Welcome to Straight Talk on Health, I’m your host Dr. Chet Zelasko. Straight Talk on Health is a joint production with WGVU in Grand Rapids MI. I examine the world of health. Nutrition. Exercise. Diet. Supplementation. If there’s something new, I look at the science behind them, and let you know whether it’s real or not. You can check out other things that I do on my website Drchet.com and sign up for my free emails.
I think something major happened while no one was paying attention. The FDA and the FTC stopped a dietary supplement company from selling its products and closed down production until the company come back into compliance with all laws and regulations pertinent to dietary supplement. Why is that major? Let me provide you with a little background.
In 2022, the FDA and AMA partnered to release two short videos to physicians. They also had a version for consumers. The goal was to teach physicians about dietary supplements. I actually got excited about that because physicians, for the most part, know little to nothing about supplements
The first video spent time defining and explaining what a dietary supplement is, the delivery systems companies use such as tablets, gummies, bars, etc., and the role the FDA plays in the process. The second video focused on adverse events, how to report them, and a sample conversation between a doctor and patient. I encourage you to watch the videos via links in the show notes.
I think there are two important points of the videos. First, the FDA does not approve dietary supplements in the same way that they approve pharmaceuticals—obviously their main point because it was repeated several times. In exchange for allowing supplements to be introduced quickly, companies do not have to prove safety or effectiveness. However, if a company makes any health claim, they must report that to the FDA within 30 days of making the claim. Those claims are restrictive; a company can’t say on the bottle or promotional materials “cures heart disease” but can say “contributes to a healthy heart.”
Second, you should always discuss the supplements you take with your physician, especially if you take medications. It can be a pain if you take a lot of supplements, but you must do it because there can be interactions. For example, calcium, whether from food or a supplement, interferes with the absorption of thyroid medications. They should not be taken together.
Those are what I see as the positives of these videos that cover supplement companies and patients; there’s no information about how supplements work or which supplements do what. I came away with three opinions about the videos, other than they really focused on dietary supplements not being approved by the FDA. Of course, no legitimate healthcare professional or supplement manufacturer ever said they were; consumers may not know that, but I would hope doctors did.
First, the second video discussed potential drug-supplement interactions. There have been few direct studies on those interactions; most are case studies involving the use of herbs such as St. John’s wort and ginkgo biloba that have been published in peer-reviewed journals. What they don’t say is that very few studies have examined drug-drug interactions either. How do they find out about them? Trial and error from reports to the FDA’s adverse effects reporting system.
That addresses my second opinion. There was a strong focus on reporting adverse events from dietary supplements to the FDA. One would think that’s a good thing, but the list of adverse events they listed included every system in the body. I get reporting an allergic reaction, but how would a physician attribute gastrointestinal or cardiovascular issues to a dietary supplement after putting the person on a new medication? It’s just as likely to be due to the medication. Seems to me like an open door to lots of irrelevant reports.
Finally, they spoke about some supplements interacting with blood tests. The only one I’m aware of is excessive biotin intake affecting the troponin test for potential cardiac events. One would expect an extensive list would be provided; the problem is none exists because that’s the only known interaction.
There are 13 vitamins. There are dozens of minerals, most found in trace amounts. There are hundreds of herbs, plus nutrients that don’t fall into any of those categories. All can be found in dietary supplements. If I were a physician who spent time watching the videos, I really wouldn’t know more about those nutrients in supplements than I did before I watched. Very disappointing to say the least because the message is that supplements are not approved nor regulated and everything that in any way a patient says should be reported as an adverse effect if they are taking supplements.
One more thing: Those prenatal multivitamins that are physicians prescribe to pregnant women? Those have never been tested in a clinical trial either. In one case, let’s get the supplement business because there are no significant clinical trials but let’s prescribe supplements for pregnant women that have never been tested. As you can tell, that one always makes me hot.
What’s the thing that happened that flies in the face of the effort of the FDA and AMA opinions expressed in those videos? You may have seen those incessant commercials for a dietary supplement that contains dehydrated vegetables and fruit. They always begin with someone who has more energy, feels better, thinks more clearly. Then, the camera pans to the person taking a couple of capsules and the pitch is on for getting the viewer to purchase the product as well. The implication is that you’ll get the same benefit if you take them.
Actually, that’s not that bad. However, on their website, they had testimonials from people who make claims about diseases and conditions which have improved since taking the supplement. Remember what I said earlier? That’s a big no-no. Structure function claims are okay but nothing that describes a disease.
Ever remember reading or hearing this? This product has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
That’s everything in a nutshell The company violated the rules. Here’s what the FDA said:
“The company’s products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs. The FDA has not approved thee products for any use, despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19.”
On top of that, the company was told to stop manufacturing products immediately, Again, the FDA:
The company in question manufactured products in violation of multiple current good manufacturing practice (CGMP) requirements, such as failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.
The company has been given a way to comply but as of yet, hasn’t. We’ll see what happens. For now, when you hear that the dietary supplements industry is not regulated, you know that it’s not true. It is regulated differently than pharmaceuticals but it is regulated nonetheless. I hope the FDA and AMA were paying attention so they can train their physicians properly by re-shooting those videos. Thanks for listening but we’re out of time. This is Dr. Chet Zelasko saying health is a choice. Choose wisely today and every day.
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