FDA Speaks out on Ephedrine, & gives us chance to speak back...

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    FDA Speaks out on Ephedrine, & gives us chance to speak back...


    Your chance to speak out on preventing the ban/regulation of ephedra/ephedrine...

    U.S. Food and Drug Administration
    Telephone: 1-888-INFO-FDA

    Posted: 2/28/2003

    HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra

    The Department of Health and Human Services (HHS) today announced a series
    of actions designed to protect Americans from potentially serious risks of
    dietary supplement products containing ephedra.

    The results of a RAND Corporation study commissioned by the National
    Institutes of Health, as well as other recent studies, provide additional
    evidence that ephedra may be associated with important health risks. The
    Rand report also finds only limited evidence of health benefits resulting
    from ephedra use.
    On the basis of new evidence in the medical literature and in adverse event
    reports, there are reasons for heightened concern that dietary supplements
    containing ephedra may present a significant and unreasonable risk of
    illness and injury.

    To protect Americans from the potentially serious risks of these dietary
    supplements, HHS and FDA are going to:

    * Seek rapid public comment on the new evidence on health risks
    associated with ephedra to establish an up-to-date record as quickly as
    possible to support new restrictions on ephedra-containing products.

    * Seek rapid public comment on whether the currently available evidence
    and medical literature present a 'significant or unreasonabl risk of
    illness or injury' from dietary supplements containing ephedra.

    * Seek rapid comment on a strong new warning label on any ephedra products
    that continue to be marketed.

    * Immediately execute a series of actions against ephedra products making
    unsubstantiated claims about sports performance enhancement.

    * In addition, the nation's top public health officials issued strong
    statements cautioning about the use of ephedra-containing products,
    especially under conditions of strenuous exercise and in combination
    with other stimulants, including caffeine.

    'We want to caution all Americans - particularly athletes and those who
    engage in strenuous activities - about using dietary supplements that
    contain ephedra,' said Secretary of Health and Human Services Tommy G.
    Thompson. 'There continue to be serious questions about the risks
    surrounding this particular dietary supplement.'

    'FDA will do all we can to protect Americans from potentially dangerous
    dietary supplements,' said Commissioner of Food and Drugs Mark B.
    McClellan, M.D., Ph.D. 'We are particularly concerned about the risks of
    using products containing ephedra during heavy workouts, with caffeine and
    other stimulants, in a diet program that stresses the cardiovascular
    system, or by people under the age of 18. We are also concerned about
    potential stresses to the body caused by the long-term use of ephedra. The
    standard for regulating the safety of dietary supplements is largely
    untested, but we are committed to finding the right public health solution.'

    Ephedra is a naturally occurring substance derived from the Chinese herbal
    Ma Huang. Its principal active ingredient is ephedrine, which when
    chemically synthesized is regulated as a drug. While products containing
    natural ephedrine alkaloids have long been used to treat certain
    respiratory symptoms in traditional Chinese medicine, in recent years they
    been extensively promoted and used with the goals of aiding weight loss,
    enhancing sports performance, and increasing energy.

    Many of today's proposed actions involve a Federal Register notice, which
    went on display today, reopening for 30 days the comment period on a draft
    regulation FDA first proposed in 1997 and modified in 2000.

    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 nervous system and heart.

    In addition, evidence is accumulating about potentially serious safety
    problems following the use of ephedra-containing products. The RAND study
    has concluded that ephedra is associated with higher risks of mild to
    moderate side effects such as heart palpitations, psychiatric and upper
    gastrointestinal effects, and symptoms of autonomic hyperactivity such as
    tremor and insomnia, especially when it is taken with other stimulants.

    Moreover, its review of some 16,000 adverse event reports revealed two
    deaths, four heart attacks, nine strokes, one seizure, and five
    psychiatric cases involving ephedra in which the records appeared thorough
    and no other contributing factors were identified. RAND called such cases
    'sentinel events,' because they may indicate a safety problem but do not
    prove that ephedra caused the adverse event. The study recognized that such
    case studies are a weak form of scientific evidence. Other unmeasured
    factors may have contributed, and such serious adverse events are likely to
    happen (albeit at very low rates) among the millions of users of ephedra
    anyway. The study also identified other such events potentially associated
    with ephedra, in which other factors may have contributed to the adverse
    events or in which records were inadequate.

    Two recent studies of ephedra's safety were published too late to be
    included in the RAND Corporation's review, and each raises further
    concerns about ephedra. One, published this month in the Annals of
    Internal Medicine, found that although ephedra-products make up less than
    one percent of all dietary supplement sales, these products account for 64
    percent of adverse events associated with dietary supplements.

    Another 'case-control' study, published in the journal Neurology,
    concluded that the rate of hemorrhagic (bleeding) strokes among ephedra
    users was statistically significantly higher than among non-users, for
    people who take doses above 32 milligrams a day. Many ephedra dietary
    supplement labels recommend that users take up to approximately 100 mg of
    ephedra daily.

    Additional relevant evidence on whether the current system of regulating
    ephedra's safety is adequate comes from results under FDA's more extensive
    regulation of synthetic ephedrine, which is identical to the main
    active ingredient in ephedra. Ephedrine has long been available in some
    FDA-approved over-the-counter and prescription drugs. It appears that the
    more controlled availability of synthetic ephedrine products, which are
    available primarily for approved uses for respiratory symptoms and carry
    mandatory warning labels, has not been associated with the same kind of
    severe adverse events as have occurred with dietary supplements containing
    ephedra. This long experience with synthetic ephedrine (in
    over-the-counter drug products, not in dietary supplements) suggests that
    significant restrictions on labeling, marketing, and/or access to
    ephedrine might effectively address unreasonable risks associated with
    certain forms of ephedra today.

