[全球视线]醒醒吧！EFT的中国消费者同胞们！揭露虚假谎言！(转载)

EFT Inc 8/19/09

　　Department of Health and Human Services Public Health Service

　　Food and Drug Administration

　　 Los Angeles District Office

　　19701 Fairchild

　　Irvine, CA 92612 - 2506

　　Telephone: 949-608-2900

　　FAX: 949-608-4415

　　WARNING LETTER

　　CERTIFIED MAIL

　　RETURN RECEIPT REOUESTED

　　August 19, 2009

　　W/L 27-09

　　Mr. Jack Qin

　　President

　　EFT Biotech Holdings Inc.

　　929 Radecki Ct.

　　City of Industry, CA 91748-1132

　　Dear Mr. Qin:

　　On March 3,2009, the Food and Drug Administration (FDA) collected a sample of your product, 2006 Celprotect I, at your facility, located at 929 Radecki Ct., City of Industry, CA 91748-1132. In addition, we reviewed your website at the Internet address

　　

　　2006 Celprotect l:

　　Your product 2006 Celprotect I is adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that it bears or contains a poisonous or deleterious substance, lead, which may render it injurious to health. The FDA laboratory found 5.2 ug of lead (pb)/gram in the product. Under the maximum recommended conditions of use (4 capsules per day), the total possible lead consumption from this product is 12 ug Pb/day. Lead is a poisonous or deleterious substance in this product because it is present in an amount that contributes to an unacceptable dietary exposure for children under the age of seven. If a child under the age of seven is exposed to lead at the levels present in your product on a routine basis, permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems. In addition, sustained consumption of products containing high lead levels can produce lead poisoning, which has a number of symptoms including anemia, neurological effects such as ataxia and irritability, constipation, muscular weakness, and chronic nephritis.

　　You were verbally notified of these results on March 20, 2009. You deferred your firm's response to your contract manufacturer (b)(4). Response letters were received from (b)(4) on (b)(4) and (b)(4) stating that a (b)(4). However, a copy of the proposed label has not yet been received by the Los Angeles District Compliance Branch.

　　Dietary Supplements with Therapeutic Claims:

　　This letter also serves to advise you that the FDA has determined that your products 2006 Celprotect 1, 2007 Celprotect II Bullet Points, Colostrum #3008, Colloidal Silver #2003, SuperCal #3015, MSM #3003 + IONICS, Re-Live Again #3004, GlucoBalance #3017, Cardio Support #3019, PerformPlus #3006, and VisionPlus #3012 are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violate the Act.

　　Examples of claims observed on your website include:

　　2006 Celprotect I

　　#8226; "Broad spectrum anti-viral (protects and helps eliminate viruses)."

　　#8226; "Helps diminish painful cold sores."

　　2007 CelProtect II Bullet Points

　　#8226; "Can eliminate food poisoning within minutes"

　　Colostrum #3008

　　#8226; "Maintain Blood-sugar balance"

　　#8226; "Fight viral, bacterial fungus infections"

　　#8226; "Improve well being of arthritis sufferers"

　　#8226; "Relieve pain"

　　#8226; "Fight gum disease"

　　Colloidal Silver #2003

　　#8226; "Research has demonstrated that Colloidal Silver is effective over a broad spectrum of bacterial, fungal and even viral species. Not only less costly then available

　　antibiotics and anti-viral agents, Colloidal Silver use does not result in mutations of resistant species."

　　#8226; "Because of known disease-causing organism can live in the presence of even minute traces of the chemical element of mettalic [sic] silver, #2003 is effective against more

　　than 650 different disease causing pathogens including viruses."

　　#8226; "All fungus, virus, bacterium, streptococcus, staphylococcus, and other pathogenic organisms are killed in three or four minutes; in fact, there is no microbe know [sic]

　　that is not killed by #2003 in six minutes or less ...."

　　#8226; "It would appear highly unlikely that even germ warfare agents could survive an encounter with #2003, since viruses like E Bola and Hanta, or even the dreaded 'flesh-eating bacteria' are, in the end, merely hapless viruses and bacteria."

　　#8226; "In addition to its anti-microbial properties, 'EFT' silver solution is also a powerful anti-inflammatory agent."

　　SuperCal #3015

　　#8226; "Calcium [an ingredient in the product] ... help[s] to prevent the risk of degenerative diseases."

