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EPHEDRA UPDATE: Beware of This Dangerous Herbal SupplementOct 1, 2003 In our August 2002 Newsletter we provided you with information regarding the health risks associated with a number of herbal supplements. At this time, however, we believe that it is necessary to devote an entire issue to what has become the most controversial dietary supplement on the market today, Ephedra.
Amazingly, even a simple search on www.Google.com will produce 1,500,000 results relating to Ephedra in 1/10 of a second. More amazing, however, is the incredibly broad spectrum of opinion with respect to the safety and effectiveness of Ephedra. There are those who believe Ephedra is safe and highly effective when used as directed and properly monitored. On the other hand, there are an ever growing number of medical and dietary experts who believe Ephedra is both ineffective and extremely dangerous. We believe that the limited benefits which Ephedra might produce are simply not worth the enormous risks now associated with its use as a dietary supplement.
What is Ephedra?
Ephedra is a stimulant containing ephedrine, an herbal “remedy” often used for weight loss, increased energy, and to relieve the symptoms associated with asthma, congestion, hay fever and allergies, and the common cold. (Ephedrine-containing products may list any of the following ingredients on their labels: ma huang, Chinese Ephedra, ma huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder, Sida Cordifolia, or epitonin.)
Ephedra is a shrub-like plant that is found in desert regions in central Asia and other parts of the world. The main active ingredients in Ephedra are the alkaloids ephedrine and pseudoephedrine.
What adverse reactions are associated with Ephedra?
Ephedra, which is or has been used in a wide array of products, has been accused of causing adverse reactions including heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, neuropathy (nerve damage), myopathy (muscle injury), palpitations (rapid heart rate), hypertension (elevated blood pressure), memory loss, insomnia, nervousness, tremors, seizures, respiratory depression, and even death.
Efforts to monitor and control its use.
Since its introduction to the market, Ephedra has been under close watch by groups such as the Food and Drug Administration (FDA) and the Consumer Health Products Association (CHPA). With all the unsettling reports of negative side effects, consumers are presently being told to be extremely cautious when using products which contain Ephedra or any of its derivatives or associated compounds.
The primary reason for such strict warnings is that while most of the products containing Ephedra include only the recommended or otherwise permissible amounts of the supplement, some of the products, such as those designed for weight-loss and body building, often contain unsafe amounts of the substance, are used in unsafe concentrations, are used under conditions which greatly increase the risk of injury, or are taken by people who have one or more risk factors which made the use of Ephedra extremely dangerous.
Following a series of reports of adverse health events after its introduction to the market in 1994, the FDA issued a statement on Ephedrine regulation. The FDA sought to limit the amount of Ephedra in products to less than 8 mg of Ephedrine alkaloids per serving and a daily intake of less than 24 mg. The FDA also proposed that a requirement be issued for labels instructing consumers not to use the product for more than seven days. This is based on the fact that the likelihood of suffering serious health problems increases as the exposure to Ephedra-containing products increases. However, even short-term use at increased levels, or under adverse conditions, or by those with known risk factors, may prove to be even more dangerous. Sudden “jolts” of Ephedra in high dosages may result in heart attack, stroke, seizure, or death.
The difficulty associated with regulating Ephedra.
The problem with regulating the distribution of any dietary supplement such as Ephedra stems from a law known as the Dietary Supplements Health and Education Act (DSHEA) which prevents the FDA from regulating these non-drug products. The DSHEA essentially reduced the FDA’s control over these products since, under that law, these substances are defined as “products intended to supplement the diet.”
According to the DSHEA, suppliers may sell any product that meets this vague definition either on its own or as an additive in other properly marketed product such as food, dietary supplements, or over-the-counter remedies of all types. Distributors are also free to make unsubstantiated claims about the supposed health benefits, quality, or effectiveness of these supplements.
Disturbing recent developments and efforts to ban Ephedra.
The following information is a chronological account of some of the most important discoveries related to Ephedra products.
In October of 2002, guidelines regarding dosage levels and label warnings were adopted by all of the trade associations for herbal product manufacturers. These guidelines noted that products should not contain more than 25mg of ephedrine per serving and that total daily consumption should never exceed more than 100mg of ephedrine.
In addition to these specified amounts, the guidelines also require that product labels should always contain an adequate cautionary statement which provides the consumer with the necessary information for them to avoid all associated health risks.
