
The FDA’s MedWatch Reporting System Fails Consumers and Physicians
- As PBS attempts to slam the supplement industry, it ends up revealing the shortcomings of the FDA
- Over 22,000 Americans die from prescription drug overdoses annually. Could some of these be the FDA’s fault?
- The government won’t help you, but Living Well will. Learn how to buy safe supplements with these five helpful tips.
Recently, PBS released an hour-long expose episode of Frontline that attempted to bash the dietary supplement industry.
As usual, the main points of criticism hinge on the worn-out claims of the supplement industry’s loose regulations, selling of worthless and/or harmful products, and hoodwinking of unassuming customers for billions of dollars every year.
$30 billion annually, to be exact, as correspondent Gillian Findlay gladly points out.1
While $30 billion may seem like a sizable amount, it’s small potatoes compared with Big Pharma’s $711 billion annual profits.2
But beyond the profits and exhausted pitfalls, the most damning and clear theme of the documentary is the incompetence and carelessness of the FDA’s adverse-reaction reporting line, MedWatch.
The documentary profiles two cases of adverse reactions. Frontline reveals how MedWatch’s many blunders in reporting resulted in lengthy waits by consumers and physicians for answers. The documentary goes on to show how this faulty reporting system kept dangerous products on the shelves up to six months after receiving an initial report.
In fact, the reactions of the some of these FDA employees will shock you.
Today, we will explore these cases a bit further to see where the FDA failed to protect the public.
More importantly, I want to assure you that there are safe, reliable, and pure dietary supplements on the market. The key is knowing how to find them.
I will guide you through the best buying practices for supplements in a bit.
First, let’s explore MedWatch’s responsibilities and how they failed consumers in two cases.
Oh, You Think Your Medication Is Killing You? Hold, Please… I’ll Transfer You.
According to the MedWatch website, it’s an avenue “to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement, or cosmetic.”3
MedWatch is the first stop for adverse-reaction reporting for so many different types of consumers and manufacturers. It’s troublesome to think about how many different types of dangers are slipping through the cracks.
In the highlighted cases, it wasn’t MedWatch’s balancing act of all of these industries that led to the injury of supplement consumers but rather MedWatch’s failure to act on reported adverse reactions that cost some folks their health.
Kenneth Spaeth, a doctor involved in the first of the cases, told Frontline in an email he tried to reach the FDA via email regarding the suspected contamination of a supplement. This supplement, made by a company called Purity First, was affecting 20 of his patients.
After the FDA ignored his first email, Spaeth emailed them again. Finally, the FDA responded by referring him to the MedWatch hotline.
Spaeth called MedWatch numerous times. He was placed on hold and transferred several times before being disconnected not once, but twice.
Once he did get through, Spaeth reported the operator he spoke with “was acting as if I was telling her that aliens put messages in my Cheerios” when he was giving her the report.
Sounds like a real top-notch team working at MedWatch.
Five weeks later, he still didn’t have any answers for his patients.
According to the manufacturers of the reported contaminated supplement, when FDA representatives came to investigate the claim, it was never specified which product was under scrutiny. Furthermore, when they asked the FDA if they should stop making the supplements, FDA representatives replied, “Nobody died, you don’t have to pull the product.”
When the manufacturers offered to pull the products, the FDA replied, “People call the FDA all the time to report minor things, so don’t worry about it.”
Of course, the FDA denies these claims.
It took the FDA six months to get the Purity First supplements off the market.
In the next case, a dietary supplements caused liver damage to consumers living mostly in Hawaii.
Physicians made several attempts to reach MedWatch via their website and by telephone. It was only after they reached out to the state health authority that they got a response from the FDA.
Per Dr. Wong, a transplant specialist, the FDA told one of the liver doctors attempting to reach them that they thought she was a “prankster” because she had used her private email address.
Dr. Wong went on to say, “They [FDA] thought we were joking.”
It took a month for the FDA to remove the product, and this was after 20 reported cases of liver damage.
These types of cases raise important questions:
- How many times a day does a concerned consumer or physician call MedWatch just to have these negligible results?
- How many consumers have died or been harmed due to inaction of the FDA?
While we may never have firm answers, these situations do point us to one clear fact — you can’t trust your health to someone else, especially a government entity.
And I am not denying there is room for improvement with the regulation of dietary supplements, just as there is for prescription drugs.
However, it is worth mentioning, your chances of dying from a dietary supplement reaction are significantly lower than the odds of your dying from a prescription drug overdose.
For example, in 2013 (most current data I could find), over 22,000 Americans died from prescription overdoses, while there were only two deaths from dietary supplement usage .4,5
The bottom line is you need to get your supplements from reliable sources.
I recently sat down with Jasmine LeMaster, head of quality assurance here at Living Well Daily, and she shared some important pointers on how to find a quality supplement:
- Research the company: A simple Google search of a supplement company can provide you with important information about their manufacturing process. You want to be sure they are (or use) a manufacturer certified in Good Manufacturing Practices (GMPs). If you can’t find that information on their website, call the company and ask them about their manufacturing processes.
