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“Should the FDA Regulate Diet Supplements as Drugs?”

Published on Feb 21, 2014 at 8:18 am in Dangerous Drugs.

Kentucky Dangerous DrugsDiet supplements have grown increasingly popular in the last 10 years, but not many people understand the risks associated with the supplements themselves. The U.S. Food and Drug Administration (FDA) currently provides no oversight over the dietary supplement industry. Several high profile cases have pointed out the dangers that diet supplements can present. The FDA has issued warnings recently against supplements found to contain meth-like substances, and to supplements that are damaging people’s livers.

But the problem continues with the FDA failing to regulate supplements as they do drugs. According to the FDA, “the manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.” This leaves the quality control to the company providing the supplement, many of which have very few credentials or assets should a lawsuit be necessary.

One of the most famous examples of this was the supplement Metabolife. Metabolife was created by a former police officer on probation for connection to a methamphetamine laboratory. Metabolife contained the supplement ephedra, which could cause heart attacks and had a similar chemical compound as methamphetamine. However, without FDA regulation the product was available on the market without a warning to consumers of the dangerous effects of the supplement. The creator of Metabolife filed for Chapter 11 bankruptcy before many of the victims could recover for their losses and is currently in prison for tax evasion.

Two doctors at the Children’s Hospital of Philadelphia point out that supplements such as vitamins, amino acids, herbs, minerals, and other botanicals all have pharmacological effects – so they are drugs. In an opinion published by The New York Times, the doctors noted that supplements “aren’t tested for safety and efficacy before they’re sold. Many aren’t made according to minimal standards of manufacturing … and many are mislabeled, accidentally or intentionally.”

They gave an example of some ayurvedic remedies sold in health food stores that were found to contain dangerous levels of lead, mercury, or arsenic. In another case, popular supplements claiming to be St. John’s wort or gingko biloba didn’t contain those herbs, and/or included contaminants.

The FDA has the power to regulate supplements, but not the resources or the will.
This leaves users on their own, meaning that the users have no way of knowing what is truly in the supplement that they are taking. One step consumers can take is to look for “U.S.P. verified” on the label, which shows it has been inspected and approved by the nonprofit US Pharmaceutical Convention standards. However, less than 1% of products on the market today bear this label.

Otherwise, the doctors recommend that until studies show these supplements are effective, and the FDA regulates them like drugs, consumers should avoid them.