The Dangers of Dietary Supplements

The word is out about dietary supplements, and across the United States, millions of people are being made aware of the risky side effects that can come with taking these over-the-counter products. Estimates suggest that more than 2,000 Americans suffer illness or death from dietary supplements every year, which is due in large part to the undefined boundaries of the U.S. Food and Drug Administration (FDA).

Dietary supplements don’t fit under the category of food, nor can they be classified as medicines, which leaves them just out of reach of some of the FDA’s most important safety regulations. As stated in the Dietary Supplements Health and Education Act, supplements for diet and exercise can be sold to consumers without first passing the same set of safety testing that that other foods and drugs must go through under the FDA. The director of the Division of Dietary Supplement Programs at the FDA described the process best when he said, “We don’t approve these products for safety or efficacy prior to going to market…They’re not like drugs. The way the law is, firms don’t have to register their products, so dietary supplements come on the market freely.”

The law essentially allows for pill- and powder-versions of supplements to be sold in stores and online without first being deemed as safe for use. Until someone becomes ill from the use of these supplements, the pills and powders can remain available to consumers in states across the country. Even then, the burden is still on the FDA to prove that the supplement is the direct cause of harm.

One of the most recent examples of the FDA’s restrictions when it comes to the regulations it can and cannot enforce on dietary supplement firms is USP Labs, the manufacturer of the now-infamous dietary and workout supplement OxyElite Pro. The product, along with another popular supplement of USP Labs, Jack3d, contained the amphetamine-like substance DMAA all the way up until just four months ago when the products were restructured. First introduced to the market in the 1940s, DMAA was only recently banned by the FDA (in April 2012) after a series of deaths and more than 100 reports of illness.

Since July, a “new and improved” version of OxyElite Pro has been released on the market; however, the supplement is still believed by some to be linked to an outbreak of liver failure among some users. The FDA has yet to confirm this and has not banned the product from the market. As stated earlier, the FDA is bound by a powerful industry that has long since been backed by strong supporters in Washington. The Dietary Supplements Health and Education Act is still heavily enforced in the U.S., and until this law is amended, consumers will continue to be allowed to purchase and use potentially harmful supplements that have not been tested for safety.