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- Taken together, the FDA recommends that consumers immediately stop using dietary supplements containing ephedra or ephedrine alkaloids.<a href="#hdng0">(More...)</a>
- The rule will become effective in 60 days.<a href="#hdng1">(More...)</a>
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Taken together, the FDA recommends that consumers immediately stop using dietary supplements containing ephedra or ephedrine alkaloids. While respecting the traditional uses of herbal medicines, their long history of use, and their potential health benefits, NCCAM believes that ephedra poses unique public health risks that warrant the FDA's actions to prohibit the sale of ephedra-containing dietary supplements. <a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a> In order to protect consumers, the FDA published a final rule on April 12, 2004, that bans the sale of dietary supplements containing ephedrine alkaloids. After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a>
The U.S. Food and Drug Administration (FDA) advises consumers to stop using dietary supplements containing ephedra.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a>
NCCAM will not fund any new studies of existing ephedra-containing products. Essentially all currently marketed dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, ma huang, Sida cordifolia, and pinellia, are affected by this rule.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a> In addition to supporting the RAND study, NCCAM supported a study of calls to poison control centers that revealed a disproportionate rate of reactions to ephedra relative to other herbal products.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a>
The FDA considered additional recent studies confirming that ephedra use raises blood pressure and otherwise stresses the circulatory system.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a> In recent years, ephedra products have been marketed as dietary supplements to promote weight loss, increase energy, and enhance athletic performance. The FDA reviewed information about ephedra's pharmacology, studies of its safety and effectiveness, newly available adverse event reports, and the RAND Corporation report--a review of the published scientific literature on ephedra efficacy and safety, sponsored by NCCAM and the National Institutes of Health's Office of Dietary Supplements.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a>
There is strong evidence that ephedra is associated with an increased risk of side effects, possibly even fatal ones.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a> Ephedrine alkaloids are found naturally in a number of plants, including the ephedra species (also known by the traditional Chinese medicine name--ma huang or Chinese Ephedra, or epitonin).<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a>
In February 2003, the agency solicited public comments regarding ephedra's side effects and whether ephedra-containing dietary supplements pose a "significant or unreasonable risk of illness or injury."<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a> The data showed little evidence of ephedra's effectiveness, except for short-term weight loss, while confirming that the substance raises blood pressure and stresses the heart.<a href="
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm" TARGET="_blank"
[1]</a>
An NCCAM-funded study that analyzed phone calls to poison control centers found a higher rate of side effects from ephedra, compared with other herbal products. Other studies and systematic reviews have found an increased risk of heart, psychiatric, and gastrointestinal problems, as well as high blood pressure and stroke, with ephedra use.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a> Between 1995 and 1997, the FDA received more than 900 reports of possible ephedra toxicity. Serious adverse events such as stroke, heart attack, and sudden death were reported in 37 cases. Taking ephedra can also result in nausea, anxiety, headache, psychosis, kidney stones, tremors, dry mouth, irregular heart rhythms, heart damage, high blood pressure, restlessness, sleep problems, irritation of the stomach, and increased urination.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a> In 2004, the FDA banned the U.S. sale of dietary supplements containing ephedra. The FDA found that these supplements had an unreasonable risk of injury or illness--particularly cardiovascular complications--and a risk of death.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a> Ephedra use may lead to serious health problems when used with other dietary supplements or medicines.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a> Ephedra has been used for more than 5,000 years in China and India to treat conditions such as colds, fever, flu, headaches, asthma, wheezing, and nasal congestion. It has also been an ingredient in many dietary supplements used for weight loss, increased energy, and enhanced athletic performance.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a>
Combining ephedra with caffeine increases the risk of potentially serious side effects.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a> Women who are pregnant or breastfeeding and children should avoid taking ephedra. Using ephedra may worsen many health conditions such as cardiovascular disease, kidney disease, sleep disorders, and diabetes.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a>
According to the FDA, there is little evidence of ephedra's effectiveness, except for short-term weight loss.<a href="
http://nccam.nih.gov/health/ephedra/" TARGET="_blank"
[2]</a>