The label must instruct consumers to consult a health care professional prior to using the product if they have heart disease, thyroid disease, diabetes, high blood pressure, psychiatric problems, difficulty in urinating, prostate enlargement, or seizure disorder. The label must also instruct consumers to seek medical advice if they are using an MAOI inhibitor or any other prescription drug, especially ones which contain ephedrine.
In August of 2001, Health Canada, the Canadian equivalent of our Department of Health and Human Services, issued a report advising Canadians to avoid using products containing Ephedra, in general, and specifically in combination with caffeine and other stimulants. The Health Canada proposal for guidelines to prevent the possibility of exposure to health risks from dietary supplements included some of the following statements:
* Pre-market approval should be required for all dietary supplements. (As it exists now, especially in the United States, these supplements are all too often released onto the market before they are adequately tested.)
* Any serious adverse reaction occurring both in and outside of Canada would have to be reported within 15 days.
* The product license for a specific dietary supplement could be immediately suspended if the supplement is found to present a serious health risk to the public.
As a result of these steps taken by Health Canada to stop the improper use of Ephedra, the sale of Ephedra products was banned completely in January 2002.
Following the reports of illnesses related to Ephedra-containing products, the FDA was still attempting to warn consumers of the health risks associated with Ephedra and Ephedra products, even though it was still unable to have these products banned. The government also began a criminal investigation of whether one manufacturer lied about the herb’s alleged safety.
In October 2002, the FDA announced that it was stopping imports of “Yellow Jackets,” an herbal amphetamine product which contains Ephedra among other stimulants. This action was likely a response to the death of a teenager who died after taking Yellow Jackets. The FDA claimed that there did not seem to be any legitimate use for this product and that it was being marketed to consumers as an alternative to cocaine and other “street drugs”. The issue here also related to one of the aforementioned improper uses of Ephedra, namely, exceeding the daily prescribed limit. With over-the-counter products like Yellow Jackets, users are often unable to monitor their total Ephedra intake.
In February 2003, the Department of Health and Human Services (HHS), working in conjunction with the FDA, announced that they were finally going to take action to protect Americans from potentially serious risks associated with products containing Ephedra. HHS and the FDA stated that they would now make information concerning the health risks associated with Ephedra more readily available to the public in order to support new restrictions on Ephedra-containing products. In addition, they demanded that new warning labels, which accurately explain the risks associated with Ephedra use, appear on any products which continue to be marketed. They also sought to eliminate false or misleading advertising associated with the substance (as in the case of Yellow Jackets and energy-boosting products which promise enhanced athletic performance).
The results of a RAND Corporation study were perhaps responsible for this change in FDA and HHS policy as these results illustrated just how harmful Ephedra can be when used both properly and improperly. The results of the study listed about 16,000 adverse side effect reports including two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases. The report also concluded that while Ephedra-products make up less than one percent of all dietary supplements sales, these products account for 64% of adverse events associated with dietary supplements. As a result of these findings, the FDA sent warning letters to more than two dozen firms marketing dietary supplements that contain ephedrine. The FDA also proposed a new warning label which illustrates the serious health risks associated with Ephedra and the heightened risk of these health conditions when the supplement is taken in unsafe dosages, with strenuous exercise, and with other stimulants such as caffeine.
On February 17, 2003, 23-year-old Baltimore Oriole pitcher Steve Belcher died of multiple organ failure while at spring training. He was 6’2” tall and 239 pounds. At the time, he had been using Xenadrine, an Ephedra based weight loss product. Belcher was working out in extremely hot weather with heavy clothing in an attempt to lose weight. He also had a number of risk factors which should have discouraged him from using the product. This points out the fact that warnings are either inadequate or not being driven home. It also indicates that people may be disregarding the warnings or not fully appreciating the risk factors they may have. Belcher’s wife has instituted a $600 million dollar lawsuit against the product manufacturer.
On November 21, 2002, Johnny Perry, a 30-year-old strongman (6’5” and 375 pounds) died shortly after finishing among the top qualifiers in the World’s Strongest Man competition. Perry, who also used steroids, was known to “get wired” before a competition by taking 5 or 6 capsules of Ephedra.
