8 Huge Mistakes The FDA Has Made Over The Years

If and when you think about the public sector, you might think of times when bureaucratic incompetence has had you feeling totally inconvenienced. You wait in line at the Department of Motor Vehicles (DMV) for ages, and then every step in the process is sluggish, for instance. But then there are agencies like the Food and Drug Administration (FDA), which is uniquely tasked with making sure that the things you consume (or even the medical devices you use) won’t harm or kill you.

Over the years, however, the FDA has made some major mistakes that, sadly, get quietly memoryholed by those who weren’t affected by lethal levels of incompetence or even corruption. Now, not every decision the FDA makes undermines public health, and they have of course protected many people from ineffective to outright dangerous scams. 

But when too many errors stack up and lead to thousands upon thousands of adverse health events or even deaths, it’s worth pointing out the agency’s shortcomings. Is the FDA so deeply whipped by corporate greed and self-serving bureaucrats that they’re past the point of no return? These tragic stories might have you hoping for a full-fledged overhaul of the system.

1. OxyContin

Prior to the 1990s, doctors allegedly avoided prescribing their patients opioids to deal with chronic pain unless they were dealing with something like cancer, for example. But, in 1995, the FDA, under the direction of Dr. Curtis Wright, who was acting as team medical review officer at the time, approved OxyContin for more than just extreme pain. If you had “moderate to severe pain,” you could now be prescribed opioids, despite the medication previously not being available for that use due to addiction concerns.

And, what do you know! Today, the opioid crisis has reached epidemic proportions. Some even say it’s the “greatest medical disaster in U.S. history” because of how deaths from drug overdoses have reportedly topped the death count from both World Wars combined. 

At the time that the FDA gave OxyContin its seal of approval, they concluded that addiction to opioids that were being “legitimately used in the management of pain” was “very rare.” 

While some may argue that opioid deaths have skyrocketed due to the synthetic varieties like fentanyl, oxycodone, or heroin which differ from prescription opioid usage, it has been estimated that at least 2 million people struggle with opioid use disorder involving prescription opioids. 

Back in 2016 when those numbers were published by the U.S. Department of Health and Human Services, it was said that that figure was “likely to increase in the coming years, regardless of what policies are put in place.” Well, just a few years later, that number jumped to an estimation of 2.5 million adults. Not to be a total doomer, but I highly doubt we’ll see a decrease any time soon.

2. Baby Formula

While the FDA doesn’t “approve” baby formula, per say, their rules and regulations require U.S. manufacturers (and European exporters) of the product to uphold specific requirements if they are to be “FDA-registered.” After the Infant Formula Act of 1980 passed, the FDA was tasked with enforcing federal nutrition and quality control requirements.

What the FDA has done is create roll on roll of red tape for U.S. formula manufacturers to adhere to…even if that means triggering a nationwide shortage and gatekeeping American moms and dads from being able to feed their babies. In America, the FDA’s fatty acid profile requirements can be met by using hydrogenated vegetable oils (yes, seed oils) which reduces their quality. 

One American entrepreneur started a formula company that brought European quality to the American market, saying, “Here we were with our first kid, turning around the back of the can and going, ‘Why is corn syrup the first ingredient that I’m going to give my week-old baby? Doesn’t that feel wrong? It’s something I wouldn’t feed myself!’”

But once she started selling her formula, called Bobbie, the FDA allegedly forced a recall until she added two seed oils to be able to sell legally in the states. 

European formula, which doesn’t allow for corn syrup but requires a higher amount of lactose, is taxed at rates as high as 17% and has been seized at the border when some Americans attempt to get it straight from our neighbors across the Atlantic. Perhaps we wouldn’t have had shortages to the extent of almost 30% of baby formula products being sold out in 2022 if the FDA didn’t fumble their formula requirements.

3. Phenylephrine

When you were growing up and got sick, how often did you try to clear your congestion using Sudafed, Robitussin, Benadryl, or any of the common decongestants that contain the active ingredient phenylephrine? Well, if you thought you got any relief…that may have just been a placebo!

