ONLY TWO countries that allow pharmaceutical companies to advertise to the public?  The United States and New Zealand.

That's it.

Did you also know that under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA regulates prescription drug ads. 

That's right.  Pursuant to FDA rules, companies must:

• Present a “fair balance” of risks and benefits.

• Not omit important safety information.

• Ensure claims are truthful and not misleading.

Soooooo, what happens when a pharmaceutical company doesn't present a fair balance of risks and benefit OR omits important safety information OR ensures claims are truthful and not misleading?

Well, they get fined or get sent a really nasty letter.

A letter?  You're kidding right?!

Actually, no.  

Officially, if a company misleads the public (e.g., downplays side effects), the FDA can issue:

• A scary warning letter or Untitled Letters (formal notices to stop certain ads).

• Seizure or injunctions (rare).

• Referral to the Department of Justice (DOJ) for civil or criminal prosecution.

But, you say, the FDA doesn't really send out letters when there is a clear violation by a BILLIONS in profit each year MULTINATIONAL corporation?

Say it isn't so, Joe!

1. Celgene – Revlimid (2015, Untitled Letter)

• Issue: Promotional materials overstated effectiveness in treating multiple myeloma and downplayed risks.

• FDA Action: Issued an untitled letter directing Celgene to correct the materials.

• Criticism: No fine or sanction, even though Revlimid was a multi-billion-dollar drug.

2. Amgen – Neulasta (2010, Warning Letter)

• Issue: TV ad minimized serious risks (e.g., spleen rupture, acute respiratory distress) and overstated benefits for chemotherapy patients.

• FDA Action: Sent a warning letter. The ad was pulled, but no financial penalties were imposed.

3. Novartis – Tasigna (2013, Untitled Letter)

• Issue: Website and YouTube videos exaggerated the cancer drug’s effectiveness while minimizing life-threatening side effects.

• FDA Action: Issued an untitled letter requiring corrections, but no fines.

4. Otsuka – Rexulti (2016, Warning Letter)

• Issue: Sales reps made false claims to physicians, suggesting Rexulti was safer and more effective than proven.

• FDA Action: Sent a warning letter. Again, no penalties beyond compliance.

5. AstraZeneca – Seroquel XR (2009, Warning Letter)

• Issue: Print ad overstated effectiveness for generalized anxiety disorder and omitted major safety warnings (including metabolic risks).

• FDA Action: Warning letter only — no fines.

OK, OK, so they send out letters.  But no fines/money?  There's gotta be instances where companies who violate the law get fined, right?!? 

Well, yes - fines are levied.  The problem is when the company makes BILLIONS in profit each year, any fine is basically a tickle.  For example:

1. GlaxoSmithKline (GSK) – Fined $3 billion (2012)
• Drugs: Paxil, Wellbutrin, Avandia
• Violation: Misbranding, illegal promotion, and failure to report Avandia’s cardiovascular risks.
• Profit in 2012: $7.1–7.5 billion USD  
2. Pfizer – Fined $2.3 billion (2009)
• Drug: Bextra (and others)
• Violation: Off-label promotion, false marketing, and kickbacks.
• Profit in 2009: About $8.6 billion USD
3. Johnson & Johnson – $2.2 billion (2013)
• Drug: Risperdal (antipsychotic)
• Violation: Misbranding and hiding risks, especially promotion to elderly patients despite stroke risk.
• Profit in 2013: $13.8 billion USD
4. Abbott Laboratories – $1.5 billion (2012)
• Drug: Depakote
• Violation: Promoting for unapproved uses (e.g., dementia, schizophrenia).
• Profit in 2012: $6.0 billion USD
5. Eli Lilly – $1.4 billion (2009)
• Drug: Zyprexa (antipsychotic)
• Violation: Off-label promotion (especially to children and elderly) while downplaying diabetes risks.
• Profit in 2009:  $4.33 billion USD
6. Merck – $950 million (2011)
• Drug: Vioxx (painkiller)
• Violation: Misbranding and failing to disclose cardiovascular risks.
• Profit in 2011: $6.27 billion USD
7. Amgen – $762 million (2012)
• Drug: Aranesp (anemia drug)
• Violation: Misbranding, off-label promotion, false claims to Medicare.
• Profit in 2012: $4.3 billion USD
8. Allergan – $600 million (2010)
• Drug: Botox
• Violation: Promoting for unapproved uses (headaches, juvenile cerebral palsy, pain).
• Profit in 2010: $0.28 billion on revenue of $4.8 billion USD
9. Schering-Plough/Merck – $435 million (2006)
• Drug: Temodar, Intron A, others
• Violation: Off-label promotion, false claims.
• Profit in 2006: $1.6 billion USD
10. Purdue Pharma – $634.5 million (2007)
• Drug: OxyContin
• Violation: Misbranding, falsely claiming OxyContin was less addictive and safer than other opioids.
• Total Revenue in 2007: $2.8 billion USD

What does all this indicate?  Simply, that money is no option for some companies.  Even though Purdue Pharma got hit with a $634.5 million fine, it was still not enough to sink the company because there is so much money in drugs.

