[注意]美國中藥最新動態

兰心

FDA Released Final Rule on Ephedra
FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing
Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using
These Products
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.
The rule will become effective 60 days from the date of publication.

兰心

[这个贴子最后由兰心在 2004/02/10 11:20pm 第 2 次编辑]

譯文如下﹕
美國FDA 發佈了一條法規﹐禁止銷售含有麻黃碱成份的藥品。並且再一次勸告顧客停
在使用這些產品。
食品和藥物管理局(FDA)今天發佈了禁止銷售含有麻黃碱成份的藥品的最後法規﹐因為
這種藥品導致了不明原因之疾病或損害的風險。
該法規將在公佈日後60天生效

兰心

記得幾個月前我們還和黃羨明黃老談到過麻黃的問題﹐他說美國政府不准我們用麻黃﹐簡直是豈有此理。他說經過他們多方爭取﹐這個問題應該能夠解決。誰知道3天前(2004年2月6號)﹐美國政府來了個最後通牒。看來讓世界全面接受中醫中藥﹐還仍是任重而道遠啊。

含笑半步癫

哪位有好主义呀？是不是含麻黄碱的药物都被禁止呢？

桂枝汤

下面引用由含笑半步癫在 2004/02/10 02:15pm 发表的内容：
哪位有好主义呀？是不是含麻黄碱的药物都被禁止呢？

美国有明文规定:不禁止植物药-----麻黄.

兰心

我寫錯了﹐應該是麻黄碱而不是麻黃。不過﹐麻黃中當然含有麻黄碱﹐恐怕難逃惡運。

刘茂山

下面引用由兰心在 2004/02/10 11:46pm 发表的内容：
我寫錯了﹐應該是麻黄碱而不是麻黃。不過﹐麻黃中當然含有麻黄碱﹐恐怕難逃惡運。

说的难听一点：狡辩！
看看五积散的帖子，他是怎么说不知道的，他又是怎么认错的。
收徒那张帖子。

兰心

你是不是神志不正常啊﹖我有什麼好狡辯的﹖真是語無倫次﹐不知所雲﹗我懷疑你根
本就是個卑鄙的馬甲﹐而且不懂英文﹐卻故意上英文版搗亂。

刘茂山

下面引用由兰心在 2004/02/10 11:46pm 发表的内容：
不過﹐麻黃中當然含有麻黄碱﹐恐怕難逃惡運。

1:是否可以这样理解：从大米当中提取的某种剧毒（名称忘记了）用来制造生物武器，那么大米当中含有剧毒，恐怕大米也罪责难逃？
2：桂枝汤的帖子说的清清楚楚。
3：怎么张嘴就骂人？你缺少家教。
4：不要听不得善意的忠告。

明堂振衣

下面引用由刘茂山在 2004/02/11 01:23pm 发表的内容：
1:是否可以这样理解：从大米当中提取的某种剧毒（名称忘记了）用来制造生物武器，那么大米当中含有剧毒，恐怕大米也罪责难逃？
2：桂枝汤的帖子说的清清楚楚。
3：怎么张嘴就骂人？你缺少家教。
4：不要听不得善 ...

知不知道别人在讲什么？不知道的话就应该先去学习学习，否则被人当成神经不正常一点儿也不冤枉。没事儿少扯皮，中医就是扯皮的人太多了，做事的人太少了。
下面两段转自ＦＤＡ网站，供大家参考，这件事情本来就是针对麻黄而来，没有诸位中医的努力，现在在美国可用而有限的一百二十几种中药迟早会被清除得一干二净，
1. FDA Announces Plans to Prohibit
Sales of Dietary Supplements Containing Ephedra
Consumers Advised to Stop Using Ephedra Immediately
On Dec. 30, 2003, FDA issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products.
Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy.
Also on Dec. 30, FDA notified manufacturers that it intends to publish a final rule stating 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 these products as soon as it becomes effective, 60 days after publication.

2. FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products
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. The rule will become effective 60 days from the date of publication.
"This FDA rule reflects what the scientific evidence shows - that ephedra poses an unreasonable risk to those who use it," Health and Human Services 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."
"In December, we advised consumers to stop using ephedra products, and we asked responsible companies to stop selling them," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We intend to use this regulation to make sure consumers are protected by removing these risky products from the market."
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use. FDA's final regulation presents a framework for applying this unique statutory standard.
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. The FDA also reviewed tens of thousands of public comments on the agency's request in March 2003 for information about ephedra-associated health risks.
In recent years, dietary supplements containing ephedrine alkaloids have been extensively promoted for aiding weight control and boosting sports performance and energy. The totality of the available data showed little evidence of ephedra's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke. "Until the final rule prohibiting the sale of ephedra-containing dietary supplements takes effect, FDA reiterates its warning to consumers: 'Do not take these products. They are simply too risky,'" said Dr. McClellan.
Ephedra, also called Ma huang, is one of the plants that are a source of ephedrine alkaloids, including ephedrine and pseudoephedrine. When chemically synthesized, ephedrine and pseudoephedrine are regulated under the Federal Food, Drug, and Cosmetic Act as drugs. In contrast to the DSHEA-regulated dietary supplements that contain ephedrine alkaloids, the safety and effectiveness of drug products containing ephedrine alkaloids in drug products have to be proven by the manufacturer.
The issuance of this final rule continues a process that started in June, 1997 when FDA first issued a proposal that required a statement on dietary supplements containing ephedrine alkaloids warning that they are hazardous and should not be used for more than seven days. FDA also proposed to restrict the amount of ephedrine alkaloids in dietary supplements and to prevent combining ephedra with other ingredients that have a known stimulant effect.
FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included taking enforcement actions against firms making unsubstantiated claims regarding enhanced athletic performance for their ephedra-containing products. FDA also issued warning letters to firms promoting these products as alternatives to illicit street drugs. Many firms have complied with FDA's warning against making such claims. FDA has also followed up with seizures and injunctions and joint enforcement actions with the Federal Trade Commission and the Department of Justice.