婕斯的产品从来没有号称经美国FDA核准, 因为Reserve白藜芦醇沛泉精华(隶属于膳食补充剂)与Luminesce赋活精华露(隶属于化妆品), 在美国FDA法规中, 并不需要经FDA核准. 然而, 公司产品都是从经过FDA注册认可并查验合格的实验室所研发生产出来的.
因此我特别连到美国FDA官方网站, 去一探究竟 : http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
为了让大家阅读中文方便, 我又用google 线上翻译把它直接翻成中文, 大家可以参照一下: 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, 中英对照版本如下:
FDA (美国食品药物管理局) 的职权是:
FDA不批准公司。
FDA does not "approve" health care facilities, laboratories, or manufacturers.
FDA不“批准”的医疗设施，实验室，或制造商。 FDA does inspect product manufacturers to verify that they comply with good manufacturing practices.
FDA检查产品制造商，以确认他们遵守良好生产规范。
Owners and operators of domestic or foreign food, drug, and most device facilities are
required to register with FDA.国内或国外的食品，药品，大部分设备设施的所有者和经营者必须向FDA注册。 Blood and tissue facilities also must register with the agency.血液和组织中的设施也必须与该机构登记。
Mammography facilities must be FDA certified.乳房X光检查设施必须是FDA认证。 Mammography facilities are required to display their FDA certificates where patients can see
them.乳房X光检查设施必须显示他们的FDA认证，患者可以看到它们。 The certificate indicates that the facilities have met stringent standards and can provide quality
mammography.该证书表明，设施都符合严格的标准，并能提供优质的乳房X光检查。
FDA批准新的药物和生物制剂。
New drugs and biologics must be proven safe and effective to FDA's satisfaction before
companies can market them.新的药物和生物制剂，必须证明之前，公司可以推销他们的安全和有效的FDA的满意度。
FDA does not develop or test products; FDA experts review the results of laboratory, animal,
and human clinical testing done by manufacturers.
FDA不开发或测试产品，FDA的专家审查实验室，动物，和厂商进行人体临床试验的结果。
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，这意味着该机构已确定达到预定可使用产品的好处大于风险。
FDA 不批准复合药物。
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.复合药剂业是一个古老的药剂师结合的实践中，混合，或改变成分，以创造独特的药物，以满足个别患者的具体需要。
It's also a practice that is under FDA scrutiny—mainly because of instances where compounded
drugs have endangered public health.这也是一种做法是，根据FDA的审查，主要是因为复合药物危害公众健康的情况下。 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.在其传统的形式，药房复利是一个重要的服务，帮助许多人，包括那些是FDA批准的药品中的非活性成分过敏。 But consumers need to be aware that compounded drugs are not
FDA-approved.但消费者需要注意复合药物是未经FDA批准。 This means that FDA has not verified their safety and effectiveness.这意味着，FDA尚未验证其安全性和有效性。 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.部分药物化合上的不良行为可能导致污染或不具备的实力，质量和纯度要求的产品。
FDA采用以风险为基础，分层的办法，为规范医疗器械。
FDA classifies devices according to risk. FDA的分类，根据风险的设备。 Only the
highest-risk devices, such as mechanical heart valves and implantable infusion
pumps, require FDA approval before marketing.唯一的风险最高的设备，如机械心脏瓣膜，植入式输液泵，要求美国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.为了获得美国FDA批准为这些设备，制造商必须证明其设备的安全性和有效性提供合理的保证。
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.中等风险的医疗设备（如透析设备和多种类型的导管）被清除市场营销的基础上，他们大致相当于一个同类型的设备已经合法上市的FDA的决心。
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豁免某些低风险医疗器械（例如，某些绷带）从上市前审查时，他们同样使用相同的技术。
FDA批准在人类食物添加剂。
FDA field investigators inspect food companies, examine food shipments from abroad, and
collect samples. FDA的现场调查，检查食品公司，从国外考察食品装运，并采集样品。 Laboratory scientists analyze samples.实验室的科学家们分析样品。 Compliance