Obviously, Belcher and Perry were not using Ephedra in the safest ways but, this is precisely why the medical community is so concerned about the use of the substance, in general, and by average people including young athletes and teenagers seeking to lose weight.
In May of 2003, following the death of a 16-year-old boy in Illinois who ingested Ephedra in order to help him make the football team, a nationwide class action lawsuit against Metabolife and other manufacturers of Ephedra-containing products was commenced. As a result of this lawsuit, Illinois became the first state to completely ban the sale of Ephedra.
Many sports organizations such as the NCAA, the NFL, and the International Olympic Committee have already banned Ephedra while others are considering similar bans. Many States and municipalities around the country are working towards a nationwide ban of Ephedra-containing products.
In addition, General Nutrition Centers (GNC) announced that it will no longer sell Ephedra-containing products due to the overwhelming reports of adverse health events. Many of the manufacturers of products which had included Ephedra or one of its derivatives or associated compounds have reformulated their products to exclude those substances. Their advertising campaigns clearly announce their products are now "Ephedra free.”
With all of the information regarding the health risks surrounding Ephedra, it would appear that it is only a matter of time before Ephedra is taken off the market in the United States. Law suits are helping to accelerate this event. (Unfortunately, as is the case with many banned substances, black-market or internet sales will unquestionably continue and pose a great danger to those purchasing Ephedra in this way because of the complete absence of regulation and the impossibility of holding the sellers accountable for injuries caused by their bootleg products.)
Although there are still many websites touting the supposed benefits of Ephedra as a “natural substance” with many beneficial uses, most now contain disclaimers similar to the following:
“Neither the server maintainers nor any contributors can be held liable in any way for any information about Ephedra and/or data about Ephedra made available, or omitted, by the Ephedra-Mahuang website or its hosted sites. We cannot guarantee the accuracy or completeness of any information. All material is supplied "as is" without warranty of quality or accuracy of any kind. The entire risk as to the quality and/or accuracy of the information about Ephedra on this server is with you. Should any such material, information, etc. prove to be inaccurate or in any way defective, you (and not the server maintainers, or any contributors) assume the risk of relying on such material, including any consequential damages. Under no circumstances will the server maintainers, or any contributors, be liable for any damages from your reliance upon anything derived from this server even if the server maintainers have been advised that such defect or unsuitability exists. The server maintainers and contributors disclaim all liability to you for damages, costs and expenses, including legal fees, and YOU HAVE NO REMEDIES FOR NEGLIGENCE OR UNDER STRICT LIABILITY, OR FOR BREACH OF WARRANTY OR CONTRACT, INCLUDING BUT NOT LIMITED TO INDIRECT, CONSEQUENTIAL, PUNITIVE OR INCIDENTAL DAMAGES, EVEN IF YOU GIVE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. You will indemnify and hold the server maintainers and contributors harmless from all liability, cost and expense, including legal fees, that arise directly or indirectly from any of the following that you do or cause: 1. distribution of this information from this server, 2. alteration, modification, or addition to the information from this server. By your use of this server, you agree to hold harmless the server maintainers and its contributors against ANY AND ALL CLAIMS arising out of said use, regardless of the cause, effects, or fault. Some of the material on this server may describe activities that are illegal for you to perform depending on your jurisdiction, without being identified as illegal. It is the responsibility of the individual reader to verify the legality of any actions described in these files. It is not recommended that any of the activities described herein actually be carried out. Specifically, we do not recommend growing, synthesizing, purchasing, using, administering, or selling any of the chemicals, plants, animals, fungi, and preparations described herein, regardless of legality. These files are provided FOR INFORMATION ONLY.”
We hope that this information has convinced our readers that Ephedra and Ephedra-based products are dangerous and should not be used. Moreover, we strongly suggest that parents carefully monitor their children with respect to the products they may be using for such things as weight loss, bodybuilding, and dietary supplementation associated with athletic training. Read all labels thoroughly to determine if Ephedra or one of its derivatives is contained in the product. Be aware of the adverse reactions associated with Ephedra as well as the risk factors which may seriously increase the dangers posed by Ephedra use.
In the event that you or a loved one has suffered an injury as a result of Ephedra use, or if you suspect this may be the case, please do not hesitate to contact Parker & Waichman for a free case evaluation. You may also wish to read more about Ephedra on our website at www.yourlawyer.com.