今天很幸運的, 有人問起婕斯的產品是否有經美國FDA核准, 我也感到很好奇, 所以查了一下. 因為很多美國的健康食品或藥物, 號稱"FDA核准". 但有沒有人知道, FDA (美國食品藥物管理局) 到底會核准哪些項目?
婕斯的產品從來沒有號稱經美國FDA核准,因為Reserve白藜蘆醇沛泉精華(隸屬於膳食補充劑)與Luminesce賦活精華露(隸屬於化妝品), 在美國FDA法規中,並不需要經FDA核准,然而,公司產品都是從經過FDA註冊認可並查驗合格的實驗室所研發生產出來的.
因此我特別連到美國FDA官方網站, 去一探究竟 : http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
為了讓大家閱讀中文方便, 我又用google 線上翻譯把它直接翻成中文, 大家可以參照一下: http://translate.google.com.tw/translate?hl=zh-TW&sl=en&u=http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm&ei=pmsuT5mwB4SQ0AWEmo2tCA&sa=X&oi=translate&ct=result&resnum=1&ved=0CCUQ7gEwAA&prev=/search%3Fq%3DFDA%2Bdoes%2Bnot%2B%2522approve%2522%2Bhealth%2Bcare%2Bfacilities,%2Blaboratories,%2Bor%2Bmanufacturers%26hl%3Dzh-TW%26biw%3D1920%26bih%3D911%26prmd%3Dimvns
因此, 中英對照版本如下:
FDA (美國食品藥物管理局) 的職權是:
FDA不批准公司。
Owners and operators of domestic or foreign food, drug, and most device facilities are required to register with FDA.國內或國外的食品，藥品，大部分設備設施的所有者和經營者必須向FDA註冊。 Blood and tissue facilities also must register with the agency.血液和組織中的設施也必須與該機構登記。
Mammography facilities must be FDA certified.乳房X光檢查設施必須是FDA認證。 Mammography facilities are required to display their FDA certificates where patients can see them.乳房X光檢查設施必須顯示他們的FDA認證，患者可以看到它們。 The certificate indicates that the facilities have met stringent standards and can provide quality mammography.該證書表明，設施都符合嚴格的標準，並能提供優質的乳房X光檢查。
FDA批准新的藥物和生物製劑。
New drugs and biologics must be proven safe and effective to FDA's satisfaction before companies can market them.新的藥物和生物製劑，必須證明之前，公司可以推銷他們的安全和有效的FDA的滿意度。 FDA does not develop or test products; FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. FDA不開發或測試產品，FDA的專家審查實驗室，動物，和廠商進行人體臨床試驗的結果。
If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.如果FDA授予的批准，這意味著該機構已確定達到預定可使用產品的好處大於風險。
FDA 不批准複合藥物。
Pharmacy compounding is an age-old practice in which pharmacists combine, mix, or alter ingredients to create unique medications that meet specific needs of individual patients.複合藥劑業是一個古老的藥劑師結合的實踐中，混合，或改變成分，以創造獨特的藥物，以滿足個別患者的具體需要。 It's also a practice that is under FDA scrutiny—mainly because of instances where compounded drugs have endangered public health.這也是一種做法是，根據FDA的審查，主要是因為複合藥物危害公眾健康的情況下。 In its traditional form, pharmacy compounding is a vital service that helps many people, including those who are allergic to inactive ingredients in FDA-approved medicines.在其傳統的形式，藥房複利是一個重要的服務，幫助許多人，包括那些是FDA批准的藥品中的非活性成分過敏。 But consumers need to be aware that compounded drugs are not FDA-approved.但消費者需要注意複合藥物是未經FDA批准。 This means that FDA has not verified their safety and effectiveness.這意味著，FDA尚未驗證其安全性和有效性。 Poor practices on the part of drug compounders can result in contamination or in products that don't possess the strength, quality, and purity required.部分藥物化合上的不良行為可能導致污染或不具備的實力，質量和純度要求的產品。
FDA採用以風險為基礎，分層的辦法，為規範醫療器械。
FDA classifies devices according to risk. FDA的分類，根據風險的設備。 Only the highest-risk devices, such as mechanical heart valves and implantable infusion pumps, require FDA approval before marketing.唯一的風險最高的設備，如機械心臟瓣膜，植入式輸液泵，要求美國FDA批准上市前。 To receive FDA approval for these devices, the manufacturer must demonstrate that its devices provide a reasonable assurance of safety and effectiveness.為了獲得美國FDA批准為這些設備，製造商必須證明其設備的安全性和有效性提供合理的保證。
Moderate-risk medical devices (eg, dialysis equipment and many types of catheters) are cleared for marketing based on an FDA determination that they are substantially equivalent to an already legally marketed device of the same type.中等風險的醫療設備（如透析設備和多種類型的導管）被清除市場營銷的基礎上，他們大致相當於一個同類型的設備已經合法上市的FDA的決心。
