-Examiner

08/04/2009 - In a post-Ephedra market, consumers by now should be well aware that products on drugstore shelves can be harmful. But the fact that your supplement isn't approved by the government doesn't mean it's unsafe. The U.S. Food and Drug Administration does not approve dietary supplements before they come to the market but rather may become involved after they are on shelves.

Within the past 12 months over 86 weight loss supplements have been flagged by the FDA as unsafe. Over 70 products tested positive for potentially harmful prescription drugs and chemicals that were not declared by their manufacturers. Fourteen Hydroxycut products were also recently recalled after the FDA reported possible liver damaging side effects.

How do these products land on shelves in the first place? According to the FDA's website, “the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.”1

That is unless it contains an ingredient that was not previously for sale in the US prior to 1994. In that case, the FDA will review – not approve – the supplement for safety not effectiveness.

According to the FDA, dietary supplements are not drugs. They lie under the umbrella labeled as food. Dietary supplements include vitamins, minerals, and other less familiar substances — such as herbals, botanicals, amino acids, enzymes, and animal extracts. 2

As for the FDA's post-marketing responsibilities, they have the power to take supplements off the market if deemed unsafe or if the claims on the product are false and misleading.

Once a product is marketed, the FDA is responsible for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or to remove it from the marketplace.

In order to monitor safety, in 2007 the FDA passed a set of new regulations requiring manufacturers to follow a set of Good Manufacturing Practices (GMP). The new rules require manufacturers to evaluate the identity, purity, quality, strength, and composition of dietary supplements.

Also under the new requirements, companies must report all serious dietary supplement adverse events to the FDA. This year Hydroxycut was recalled as a response to consumer complaints, and 70+ other supplements were flagged for containing unspecified ingredients.

While some believe recent events are good examples of how the new regulations are working to keep consumers safe, others see them as another reason why supplements should be more heavily regulated.

To ensure your own safety, read labels carefully. If you take prescription medication, be sure to speak with your health care provider before using any dietary supplements, as they may interact. If you experience any adverse reaction, report it to the FDA MedWatch program and contact your physician.

A little bit of research on your part can do your health a lot of good. There is plenty of information on the web about most ingredients regarding harmful side effects or adverse reactions when used as directed. While the ingredients of your supplement may be safe, the marketing claims may not be accurate. Look for products with free trials or money back guarantees.

For now, consumers should be beware of dietary supplements but know that just because it's not FDA approved, doesn't mean it's unsafe.

For more information about the Hydroxycut Recall, Hydroxycut Liver Damage, or Hydroxycut Lawsuit visit http://www.the-hydroxycut-lawyer.com