Dietary Supplements Account for Over Half of Drug Recalls

The FDA defines a dietary supplement as a product taken by mouth that contains a dietary ingredient such as vitamins, minerals, herbs, botanicals, or amino acids, and it does not require approval before supplements can be sold.

The statistics are shocking: Dietary supplements accounted for more than half of Food and Drug Administration (FDA) Class I drug recalls between 2004 and 2012. During that time frame, 465 drugs were subjected to a Class I recall in the United States, and of those, 237—51 percent—were dietary supplements.

FDA Recalls Dietary Supplements

A Class I designation means that the ingredients contained within the supplements had a reasonable probability of causing serious adverse health consequences or death.

Supplements with the highest recall rate fall into three categories: sexual enhancement, bodybuilding, and weight loss.

Manufacturers Aware of Penalties

Supplement manufacturers are aware that their products do not have to earn FDA approval, but they are also aware of the severe penalties if they market their products containing certain ingredients or make an absolute assertion about what the supplement will do.

One example is the Airborne lawsuit. Airborne advertised their product as a way to prevent and treat colds. Due to a $23.3 million class-action settlement for false advertising, Airborne now simply refers to their products as immune boosters.

Contact a Drug Injury Attorney Today

If you or a loved one have been injured as a result of a drug or supplement, you are urged to contact the Indianapolis Drug Injury Attorneys of Wilson Kehoe Winingham. The lawyers at WKW can help you get the compensation you deserve. Call 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation.

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