以往很多不良商家在推销保健食品时,总是将保健品与药品混为一谈,夸大保健品的医疗效果。新修订的《中华人民共和国食品安全法》近日获得人大表决通过,并将于2015年10月1日正式施行,其中明确保健食品必须在说明书中声明“不能替代药物”。
新修订的食品安全法被称为史上最严。专家认为,新食品安全法再次加强保健食品的管理规定,有利于整肃保健食品非法生产、非法经营、非法添加和非法宣传等乱象,也有利于帮助消费者科学选择、理性消费保健食品。
保健品须声称“不能替代药物”
近日,十二届全国人大常委会第十四次会议举行了闭幕会,表决通过了新修订的《食品安全法》,将于2015年10月1日起施行。新修订的《食品安全法》对保健食品、特殊医学用途配方食品、婴幼儿配方食品的监管作了进一步完善。
其中,第七十五条规定,保健食品声称保健功能,应当具有科学依据,不得对人体产生急性、亚急性或者慢性危害。保健食品原料目录和允许保健食品声称的保健功能目录,由国务院食品药品监督管理部门会同国务院卫生行政部门、国家中医药管理部门制定、调整并公布。
保健食品原料目录应当包括原料名称、用量及其对应的功效;列入保健食品原料目录的原料只能用于保健食品生产,不得用于其他食品生产。有些物质属于药食同源,既可以用于普通食品,也可以用于保健食品,为了清晰地界定保健食品与其他食品的区别,新《食品安全法》中明确提出了列入保健食品原料目录的原料,按照目录规定的用量、声称的对应功效只能用于保健食品的生产,这条规定进一步明确了保健食品和其他食品的区别。
鉴于我国添加中药材的保健食品较多,在前两次审议稿针对保健食品的原料、保健食品的注册和备案等方面作出规定的基础上,提交三审的草案再次加强了对保健食品标签、说明书的管理。新《食品安全法》第七十八条规定,保健食品的标签、说明书不得涉及疾病预防、治疗功能,内容应当真实,与注册或者备案的内容相一致,载明适宜人群、不适宜人群、功效成分或者标志性成分及其含量等,并声明“本品不能代替药物”。保健食品的功能和成分应当与标签、说明书相一致。
功效宣传常误导消费者
保健食品与普通食品标示不明,这种情况实际上是保健食品市场的“常态”。一些品牌较大的保健品,大都已经在外包装上注明“本品不能替代药品”的字样。但是销售人员在推销时,却会有意无意把保健品和药品混作一谈。
广东省营养产业协会秘书长张咏对媒体表示,就广东而言,目前市面上七成以上保健品存在夸大宣传情况,而普通食品冒充保健品销售、保健品冒充药品扩大宣传销售、药品冒充普通食品销售的混乱情况更是屡见不鲜。
一些非法保健食品广告利用国家机关及事业单位、医疗机构、学术机构、行业组织的名义和形象,为产品的功效作说明,以增强产品的权威性和说服力。还有一些广告含有无法证实的所谓“科学或研究发现”、“实验或数据证明”等方面内容,极力宣扬“药到病除”。
“保健食品不是药品,不能声称治疗功效,更不能达到代替药物的作用。”保健品销售业内人士提醒称,所有正规的保健品都不可能具有任何替代药物的功能,所以目前市面上销售的,所谓通过高科技从中药提取、对人无任何毒副作用的降糖降压、治疗心脑血管、各类骨关节产品,都绝对是骗人的。
“此次之所以加强对保健食品标识说明书的管理,是因为现在虚假宣传太多,标识说明中有一些功效的宣传误导消费者。”业内人士表示,新《食品安全法》规定保健食品的标识说明书,包括广告,应当与注册、备案的名称相一致,并标明“食品不能代替药物”,就是告诉消费者在买保健食品的时候,脑子里一定要有一根弦,不能代替日常用药。
业内人士分析认为,新《食品安全法》将对保健食品“夸大宣传”及“堪比药效”的营销形式进行严管,这可能令保健食品企业短期内产生阵痛,但长远来看,对企业在产品生产、销售和品牌建立等方面有极大帮助。
保健品管理注册备案双轨并行
2014年7月,《食品安全法(修订草案)》向社会公开征集意见,当年12月30日,全国人大发布《中华人民共和国食品安全法(修订草案二次审议稿)》,关于保健食品的注册,两次草案均提到了实施备案制。新《食品安全法》则明确了对保健食品实行注册与备案分类管理的方式,改变了过去单一的产品注册制度。
新《食品安全法》第七十六条规定,使用保健食品原料目录以外原料的保健食品和首次进口的保健食品应当经国务院食品药品监督管理部门注册。但是,首次进口的保健食品中属于补充维生素、矿物质等营养物质的,应当报国务院食品药品监督管理部门备案。其他保健食品应当报省、自治区、直辖市人民政府食品药品监督管理部门备案。
业内人士表示,保健食品注册制向备案制的过渡是一个逐步的过程,目前注册制与备案制双轨并行的方法更适合国内市场实际情况。“保健食品的注册制度实行近20年,大量不安全的、功效评价不合格的产品没有通过注册,保障了产品的安全性和消费者的利益,如果取消注册,必将产生一系列的安全问题。”
此前,中国保健协会理事长张凤楼在接受媒体采访时表示,从严格的注册改变为绝大部分产品宽松的备案,这样的大跨度法制变化,是不是能够起到严格监管的作用,令人堪忧。而实施保健食品分级分类注册和备案管理的法律制度,可形成良好的生产规范。
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