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Ephedra Banned: Consumers Advised to Stop Using Ephedra Products Immediately
Ephedra Banned Consumers Advised to Stop Using Ephedra Products Immediately Carolyn Davis Cockey, MLS
t Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart
February | March 2004
The FDA is publishing a final ruling that effectively bans the use of ephedra after seeking evidence and commentary regarding the use of ephedra since early 2003 (see AWHONN Lifelines, 7(2), 103106). FDA has also issued an alert advising consumers to stop using products containing ephedra immediately. In late December 2003, FDA notified manufacturers in writing and on its Web site of its intent to publish a final rule on dietary supplements containing ephedrine alkaloids. The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the
sale of dietary supplements containing ephedrine alkaloids when it becomes effective, 60 days following publication. In publishing the ruling, FDA officials said the agency obtained and reviewed all of the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra’s safety and effective-
AWHONN Lifelines
19
Carolyn Davis Cockey, MLS, is executive editor of AWHONN Lifelines and associate director of publications for AWHONN
20
AWHONN Lifelines
ness, adverse event reports and reviews by independent experts. According to the Federal Food, Drug, and Cosmetic Act, a dietary supplement product is adulterated if it or a dietary ingredient within it presents a significant or unreasonable risk of illness or injury under conditions of use suggested in the labeling or under ordinary conditions of use. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk to prevent it from being marketed; in contrast, for drugs that have similar pharmacologic properties to ephedra, manufacturers bear the burden of proof of showing that the drug is safe and effective before it can be marketed. Ephedra, also called ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy. FDA’s concerns about dietary supplements containing ephedra arise in part from ephedra’s mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. FDA’s evaluation also reflects the available studies of the health effects of ephedra. This includes many studies reviewed by the RAND Corporation, which found little evidence for effectiveness other than for shortterm weight loss, as well as evidence suggesting safety risks. Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
FDA’s notification reflects the agency’s recent comprehensive evaluation of the science as well as a public comment period intended to cap years of debate about the risks and safety of ephedra in dietary supplements. In 1997, FDA first proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. FDA modified this proposed rule in 2000, and last February the agency announced a series of comprehensive actions designed to protect Americans from the potentially serious risks of dietary supplements containing ephedra. To solicit comments on new evidence about ephedra as well as on a proposed warning statement, last February’s actions included publishing a Federal Register notice outlining FDA’s concerns and reopening the comment period. Following publication of this notice, FDA received and reviewed tens of thousands of comments. The agency has also reviewed a comprehensive RAND Corporation report on the data on ephedra and a series of adverse event reports that it was unable to obtain more quickly because under the Dietary Supplement Health and Education Act such adverse event reports are not required to be submitted to FDA. FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids alerting them of this future rule. The action is a continuation of a process that started in June 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than seven days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products. Some of the more popular products containing ephedra include Metabolife, Metab-OLite, Metabolift, Diet Fuel, Stacker 3 and Hydroxycut, to name but a few. Ephedra may be present in the following forms in other products: ephedrine, ma huang, ephedra sinica, sida cordifolia and pinellia.
Volume 8
Issue 1
Eating Disorders Raise Substance Abuse Risks
U
p to one-half of individuals with eating disorders abuse alcohol or illicit drugs, compared to 9 percent of the general population, according to “Food for Thought: Substance Abuse and Eating Disorders,” the first comprehensive examination of the link between substance abuse and eating disorders. Conversely, up to 35 percent of alcohol or illicit drug abusers have eating disorders compared to 3 percent of the general population, says the 73-page report released by The National Center on Addiction and Substance Abuse (CASA) at Columbia University. “For many young women, eating disorders like anorexia and bulimia are joined at the hip with smoking, binge drinking and illicit drug use,” say the authors of the report. “This lethal link between substance abuse and eating disorders sends a signal to parents, teachers and health professionals—where you see the smoke of eating disorders, look for the fire of substance abuse and vice versa.” The exhaustive report finds anorexia nervosa and bulimia nervosa as the eating disorders most commonly linked to substance abuse and for the first time identifies the shared risk factors and shared characteristics of both afflictions. Those shared risk factors include: • • • • • •
Occur in times of transition or stress Common brain chemistry Common family history Low self-esteem, depression, anxiety, impulsivity History of sexual or physical abuse Unhealthy parental behaviors and low monitoring of children’s activities • Unhealthy peer norms and social pressures • Susceptibility to messages from advertising and entertainment media According to the report, the shared characteristics include: • Obsessive preoccupation, craving, compulsive behavior, secretiveness, rituals • Experience mood-altering effects, social isolation • Linked to other psychiatric disorders, suicide • Difficult to treat, life threatening • Chronic diseases with high relapse rates • Require intensive therapy The report lists caffeine, tobacco, alcohol, diuretics, laxatives, emetics, amphetamines, cocaine and heroin as substances used to suppress appetite, increase metabolism,
