FDA(美國食品及藥物管理局寵物食品法規) FDA's Regulation of Pet Food
在此法案中“藥品”在某種程度上是：旨在用來診斷、治愈、減緩、治療或者預防某種疾病，或者旨在區別于食品來講對身體的某部分構造起到一定作用的用品。 (Sec. 201 (g)(1)) 在藥物學法案定義中，法院已對“食品”進行解釋：用以提供營養、滋味或者芳香的物品。如果食品影響著身體某部分結構，其也必須具備此類功能（如：某種食品可供給營養物質比如鈣，會對骨骼結構產生影響；亦或者?；撬釙ω埧苿游锏男呐K健康有益等）。但是，如果某種物質不僅影響了身體部分構造或者功能，而且其影響遠超出它自身的營養功效，比如能使尿液酸化或者提高關節的功能等，那其物質就應該被視為一種藥物。（藥物）對身體結構、功能的影響效應遠超出“食品”的范圍，但是同時也應要求（藥物）的生產及功效應用于改變或提高（身體某部分）的功能。
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.
當一種物質包含一種被認為是食物的物質，但其旨在用于治療或預防某種疾病或者其物質本身為“非食品”的結構、功效的，FDA視其為一種藥物。在聯邦法律定義下，一種新的動物藥物必須被證明安全且有足夠充分的數據證明其符合新型動物藥物應用法案（21 CFR, Part 514）的相關規定。如果一種上市產品并沒有得到核準，其應該被視為一種劣質藥物并被我局監管。
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 (21 CFR, Part 514). If a product on the market is not approved, it may be deemed an adulterated drug and subject to regulatory action.
在1958年，旨在回應公眾對日益增加的食品及食品生產過程中的化學添加劑的擔心，國會修改了法案以要求（食品）在入市前預檢中應明確列出不被大眾所熟知的添加劑成分，并規定如果某種食品包含了不被批準的食品添加劑，將被視為不安全食品。在此法案的Sec.201(s)中對食品添加劑的定義為：所添加的物質須為一般認為安全的（GRAS），如所添加物質非“食品添加劑”則應豁免于入市前預檢手續。
In 1958, 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 of additives 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.
食品添加劑申請書是由FDA發展而來的一項旨在證實一種未知食品添加劑在其預期用途及實用功效上是否安全的預檢機制。如果FDA通過該申請，一項相關的聯邦法規（21 CFR, 573部分）食品添加劑在動物喂食及飲用水方面的許可將被相應的修改。該申請中所必要的信息如聯邦法規第571部分，21篇所描述。簡短說來，該申請書必須包括：對申報產品的化學屬性的描述、加工流程及過程控制、分析方法、實際應用數據、人類食品級別安全數據、目標應用動物類安全數據、產品標識以及在某些特定情況下的環境評估。
A food additive petition is the pre-clearance mechanism developed by the FDA for demonstrating that a food additive is safe for its intended use and has utility. If the FDA agrees with the petition, a regulation is published in the Federal Register and 21 CFR, Part 573, Food Additives Permitted in the Feed and Drinking Water of Animals, is amended. The information needed in a food additive petition is described in Part 571 of Title 21. Briefly, a petition contains a description of the chemical identity, manufacturing process and controls, analytical methods, utility data, human food safety data, target animal safety data, product labeling, and in some cases an environmental assessment.
一種GRAS（一般認為安全）的物質僅在其預期目的上被認為是普遍安全的。比如：氯酸歸納在被作為一種抗凝劑時被認為是GRAS（一般認為安全）的物質，但是同時此物質據稱會在凝固霉菌毒素以及在腸道吸收功能方面被認為不是一種一般認為安全的物質。一種食品也不能在其預防、治療、減緩某種疾病時被認為是一種一般認為安全的物質。因此，硫酸軟骨素在治療關節炎時不能被認為是一種一般認為安全的物質，而應被視為一種藥物。
A GRAS substance is GRAS only for an intended purpose. For example, sodium aluminosilicate is GRAS as an anticaking agent. It has been purported to bind mycotoxins and prevent absorption from the intestinal tract but would not be GRAS for this use. A food substance also cannot be GRAS for the prevention, treatment, or mitigation of a disease. So, chondroitin sulfates cannot be GRAS to prevent or treat arthritis. For this use it would be a drug.