So, why doesn't the FDA hit Pharma companies harder? Well, up to now, the Feds were in bed with Big Pharma.

The most direct evidence of bribery occurred in the late 1980s, where an industry whistleblower uncovered a major scandal involving FDA officials.

• What happened: Several FDA employees in the generic drugs division were found to have accepted bribes and illegal gratuities from generic drug companies. In exchange, officials sped up drug approvals or provided inside information.
• The outcome: The scandal led to criminal convictions and prompted the FDA to implement new policies to detect fraudulent data submissions and address bribery

Outside of direct bribery, critics point to other structural issues that can create a "cozy relationship" between the FDA and the pharmaceutical industry. 

• User fees: Since 1992, the FDA's drug division has been partially funded by "user fees" collected from pharmaceutical companies. This system raises concerns about a potential conflict of interest, as the FDA becomes dependent on the industry it regulates.
• The "revolving door": It is a common practice for senior FDA officials and drug reviewers to leave the agency and take high-paying jobs at the pharmaceutical companies they once regulated.
  • Potential concerns: This practice raises concerns that former officials could use their inside knowledge and relationships to benefit their new employers.
  • Arguments for the practice: Supporters argue that the deep knowledge of former FDA employees can help companies navigate the complex approval process more efficiently. 

The pharmaceutical industry also has a documented history of paying illegal kickbacks and bribes to healthcare providers, but these cases typically involve influencing doctors' prescribing habits rather than directly corrupting FDA officials.  For instance, in 2016, pharmaceutical executives were charged with a racketeering scheme involving paying kickbacks to doctors to promote an addictive opioid.

 

So, I'm wondering whether any of this is going to stop with the new administration?  Obama didn't care about the kickbacks.  Biden didn't care, either. 

Will Trump, et al. care?  

Time will tell.  

 

In the meantime, what can regular folks do against big pharma and FDA corruption?  

 

Well, we can advocate for legislative reforms, such as increased transparency in funding for researchers and advocacy groups, and reforms to the FDA's fee system that increases industry influence. 

 

We can supporting independent journalism that investigates misconduct, reporting potential conflicts of interest.

 

We can join or support non-profit organizations that work to promote patient safety and advocate for stricter regulations.

 

It's not a lot but at least it's something and sometimes, it's the little things that bring down the mountain.

 

But It Still Smells OK

The other day I was shuffling through my spice box and noticed that many of my spices were out of date.  

Take for example my bottle of Smoked Paprika.  I love it and use it all the time - though, apparently not ALL the time as I still had some in the bottle 2 years after I bought it.  Thing is, I opened the bottle and it still smelled and tasted like Smoked Paprika. 

So, I got to thinking what other spices do I have that are "out of date?"   Turns out I had a number of items like my kosher salt and "fresh" ground pepper.  OK, it's not so freshly ground anymore but it still tastes like pepper, which is good enough for me and the people I cook for.

This all got me thinking about all of these out of date stamps found on food, these days.  If the products still taste/smell like what they're supposed to taste/smell like, then are the food companies wrong or what's the purpose of these dates, anyway.

For that matter, when did all these dates on food start?

Turns out, following concerns over foodborne illness in the 1930s, including cases linked to spoiled milk, reported mobsterAl Capone reportedly lobbied for expiration dates on dairy products.   

As people shifted from buying at local farms to supermarkets after World War 2, manufacturers added closed-coded dates for retailers to manage inventory rotation.  

Then in the 1970s widespread adoption of easy-to-read "sell-by" and "best-by" dates occurred, driven by consumers wanting to know when food was packaged.

These days, consumers can find the packaging of nearly every item labeled with dates.  One might say sell-by while another might say best-by or use-by.  Many consumers assume that all such dates are “expiration dates,” after which the food should be discarded. 

And that might be so if these expiration dates were actually regulated by the federal government.  The truth of the matter is that the Feds have nothing to do with any of these expiration dates. 

Well, let me qualify that.  Baby formula is the one major food product in the U.S. that must have a federally regulated expiration (“use by”) date. 

For most of the 20th century, infant formula was regulated only under general food law—the Federal Food, Drug, and Cosmetic Act.  That meant there were no formula-specific nutrient standards, no required testing for long-term nutrient stability, and no mandated “use by” dates tied to nutrition.  In other words, formula was treated basically like any other processed food.

Then in the 1970s, the turning point came about involving a product made by Syntex Corporation.  Their formula (marketed as “Neo-Mull-Soy”) had insufficient chloride.  Infants who relied on their formula developed metabolic alkalosis, growth problems, and had serious health complications

Why this was a big deal was because babies were using it as their sole nutrition source and the the harm developed over time—not immediately like food poisoning.  This exposed a regulatory gap:  Food law protected against contamination—but not against nutritional inadequacy over time.