February | March 2004
purge unwanted calories and self-medicate negative emotions. The report found that because health professionals often overlook the link between substance abuse and eating disorders, treatment options are virtually nonexistent for these co-occurring conditions. “The public health community, parents and policy makers must educate our children about healthy body images from a very young age, and treatment and prevention programs must address the common co-occurrence of substance abuse and eating disorders,” stated Susan Foster, vice president and director of policy research and analysis at CASA, who spearheaded the project. “Advertisers put children at greater risk of developing an eating disorder through the portrayal of unrealistic body images,” the report noted. “The average American woman is 5’4” tall and weighs approximately 140 pounds, but the average model that purportedly epitomizes our standard of beauty is 5’11” tall and weighs 117 pounds.” The report found that women’s magazines contain more than 10 times more ads and articles related to weight loss than men’s magazines, which is the same gender ratio reported for eating disorders. The report finds that while only 15 percent of girls are overweight, 40 percent of girls in grades one through five and 62 percent of teenage girls are trying to loose weight. These girls are especially vulnerable to eating disorders and related substance abuse problems. Other findings noted within the report include: • Middle school girls (10- to 14-year-olds) who diet more than once a week are nearly four times likelier to become smokers • Girls with eating disorder symptoms are almost four times likelier to use inhalants and cocaine • 12.6 percent of female high school students take diet pills, powders or liquids to control their weight without a professional’s advice • Bulimic women who are alcohol dependent report a higher rate of suicide attempts, anxiety, personality and conduct disorders and other drug dependence than bulimic women who are not alcohol dependent • Hispanic girls are slightly more likely than Caucasian girls and significantly more likely than African American girls to report having fasted for 24 hours or more and having vomited or taken laxatives to lose weight To access the full report, go to www.casacolumbia.org.
AWHONN Lifelines
21
t Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart
February | March 2004
The FDA is publishing a final ruling that effectively bans the use of ephedra after seeking evidence and commentary regarding the use of ephedra since early 2003 (see AWHONN Lifelines, 7(2), 103106). FDA has also issued an alert advising consumers to stop using products containing ephedra immediately. In late December 2003, FDA notified manufacturers in writing and on its Web site of its intent to publish a final rule on dietary supplements containing ephedrine alkaloids. The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the
sale of dietary supplements containing ephedrine alkaloids when it becomes effective, 60 days following publication. In publishing the ruling, FDA officials said the agency obtained and reviewed all of the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra’s safety and effective-
AWHONN Lifelines
19
Carolyn Davis Cockey, MLS, is executive editor of AWHONN Lifelines and associate director of publications for AWHONN
20
AWHONN Lifelines
ness, adverse event reports and reviews by independent experts. According to the Federal Food, Drug, and Cosmetic Act, a dietary supplement product is adulterated if it or a dietary ingredient within it presents a significant or unreasonable risk of illness or injury under conditions of use suggested in the labeling or under ordinary conditions of use. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk to prevent it from being marketed; in contrast, for drugs that have similar pharmacologic properties to ephedra, manufacturers bear the burden of proof of showing that the drug is safe and effective before it can be marketed. Ephedra, also called ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy. FDA’s concerns about dietary supplements containing ephedra arise in part from ephedra’s mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. FDA’s evaluation also reflects the available studies of the health effects of ephedra. This includes many studies reviewed by the RAND Corporation, which found little evidence for effectiveness other than for shortterm weight loss, as well as evidence suggesting safety risks. Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
FDA’s notification reflects the agency’s recent comprehensive evaluation of the science as well as a public comment period intended to cap years of debate about the risks and safety of ephedra in dietary supplements. In 1997, FDA first proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. FDA modified this proposed rule in 2000, and last February the agency announced a series of comprehensive actions designed to protect Americans from the potentially serious risks of dietary supplements containing ephedra. To solicit comments on new evidence about ephedra as well as on a proposed warning statement, last February’s actions included publishing a Federal Register notice outlining FDA’s concerns and reopening the comment period. Following publication of this notice, FDA received and reviewed tens of thousands of comments. The agency has also reviewed a comprehensive RAND Corporation report on the data on ephedra and a series of adverse event reports that it was unable to obtain more quickly because under the Dietary Supplement Health and Education Act such adverse event reports are not required to be submitted to FDA. FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids alerting them of this future rule. The action is a continuation of a process that started in June 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than seven days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products. Some of the more popular products containing ephedra include Metabolife, Metab-OLite, Metabolift, Diet Fuel, Stacker 3 and Hydroxycut, to name but a few. Ephedra may be present in the following forms in other products: ephedrine, ma huang, ephedra sinica, sida cordifolia and pinellia.