officers recommend legal action and follow through on enforcement issues.合规人员建议采取法律行动，并按照执法问题通过。 What undergoes premarket approval?上市前批准经历了什么？ New food additives and color additives must be approved before they can be used in foods.新的食品添加剂和色素添加剂必须核准，才可以在食品中使用。
These additives are considered food under the law.这些添加剂被认为是法律规定的食品。
collect samples. FDA的现场调查，检查食品公司，从国外考察食品装运，并采集样品。 Laboratory scientists analyze samples.实验室的科学家们分析样品。 Compliance
officers recommend legal action and follow through on enforcement issues.合规人员建议采取法律行动，并按照执法问题通过。 What undergoes premarket approval?上市前批准经历了什么？ New food additives and color additives must be approved before they can be used in foods.新的食品添加剂和色素添加剂必须核准，才可以在食品中使用。
These additives are considered food under the law.这些添加剂被认为是法律规定的食品。
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剂，包括物质的食品和药物，可能会迁移到食物的联系，因为它们的食物（如食品包装）必须证明是安全的FDA满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.要添加新食品添加剂的公司，提供信息表明，添加剂是安全的FDA承担责任。 FDA experts review the results of appropriate tests done by companies to ensure that the additive is safe for its intended use.
FDA的专家审查由公司完成，以确保达到预定可使用的添加剂是安全的相应的测试结果。
An approved food additive must be used in compliance with its approved uses, specifications, and
restrictions.经批准的食品添加剂，必须使用符合其批准的用途，规格和限制。 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历史悠久，不需要上市前批准。
FDA批准的饲料中的药物和添加剂。
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是负责批准给，或使用，宠物超过一亿，再加上数以百万计的家禽，牛，猪，小型动物物种的药物和食品添加剂。 (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.) （小型动物物种，包括其他动物比牛，猪，鸡，火鸡，马，狗，猫）。
one hundred million pets, plus millions of poultry, cattle, swine, and minor animal species.
FDA是负责批准给，或使用，宠物超过一亿，再加上数以百万计的家禽，牛，猪，小型动物物种的药物和食品添加剂。 (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.) （小型动物物种，包括其他动物比牛，猪，鸡，火鸡，马，狗，猫）。
FDA does not approve pet food, but rather approves the food additives that are used in pet
food. FDA不批准的宠物食品，而是批准在宠物食品中使用食品添加剂。 FDA has the
authority to take action against pet food products that are in violation of the law. FDA有权采取行动，对违反法律的宠物食品。
FDA批准FDA监管的产品中使用的颜色添加剂。
This includes those used in food, dietary supplements, drugs, cosmetics, and some medical
devices.这包括在食品，膳食补充剂，药品，化妆品，医疗器械使用的。 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.这些颜色添加剂（煤焦油染发剂除外）的法律机构批准，每个人都必须在符合其批准的用途，规格和限制使用。
In the approval process, FDA evaluates safety data to ensure that a color additive is safe for
its intended purposes.在审批过程中，FDA安全性数据进行评估，以确保颜色添加剂，其目的是安全的。
FDA不批准的化妆品。
Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body
cleansers, and shaving preparations.化妆品的例子是香水，化妆品，润肤霜，洗发水，染发剂，脸部和身体的清洁剂，剃须准备。
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.化妆品产品和原料不要求FDA批准之前，他们去市场上有一个例外：（比煤焦油染发剂）色素添加剂，化妆品必须是安全的，其用途和正确标记。
FDA field investigators inspect cosmetic companies, examine imports, and collect samples
for analysis. FDA实地调查的化妆品公司检查，检查的进口，并收集样品进行分析。 FDA may take action against non-compliant products, or against firms or individuals who violate the law. FDA可能采取行动，对不符合规定的产品，或对那些违反法律的企业或个人。
FDA不批准的医疗食品。
A medical food is used for the dietary management of a disease or health condition that requires
special nutrient needs.医疗食品用于疾病或健康状况，需要特殊营养需要的膳食管理。 An example of a medical food is a food for use by persons with phenylketonuria, a genetic