　　#8226; "[Calcium] [h]elps achieve an alkaline balance therey [sic], neutralizing acidity level, increase muscle and joint mobility to combat artihritic conditions, heart disease ... helps sports injuries, headaches, high or low blood pressure, high cholesterol, osteoporosis, rheumatoid arthritis, ulcers, . . . psoriasis, ulcerative colitis, gastroenteritis, hiatal hernia and cataracts."

　　#8226; "Other medical men of wisdom have also discovered that calcium supplements, such as SuperCal Spray, could indeed reverse cancer."

　　#8226; "The January 14, 1999 issue of the Phoenix Republic wrote in an article entitled 'Calcium Reduces Tumors' that the New England Journal of Medicine reported 'adding calcium can keep you from getting tumors in your large intestine'."

　　MSM # 3003 + Ionic Minerals

　　#8226; "Unlike NSAIDS's, such as aspirin, ibuprofen, etc., which cause more problems than the symptoms they're designed to relieve*, MSM has no known side effects, no overdose toxicity (it's safer than water!), and it benefits the body overall while relieving and rebuilding connective tissue and joints."

　　#8226; "Its benefits are legendary: ... relief of muscle cramps, mental normalcy, anti-bacterial/inflammatory/parasitic effect ... and relief of muscle spasms and joint pain!"

　　Re-Live Again #3004

　　#8226; "Zinc [an ingredient in the product]: [T]his essential mineral has been useful in the treatment of dwarfism and retarded growth in children."

　　GlucoBalance #3017 (describing ingredients in the product)

　　#8226; "Bitter Melon - Researchers have found that Bitter Melon helps improve glucose tolerance and can help lower blood sugar levels."

　　#8226; "Barley Sprout - Barley extract is another traditional medicine that scientists have found may significantly help normalize blood sugar levels."

　　#8226; "Gymnema - Helps lower blood sugar levels ...."

　　#8226; "Cinnamon - Scientists have found that Cinnamon extract contains compounds that help maintain healthy blood sugar levels by enhancing insulin activity in body."

　　Cardio Support #3019 (describing ingredients in the product)

　　#8226; "Vitamin B3 ... helps reduce levels of 'bad' LDL cholesterol and triglycerides (fats)."

　　#8226; "Ginger - inhibits abnormal platelet clumping and helps protect against abnormal blood clots that can clog arteries."

　　#8226; "Green tea ... may help to lower blood pressure and reduce elevated cholesterol."

　　#8226; "Salvia (Dan Shen) - supports . . . reduced platelet clumping for optimal cardiovascular health."

　　PerformPlus #3006

　　#8226; "Sarsaparilla Extract (smilax officinalis) [all ingredient in the product]: This herb ... helps lower cholesterol ...."

　　#8226; "Ginkgo Biloba [an ingredient in the product]: This extract [is] helpful in cases of erectile dysfunction."

　　#8226; "Tribulus Terrestris [an ingredient in the product] ... In China, it has long been used for impotency in men, ..."

　　#8226; "Schisandra [an ingredient in the product]: This herb has been used for centuries to improve ... staying power in men."

　　#8226; "perform plus: 'I Can't Believe It's Not Viagra' is an all-natural, scientifically balanced formula designed by nutritional experts and health care professionals to respond to each and everyone of these varying problems associated with poor sexual function and lack of Libido, and to promote peak performance in both men and women."

　　VisionPlus #3012 (describing ingredients in the product)

　　#8226; "Vitamin C [and Vitamin E] ... can help prevent age-related cloudiness of the lens of the eye caused by excessive UV light from the sun, and can significantly slow the

　　deterioration of vision."

　　#8226; "Vitamin A Beta Carotene: Results of a case-control" study found a significant inverse association between the consumption of carotenoid rich food and the risk of age-related macular degeneration, the leading cause of irreversible blindness in adults."

　　#8226; "Lutein is highly concentrated in the macula of the eye, and helps protect the eyes from sun damage and age-related degeneration of the macula. Lutein supplementation

　　has been shown to improve visual function for subjects with age-related macular degeneration and also for some subjects with Retinitis Pigmentosa (slow retinal degenerations)."

　　#8226; "Zeaxanthin ... These yellow carotenes function in preventing oxidative damage to the macula and obviously play a central role in protecting against the development of

　　macular degeneration. Increasing the concentration of Lutein and/or Zeaxanthin may offer significant protective effects against the development of macular degeneration."

