April 25, 2018

FDA: Tell Us If You’ve Been Injured By A Dietary Supplement

If you’ve been injured by a dietary supplement, the U.S. Food and Drug Administration (FDA) wants to know about. The agency announced today that it is now accepting online submissions of reports about adverse health events triggered by the use of dietary supplements.

Both voluntary and mandatory reports can now be submitted online. To make a report, click here.

According to the Dietary Supplement and Nonprescription Drug Consumer Protection Act,  if a manufacturer, packer, or distributor’s name appears on the label of a dietary supplement,  the company must share with the FDA any reports of serious adverse events associated with the use of the product.

There are more than 85,000 dietary supplements Dietary-Supplementson the market. In terms of regulation, the FDA considers them food, not drugs and they are therefore not required to undergo pre-market evaluation by the agency. Some companies include banned or untested  substances in their products that can cause serious injury to users. These ingredients are not lusted on product labels.

Recently, reports of liver failure have been associated with a number of dietary supplements including Mass Destruction and OxyLitePro. One recent study by the Drug-Induced Liver Injury Network found that dietary supplements account for nearly 20 percent of drug-related liver injuries treated at hospitals.

Another study, published last fall  in the journal Drug Testing and Analysis, revealed that pharmaceuticals and banned substances have been detected in hundreds of “natural” dietary supplements. Craze, a popular body-building supplement manufactured by Driven Sports, was found to contain a meth-like stimulant, N,alpha-diethylphenylethylamine (N,alpha-DEPEA), that had never been studied in humans. The drug was not listed as an ingredient.

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