FDA has exempted certain low-risk medical devices (eg, certain bandages) from premarket review when they are for the same use and of the same technology. FDA豁免某些低風險醫療器械（例如，某些繃帶）從上市前審查時，他們同樣使用相同的技術。
FDA批准在人類食物添加劑。
FDA field investigators inspect food companies, examine food shipments from abroad, and collect samples. FDA的現場調查，檢查食品公司，從國外考察食品裝運，並採集樣品。 Laboratory scientists analyze samples.實驗室的科學家們分析樣品。 Compliance officers recommend legal action and follow through on enforcement issues.合規人員建議採取法律行動，並按照執法問題通過。 What undergoes premarket approval?上市前批准經歷了什麼？ New food additives and color additives must be approved before they can be used in foods.新的食品添加劑和色素添加劑必須核准，才可以在食品中使用。 These additives are considered food under the law.這些添加劑被認為是法律規定的食品。
New food additives, including substances added intentionally to food and substances that may migrate to food because they contact food (eg, food packaging) must be shown to be safe to FDA's satisfaction before companies can market them.有意添加新的食品添加劑，包括物質的食品和藥物，可能會遷移到食物的聯繫，因為它們的食物（如食品包裝）必須證明是安全的FDA滿意的公司可以上市之前。
Companies that want to add new additives to food bear the responsibility of providing FDA with information demonstrating that the additives are safe.要添加新食品添加劑的公司，提供信息表明，添加劑是安全的FDA承擔責任。 FDA experts review the results of appropriate tests done by companies to ensure that the additive is safe for its intended use. FDA的專家審查由公司完成，以確保達到預定可使用的添加劑是安全的相應的測試結果。
An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.經批准的食品添加劑，必須使用符合其批准的用途，規格和限制。 Certain food ingredients, such as those with a long history of safe use in food, do not require premarket approval.某些食物成分，如食品中的安全使用歷史悠久，不需要上市前批准。
FDA批准的飼料中的藥物和添加劑。
FDA is responsible for approving drugs and food additives given to, or used on, over one hundred million pets, plus millions of poultry, cattle, swine, and minor animal species. FDA是負責批准給，或使用，寵物超過一億，再加上數以百萬計的家禽，牛，豬，小型動物物種的藥物和食品添加劑。 (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.) （小型動物物種，包括其他動物比牛，豬，雞，火雞，馬，狗，貓）。
FDA does not approve pet food, but rather approves the food additives that are used in pet food. FDA不批准的寵物食品，而是批准在寵物食品中使用食品添加劑。 FDA has the authority to take action against pet food products that are in violation of the law. FDA有權採取行動，對違反法律的寵物食品。
FDA批准FDA監管的產品中使用的顏色添加劑。
This includes those used in food, dietary supplements, drugs, cosmetics, and some medical devices.這包括在食品，膳食補充劑，藥品，化妝品，醫療器械使用的。 These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions.這些顏色添加劑（煤焦油染髮劑除外）的法律機構批准，每個人都必須在符合其批准的用途，規格和限制使用。
In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.在審批過程中，FDA安全性數據進行評估，以確保顏色添加劑，其目的是安全的。
FDA不批准的化妝品。
Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations.化妝品的例子是香水，化妝品，潤膚霜，洗髮水，染髮劑，臉部和身體的清潔劑，剃須準備。
Cosmetic products and ingredients do not require FDA approval before they go on the market, with one exception: color additives (other than coal tar hair dyes.) Cosmetics must be safe for their intended use and properly labeled.化妝品產品和原料不要求FDA批准之前，他們去市場上有一個例外：（比煤焦油染髮劑）色素添加劑，化妝品必須是安全的，其用途和正確標記。
FDA field investigators inspect cosmetic companies, examine imports, and collect samples for analysis. FDA實地調查的化妝品公司檢查，檢查的進口，並收集樣品進行分析。 FDA may take action against non-compliant products, or against firms or individuals who violate the law. FDA可能採取行動，對不符合規定的產品，或對那些違反法律的企業或個人。
FDA不批准的醫療食品。
