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xiaoruoqiu銅蟲 (正式寫手)
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[求助]
求高手幫忙看看二三段(主要是第三段)是什么意思,無須全文翻譯
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主要是第三段涉及到法律條文部分看得暈暈的 ,求大神指點一二FDA considers ENDS (電子香煙) to be combination drug and medical devices, and marketing of these products is illegal without regulatory approval. FDA has announced that a claim or representation for smoking cessation is not the only element it evaluates in making these determinations. It also focuses on the product’s intended uses, on whether they are intended to affect the body’s structures and functions and/or to treat, mitigate or prevent disease (e.g. nicotine addiction). FDA has reviewed electronic cigarettes, cigars and pipes and their components and classified them as drug–device combinations under section 503 (g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC § 353(g)(1)) with their‘drug’ uses, as defined in section 201(g) of the Act (21 USC § 321 (g)), as the primary mode of action, which are intended to affect the body’s structures and functions and, in some cases, to treat or prevent withdrawal symptoms of nicotine addiction. |
銅蟲 (正式寫手)
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金蟲 (小有名氣)
新蟲 (初入文壇)
| 第三段主句是 FDA has reviewed electronic cigarettes, cigars and pipes and their components and classified them as drug–device combinations and as the primary mode of action. 一是從食品藥物的屬性對其進行考察,是否對人體有傷害,二是從行為學(xué)的屬性看其效果,是否可以減輕尼古丁隱~ |
金蟲 (著名寫手)
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FDA宣布對戒煙的要求或表示不是評價做出這種決定的唯一因素。 同時也重點關(guān)注產(chǎn)品的預(yù)期用途,關(guān)注它們是否是用來影響人體的結(jié)構(gòu)與功能及/或是用來治療、緩解或防止疾。ɡ缒峁哦∩习a)。 FDA已考察了電子的香煙、雪茄和煙斗以及它們的成分并把它們作為藥物裝置組合分類于美國食品藥品化妝品法案(法案) (21 USC§353 (g) (1))的,503章(g)(1)項下,它們的藥物用途規(guī)定于本法案(21 USC§321 (g))的201章,它們主要的作用方式是用來影響人體的結(jié)構(gòu)與功能并且在某些情況下用來治療或防止尼古丁上癮的戒斷癥狀。 |
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