Recently, I stated that probiotics are marketed and sold free from the strict scrutiny of Food and Drug Administration (FDA) oversight that our prescription drugs routinely undergo. And this is just how these companies want it. Trust me, if probiotics had to endure the same vetting process that actual drugs go through, most of them would be snuffed out along the way.
Here’s a simplified glimpse of how the system works.
Many probiotics are classified
by the FDA as dietary supplements, rather than drugs. Indeed, it is this classification that allows the industry to thrive. The FDA regulates supplements
much more leniently than they do conventional prescription drugs that must
endure years of intensive vetting and successive clinical trials. The drug approval process is so rigorous that most drug candidates will not reach the finish line. The FDA maintains high standards for safety and efficacy. However, because probiotics are not drugs, they do not
need to establish that they are effective.
This is why when you see or hear them advertised, there is always the
disclaimer that the supplement is not intended to diagnose, treat, cure or prevent
any disease. Yet, the ads use coded
language that strongly suggests that these supplements do in fact treat diseases. Phrases such as ‘good for bone health’ or is
‘good for digestion’ or 'improves memory and recall', sound to most of us like they are actual treatments for these diseases.
And this regulatory system for
supplements is their Holy Grail. They
are making billions of dollars selling zillions of bacteria without ever having
to prove that they actually work. Not a bad business model, eh?
Comments
Post a Comment