　　Moreover, these products not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your products are all misbranded within the meaning of section 502(f)(1) of the Act in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

　　Dietary Supplements Containing Androstenedione, Humic Acid, and Fulvic Acid:

　　Despite the therapeutic claims on your website that cause your products to be drugs, your products are labeled and/or promoted as dietary supplements. The term "dietary supplement" is defined in section 201(ff) of the Act [21 U.S.C. § 321(ff)]. The PerformPlus #3006 product ingredients list on your website declares androstenedione (among other names, also called 4-androstenedione or 4-androstene-3, 17- dione) as an ingredient. The 2007 Celprotect II Bullet Points product ingredients list on your website declares humic and fulvic acids as ingredients. The 2006 Celprotect I product declares humic and fulvic acids as ingredients on the label.

　　Given that you have labeled these products as a dietary supplements, we assume you have a basis to conclude that androstenedione, humic, and fulvic acids are "dietary ingredients" under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Assuming that androstenedione, humic acid, and fulvic acids are "dietary ingredients," they would also be "new dietary ingredients" under section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6, for which a notification is required.

　　Under section 413 of the Act [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:

　　(1)The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

　　(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of

　　the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

　　FDA is not aware of any information demonstrating that androstenedione, humic acid, and fulvic acid were lawfully marketed as a dietary ingredient in the United States before October 15, 1994. Nor is FDA aware of any information demonstrating that these ingredients have been present in the food supply as articles used for food in a form in which the food has not been chemically altered. In the absence of such information, androstenedione, humic acid, and fulvic acid are subject to the notification requirement for a new dietary ingredient under section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. Because you have not submitted the required notification, PerformPlus #3006, 2007 Celprotect II Bullet Points, and 2006 Celprotect I are adulterated under sections 402(f)(1)(B) and 413(a) of the Act [21 U.S.C. § 342(f)(1)(B) 350b(a)].

　　Even if the required notification had been submitted, based on what we know now, we know of no evidence that would establish that your products are not adulterated. In the absence of a history of use or other evidence of safety establishing that androstenedione, fulvic acid, or humic acid when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, a product containing androstenedione, fulvic acid, or humic acid is adulterated under 21 U.S.C. § 342(f)(1)(B) and 350b(a) as a dietary supplement that contains a new dietary ingredient for which there is. inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. § 331(a) and (v). FDA is aware of no history of use or other evidence of safety establishing that androstenedione, fulvic acid, or humic acid will reasonably be expected to be safe as a dietary ingredient. In the absence of such history of use or other evidence of safety, your products would be considered adulterated even if you had submitted a notification.

　　This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

　　We request that you take prompt action to correct these violations. Failure to immediately cease distribution of the products listed above as well as other products in violation of the Act could result in enforcement action by FDA without further notice. The Act provides for seizure of violative products, injunction against the manufacturers and distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.

　　Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

　　Your written reply should be addressed to:

　　James P. Stumpff

　　Acting Director, Compliance Branch

　　Food and Drug Administration

　　19701 Fairchild

　　Irvine, CA 92612-2506

　　If you have any questions regarding this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

　　Sincerely,

　　/S/

　　Alonza E. Cruse

　　Director

　　Los Angeles District

　　CC: Jeff Farrar, DVM, PhD, MPH

　　Branch Chief, Food and Drug Branch

　　California Department of Public Health

　　1500 Capitol Avenue - MS 7602

　　P.O. Box 997413

　　Sacramento, CA 95899-7413

　　 谷歌网页在线翻译原文如下：

　　EFT公司8/19/09

　　卫生和人类办事部 公共卫生办事

　　食物和药物治理局

　　 洛杉矶民政事务处

　　19701新时代

　　尔湾，加利福尼亚92612 - 2506

　　德律风： 949-608-2900

　　传实： 949-608-4415

　　警告信

　　挂号信

　　回执REOUESTED

　　2009年8月19日

　　的W / L 27-09

　　杰克先生秦

　　总统

　　生物科技控股公司EFT

　　929拉德基CT查抄。

　　市工业，加利福尼亚91748-1132

　　亲爱的秦先生：

　　3,2009年3月，美国食物和药物治理局（FDA ）搜集了你的产物，样品2006 Celprotect我在您的设备在929拉德基CT定位，。 ，城市工业，加利福尼亚91748-1132 。此外，我们审查了2009年7月互联网地址的规定在