disorder.医疗食品的一个例子是苯丙酮尿症，一种遗传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.这种疾病的人，可能需要制定医疗食品是免费的氨基酸苯丙氨酸。 A medical food is
intended for use under the supervision of a physician.医疗食品的目的是为医生的监督下使用。
Medical foods do not have to undergo premarket approval by FDA.医疗食品没有接受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.但必须符合其他要求，如良好的生产实践和食品设施的登记，医疗食品公司。 Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and non-misleading.医疗食品不包括其标签上的营养信息，并在其标签的任何索赔，必须是真实的，和非误导。
FDA不批准婴幼儿配方奶粉。
FDA does not approve infant formulas before they can be marketed. FDA不批准才可以销售的婴幼儿配方奶粉。 However, manufacturers of infant formula are subject to FDA's regulatory oversight.然而，婴幼儿配方奶粉制造商都受到FDA的监管。
Manufacturers must ensure that infant formula complies with federal nutrient requirements.制造商必须确保婴幼儿配方奶粉符合联邦的营养需求。 Manufacturers are required to register with FDA and provide the agency with a notification before marketing a new formula.制造商必须向FDA注册和营销一个新的公式之前，该机构提供了一个通知。
FDA不批准膳食补充剂。
Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety
and effectiveness.新的药物不同，膳食补充剂都没有检讨其安全性和有效性的基础上，通过FDA批准。 Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not
marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.包含一个新的膳食成分（，1994年10月15日之前没有在美国销售的膳食成分）的膳食补充剂要求上市前通知FDA的75天。
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.通知必须包含的信息是制造商或分销商的基础上得出结论认为，膳食补充剂，合理预期是安全的。 After dietary
supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.膳食补充剂市场上后，FDA通过研究和不良事件监测评估其安全性。
FDA不批准的食品标签，包括营养成分。
FDA does not approve individual food labels before food products can be marketed. FDA不批准个别食品标签才可以销售食品。 But FDA regulations require nutrition information to
appear on most foods, including dietary supplements.但FDA的法规要求，出现大部分食品，包括膳食补充剂的营养信息。 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，对食品的任何索赔必须是真实的和非误导性的，必须遵守任何特殊要求索赔的类型。
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.)要求制造商提供的每份食品标签上的“营养成分”面板中的养分含量的食品和有关信息服务的大小（或膳食补充剂面板上的“营养成分”。）
FDA不批准膳食补充剂和其他食品的结构与功能的索赔。
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.结构功能声称描述的食物或食物成分（如营养），目的是要影响人体的结构或功能的作用。 One example is "calcium builds strong bones."一个例子是“钙建立强壮的骨骼。”
Dietary supplement firms that make structure-function claims on labels or in labeling must submit a notification to FDA.使标签或标签中的结构功能声称的膳食补充剂的公司必须向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.该通知必须不迟于30天内提交上市后的结构/功能声称的膳食补充剂。 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，通知中必须包括索赔的文本，以及其他信息，如名称和地址通知。 FDA does not require conventional food manufacturers to notify FDA about their structure-function claims. FDA不要求传统的食品制造商通知其结构功能声称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.膳食补充剂的结构功能声称携带一个声明，说明索赔未获通过FDA审查，该产品不用于诊断，治疗，治愈或预防任何疾病。 Conventional foods are not required to carry such a disclaimer.传统食品并不需要进行这样的声明。
FDA的标志使用不当，可能会违反联邦法律。
FDA's logo should not be used to misrepresent the agency nor to suggest that FDA endorses any
private organization, product, or service. FDA的标志不应该被用来歪曲的机构也认为FDA认可任何私人组织，产品或服务。
private organization, product, or service. FDA的标志不应该被用来歪曲的机构也认为FDA认可任何私人组织，产品或服务。
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