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How to get your child to put away toys. Is a common pain reliever safe during pregnancy? The dangers of the herb ephedra January 20, Print This Page Click to Print. Staying Healthy.
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I want to get healthier. Despite the good safety record of most popular herbs in the U. Thompson said that the FDA could not have acted any sooner because DSHEA does not require manufacturers to prove a product safe prior to bringing it to the market.
To remove an unsafe supplement from the market, FDA must prove a clear danger to public health. Now, Congress should take a look at whether or not they want that to continue. To clarify this issue, a leading Washington, D. In an action related to the announcement, FDA sent letters to 62 firms that market dietary supplements containing ephedrine alkaloids "to give you advance notice of the publication of this rule to facilitate your earliest compliance," and to inform these firms that "FDA intends to begin enforcing the rule as soon as it becomes effective" i.
Questions from reporters sought the identity of additional herbs whose safety may be considered questionable that FDA may consider banning. At the press conference, Commissioner McClellan did not reveal any names, but stated, "Many dietary supplements have important values.
On three separate occasions Secretary Thompson expressed his desire to have the authority to receive [mandatory] reports of adverse events from supplement manufacturers. Using the challenging standard provided under the law, we have done all we can to make sure our regulatory action will succeed,"said Dr. Numerous professional and amateur sports associations, including the International Olympic Committee, and various branches of the military have banned ephedra supplements.
In the past year California, Illinois and New York have banned retail sales of dietary supplements containing the herb. Last March, FDA proposed strict new warnings for the primary display panel on all ephedra supplement labels.
FDA has apparently attempted create a solid scientific case capable of withstanding a potential challenge in an administrative hearing, as permitted by DSHEA. One of the consistent responses by leaders of the herb industry was that this action validates that many in the industry have been saying for years, that contrary to protestations by previous FDA officials and some members of Congress, FDA does have adequate authority and power to remove dietary supplements from the market that it deems unsafe.
He added, "AHPA will attentively evaluate the data on which this decision to ban ephedrine-containing supplements was based as soon as that information is available. For years, NNFA has urged the agency to use its powers to resolve the debate over ephedra. It was not clear at press time January 12 whether any industry group or individual companies would sue the FDA to challenge the ban. Industry veteran Loren Israelsen, executive director of the Utah Natural Products Alliance, a trade group representing manufacturers primarily in the Utah region, was quoted in the New York Times calling ephedra "a political lightning rod.
Israelsen said other supplement makers feared that if the F. The FDA stated, "Essentially all currently marketed dietary supplements will be affected by the rule. The rule does not pertain to traditional Chinese herbal remedies. Unlike ephedrine, we have not learned of thousands of adverse events being reported to the FDA. So despite BMPEA being an amphetamine isomer, use may not be as unsafe as it is being made to look, whether or not the drug belongs in supplements.
The FDA has been aware of some dietary supplements containing BMPEA for over two years now, but they have not yet recalled these products or issued a public warning that some products contain this drug.
However, these new findings from the Harvard researchers may in fact prompt a warning. But there is always a chance that a warning will be somewhat ineffective and that, like ephedrine, this drug may remain available. If people were using BMPEA to get high if it is even possible instead of using it for fitness purposes, it would be a different story and the Drug Enforcement Administration DEA would likely step in to control use.
Putting discussion of the need for proper testing and labeling aside, is the appearance of this new drug really unexpected? While some stores are willingly removing these products from their shelves, it would likely take a while for the FDA to issue a ban.
My question is what should we worry about more — the products containing this untested stimulant drug or the new untested stimulant drug that will eventually replace it? Stimulant drugs — whether used as dietary supplements or used to get high — will always have replacements once they are banned or controlled.
Festival of Social Science — Aberdeen, Aberdeenshire.
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