在鑒別某種物質是否為一般承認的安全物質時，對其預期作用的評估鑒定是否僅依靠經過科學培訓并且有經驗的專家通過觀察鑒別從而定義，是非常重要的。一般而言由FDA和法院解釋：某種物質被定義為一般承認并且普遍認為安全前必須符合以下兩個方面的要求：
It is very important to recognize that general recognition of safety of a substance for an intended use may only be based on the views of experts qualified by scientific training and experience to evaluate the safety of the substance. As interpreted by FDA and the courts, there are two requirements that must be satisfied before a substance can be GRAS -- general recognition and safety:
1、如果某物質被認為一般安全時，其前提必須在視為一種食物原料時被專家普遍共識為一種安全的物質；
For general recognition, there must be an expert consensus that the substance is safe for use as a component of food, and;
2、專家共識該物質為安全物質的前提是：要么符合a)從1958年前的公眾數據及信息中證實該物質一直被大眾作為一種食品飼料所用； b)科學程序，即相同數量及質量的物質的實驗數據已被FDA批準，被視為一種安全的食品添加劑。另外，該實驗信息必須在大眾科學期刊中發表過。
This expert consensus of safety must be based on either (a) generally available data and information to show common use of the substance in animal feed prior to 1958 or (b) scientific procedures, which require the same quantity and quality of scientific data needed for FDA approval of the substance as a food additive. In addition, this information must be published in the scientific literature.
這兩種要求：大眾承認的和安全的，都必須基于該物質是被視為是一種GRAS（一般認為安全）的基礎上。而GRAS的要求其實比單獨就某種食品添加劑的審批過程要嚴格很多，因為被視為一種GRAS物質必須要求該物質在一定時期內以相同數量和質量的食品添加劑成分存在。此外，該物質的信息必須發表于相應的科學刊物上且被專家普遍共識為安全的物質，基于上述數據，此物質可被視為使用安全。作為公司年度報告的期刊數據不符合科學出版物的標準。為佐證大眾普遍承認且安全而存在的數據，必須是刊登在相關專家認可的科學期刊上。聯邦法案準許公司自行制定自己的GRAS裁定，而且很多時候GRAS板塊是由相關領域的專家在對該物質的預期用途的安全性具體評估后刊登的。盡管如此，無論是FDA還是公司制定的GRAS裁定，其標準必須是一致的。
Both of these requirements, general recognition and safety, must be met for a substance to be considered as GRAS. The GRAS standard is actually more stringent than that required for a food additive approval because for a substance to be GRAS there must exist the same quality and quantity of information needed for a food additive approval. In addition, the data must be published and there must be a consensus among qualified experts, based on the data, that the substance is safe for that use. Publication of data in a company's annual report does not meet the publication standard. For general recognition of safety to exist, the data must be available to the experts by publication in the scientific literature. The Act permits companies to make their own GRAS determination, and many times GRAS Panels will be assembled that are comprised of scientific experts in a particular field to evaluate the safety of a substance for an intended use. However, regardless of who makes the determination, the FDA or the company, the standard for GRAS is the same.
