Ephedra refers to a plant that had been used in China for many centuries already for medicinal purposes. It has names such as Ma Huang, Mahuang, Mahuanggen, Ma Huang root, and herbal ecstacy. Ephedra was the main active component for weight loss, bodybuilding, energy supplements, including Duper Diet, Diet Max, Metabolife, and HerbaLife, since 1990 until it was vetoed by the US Food and Drug Administration in 2004. It was found out that when it was mixed with caffeine, ephedrine restrains the appetite and stimulates the metabolism of the body. However it has a short term effect which means that it will be effective only while it is taken.
Since ephedra is sold as a dietary supplement, the US FDA has limited control over it until just recently. Normally, manufacturers are responsible for making sure that a dietary supplement is safe before it reaches the market. Because of this, US FDA could not control ephedra unless it was proven not safe for human use. Then, in the late 2003, FDA was able to find that it was unsafe, announced that consumers should discontinue using the dietary supplement with ephedra. The ban was in full blast countrywide in April 12, 2004.
Ephedra and its Health Risks
It was proven that ephedrine refers to an amphetamine-like substance, and these amphetamines increase heart beat and blood pressure level. And because ephedra can make one’s heartbeat very fast and causes their blood vessels to narrow, thus, increasing its chances for heart attack, stroke, seizures, and abrupt death.
As a result, some companies that produced and distributed ephedra supplements attempted to hide their ingredients and health risks. They tried to mislead the users by putting on their labels that the ingredients of the product are all natural, but the fact is, these ephedra products has synthetic chemicals. Take note, that any product that claims to help consumers lose weight or has the ability to provide energy has ephedrine in it.
FDA Attention to Ephedra
After more than 800 negative events reports or AERs in 1997 were linked with ephedra were submitted to the FDA and FDA, later proposed policies for dietary supplements that have ephedrine. FDA’s proposed regulations directed that a warning on the product label and a statement that the product must be used more than 7 days. They also recommended the required amount of ephedrine in one dose of a supplement is 8 milligrams (mg) with a total of not more than 24 mg each day.
Later in 2000, the main trade associations that represented the dietary supplement industry made a petition to the FDA for the recall of the remaining parts of the 1997 proposal. The petition also recommended the use of an industry standard for the labeling and marketing of dietary supplement products with ephedrine.
The Public Citizen Health Research Group has made a petition in September 2001 for the FDA to stop dietary supplements with ephedra. The petition claimed that FDA was given 1,393 reports of adverse side effects, including 81 deaths, which were associated with the ephedra supplements, from period of January 1993 to February 2001. FDA, at that time, said that they would consider the petition.
It was in June 14, 2002, when the US Department of Health and Human Services or HHS Secretary Tommy Thompson declared that the government had employed the RAND Corporation to review the present science on the safety of ephedrine, especially as an active ingredient for dietary supplements. The review was estimated to complete by early Fall 2002. Once, the review was done and completed, the result would be submitted to the National Institutes of Health or NIH to see if another research would be needed.
Sometime in July 2003, Kiley Bechler, the widow of a Major League Baseball pitcher filed a $600-million for the wrongful death legal case against the manufacturer of an ephedra-based dietary supplement. Kiley Bechler claimed that the supplement has resulted to the death of her husband from heat stroke during their team practice in Florida.
The US Food and Drug Administration gave a stern ruling in February 2004, stopping the sale of all dietary supplements that has ephedra as its main and active ingredient. Basing on the conclusion of the US FDA, that suing of ephedra in supplements gave an unreasonable health risks to its consumers. The complete ban became effective in April 12, 2004, 60 days after the publication of the official ruling.
Getting Legal Help
With the safety concerns raised over ephedra and the complete ban of the US FDA on all dietary supplements where it were found, the injured users may be able to recover the damages from the manufacturers and even the distributors of the products that have ephedra, aside from diet drugs. Since all dietary products have their particular side effects, the manufacturer has the obligation to its consumers, to provide sufficient information regarding the health risks associated with its products. If the manufacturer has failed to do so, they can be held legally liable to patients who had been injured as the consequence of insufficient warnings, under a product liability theory. If you have taken the product with ephedra and are experiencing any unusual side effects, contact your doctor immediately. Then, you can look for a reliable and experienced product liability lawyer to discuss your legal rights in recovery claims due to injury sustained due to the use of ephedra.