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Allegedly Tainted Supplements, the FDA, and the No-Trust-in-Institutions Dilemma

AP Photo/Mark Lennihan

The term “dietary supplement,” in the United States, has a specific and officially defined meaning, as determined by legislation passed thirty years ago that distinguishes it in the federal regulatory scheme from food products or pharmaceutical products.

If you have ever bought so much as a multivitamin in your local supermarket that claims to offer any health benefit whatsoever, not matter how well-vetted, and read the label, you will have noticed the familiar phrase: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Via United States Food and Drug Administration (emphasis added):

This statement, known as a "disclaimer," is required by law (21 U.S.C. 343(r)(6)(C) and 21 CFR 101.93(b)–(d)) when a manufacturer makes a structure/function claim or certain other claims in dietary supplement labeling. In general, structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans or characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function. The other dietary supplement labeling claims that require the disclaimer are claims of a benefit related to a classical nutrient deficiency disease and claims of general well-being from consumption of a dietary ingredient. These three types of claims are not approved by FDA and do not require FDA evaluation before they are used in dietary supplement labeling. Accordingly, DSHEA requires that when a dietary supplement label or other labeling includes such a claim, the claim must be accompanied by a disclaimer informing consumers that FDA has not evaluated the claim. The disclaimer must also state that the product is not intended to "diagnose, treat, cure, or prevent any disease" because only a drug can legally make such a claim.

So, by way of example, in practice, if a supplement manufacturer would like to promote the proven beneficial effects of vitamin D on brain health, they are required by law to include prominently the above disclaimer that the claim “has not been evaluated by the FDA.”

Related: Study: Vitamin D Reduces Dementia Risk by 40%

What the point of this exercise could feasibly be — when it would be so easy for the FDA to investigate whether the claim is true — other than an attempt to delegitimize in the minds of consumers any natural product that can’t be patented and sold by pharmaceutical corporations for windfall profits (a portion of which are kicked back to the regulators, as happened with COVID-19 “vaccines”) is unclear.

Consider Anthony Fauci’s NIAID’s notorious refusal to promote affordable and accessible vitamin D (or even non-patented pharmaceuticals like ivermectin) as a frontline defense against COVID-19 despite reams of evidence speaking to their efficacy.

 Now, it would be nice, even ideal, if the FDA used the massive public resources at its disposal to investigate the safety and efficacy of affordable supplements as part of its work. Then it could definitely state whether any claim is true or not instead of the vague “has not been evaluated” cop-out.  

But it doesn’t conduct any such investigations, presumably because it doesn’t want to be forced to disclose to the public that natural and cheaper competitors to pharmaceutical products might be more efficacious with fewer side effects.

RelatedFeds Move on MASSIVE, Budget-Breaking Subsidy for Ozempic, Mounjaro as Pharma Stocks Surge

Given the convoluted incentives and shady practices, therefore, it’s difficult to take the administration seriously when the FDA and its TV doctor representatives come out to warn about alleged contamination of these products that compete with their pharma cash cows.  

 

No one with any sense would trust their proclamations, for the reasons I just explained.

… Such is the consequence, in a microcosm, of a regulatory agency hijacked by the very industry it’s supposed to regulate.

 

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