In 2005, the Combat Methamphetamine Epidemic Act was passed, which restricted drugmakers from using phenlyephrine’s predecessor, pseudoephedrine (which is an ingredient in meth), in common decongestants, leading to the use of phenlyephrine instead. But last year, the FDA recently reversed its guidance on virtually all the most popular decongestants. Why? Because, even at very high doses, phenylephrine-based products didn’t reduce nasal congestion and the early studies which were used to support its usage over-the-counter were flawed in several ways. That’s right, it somehow took the FDA 50 years to figure out and then announce that these drugs are no more effective than using a placebo. 

One survey suggests that half of American households used oral decongestants (like the aforementioned ones) within a one year time period, and another study showed that half of American households bought them within a year, with many doing so several times in that one-year period. So for years and years, millions of people with allergies, colds, or anything else that causes congestion wasted their money on ineffective products.

4. Mifepristone

The FDA put politics above the health and safety of women and girls by approving mifepristone, a chemical abortion drug, for OTC use. According to a recent lawsuit, back in 2000, the FDA used its authority to accelerate the drug approval process for abortion pills, despite this authority typically being used to fast-track the approval of treatments for life-threatening illnesses. Without scientific evidence to back it up, the FDA was able to do this by labeling pregnancy as an “illness” and said that these drugs could have a “meaningful therapeutic benefit.” 

OTC chemical abortion pills change the game entirely for terminating a pregnancy, but their convenience doesn’t come without negative side effects. In 2019, the FDA actually released some data about mifepristone, which showed that there were 24 deaths and 97 ectopic pregnancies reported following its release. 4,195 adverse events were reported as well, and nearly 600 women needed to get a blood transfusion after using mifepristone to terminate their pregnancy. 

Taking abortion pills without the supervision of a physician might cause an ectopic pregnancy, though it's rare. This causes a domino effect, because ectopic pregnancies can cause extensive intra-abdominal hemorrhaging and, sadly, maternal deaths. In addition to these complications that appear to be minimized by those in favor of OTC abortion pills, there might be future complications with pregnancies later down the road.

Mifepristone is unfortunately responsible for a 500% increase in emergency room visits related to abortions. According to the same study which found that 500% increase, they also found that these chemical abortions are riskier than surgical abortions. The FDA has admitted that 1 in 25 women who take mifepristone will end up hospitalized. You can’t discount the emotional complications that chemical abortion pills genuinely cause as well.

Reasons like these are why a federal judge in Texas recently ruled that the FDA made a mistake in approving mifepristone. The U.S. Supreme Court also recently heard oral arguments about whether or not the FDA violated the law by approving mail order abortion pills, so perhaps there is a chance that their mistake will be corrected.

5. Ivermectin

Despite the application of ivermectin in medicine for humans winning a Nobel Prize in 2015, it was slammed by many mainstream sources for allegedly being a useless horse dewormer. Podcaster Joe Rogan, NFL quarterback Aaron Rodgers, and even former President Donald Trump were ridiculed for discussing how this inexpensive, widely available anti-inflammatory drug could save lives during the coronavirus pandemic.

Under oath and in front of Congress, FDA Commissioner Dr. Robert M. Califf urged that ivermectin wasn’t a viable treatment for Covid-19. This followed several years of the FDA publishing documents and posting on social media that ivermectin was dangerous for humans. 

However, many medical professionals found that the drug actually was effective for treating Covid-19. So, several banded together to file a lawsuit against the FDA and the U.S. Department of Health and Human Services for their attempts at preventing people from treating coronavirus with ivermectin.

The lawsuit argues: “The FDA generally cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling – commonly referred to as ‘off-label’ use. ... The FDA also cannot advise whether a patient should take an approved drug for a particular purpose.”

Was it collusion? Was it driven by a desire to drum up profits for the vaccines and subsequent boosters? Some may say that the deep state wasn’t actually following “the science” and instead they were following their own, corrupt agenda. In any case, it’s shameful that the FDA leveraged such a strong smear campaign against a life-saving treatment for many.

6. DES

Once labeled by the FDA as a “safety drug,” the synthetic form of estrogen known as DES caused very serious health complications for the many women who took it and their unborn babies exposed to it. The FDA approved DES for preventing premature labor and miscarriage despite it being very unsuccessful at doing that. 