　　 。

　　2006年Celprotect升：

　　您的产物我是2006年Celprotect搀杂在第402意义（ 1 ）（1 ）该法[21南加州大学§ 342（ 1 ）（1 ）在那]熊或它包罗有毒或有害物量，铅，那可能使其有害安康。 FDA的尝试室发现5.2微克的铅（铅）/克的产物。根据更大选举利用前提（天天4粒） ，从该产物的总消费量可能招致铅12微克/天。铅是一种有毒或本产物有害物量，因为它是在一个数额有助于一个不成承受的儿童炊事表露在目前的7岁。假设一个未满7岁的儿童表露于例行的根底上，各级指导对你的产物目前，永久性的损害中枢神经系统，可能会发作。那会招致进修障碍，发育缺陷，和其他持久的安康问题。此外，继续含有铅含量高可能产生铅中毒，此中有包罗贫血症状，如共济失调和烦躁，便秘，神经肌肉无力影响产物的消费数量和慢性肾炎。

　　你是口头通知对2009年3月20日那些成果。您递延贵公司的回应你的合同造造商 （二）（4 ）。收到信的回应 （二）（4 ） 关于 （二）（4 ） 和 （二）（4 ） 并指出， （二）（4 ）。然而，拟议的标签复造尚未收到洛杉矶区合规部。

　　炊事填补剂与治疗索赔：

　　那封信也是为了提醒各人， FDA已经确定， 2006年Celprotect 1你的产物， 2007年Celprotect第二要点，初乳＃ 3008 ， ＃ 2003银胶体， SuperCal ＃ 3015 ， ＃ 3003 + IONICS男男性接触者，从头生活再次＃ 3004 ， GlucoBalance ＃ 3017 ， ＃ 3019心撑持， PerformPlus ＃ 3006 ，和VisionPlus ＃三千〇一十二顷晋升为前提，使产物的是毒品根据第201（克）（1 ）（ B款[21 ）南加州大学§ 321（克）（1 ）（ b）条] 。在您的网站声称成立的治疗，那些产物是因为他们在治疗，缓解，治疗或预防疾病目标的药物。对那类索赔的那些产物的销售违背该法。

　　做者声称的例子看察您的网站包罗：

　　我2006年Celprotect

　　#8226;“广谱抗病毒（庇护和搀扶帮助消弭病毒） 。 “

　　#8226; “有利于削减痛苦冷疮。 “

　　2007 CelProtect第二要点

　　#8226;“在几分钟之内能够消弭食物中毒“

　　初乳＃ 3008

　　#8226; “连结血糖平衡“

　　#8226;“抗击病毒，细菌和实菌传染“

　　#8226; “改进关节炎患者的幸福生活“

　　#8226;“行痛“

　　#8226;“扑灭胶病“

　　胶体银＃2003

　　#8226; “研究表白，在胶体银是一种广谱有效的细菌，实菌和病毒，以至物种。不只成本更低，然后用

　　抗生素和抗病毒药物，胶体银的利用不会招致抗药性突变种。 “

　　#8226;“因为寡所周知的致病微生物能够生活在对mettalic [微量化学元素，以至存在原文]银，＃ 2003是更有效的冲击

　　超越650个差别的致病病原体，包罗病毒。 “

　　#8226; “所有的实菌，病毒，细菌，链球菌，葡萄球菌等致病微生物被杀死在三，四分钟，事实上，没有微生物晓得[原文]

　　那不是在6分钟内杀死或较少遭到＃2003 ...."

　　#8226; “那似乎不大可能，即便细菌战剂可以保存与＃2003碰着的，因为博拉病毒，如：E和汉坦，以至是可怕的'食肉菌'是，到了最初，只是不利的病毒和细菌。 “

　　#8226;“除了它的抗菌性能，'电汇'银处理计划也是一个强大的消炎剂。 “

　　SuperCal ＃ 3015

　　#8226;“钙[ 1在产物]成分...搀扶帮助[的] ，以避免退化性疾病的风险。 “

　　#8226;“ [钙] [ H]的电子进修产物到达碱性平衡therey [原文如斯] ，中和酸度程度，增加肌肉和关节活动，以冲击artihritic前提，心脏病...有助于运动损伤，头痛，血压高或低，高胆固醇，骨量松散症，类风湿关节炎，溃疡，。。 。银屑病，溃疡性结肠炎，肠胃炎，裂孔疝和白内障。 “

　　#8226;“伶俐的其他医疗汉子们还发现，钙填补剂，如SuperCal喷雾，确实能够改变癌症。 “

　　#8226;“ 1999年1月14日的凤凰共和国问题写了一篇题为'钙降低肿瘤' ，新英格兰医学杂志报导'添加钙能够让你远离大肠癌的肿瘤你。“

　　男男性接触者＃ 3003 +离子矿物

　　#8226;不像利用NSAIDS的，如阿斯匹林， “布洛芬等，招致比它们被设想用来减轻症状*更多的问题，男男性接触者没有已知的副感化，无毒性药物过量（它比水更平安！ ），它的益处同时减轻了身体的整体和重建结缔组织和关节。 “

