Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. 2014年,就在法布里坎特博士离开F.D.A.重返协会不久前,F.D.A.又从该组织中聘请了另一位官员卡拉·韦尔奇(CaraWelch)。
I am hoping you folks are taking this seriously, Dr. Spaeth wrote to Dr. Fabricant and other F.D.A. officials in an email on April 17, 2013. 我希望你们能认真对待这件事,施佩特博士在2013年4月17日写给法布里坎特博士和其他F.D.A.官员的电子邮件中写道。
F.D.A. officials did not, however, name the specific products. 然而,F.D.A.官员没有公布具体的产品名称。
But the job of the F.D.A. should be to guarantee a reasonable expectation of protection from danger, not to wait until people become sick before taking products off the market. 但FDA应当满足公众不受危害的合理预期,而不是等到人们患病之后,才勒令产品退出市场。
He said he told the F.D.A. he suspected the vitamins were contaminated with anabolic steroids. 他告诉F.D.A.他怀疑该维生素受到了合成类固醇的污染。
Dr. Fabricant said that the agency needed time to build a case against the vitamins because it had a legal burden to prove that they were dangerous before it could seek to have them recalled. 法布里坎特博士则称,F.D.A.需要一定时间来立案调查该维生素,因为遵照法律,在要求召回该产品之前,该机构有责任先证明它们确实有害。
It may be really expensive for Big Food to replace partially hydrogenated oils the F.D.A. itself estimates the cost at$ 6 billion mainly because trying to mimic their performance is going to be tricky. 让大型食品企业更换部分氢化油,成本可能非常高昂(FDA自己估计,成本高达60亿美元),主要原因在于模仿部分氢化油的表现十分困难。
After a stint with a consulting firm, Pinney Associates, he returned to the F.D.A. in early 2013 to lead the effort to finally regulate the tobacco industry. 之后他在咨询机构PinneyAssociates工作过一段时间,于2013年初回到FDA,着手实现对烟草行业的监管。
The bottom line is that I feel the F.D.A. did not do everything they could to protect the health of my patients and anyone else taking these supplements, Dr. Spaeth said. 施佩特博士说:总而言之,我觉得F.D.A.并没有尽力保护我的患者和服用这些补充剂的其他人的健康。
The F.D.A. usually follows the recommendations of its advisory panels, but not always. FDA通常会听取咨询委员会的建议,但也并非总是如此。
The company says the F.D.A. agreed to decide whether to approve their drug by July 24. 该公司表示,FDA同意在7月24日之前做出是否批准该药物的决定。
Dr. Spaeth said he got no response for weeks and called the agency numerous times. He also sent multiple emails to Dr. Fabricant and other F.D.A. officials, pleading with them to get the vitamins off the market. 施佩特博士说,数周来,他还给该机构打过很多电话,也给法布里坎特博士和F.D.A.的其他官员发了数封电子邮件,请求他们将该维生素下市,但从未得到任何回应。
The F.D.A. knows this: Its acting commissioner, Stephen Ostroff, said that eliminating trans fats is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year. FDA了解这一点:代理局长斯蒂芬·奥斯特洛夫(StephenOstroff)表示,消除反式脂肪预计可以降低冠心病发病率,每年避免数千人死于心肌梗塞。
The F.D.A. issued a health alert warning consumers about DMAA 16 months later& long after Australia, Britain, Canada and Sweden had banned it. 16个月后,F.D.A.向消费者发布了有关DMAA的健康警告&相比于澳大利亚、英国、加拿大和瑞典对此类产品颁布禁令的时间已经迟了很久。
He left the F.D.A. last year and returned to the association as its chief executive. 去年,法布里坎特博士离开了F.D.A.,又回到了该协会担任首席执行官。
In 2009, the F.D.A. issued a warning about the potential health risks associated with e-cigarettes, saying laboratory studies of some samples had found the presence of toxic chemicals, including diethylene glycol, which is used in antifreeze. 2009年,FDA发布了一条与电子烟相关的潜在健康风险警告称,在对一些样本进行实验室研究后发现,里面存在二甘醇等有毒化学物质,而这些东西是用于防冻剂的。
The F.D.A. is now considering whether a safety level should be set for arsenic in rice. 食品和药品监督局现在正考虑是否要对大米中的砷含量设定一个安全上限。
Some Chinese companies, however, are trying to get ahead of the anticipated F.D.A. rules. 但一些中国公司正设法赶在FDA出台规定前赢得利润。
The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any ethical and social policy issues are outside its scope. FDA顾问专家组称,此次会议对线粒体操作的思考将仅限于科学层面,任何伦理和社会政策问题都不在关注范畴内。
The F.D.A. does not yet have standards for e-liquids, but many of the Chinese companies say they make them in labs in the United States that have passed F.D.A. quality-control standards. FDA目前还没有关于电子烟液的标准,但许多中国企业都声称,他们是在美国的一些达到FDA质量控制标准的实验室制造这些液体的。
Eventually, analysts say, the F.D.A. could be compelled to certify e-cigarette factories and the manufacturing standards. 分析人士称,FDA最终将被迫对电子烟工厂和制造标准进行资质认证。
Advisory panels, which are made up largely of practicing doctors, sometimes look more kindly on a drug than the F.D.A., whose analysis is to some extent intended to note flaws in the data. 大部分由临床医生组成的咨委专家组对一种药的评价常较食物与药品管理局乐观一些,食物与药品管理局的分析在一定程度上倾向于提及资料中不好的一面。