Congressional response: Infant Formula Act of 1980

In 1980, Congress responded by passing legislation under the authority of the U.S. Food and Drug Administration in the way of the Infant Formula Act of 1980.  The issue wasn’t just what’s in the formula—it was how long it stays nutritionally valid because over time vitamins degrade, fats oxidize, and nutritional value can fall below safe thresholds.

So regulators required a scientifically supported “use by” date guaranteeing nutrition and safety up to that point.  This is why formula dates are fundamentally different from normal food labels as they are legally enforceable nutrient guarantees, not quality estimates 

Consequently, and currently, baby formula is regulated by the U.S. Food and Drug Administration under:

• 21 U.S.C. § 350a (Infant Formula Act authority)

• 21 C.F.R. § 107.20 (specific regulations)

So, why are baby formula (food) regulated and adult food not?  Well, infants are fully dependent (often 100% on formula)  and are highly vulnerable to deficiencies.  

By contrast, adults eat varied diets and can tolerate fluctuations in one food.

Maybe your asking yourself: OK, that's great but what about us Adults?  Aren't we allowed to be protected, too?  Well, if the federal government required all foods to:

• Maintain full nutrient accuracy through a specific date

• Back that with stability testing

it would probably result in massive compliance costs, shorter shelf lives of key food items, higher food prices, and increased food waste (well, more than we now have).  So, Congress chose a targeted regulation model instead and left we the adults on our own.

So, knowing that we're on our own and that these expiration dates are not regulated, what do these dates actually mean?

“Sell-By” Date: This date is a message from the manufacturer to the retailer, not to you the consumer. "Sell-by is a business-to-business date" designation to ensure that stores rotate stock by pulling older products and replacing them.  In general, sell-by dates build in a buffer of time—days, weeks, or months, depending on the type of food and the rate the manufacturer assumes the consumer will use it—for the food to make it home and be used.  Food at or near the sell-by date is still perfectly fine to eat.

“Best By” Date: Unlike sell-by dates, consider "best by" and "best if used by" dates the manufacturer speaking to you, the consumer, about quality.  This label refers to quality, not safety. The food may not taste as fresh after this date, but it’s still safe to eat. 

“Use-By” Date: This one sounds the most serious and in some cases deserves the most attention, but even use-by dates are not a safety cutoff for most foods.  This label is the last date recommended for the use of the product while at peak quality.  In most cases, a one-week grace period applies if stored properly.

Expiration Date: People often use the term "expiration date" as a catch-all that can apply to any of the above types of dates.  However, if the date passes during home storage, a product should still be safe and wholesome if handled properly until the time spoilage is evident. If a food has developed and odd odor, flavor, or texture due to naturally occurring spoilage bacteria, it should not be eaten.

 

So, knowing that most of these dates are merely suggestions, how can you know whether to toss or keep something in your refriderator or pantry?  Following is a practical guide assuming proper storage:

Dairy

• Milk: ~5–7 days after opening

  • Trust your nose—sour smell = done

• Yogurt: 1–3 weeks unopened; ~1 week opened

• Sour cream: ~1–2 weeks after opening

Dairy spoils visibly/smell-wise—pretty reliable.

Meat & Fish (high risk)

• Raw ground meat: 1–2 days

• Raw steaks/chicken: 3–5 days

• Fish: 1–2 days (very perishable)

• Cooked meat: 3–4 days

If it smells off, feels slimy, or you’re unsure—don’t risk it.

Shelf-stable foods

• Canned goods: 1–5+ years (if can isn’t bulging/rusted)

• Pasta (dry): 1–2 years+

• Cereal: 6–12 months (goes stale, not unsafe)

These rarely become dangerous—just lower quality.

Condiments

• Mustard, ketchup: ~6 months opened (longer in fridge)

• Olives (jarred): 1–2 weeks after opening

• Pickled items: months (acid preserves them)

Oils & fats

• Olive oil: ~6–12 months after opening

• Other oils: similar

They go rancid, not “rotten”—smell like crayons/paint = toss.

Medications & vitamins

• Prescription drugs: Dates matter more.

  • Often still effective after, but potency can drop

  • Some (like certain antibiotics, nitroglycerin) can degrade faster

• Vitamins: Lose potency over time, not dangerous

With meds, it’s safer to respect the date.

When food is actually unsafe

Watch for:

• Sour, rotten, or unusual smell

• Slimy texture (especially meat)

• Mold (exception: hard cheese—can cut around it)

• Bulging cans (possible Botulism risk—serious) 

I suspect the moral to all of this is to use your senses first and to know that when dealing with high rist foods (meat, fish, dairy), common sense in king.  

Some rules of thumb might be: if fish smells fishy, it is and should probably not be eaten. Sour cream can go sour, and if the steak you bought 2 days ago smells funky, don't eat it.

Essentially: when it doubt, throw it out. 

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.