Substantial evidence of harm emerged in 2003, when a major study reported more than 16,000 adverse events associated with the use of ephedra-containing dietary supplements, including heart palpitations, tremors and insomnia. The study also found little evidence that ephedra is effective in boosting physical activities and weight loss -- as claimed by its promoters.<a href="
http://www.fda.gov/oc/initiatives/ephedra/february2004/" TARGET="_blank"
[3]</a> Dietary supplements that contain ephedra have been banned in the United States since April 2004. FDA banned the products after it determined that ephedra posed an unreasonable risk to those who used it.<a href="
http://www.fda.gov/oc/initiatives/ephedra/february2004/" TARGET="_blank"
[3]</a> FDA subsequently determined that ephedra presents an unreasonable risk of illness or injury.<a href="
http://www.fda.gov/oc/initiatives/ephedra/february2004/" TARGET="_blank"
[3]</a> Ephedra, also called Ma huang, is a plant or herb that contains ephedrine, a substance that is regulated by FDA as a drug when created chemically in the lab. As such, it is subject to strict federal standards for safety and effectiveness.<a href="
http://www.fda.gov/oc/initiatives/ephedra/february2004/" TARGET="_blank"
[3]</a> Ephedra has generally been marketed as an ingredient in dietary supplements, which are not bound by the same strict standards as drugs.<a href="
http://www.fda.gov/oc/initiatives/ephedra/february2004/" TARGET="_blank"
[3]</a> On April 12, 2004, the agency's final rule prohibiting the sale of dietary supplements containing ephedra went into effect.<a href="
http://www.fda.gov/oc/initiatives/ephedra/february2004/" TARGET="_blank"
[3]</a>
The final rule, published Feb. 6, 2004, becomes effective on April 12, 2004. "This FDA rule reflects what the scientific evidence shows--that ephedra poses an unreasonable risk to those who use it," Health and Human Services Secretary Tommy G. Thompson said. "The regulations prohibit the sale of dietary supplements containing ephedra, and we intend to take swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect."<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> The burden of proof for showing a dietary supplement is unsafe rests with the FDA. Based on the FDA's recent comprehensive evaluation of the science, as well as a review of adverse event reports associated with products containing ephedra, the agency alerted consumers to stop buying and using these products immediately. In December 2003, the agency notified firms manufacturing and marketing these products of its intent to issue a final rule prohibiting their sale.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a>
The action banning ephedra, often referred to as ma huang, marks the first time that the FDA is taking formal action to halt the sale of a dietary supplement ingredient since passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> Under DSHEA, manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed. They are not required to obtain FDA approval before producing or selling dietary supplements, but they must make sure that product label information is truthful and not misleading. Once a dietary supplement reaches the market, the FDA can take formal action against any dietary supplement shown to be unsafe, such as ephedra.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> In 2003 the FTC brought four enforcement actions challenging deceptive claims about safety and side effects for ephedra supplements marketed as bodybuilding aids and energy boosters, and as alternatives to street drugs like Ecstasy. In these cases, the marketers both overstated the benefits and understated the risks of using the products.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a>
The Food and Drug Administration has banned the sale of dietary supplements containing ephedra (ephedrine alkaloids) due to concerns over their cardiovascular effects, including increased blood pressure and irregular heart rhythm.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> Ephedra is a naturally occurring substance found in plants. Its principal active ingredient is ephedrine, an amphetamine-like compound that potentially has powerful stimulant effects on the nervous system and heart. Like an amphetamine, ephedra increases both blood pressure and heart rate, decreases appetite, and makes the user feel energetic.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a>
In recent years, however, dietary supplement products containing botanical ephedra, often in combination with caffeine, another type of stimulant, have been promoted to help people lose weight and enhance sports performance and energy.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> A study of calls to poison control centers revealed a disproportionate rate of reactions to ephedra relative to other herbal products.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a>
The agency found that supplements containing ephedra show little evidence of effectiveness, except for short-term weight loss.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> Ephedra has been suspected of causing unreasonable health risks or injuries.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a>
There is strong scientific evidence of harm associated with the use of ephedra products. The FDA has been reviewing information for many years about ephedra's effects in the body, its safety and effectiveness, and the adverse event reports associated with its use.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> In light of the FDA's actions, some ephedra products already have been removed from the market, and the demand for ephedra products has declined significantly. Many companies have reformulated their products to remove ephedra, while others pulled products from the market altogether. The FDA says there is now concern over some of the alternative ingredients to ephedra, such as bitter orange, which contains synephrine, another form of stimulant with properties similar to ephedrine.<a href="