What’s more, many physicians in as early as 1953 knew that it wouldn’t prevent miscarriage or other complications. Despite this, between 1938 and 1971, estimates suggest that as many as 4 million women in America took this synthetic estrogen…and all of their unborn children were exposed to it.

So, what did Eli Lilly’s DES even do, if not what it was approved for? For many mothers, it caused cervical and vaginal cancer, increased risk of breast cancer, increased risk of fertility complications, and contributed to early menopause. For many babies, it caused birth defects and abnormalities, increased risk of cancer, and could even cause testicular abnormalities. DES had such long-lasting impacts that even the third generation (yes, the grandkids of the mother who took DES!) could be impacted with negative health complications from the drug. 

It took until 1971 for the FDA to ban DES, despite its ineffectiveness and adverse complications being public knowledge. This failed reproductive technology makes me wonder – how many other magic pills and potions that medical professionals swear up and down are “safe and effective” are actually neither safe nor effective? Sadly, there’s a continued gap in research on reproductive health, so the fertility crisis may not be getting better any time soon.

7. Vioxx

After the FDA gave Vioxx, an anti-inflammatory medicine meant for arthritis, its seal of approval in 1999, over 20 million people started taking it. By the year 2003, it was reportedly one of the most prescribed drugs. But, although the FDA (and its manufacturers) was made well aware of its dangers in 2000, it took until 2004 for the drug to be recalled.

The original clinical trials for Vioxx didn’t indicate that the medication would increase a person’s risk of stroke or heart attack, but when further research was done on Vioxx, it was discovered that a significant number of heart attacks could be associated with taking it. Research reveals that as many as 139,000 Americans reportedly had heart attacks and strokes and an estimated 60,000 people died due to taking Vioxx.

In response, Senator Chuck Grassley from Iowa (who is still a senator to this day at age 90) stated during U.S. Senate hearings at the time that the FDA had “lost its way when it comes to making sure drugs are safe.” He also slammed the FDA’s relationship with drug manufacturers, calling it “too cosy.”

The FDA apologized and promised they’d do better in the future, but I’m not so sure they’ve made good on that promise. 

8. Lab-Grown Meat

Upside Foods and Good Meat got the FDA seal of approval to grow petri dish proteins, declaring lab-grown meat “safe to eat.”

Manufacturers harvest live stem cells of chicken tissue, grow new flesh in bioreactors, and then insist that this fake meat is just as safe for human consumption as the real deal. Cell-cultivated meat is also looking to disrupt the beef industry, but nutritionists are understandingly skeptical. The FDA has scared the general public into believing that red meat (and many animal products in general) will give them cancer, but the opposite may in fact be true.

What’s more, this “food of the future” is supposedly cruelty-free and better for the environment, but some internet investigators have found that, in both cases, it’s not.

Lab-grown meat and fish and synthetic milks were banned in Italy shortly after the country also banned flour made from bugs (crickets, locusts, and insect larvae), not only to protect Italy’s food heritage but also to protect consumers from under-researched products. 

Fake meat and dairy products in the states have been called out for obvious nutritional deficiencies, but when you’ve got Bill Gates bucks and big-name celebs backing a product, people are all the more likely to lazily pick up a poorer-quality product than the normal ingredients they’d otherwise purchase.

In Italy, where life expectancy is among the highest in the world, people eat real foods, but in the U.S., our FDA tweets out faulty, lame nutritional guidance and shuns ancestral food knowledge that kept our predecessors happy and healthy. 

Closing Thoughts

Americans rely on the FDA for their “rubber stamp” that’s allegedly the global “gold standard,” but sadly, they have fallen short so many times while insisting they’re upholding high standards of safety and efficacy. On the one hand, it seems like they let certain fishy products and treatments slide, while on the other hand, it seems like they have a vested interest in gatekeeping good ones.

In terms of human drug products, there were over 1,321 recalls issued in 2022 alone. The worst year in recent history for drug recalls was 2019, when 2,163 were pulled from the market, but on average, the agency has had to recall at least over 1,000 each year since 2012. Clearly, the FDA isn’t only making mistakes with medications, and this list couldn’t even be exhaustive if I tried. But, my hope is that these snippets provide you with a healthy dose of skepticism because, at Evie, we’re curious individuals – not blind followers of ideological echo chambers.

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