- Independent testing: Make sure the company is having quality testing done by an independent laboratory. You can request to see these results. For example, here at Living Well, Jasmine sends our products to an independent laboratory for testing to ensure the results match what our manufacturers’ test results say. This is a quality measure we take in order to assure our customers are getting the products they are paying for.
- Look for contact information: Be sure the packaging of a supplement has a direct contact number, not an email. You should scan the bottle or box to verify there is a contact number before making a purchase. When you have contact information, you can go straight to the source if you have questions about dosages or need more product information.
- Ask your doctor: Anytime you start a new supplement, you need to talk to your physician. Your doctor can give you instructions on dosages and advice on how a new supplement may interact with your current medications.
- Stop at the first sign of an adverse reaction: You know your body better than anyone else, so be sure to listen to it. If a supplement is making you feel bad or you experience signs of an adverse reaction — stop taking it immediately. You need to call your doctor, the supplement company, and even MedWatch. While your call to MedWatch may fall on deaf ears, at least you have taken the extra step that may (or may not) protect someone else.
Have you had any MedWatch or FDA experiences you would like to share? Let me know! nmoore@lfb.org
Live well,
Natalie Moore
Managing editor, Living Well Daily
Sources
[2] Big Pharma Pockets $711 Billion in Profits by Price-Gouging Taxpayers and Seniors
[3] Reporting Serious Problems to FDA
[5] Dietary Supplements: What Is Safe?
[6] The OxyContin Clan: The $14 Billion Newcomer to Forbes 2015 List of Richest U.S. Families

Written By Natalie Moore
Natalie Moore is a dedicated health researcher with a passion for finding healthy, natural, and science-based solutions. After a decade of direct healthcare experience in western and natural medicine, she was involved in public health research before joining Living Well Daily.
View More Free Articles
Weekly Habit QUINTUPLES Your Cancer Risk
Everyone knows that sugar-sweetened sodas aren’t going to win any nutrition awards. That’s not news. But now, a disturbing new study suggests these soft drinks hide a deadly secret. A regular soda habit could do far more damage than just expand your waistline or raise your diabetes risk. The new research reveals these sugary treats...
Unlikely Duo Naturally SLASHES High Blood Pressure
Some things just naturally belong together—such as peanut butter and jelly, salsa and chips, or two peas in a pod. But there’s an unlikely pair that researchers say could do wonders for your heart health. A comprehensive new study from the University of Surrey has revealed that compounds found naturally in tea and chocolate can...
The Surprising Link Between Jaw Tension and Anxiety
Ever catch yourself clenching your jaw when you’re stuck in traffic or waiting for an important phone call? Well, it might tell you something important about what’s happening “upstairs.” Turns out, that jaw tension isn’t just annoying—it’s a direct hotline to your anxiety levels. And most of us don’t even realize we’re doing it. I’ve...
Could Poor Sleep Be Hurting Your Brain?
If you’ve ever woken up groggy, unable to shake the brain fog, or struggling to focus, it might be more than just a bad night’s sleep. Sleep apnea—a condition in which breathing repeatedly stops during sleep—affects nearly 936 million people globally. But here’s the kicker: it doesn’t just leave you feeling tired. New research shows...
Mailbag: Inflammation-Fighting Protocol Clears Clogged Arteries
“I’m 70 years young and I would like to know if there is a natural treatment for clean arteries to prevent heart attack and cardiac problems. Thanks for your reply!” -Change of Heart Dear Change, I love how proactive you’re being about your heart health! Nature offers powerful solutions for keeping arteries clear and healthy....
Why Your Tech Troubles Might SAVE Your Brain
Ever feel like your smartphone is too smart for you? Or maybe you’ve struggled to figure out that new streaming device your kids gave you? Well, take heart. Those technology headaches are saving your brain cells. A groundbreaking new study suggests that spending hours figuring out your gadgets could be your best defense against cognitive...
Study Reveals the Dark Side of Sleep Meds
I’m sure you know by now that quality sleep is crucial for good health. Poor sleep, on the other hand, is linked to all kinds of health hazards, including obesity, diabetes, heart disease, stroke, depression, and anxiety. It’s the primary reason people opt to take sleep medications. But what if the pills you’re taking to...
Ancient Food Eases Modern Digestive Woes
If you turn up your nose at the pungent aroma of sauerkraut, you might want to reconsider. Because that tangy, fermented cabbage could be exactly what your gut needs to fight off inflammation and heal digestive issues. Research reveals that this humble food, enjoyed for centuries across the world, contains potent compounds that could shield...
One-Third of Dementia Cases Linked to This Treatable Condition
Dementia is on the rise—and the number of cases is expected to double by 2060. Most people focus on common risk factors like diet, exercise, or genetics. But one of the biggest threats to your brain health is something most of us take for granted… Until it starts to fade away. Worse yet, research shows...
Medications That Don't Mix Well with Coffee
If you’re a regular Living Well Daily Reader (and I certainly hope you are), I probably don’t need to tell you I’m a coffee fan. I regularly share information on coffee’s many health benefits—from boosting metabolism to reducing disease risk. But many don’t realize that cup of Joe can interact with common medications, sometimes reducing...