在1997年4月17日，食品安全及營養應用中心（CFSAN）和獸醫中心（CVM）共同在聯邦法案（62 FR 18938）中頒布了一條告知程序法案，旨在對現有的GRAS（一般認為安全）裁定原則作出修改，代替原有的GRAS裁定原則。此告知程序中規定了，任何個人都可告知我局對某種特定用途的物質作出是否為GRAS的裁定。在告知中，須注明特定物質的以下描述：適用環境，裁定是否為GRAS物質的具體標準。我局（FDA）將不會對所提供數據的任何評估數據作出引導，因為在此物質的GRAS的申請時已經給出相關確認。當然，無論GRAS申報材料中所提供的材料是否充分，或者所提供信息是否對我局評估此物質這個議題上是否有作用，我局都會對所申報物質是否被視為一種GRAS物質這個議題上作出評估。一般我局將在90天內回復申報者。關于GRAS的通告可在我局的主頁上的“摘要”一項中查看，我局同時也會回復申請者。獸醫中心一般會接受已符合GRAS通告的申請，營養中心也同樣。GRAS申請名單可從我局以下網站上找到：http://www.fda.gov/Food/FoodIngredientsPackaging/ GenerallyRecognizedasSafeGRAS/GRASListings/default.htm1.
On April 17, 1997, the Center for Food Safety and Applied Nutrition (CFSAN) and CVM published a proposed rule in theFederal Register (62 FR 18938) to amend the regulations to replace the current GRAS affirmation process with a notification procedure. Under the notification procedure, any person could notify the agency of a determination that a particular use of a substance is GRAS. The notification would include a description of the substance, the conditions of use, and the basis of the GRAS determination. The FDA would not conduct its own detailed evaluation of the data, as was done previously for GRAS affirmation petitions. Rather, FDA would evaluate whether the notice provides sufficient basis for a GRAS determination and whether the information in the notification or otherwise available to FDA raises issues on whether the use of the substance is GRAS. In the proposal FDA would have 90 days to respond to the notifier. The summary of the GRAS notifications would be available on the FDA Home Page, as would the FDA's responses to the person submitting the notification. CVM is not currently accepting GRAS notifications under the proposed rule; however, CFSAN is. A listing of the notifications that have been submitted can be found on.
一旦最終裁決被公布（關于GRAS的裁決），獸醫中心（CVM）將會接受此公告結果，并且用于動物飼料添加劑物質的GRAS申請將會在獸醫中心網站主頁公布。當此物質通過獸醫中心對其有效性的評估后，美國飼料管制協會的飼料材質主席將被告知，并將其物質作為已合格的物質發布在其協會的刊物中。
Once the final rule is published, CVM will accept GRAS notifications. It is anticipated that GRAS notifications submitted for use of substances in animal feed will be posted on the CVM Home Page. When a GRAS notification raises no issue of concern to CVM, the AAFCO Feed Ingredient Chair will be notified so that the substance and its use can be listed in the AAFCO publication.
食品強化劑及健康教育法案 The Dietary Supplement and Health Education Act
當國會在1994年10月25日頒布《食品強化劑及健康教育法案》時，創造了一個新的物質分類法以及一套新的監督管理方案。其法案中修訂了食品強化劑在食品生產中作為增強，補充某種食品所用時，至少含有一種或多種以下材質：一種維他命；一種礦物質；一種草藥或植物性食材；一種氨基酸；一種旨在增加食品攝入量而添加的物質；或者一種濃縮的，代謝的，提煉的，萃取的，也或者由上述方法組合制成的物質（詳見法案201(ff) 部分）。健康教育法案（DSHEA）主要作用是在某種食材的售前批準程序中，撤銷某種作為食品添加劑的材質。在1996年4月22日，獸醫中心曾公布過聯邦公報揭示為什么我局（FDA）不將健康教育法案（DSHEA）應用到動物食品中去，且此公報至少在一次法庭訟案中被支持。因此，當申請某種物質作為動物食品中的食品強化劑時仍須歸入人類食品的售前健康教育管轄，即其物質會被被作為一種食品，一種添加劑或者一種新型動物藥物，又或者是一種一般認為安全的物質（GRAS）取決于其預期作用。目前大多數在市流通的此類產品按其預期作用來看，多被視為未被批準的以及不安全的食品添加劑或者一種新型動物藥品。
When Congress enacted the Dietary Supplement and Health Education Act (DSHEA) on October 25, 1994, it created a new category of substances and new regulatory scheme. The Act was amended to define a dietary supplement as a product intended to supplement the diet and that contains at least one or more of the following ingredients: a vitamin; a mineral; a herb or other botanical; an amino acid; a dietary substance for use to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any of the previously mentioned ingredients (Sec. 201 (ff) of the Act). The main effect of DSHEA was to remove certain dietary ingredients from regulation as food additives, which requires pre-market approval. On April 22, 1996, CVM published a notice in theFederal Register outlining the reasons why FDA believes that Congress did not intend DSHEA to apply to substances for use in animals. This has been upheld in at least one court case. Thus, substances marketed as dietary supplements for humans still fall under the pre-DSHEA regulatory scheme when marketed for animals; that is, they are considered food, food additives, new animal drugs, or GRAS depending on the intended use. Most of these types of products on the market would be considered unapproved and unsafe food additives or new animal drugs based on current intended uses.
