This Dietary Supplement Is A Miscarriage Of Justice

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Recently, Dr. Henry Miller and I, published an op-ed entitled "Will Dangerous Dietary Supplements Finally Be Reined In?" We described the risks associated with the estimated 50,000 supplements that are now being sold, and how U.S. Poison Control Centers receive one call every 24 minutes for exposure to toxic supplements (1).

"Many herbal supplements are complex, highly variable and impure. Similar to the 19th century snake-oil preparations that were dangerous but had little if any effectiveness, some are toxic, carcinogenic or otherwise unsafe."

H.Miller, J. Bloom Insights and Issues, May 2019

Almost on cue, the FDA issued a statement earlier this week warning of the risk of miscarriage in pregnant women who take the supplement containing vinpocetine. The expression "pick your poison" has never been more accurate. The reason - vinpocetine belongs to a large class of plant-produced toxins called the indole alkaloids (2). indole alkaloids are ubiquitous in plants, which biosynthesize them as defense weapons. More than 4,000 have been identified from plants (3).

The chemical structures of indole (Left) and three (of many) indole alkaloids found in plants.

Deer aren't especially fussy eaters, but they have the sense not to eat this:

Vinca (periwinkle) flowers are deer-proof because they contain toxic indole alkaloids. 

While humans don't have the sense to avoid this:

Vinpocetine is not FDA approved for any indication in the US (4), but people take it because it (supposedly) enhances memory. This is a perfect example of what a bad joke The Dietary Supplement Health and Education Act of 1994 (DSHEA) is and how successful scummy marketing has been, convincing Americans that the "non-drug drug" in the bottle is safe, natural and chemical-free.

The marketing sure worked. People will intentionally take "therapeutic" (5) doses of this stuff but be afraid of two molecules of some plastic chemical used to make the bottle. Crazyville.

What is even crazier is that dietary supplements are regulated as foods. Foods? Are you kidding me? Even deer wouldn't eat this stuff. No, vinpocetine and the overwhelming majority of other supplements are not foods or anything like foods - they are untested drugs, courtesy of the anti-scientific DSHEA. 

drug is defined as: A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.

Source: FDA Glossary of Terms

The fact that an abortifacient (6) can be regulated (unregulated, really) and sold as a food without any FDA input, let alone any safety or efficacy evidence is a splendid example of why DSHEA needs to be thrown out. We at ACSH have made overturning this antiscientific law one of our primary goals for 2019. As a public health issue, this is a no-brainer. DSHEA needs to go away.

NOTES:

(1) It is a sure bet that there will be comments that regulated prescription drugs also have side effects, some of which are severe. This is a false argument. However good or bad a prescription drug is it has been evaluated for safety and efficacy and doses have been defined. Prescription drugs carry with them both risks and benefits. Supplements, for the most part, have no benefit and may or may not have risks. Or the risks are unknown. 

(2) Alkaloids are natural products derived from plants that contain a basic nitrogen.

(3) Source: TILLEQUIN, F., S. MICHEL, and E. SEGUIN, Tryptamine-derived indole alkaloids, in Alkaloids and Sulphur Compounds (P. G. Waterman, ed.), Vol. 8 of Methods in Plant Biochemistry (P. M. Dey and J. B. Harborne, eds.), 309–371, Academic Press, London, 1993.

(4) It is approved for use in Europe. I have no idea why.

(5) The term "therapeutic" is in quotes because no one knows what dose, if any, would be useful. "Therapeutic" is, instead, used to indicate that the "recommended" dose, 10 mg, is well within the range of therapeutic doses of many real drugs. 

(6) Abortifacients are drugs that induce abortions,