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主题:【整理】中医能治什么病?资料整理 -- 阴霾信仰

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家园 美国FDA最新正式警告:不准在美国卖西药

FDA警告

FDA警告

标题党谁不会啊。

人家FDA的warning里归类为new drug/misbranded,这类指控中西药疗法远多于中药。这次对中药协会的主要指控是:

A drug is misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.

错误标签,把只需要自我诊断的药当处方药卖。根据是中药协会宣传的疗效处于处方药范围,而在FDA在相应的处方药批准表中找不到这些中药的批准许可。因而要求整改并上交保证不再发生(reocurrence),也就是说当成非处方药卖还是可以的。

而相应的,另外一个在这类下的西药,叫crossroad的疗法,宣称抗焦虑,抗海洛因等毒品成瘾,并且 It was actually a drink called Crossroads. . . . I tried it and like 15 minutes later, leg cramps went away, upset stomach, diarrhea, restlessness, pacing back and forth – it all went away. I had no withdrawals at all.”

因为有compliant, FDA直接威胁采取法律行动了。

而且一个美国中医药协会什么时候能代表中医了?看到个FDA的警告就兴奋成这样,同种型下那么多西药疗法警告视而不见,至于么,中医黑都失去理智了吧。

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