食品標簽的健康聲明 Health Claims
國會在1990年也修訂過法案，當營養標識和健康教育法頒布時，此法案要求我局（FDA)編撰關于批準在人用食品上標注食品健康聲明的法規。有相當數量的食品已經被批準，具體名單可從營養中心（CFSAN）主頁上找到。
Congress also amended the Act when it enacted the Nutrition Labeling and Education Act in 1990. This law required FDA to write regulations to permit health claims on human food. A number of these claims have been approved for various foods. These can be found on the CFSAN web page.
獸醫中心已經綜合了營養標識和健康教育法案（NLEA）中的理念旨在寵物食品應用中批準有意義的健康方面信息，比如：在貓糧中注明食品對貓科動物泌尿系統健康的聲明，以及美國飼料管制協會（AAFCO）中要求明確，精細，少添加或者減少卡路里，或者明確，精細，少添加或者減少脂肪含量。最近，獸醫中心已經被要求完善其對控制貓類食品中對毛球病影響的因素。我們可能不會對那些已通過批準的且已達到要求功效的用以貓類食品的原料進行監管活動，比如：纖維來源。在這種情況下，我們要求申報公司提交已經從一定數量的食品，配制劑，營養成分分析以及標識中得出的信息，并給予以上信息審議后做出健康聲明。也就是說，基于某種材質的生物學目的的科學研究常識。如果該物質已證明可達到某種功效，則我局會認為該申報物質已證明安全并應當具備市場準入條件。
CVM has incorporated the philosophy of NLEA in its policies in order to permit meaningful health information on pet foods. Examples are the use of urinary tract health claim on cat food diets, and development of AAFCO regulations for light, lean, less or reduced calories, lean, and less or reduced fat. Recently, CVM has been asked about complete cat foods for the control of hairballs. We would likely not take regulatory action provided the effect is achieved by ingredients already permitted for use in cat food, such as fiber sources. In this case, we ask that the firm submit information for review on the quantitative diet formulation, nutrient analysis, and labeling, and discussion on the basis for the claim, i.e., scientific studies or common knowledge of ingredients biological properties. If novel ingredients are used to achieve the effect, then we believe data demonstrating ingredient safety should be obtained prior to marketing.
重點指出的是在健康教育法案中（DSHEA）定義術語“食品強化劑”時排除了預期目的作為傳統食品的物質。比如：圣約翰麥芽汁在添加到湯里時，不被視為一種食品強化劑。湯是一種傳統食品，而任何被添加進傳統食品的物質必須符合食品添加劑法規或者必須是一種一般認為安全的物質（GRAS）。
It is important to note that DSHEA defines the term "dietary supplement" to exclude products intended for use as conventional foods. For example, St. John's Wort would not be considered a dietary supplement if it were added to soup. Soup is a conventional food and any ingredient added to conventional foods must be used in accordance with the food additive regulation or be GRAS.Congress also amended the Act when it enacted the Nutrition Labeling and Education Act in 1990. This law required FDA to write regulations to permit health claims on human food. A number of these claims have been approved for various foods. These can be found on the CFSAN web page.
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