A medical food is used for the dietary management of a disease or health condition that requires special nutrient needs.醫療食品用於疾病或健康狀況，需要特殊營養需要的膳食管理。 An example of a medical food is a food for use by persons with phenylketonuria, a genetic disorder.醫療食品的一個例子是苯丙酮尿症，一種遺傳性疾病的人使用的食品。 A person with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine.這種疾病的人，可能需要制定醫療食品是免費的氨基酸苯丙氨酸。 A medical food is intended for use under the supervision of a physician.醫療食品的目的是為醫生的監督下使用。
Medical foods do not have to undergo premarket approval by FDA.醫療食品沒有接受FDA的上市前批准。 But medical food firms must comply with other requirements, such as good manufacturing practices and registration of food facilities.但必須符合其他要求，如良好的生產實踐和食品設施的登記，醫療食品公司。 Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and non-misleading.醫療食品不包括其標籤上的營養信息，並在其標籤的任何索賠，必須是真實的，和非誤導。
FDA不批准嬰幼兒配方奶粉。
FDA does not approve infant formulas before they can be marketed. FDA不批准才可以銷售的嬰幼兒配方奶粉。 However, manufacturers of infant formula are subject to FDA's regulatory oversight.然而，嬰幼兒配方奶粉製造商都受到FDA的監管。
Manufacturers must ensure that infant formula complies with federal nutrient requirements.製造商必須確保嬰幼兒配方奶粉符合聯邦的營養需求。 Manufacturers are required to register with FDA and provide the agency with a notification before marketing a new formula.製造商必須向FDA註冊和營銷一個新的公式之前，該機構提供了一個通知。
FDA不批准膳食補充劑。
The notification must include the information that was the manufacturer or distributor's basis for concluding that the dietary supplement will reasonably be expected to be safe.通知必須包含的信息是製造商或分銷商的基礎上得出結論認為，膳食補充劑，合理預期是安全的。 After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.膳食補充劑市場上後，FDA通過研究和不良事件監測評估其安全性。
FDA不批准的食品標籤，包括營養成分。
FDA does not approve individual food labels before food products can be marketed. FDA不批准個別食品標籤才可以銷售食品。 But FDA regulations require nutrition information to appear on most foods, including dietary supplements.但FDA的法規要求，出現大部分食品，包括膳食補充劑的營養信息。 Also, any claims on food products must be truthful and non-misleading, and must comply with any special requirements for the type of claim.此外，對食品的任何索賠必須是真實的和非誤導性的，必須遵守任何特殊要求索賠的類型。
Manufacturers are required to provide the serving size of the food and information about the nutrient content of each serving on the "Nutrition Facts" panel of the food label (or on the "Supplement Facts" panel for dietary supplements.)要求製造商提供的每份食品標籤上的“營養成分”面板中的養分含量的食品和有關信息服務的大小（或膳食補充劑面板上的“營養成分”。）
FDA不批准膳食補充劑和其他食品的結構與功能的索賠。
Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body.結構功能聲稱描述的食物或食物成分（如營養），目的是要影響人體的結構或功能的作用。 One example is "calcium builds strong bones."一個例子是“鈣建立強壯的骨骼。”
Dietary supplement firms that make structure-function claims on labels or in labeling must submit a notification to FDA.使標籤或標籤中的結構功能聲稱的膳食補充劑的公司必須向FDA提交一份通知。 This notification must be submitted no later than 30 days after marketing the dietary supplement with the structure/function claim.該通知必須不遲於30天內提交上市後的結構/功能聲稱的膳食補充劑。 Additionally, the notification must include the text of the claim, as well as other information, such as the name and address of the notifier.此外，通知中必須包括索賠的文本，以及其他信息，如名稱和地址通知。 FDA does not require conventional food manufacturers to notify FDA about their structure-function claims. FDA不要求傳統的食品製造商通知其結構功能聲稱FDA。
Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease.膳食補充劑的結構功能聲稱攜帶一個聲明，說明索賠未獲通過FDA審查，該產品不用於診斷，治療，治愈或預防任何疾病。 Conventional foods are not required to carry such a disclaimer.傳統食品並不需要進行這樣的聲明。
FDA的標誌使用不當，可能會違反聯邦法律。
FDA's logo should not be used to misrepresent the agency nor to suggest that FDA endorses any private organization, product, or service. FDA的標誌不應該被用來歪曲的機構也認為FDA認可任何私人組織，產品或服務。
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