Volume 8
Issue 1
Eating Disorders Raise Substance Abuse Risks
U
p to one-half of individuals with eating disorders abuse alcohol or illicit drugs, compared to 9 percent of the general population, according to “Food for Thought: Substance Abuse and Eating Disorders,” the first comprehensive examination of the link between substance abuse and eating disorders. Conversely, up to 35 percent of alcohol or illicit drug abusers have eating disorders compared to 3 percent of the general population, says the 73-page report released by The National Center on Addiction and Substance Abuse (CASA) at Columbia University. “For many young women, eating disorders like anorexia and bulimia are joined at the hip with smoking, binge drinking and illicit drug use,” say the authors of the report. “This lethal link between substance abuse and eating disorders sends a signal to parents, teachers and health professionals—where you see the smoke of eating disorders, look for the fire of substance abuse and vice versa.” The exhaustive report finds anorexia nervosa and bulimia nervosa as the eating disorders most commonly linked to substance abuse and for the first time identifies the shared risk factors and shared characteristics of both afflictions. Those shared risk factors include: • • • • • •
Occur in times of transition or stress Common brain chemistry Common family history Low self-esteem, depression, anxiety, impulsivity History of sexual or physical abuse Unhealthy parental behaviors and low monitoring of children’s activities • Unhealthy peer norms and social pressures • Susceptibility to messages from advertising and entertainment media According to the report, the shared characteristics include: • Obsessive preoccupation, craving, compulsive behavior, secretiveness, rituals • Experience mood-altering effects, social isolation • Linked to other psychiatric disorders, suicide • Difficult to treat, life threatening • Chronic diseases with high relapse rates • Require intensive therapy The report lists caffeine, tobacco, alcohol, diuretics, laxatives, emetics, amphetamines, cocaine and heroin as substances used to suppress appetite, increase metabolism,
February | March 2004
purge unwanted calories and self-medicate negative emotions. The report found that because health professionals often overlook the link between substance abuse and eating disorders, treatment options are virtually nonexistent for these co-occurring conditions. “The public health community, parents and policy makers must educate our children about healthy body images from a very young age, and treatment and prevention programs must address the common co-occurrence of substance abuse and eating disorders,” stated Susan Foster, vice president and director of policy research and analysis at CASA, who spearheaded the project. “Advertisers put children at greater risk of developing an eating disorder through the portrayal of unrealistic body images,” the report noted. “The average American woman is 5’4” tall and weighs approximately 140 pounds, but the average model that purportedly epitomizes our standard of beauty is 5’11” tall and weighs 117 pounds.” The report found that women’s magazines contain more than 10 times more ads and articles related to weight loss than men’s magazines, which is the same gender ratio reported for eating disorders. The report finds that while only 15 percent of girls are overweight, 40 percent of girls in grades one through five and 62 percent of teenage girls are trying to loose weight. These girls are especially vulnerable to eating disorders and related substance abuse problems. Other findings noted within the report include: • Middle school girls (10- to 14-year-olds) who diet more than once a week are nearly four times likelier to become smokers • Girls with eating disorder symptoms are almost four times likelier to use inhalants and cocaine • 12.6 percent of female high school students take diet pills, powders or liquids to control their weight without a professional’s advice • Bulimic women who are alcohol dependent report a higher rate of suicide attempts, anxiety, personality and conduct disorders and other drug dependence than bulimic women who are not alcohol dependent • Hispanic girls are slightly more likely than Caucasian girls and significantly more likely than African American girls to report having fasted for 24 hours or more and having vomited or taken laxatives to lose weight To access the full report, go to www.casacolumbia.org.
AWHONN Lifelines
21