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FDA's Regulation of Pet Food即FDA(美国食品及药物管理局宠物食品法规)

FDA's Regulation of Pet FoodFDA(美国食品及药物管理局宠物食品法规)The following consumer information is provided by Sharon Benz,Ph.D.,P.A.S.,Division of Animal Feeds,Center for Veterinary Medicine以下消费者信息由莎隆.本茨博士提供(兽医中心,动物饲料分部)FDA is charged with the enforcement of the Federal Food,Drug,and Cosmetic Act(the Act).Under the Act,a part of FDA's responsibility is to ensure that human and animal foods are safe and properly labeled.Within FDA,the Center for Veterinary Medicine is responsible for the regulation of animal drugs,medicated feeds,food additives and feed ingredients,including pet foods.The regulations based,in part,on this law are found in the Code of Federal Regulations,Title21,Food and Drugs,Part500.FDA承担着执行联邦食品,药物以及化妆品相关法案的实施。

在此法案下,FDA 的部分职责就是要为人类及动物的食品安全及正确标识负责。

在FDA内部,兽医中心主要负责动物药品,药用饲料,食品添加剂以及饲料添加,包括宠物食品。

本法规基于,某种程度上,是基于美国联邦法规,第21篇,食品及药品,第500部分。

The Act is this country's basic food and drug law.It defines food as"articles used for food or drink for man or other animals...and articles used for components of any such article." There is no requirement that pet foods have pre-market approval by FDA.The Act does require that pet foods,like human foods,be safe to eat,produced under sanitary conditions,contain no harmful substances,and be truthfully labeled.Additionally,canned pet foods must be processed in conformance with low acid canned food regulations(Title 21,Code of Federal Regulations,Part113,abbreviated as21CFR113).此法案是本国(美国)的食品及药品基本法。

其中定义食品为“用以当做人类及其他动物的食品或饮品的用品......以及用来合成类似功效的用品”。

目前没有对宠物食品规定的售前批准要求。

此法案要求宠物食品应像人用食品,必须食用安全,在卫生符合要求的环境下生产制作,不准包含任何有害物质,并且应如实进行包装。

此外,罐装宠物食品的操作必须符合低酸性罐装食品法规(美国联邦法规,第21篇,第113部分,缩写为21CFR113)In the Act a"drug"is,in part,an article intended for use in the diagnosis,cure,mitigation, treatment or prevention of disease,or an article intended to affect the structure or function of the body other than food(Sec.201(g)(1)).In the drug definition,the courts have interpreted"food"as something that provides nutrition,taste,or aroma.If a food affects the structure or function of the body,it does so by these properties(for example,a food may provide nutrients such as calcium for proper bone structure or taurine for healthy heart function in cats).However,if a substance affects the structure or function of the body apart from its nutritive value,such as urine acidification or improvement in joint function,it may be considered a drug.Structure/function effects extending beyond the "food"umbrella also include claims for improved or increased production and performance, or alteration or improvement in function.在此法案中“药品”在某种程度上是:旨在用来诊断,治愈,减缓,治疗或者预防某种疾病,或者旨在区别于食品来讲对身体的某部分构造起到一定作用的用品。

(Sec.201(g)(1))在药物学法案定义中,法院已对“食品”进行解释为:用以提供营养,滋味或者芳香的物品。

如果食品影响着身体某部分结构,其也必须具备此类功能(如:某种食品可供给营养物质比如钙,会对骨骼结构产生影响;亦或者牛磺酸会对猫科动物的心脏健康有益等)。

但是,如果某种物质不仅影响了身体部分构造或者功能,而且其影响远超出它自身的营养功效,比如能使尿液酸化或者提高关节的功能等,那其物质就应该被视为一种药物。

(药物)对身体结构/功能的影响效应远超出“食品”范围下,但是同时也应要求(药物)的生产及功效应用于改变或提高(身体某部分)的功能。

When a substance,including one considered food,is intended to be used for the treatment or prevention of disease or"non-food"structure/function effect,FDA considers it a drug.Under the law,a new animal drug must be shown to be safe and effective for its intended use by adequate data from controlled scientific studies as part of a New Animal Drug Application(21CFR,Part514).If a product on the market is not approved,it may be deemed an adulterated drug and subject to regulatory action.当一种物质,包含一种被认为是食物的物质,但其旨在用于治疗或预防某种疾病或者其物质本身为“非食品”的结构/功效的,FDA视其为一种药物。

在联邦法律定义下,一种新的动物药物必须被证明安全且有足够充分的数据证明其符合新型动物药物应用法案(21CFR,Part514)的相关规定。

如果一种上市产品并没有得到核准,其应该被视为一种劣质药物并被我局监管。

In1958,in response to public concern about the increased use of chemicals in foods and food processing,Congress amended the Act to require the pre-marketing clearance ofadditives whose safety was not generally recognized.The Act was also amended to deem food unsafe and adulterated if it contains an unapproved food additive.Under the definition for food additive in Sec.201(s)of the Act,it provides that substances added to food that qualified scientists generally recognize as safe(GRAS)under the conditions of the intended use are not"food additives"and as such are exempt from pre-clearance approval.在1958年,旨在回应公众对日益增加的食品及食品生产过程中的化学添加剂的担心,国会修改了法案以要求(食品)在入市前预检中应明确列出不被大众所熟知的添加剂成分,并规定如果某种食品包含了不被批准的食品添加剂,将被视为不安全食品。

在此法案的Sec.201(s)中对食品添加剂的定义为:所添加的物质须为一般认为安全的(GRAS),如所添加物质非“食品添加剂”则应豁免于入市前预检手续。

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