http://www.fda.gov/FDAC/features/2004/204_ephedra.html" TARGET="_blank"
[4]</a> The Food and Drug Administration (FDA) today issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury.<a href="
http://www.cfsan.fda.gov/~lrd/fpephed6.html" TARGET="_blank"
[5]</a>
To meet the standard required by the dietary supplement law, the FDA gathered and thoroughly reviewed evidence about ephedra's pharmacology; peer-reviewed scientific literature on ephedra's safety and effectiveness; adverse event reports; and a seminal report by the RAND Corporation, an independent scientific institute.<a href="
http://www.cfsan.fda.gov/~lrd/fpephed6.html" TARGET="_blank"
[5]</a>
Ephedra, also called Ma huang, is one of the plants that are a source of ephedrine alkaloids, including ephedrine and pseudoephedrine.<a href="
http://www.cfsan.fda.gov/~lrd/fpephed6.html" TARGET="_blank"
[5]</a>
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The rule will become effective in 60 days. FDA reiterates its advice that consumers stop using ephedra products immediately. <a href="
http://ods.od.nih.gov/Health_Information/Ephedra.aspx" TARGET="_blank"
[6]</a> Objectives: To assess the efficacy of herbal ephedra-containing dietary supplements and ephedrine on weight loss and athletic performance, through comprehensive literature review and synthesis of evidence. We also assessed safety of these products through review of adverse events reported in clinical trials, published case reports of adverse events, reports on file with the U.S. Food and Drug Administration (FDA), and a file of reports kept by a manufacturer of ephedra products, Metabolife.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> Reports of adverse events from controlled trials were included regardless of treatment duration. We reviewed all available reports of death, myocardial infarction (heart attack), cerebral vascular accident (stroke), seizure, and serious psychiatric illness reported to the FDA prior to September 30, 2001, and contained in their ephedra or ephedrine files, and all case reports identified in our literature search.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> The FDA provided us with copies of over 1,000 adverse event reports (AERs) related to herbal ephedra and 125 adverse event reports related to ephedrine.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> Short-term use of ephedrine, ephedrine plus caffeine, or dietary supplements containing ephedra with or without herbs containing caffeine is associated with a statistically significant increase in short-term weight loss (compared to placebo).<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a>
Data Collection and Analysis: We found 59 articles that corresponded to 52 controlled clinical trials of ephedrine or herbal ephedra for weight loss or athletic performance.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects: Structured Abstract Your browser doesn't support JavaScript.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> Forty-four were controlled trials assessing ephedra or ephedrine for weight loss. Of these, 18 were excluded from pooled analysis because they had treatment durations of less than eight weeks.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> We identified 43 additional cases as possible sentinel events with prior ephedra consumption and seven additional cases as possible sentinel events with prior ephedrine consumption.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> Prior ephedra consumption was associated with two deaths, three myocardial infarctions, nine cerebrovascular accidents, three seizures, and five psychiatric cases as sentinel events.<a href="
http://www.ahrq.gov/clinic/tp/ephedtp.htm" TARGET="_blank"
[7]</a> The two settlements and one complaint, filed in U.S. district court, target deceptive efficacy, safety, and "no side effects" claims for weight loss supplements containing ephedra (also known as Ma Huang). The FTC actions challenge false advertising claims that the ephedra supplements cause rapid, substantial, and permanent weight-loss without diet or exercise, and that "clinical studies" or "medical research" prove these claims.<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a> The FTC also challenges claims that the ephedra weight-loss products are "100% safe," "perfectly safe," or have "no side effects."<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a> The complaint further alleges that the defendants made unsubstantiated claims that the META-BIOLOGICAL ephedra weight-loss product is safe.<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a> The Federal Trade Commission today announced three enforcement actions against direct marketers of weight-loss products containing ephedra.<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a>
According to the FTC, there is no reliable evidence to suggest that ephedra, an ingredient in META-BIOLOGICAL, or androstenedione and yohimbe, ingredients in VIRILE V, are safe. The complaint alleges that they have been associated with health risks.<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a> The warning includes information that ephedra use can result in serious injury, and even death.<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a>
The order requires that a prominent warning about health risks be made in any advertisement, promotional item, or product label for an ephedra product.<a href="
http://www.ftc.gov/opa/2003/07/ephedra.shtm" TARGET="_blank"
[8]</a>
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