FDA Safety Information: Stop Recalls Before They Start

-TheLedger

08/05/2009 - Warnings and recalls are necessary components of any system that seeks to protect consumers and their health.

Yet these actions - which the U.S. Food and Drug Administration has regularly used to warn consumers after specific over-the-counter supplements caused health problems in users - are not acceptable alternatives to effective testing and regulation before such products are sold.

The FDA issued a public notice last week about "new safety information concerning products marketed for body building and increasing muscle mass." The agency warned a manufacturer, American Cellular Laboratories, that its "Xtreme" line of products - which it says are "dietary supplements" - improperly contain synthetic steroids (see http://tinyurl.com/n4owzg).

According to the warning, the eight products cited are "unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness."

Over the past two years, the FDA has received 15 reports of serious health problems - including stroke, liver problems and pulmonary embolism - associated with body-building products from various makers, reports The New York Times.

When the FDA recalled Hydroxycut - a so-called weight-loss pill - after 23 reports of "significant adverse health effects in users," the number of reported health problems linked to these supplements was not huge.

LONG SERIES OF FDA ACTIONS

Yet it is nearly impossible for the FDA to grasp the extent of side effects because the agency relies on manufacturers and customers to report them. One expert consulted by The Times estimates that 50 or more brands of supplements might contain the same synthetic steroids as the Xtreme line.

Moreover, the warning about the Xtreme products and the recall of Hydroxycut represent just the latest in a long series of FDA actions related to dietary supplements. This year alone, the FDA has identified and warned consumers about more than 70 brands of pills that illegally contain prescription-drug ingredients.

For example, in February, the FDA said a product called StarCaps - promoted as an all-natural weight-loss supplement - contained bumetanide, a potent diuretic.

Unfortunately, there's not a lot new about recalls involving dietary supplements. One of the most notable FDA actions was a ban in 2004 on ephedra - a class of natural, amphetamine-like substances found in plants - after more than 16,000 "adverse events" were reported.

This dangerous cycle will go on until the FDA is given more authority to test the products - and the claims made by their manufacturers and sellers - before they are sold.

AGENCY HAMPERED SINCE 1994

Consumers have some responsibility to protect themselves, but their defense system is inadequate. Labels that fail to list all the ingredients are part of the problem, but the biggest shortcoming is the FDA's inability to proactively examine supplements.

Under most circumstances, the law does not require dietary supplements to be proved safe to the FDA's satisfaction. Ditto for manufacturers' claims.

In general, the FDA can only act after a supplement is on the market and voluntary reports of problems - filed by consumers or physicians - trickle in. Even then, the FDA must show a "significant or unreasonable risk of illness or injury."

The FDA has been hampered since 1994, when Congress passed the Dietary Supplement Health and Education Act. When the act was approved and signed by then-President Clinton, the regulatory agency warned "about the seriousness of ... reported adverse events and their increasing number."

FDA testing and regulation of prescription drugs has on occasion fallen short of safety benchmarks and, as hundreds of overdose deaths in Florida have shown in recent years, the misuse of legal and well-tested medicines is a serious problem.

But at least consumers have a reasonable expectation that the pharmaceuticals they use have been subjected to substantial testing and research. The same cannot be said for supplements, especially those promoted as weight-loss wonders.

The supplement act should be changed to give the FDA adequate authority to ensure that the multibillion-dollar supplement industry meets essential safety standards. Unless Congress changes the law, it won't be long until the FDA issues more warnings and recalls - after more damage is done.

If you or a loved one have been injured or suffered a loss as a result of Hydroxycut use you may be entitled to compensation. Contact the Hydroxycut Lawyers of Ennis & Ennis, P.A. today for a free case evaluation by filling out the form on this page or calling toll-free: 1-800-856-6405. Our experienced Hydroxycut Attorneys can answer any questions you may have about Hydroxycut side effects, Hydroxycut recall, or a potential Hydroxycut lawsuit.