September 19, 2022

Dietary supplements as they are commonly known include vitamins, minerals, botanicals, live microorganisms and many other health products. 58% of American adults currently use them in one form or another. There are estimated 80000 supplement products available for sale in the United States today which contributed to Americans spending $55 Billion in 2020 alone.
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Dietary supplements are often sold alongside over the counter medications, but unlike the latter they are not vetted by the FDA before being introduced/sold and their advertising is often deceptive. Thousands of products have been found to not contain the advertised ingredients or to include toxic ingredients not listed on the label. Recent examples include vitamin D supplements without the declared quantity of vitamin D, potassium supplements with more than twice the listed quantity of potassium, berberine supplements without berberine, and black cohosh supplements that instead contained a cheaper plant substitute. Ingredients are sometimes marketed as effective after clinical trials have demonstrated the opposite. Ginkgo biloba, was never shown to prevent cognitive decline or dementia when studied in a large clinical trial but this product is described on the label as supporting healthy memory or supporting healthy brain function. Since 2007 the FDA has identified more than a 1000 supplements that contained prohibited prescriptions or experimental drugs. 

The risks associated with supplements are real. One such case in point; 1,3-dimethylamylamine (DMAA) a pharmaceutical stimulant which was introduced into hundreds of workout and weight loss products without being vetted by the FDA. By 2011 experts at the Department of Defense (DOD) had grown concerned that DMAA might increase the troops risk of a hemorrhagic stroke and sudden death. The DOD took the unusual step of prohibiting the use of the stimulant on military bases and under pressure the FDA banned DMAA nationwide.

What happened next was not surprising. Many supplement manufacturers responded by reformulating their products with alternative stimulants. One replaced DMAA with a new combination of aegeline, higenamine and caffeine, including synthetic versions of botanical constituents not traditionally consumed together. The firm did not notify the FDA of this change nor did it provide safety data to the agency. Within a year of being introduced the product OxyELITE Pro had been linked to an outbreak of severe hepatitis affecting 69 people; 32 of them were hospitalized, 3 required liver transplants and 2 died.

A Centers for Disease Control and Prevention study estimated that about 23000 emergency department visits and more than 2000 hospitalizations each year are attributed to adverse effects of dietary supplements. Simultaneously the incidence of liver failure has increased   by a factor of 8 between 1994 and 2021.

Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, not as drugs. The label may claim certain health benefits. But unlike medicines, supplements can’t claim to cure, treat or prevent a disease.

There is little evidence that any supplement can reverse the course of any chronic disease. Just because a supplement is promoted as “natural” doesn’t necessarily mean it’s safe. The herbs comfrey and kava, for example, can seriously damage the liver.

In the same way no vitamin is absolutely safe if taken in large quantities or more than the recommended daily allowance. Why not get your vitamins and minerals from a healthy balanced diet or even an OTC multivitamin with minerals that has the recommended daily allowance of micronutrients and is considered safe.

Little is known about which of the tens of thousands of supplement products available for sale in the United States pose the greatest risk to consumers. The FDA is tasked with removing dangerous dietary supplements from the market, but it does not have the manpower for monitoring safety nor can it track which supplements are currently being sold to consumers. Congress is trying to close this information gap, but it is off to a poor start. 

In conclusion
The responsibility for taking dietary supplements is therefore yours to bear. The ombudsman is asleep at the wheel. So don’t let your beliefs get in the way of science!
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