    'Although the overall evidence suggests that serious adverse events from
    ephedra appear to be infrequent,' said Dr. McClellan, 'we know that such
    events can be very serious and possibly fatal. We believe that the current
    scientific evidence strongly suggests that at least some ephedra products
    present an unreasonable risk. We also believe that FDA's system for
    regulating synthetic versions of the chemicals in ephedra appears to have a
    much better track record of safety. To give us the strongest
    possible basis for further regulatory action, we are asking for quick
    comments on whether these dietary supplements present an unreasonable risk
    of harm, and whether it makes sense for FDA to seek new authority in this
    area.'

    Under the Dietary Supplement Health and Education Act of 1994, FDA does
    not review dietary supplements for safety and effectiveness before the are
    marketed. Rather, the law allows FDA to prohibit sale of a dietary
    supplement if it 'presents a significant or unreasonable risk of injury.'
    This legal standard of 'significant or unreasonable risk' implies a
    risk-benefit calculation based on the best available scientific evidence.
    It strongly suggests that the agency must determine if a product's known
    or supposed risks outweigh any known or suspected benefits, based on the
    available scientific evidence, in light of the claims the product makes
    and in light of the product's being sold directly to consumers without
    medical supervision.

    In seeking comment on these issues, FDA is reopening a proposed rule
    entitled 'Dietary Supplements Containing Ephedrine Alkaloids.' That
    proposal would have required a warning statement for these products, as
    well as restrictions on their potency and composition. FDA later withdrew
    parts of this proposed rule because of concerns about the specific
    scientific evidence in the proposal, expressed by the General Accounting
    Office.

    In a broad action against potentially dangerous products, FDA today sent
    more than two dozen warning letters to firms marketing dietary supplements
    that contain ephedrine alkaloids. The letters, targeted particularly
    at products making claims for athletic performance, explain that any claims
    their products make about effects on the structure and function of the
    human body must be truthful and not misleading. They outline FDA's view in
    light of the RAND report that the claims being made are not adequately
    substantiated by scientific data, and they direct the companies to submit
    any data supporting the claims within 15 days.

    The letters also warn firms that they must not make claims about their
    products' ability to treat or cure a disease or condition such as obesity.
    Under the Federal Food, Drug and Cosmetic Act, unapproved products making
    these 'disease claims' are unapproved new drugs and therefore subject to
    other prompt regulatory actions, including injunctions against firms and
    seizures of their products.

    FDA will also continue to work closely with the Federal Trade Commission
    to ensure that dietary supplement products containing ephedra do not make
    false and misleading claims. ' If an ad says a product is 'safe,' the
    advertisers must have competent and reliable evidence to prove the claim,'
    said Timothy J. Muris, Chairman of the Federal Trade Commission.
    'Consumers depend on advertising for information. Deceptive ad claims can
    put a consumer's health at risk. That's why we will pursue
    aggressively marketers making deceptive claims about the safety or
    effectiveness of products.'

    In addition, FDA today proposed a warning label for all ephedra-containing
    dietary supplements. The proposed label warns about the risks of serious
    adverse events, including heart attack, seizure, stroke, and death;
    cautions that the risk can increase with the dose, with strenuous
    exercise, and with other stimulants such as caffeine; specifies certain
    groups (such as women who are pregnant or breast feeding) who should never
    use these products; and lists other conditions, such as diseases and the
    use of certain medications, that rule out the use of ephedrine alkaloids.

    'The steps being announced today demonstrate FDA's commitment to taking
    the most effective actions possible under current law, given the state of
    the scientific evidence,' said Dr. McClellan. 'It may be possible to use
    ephedra safely, in small doses, for some purposes. But in the face of
    continued serious adverse events following the use of ephedra, there is a
    problem. It is a problem we are determined to fix.'Once the 30-day comment
    period has ended, FDA will analyze the comments and publish its
    conclusions about the most appropriate approach to reducing the risk of
    using dietary supplement products containing ephedrine alkaloids.

    The National Advisory Council for the National Center for Complementary and
    Alternative Medicine, part of NIH, is meeting March 17th to assess the
    evidence on ephedra's safety and effectiveness in order to develop a
    research agenda on ephedra. FDA will give that committee an opportunity to
    comment on today's notice, should the committee find it appropriate to do
    so. All interested parties may send written comments on these issues
    involving ephedra until April 7, 2003, electronically to
    www.fda.gov/dockets/ecomments or by regular mail to Dockets Management
    Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room
    1061, Rockville, MD 20852.

    Additional materials about the risks of products containing ephedrine
    alkaloids, including a more technical FDA 'white paper,' may be found on
    FDA's Website

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    YellowJacket's Avatar
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    Bump- anyone who likes their freedom should read this.
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    Jedi Master's Avatar
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    Moderation is key. If people would use ephedrine wiseley there wouldnt be problems like this. There is more damage being done to people by acetaminophen (Tylenol), then there is from ephedra. Heres a link to what tylenol is doing to you. Anyways dont wanna get off subject, I just think the FDA should be concentrating thier efforts elsewhere. Just my .02 cents


    http://pulse.ucdavis.edu/scripts/01_...liver_dmg.html
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