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xiaoruoqiu铜虫 (正式写手)
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[求助]
求高手帮忙看看二三段(主要是第三段)是什么意思，无须全文翻译
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主要是第三段涉及到法律条文部分看得晕晕的 ，求大神指点一二FDA considers ENDS (电子香烟) 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. |
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