The Wild West of Dietary Supplements | Episode 104
Francine Shaw, CP-FS, FMP
CEO @ Savvy Food Safety l Co-Host @ "Don’t Eat Poop" Podcast ??? l Food Safety Expert ?? l Advisor-Consultant ????♀? l Published Author ?? l Keynote Speaker ?? l ? Goddess of Food Safety ?????
In episode 104 of Don't Eat POOP! A Food Safety Podcast, Matt Regusci and I are joined by David Lennarz, the President of Registrar Corp, a company that helps their clients to become and continue to be compliant with U.S. FDA Regulations.
?According to Matt, David is one of the most important, least-known people in the American ?food and beverage, cosmetic, medical device, and drug industries, and today, he is sharing his expertise from 22 working in the field with us.
You’ll learn about FDA Compliance nationally and internationally, what to watch out for, David’s take on the significant changes happening within the FDA and with the new administration, and more.
Catch up with previous episodes at Savvy Food Safety, Inc.'s Podcast Archives.
In this episode:
Why the Wild West?
In this episode, David very aptly named the circumstances around dietary supplements in the US as the Wild West.
The reason why this makes so much sense is because the dietary supplement industry has very little regulation around what goes into the product, making it almost a free-for-all.
With such little regulation, the possibility of products being fraudulent is real and must not be dismissed.
As things stand right now, ?all a dietary supplement company needs to do is register its facility with the FDA. They don't have to say what they're producing in that facility. They don't have to submit a label. They don't have to submit the ingredients that are going into the product.
That’s because the supplements that millions of Americans consume every day are not (and don’t need to be) approved by the FDA.
The FDA doesn’t know what the manufacturers say is in the product because they currently don’t have a way to capture that information.
Not only that, because they don’t even know the ingredients, they certainly cannot ascertain that the ingredients that manufacturers say are present in the product truly are there or, more importantly, if what’s actually in the product is at safe levels for human consumption.
This is a truly serious issue. To illustrate this, David mentions an article he read in Fortune Magazine that talks about how dietary supplements are causing liver damage.
According to the article, “herbal and dietary supplements account for roughly 20% of liver toxicity cases nationwide, according to 2017 research published in the journal Hepatology.”
So, remember, just because you can buy it on the shelf at Walmart or Target or order it through Amazon does not mean it is safe.
Did you know you can find fecal coliform on over 50% of gloves? ?????
It’s astounding to learn that many of the gloves coming into our country are contaminated. ?But Eagle Protect is changing that.?
They test every single lot of their Eagle Delta Zero? gloves for microbial contamination.
This is a company truly committed to food safety. So please check them out at eagleprotect.com and get your gloves tested!?
Let’s not forget… Don’t eat poop! ??
How Do We Better Regulate These Products?
According to David, the first step in regulating dietary supplements and making sure they are safe for consumers is to understand what the products are and who is producing them.
As we’ve seen, the FDA does not keep track of this data right now, so one important way for this to happen is for the FDA to require ?dietary supplement listings, which are already required for drug products, medical devices, and cosmetics.
The second step is testing. There must be some testing around products to see if what is claimed to be in them is actually within safe percentages and won’t lead to unexpected and negative consequences for those taking the supplement.
Why Aren’t Supplements More Regulated?
So, if that is “all” that needs to be done and this type of regulation is already in place for ?drug products, medical devices, and cosmetics, then why hasn’t this happened yet?
Actually, there was the Food and Drug Omnibus Reform Act (FDORA) of 2023, which included both cosmetics and dietary supplements and required companies to register and list their products with the FDA. However, at the last minute, dietary supplements were stripped out of it and continued to be unregulated.
The dietary supplement industry is very large in size and considerably lucrative, and their lobbying is strong. Because of that, they have managed to evade increased regulation so far.
According to David, though, there’s still some hope because there has been a call for more strictly regulating dietary supplements for many years. For him, this is not a partisan issue, it is a safety issue, and he hopes that we can see a push toward stronger regulations around dietary supplements with the FDA under RFK Jr.’s authority.
Only time will tell, but I sure hope regulation will come soon to this industry.
Now I’m curious:
?? Do you take any supplements every day?
?? Before reading this, did you know that dietary supplements are not approved by the FDA?
We'd love to hear from you!
Share your thoughts and feedback on the show, and feel free to offer any topics you would like to hear discussed.
Connect with Francine, Matt, and the "Don't Eat Poop!" podcast on LinkedIn!?
??? BE A GUEST ON DON’T EAT POOP!
Fill out this form to tell us more about yourself. We’ll reach out via email within 30 days with next steps if you’re selected.
?? Check out Francine's book Who Watches the Kitchen? on Amazon!
#FoodSafety #Food #FoodSafetyAndHygiene #DietarySupplements #MoreRegulation
Co-Founder 5280 Food Safety P.C.Q.I., HACCP, PFM, OSHA 30, LSS Yellow Belt, 5S+ Leadership, Site Sanitation, 7 Step Sanitation Process, Allergen Cross Contact Control, P.E.M. Allergen Validation, IPM 100, 200, 300,
6 天前I was thinking about this topic as I was ordering vitamin supplements last night online. I was also intrigued by the topic of tariff and how the cost is spread throughout the different entities. Being able to see a company’s risk score if your business relies on their ingredients or products and the ability to source a supplier with a lower risk score is a great tool for business.