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xiaoruoqiu

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FDA considers ENDS (µç×ÓÏãÑÌ) 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¨Cdevice combinations under section 503 (g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC ¡ì 353(g)(1)) with their¡®drug¡¯ uses, as defined in section 201(g) of the Act (21 USC ¡ì 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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xiaoruoqiu: ½ð±Ò+30, ·­ÒëEPI+1 2013-05-31 12:50:25
xiaoruoqiu: ½ð±Ò+10 2013-05-31 12:51:00
FDAÐû²¼¶Ô½äÑ̵ÄÒªÇó»ò±íʾ²»ÊÇÆÀ¼Û×ö³öÕâÖÖ¾ö¶¨µÄΨһÒòËØ¡£ Í¬Ê±Ò²ÖØµã¹Ø×¢²úÆ·µÄÔ¤ÆÚÓÃ;£¬¹Ø×¢ËüÃÇÊÇ·ñÊÇÓÃÀ´Ó°ÏìÈËÌåµÄ½á¹¹Ó빦Äܼ°/»òÊÇÓÃÀ´ÖÎÁÆ¡¢»º½â»ò·ÀÖ¹¼²²¡£¨ÀýÈçÄá¹Å¶¡ÉÏñ«£©¡£
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3Â¥: Originally posted by wbcui at 2013-05-26 22:50:29
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xiaoruoqiu: ½ð±Ò+10 2013-05-31 12:50:33
µÚÈý¶ÎÖ÷¾äÊÇ FDA has reviewed electronic cigarettes, cigars and pipes and their components and classified them as drug¨Cdevice combinations and as the primary mode of action. Ò»ÊÇ´ÓʳƷҩÎïµÄÊôÐÔ¶ÔÆä½øÐп¼²ì£¬ÊÇ·ñ¶ÔÈËÌåÓÐÉ˺¦£¬¶þÊÇ´ÓÐÐΪѧµÄÊôÐÔ¿´ÆäЧ¹û£¬ÊÇ·ñ¿ÉÒÔ¼õÇáÄá¹Å¶¡Òþ~
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