　　#8226;“它的益处是传奇：...周济的肌肉痉挛，精神一般， anti-bacterial/inflammatory/parasitic效果...和肌肉痉挛和关节痛苦悲伤！“

　　再活一次＃ 3004

　　#8226; “锌[ 1在产物]成分：]他必须的矿物量[ T不断在对侏儒症和儿童生长痴钝的治疗感化。“

　　GlucoBalance ＃ 3017 （描述产物成分）

　　#8226;“苦瓜-研究人员发现，苦瓜有助于改进糖耐量，可以搀扶帮助降低血糖程度。“

　　#8226; ：“萌芽大麦- 大麦提取物是另一个传统医学，科学家已经发现可能会大大有助于一般的血糖程度。“

　　#8226;“武靴-有助于降低血糖程度...."

　　#8226;“肉桂-科学家们发现，肉桂提取物含有的化合物，以搀扶帮助庇护体内胰岛素活性加强壮康的血糖程度。 “

　　心撑持＃ 3019（描述产物成分）

　　#8226;“维生素B3 ...有助于降低'坏'低密度脂卵白胆固醇和甜油三酯（脂肪）的程度。 “

　　#8226;“姜 -按捺血小板聚集，反常有助于避免血液凝块反常，能够阻塞动脉。 “

　　#8226;“ ...绿茶可能有助于降低血压，降低胆固醇升高。 “

　　#8226;“丹参（沉丹） - 撑持。。。血小板削减心血管安康的更佳丛生。 “

　　PerformPlus ＃ 3006

　　#8226;“萨萨帕里拉提取物（赤土厚朴）[所有产物]成分：此药草...有助于降低胆固醇...."

　　#8226;“银杏叶[ 1在产物]成分：此提取[是]在勃起功用障碍的案件有搀扶帮助的。 “

　　#8226;“蒺藜[一个在产物]成分...在中国，它持久以来不断被用于男性阳痿， ... “

　　#8226;“五味子[一个在产物]成分：此药已利用了几百年，以改进...男性后劲。 “

　　#8226;“施行加：'我不克不及相信那不是伟哥'是全天然，科学配方的营养平衡的专家和医护人员旨在应对每对性功用差，欠缺相关的那些差别的问题，各人性欲，促进男性和女性的峰值性能。 “

　　VisionPlus ＃ 3012 （描述产物成分）

　　#8226;“维生素C [和维生素E ] ...能够搀扶帮助预防与年龄有关的由来自太阳的过量紫外线灯形成眼球晶状体混浊，并且能显着减缓

　　目力恶化。 “

　　#8226; “维生素A和β-胡萝卜素：一病例比照“研究成果发现，类胡萝卜素之间的丰富的食物和年龄相关性黄斑变性的风险消耗显着负相关，在成年人不成逆转的失明的次要原因。 “

　　#8226;“叶黄素高度集中在眼睛的黄斑，并有助于避免晒伤和年龄有关的黄斑变性的眼睛。叶黄素的填补

　　已经证明，以改进与年龄相关性黄斑变性的视功用科目，也为视网膜色素变性（慢视网膜变性某些科目） 。 “

　　#8226;“玉米黄量...那些黄色的胡萝卜素在预防氧化损伤感化的黄斑，显然发扬对开展的保障核心感化

　　黄斑变性。增加叶黄素和浓度/或玉米黄量能够供给对黄斑变性开展的重要庇护感化。 “

　　此外，那些产物一般不确认为平安，为上述提及的用处，因而有效的，产物是“新药“根据第201（磷的行为[ 21）南加州大学§ 321（规划） ] 。新的药物可能无法在美国合法销售未经美国食物药物治理局事先批准，描述在第505（ 1该法[21 ）南加州大学§ 355（ a）条] 。美国FDA批准的药物由倡议人提交的科学数据的根底上，新的药物，证明那种药物是平安有效的。你们的产物都贴假标签内的502条的含义（六）（ 1）在该法对那些药物的标签利用不承担足够的标的目的[21南加州大学§ 352 （六）（ 1）] 。

　　炊事填补剂含雄烯二酮，胡敏酸，黄腐酸：

　　虽然在网站上声称，招致治疗你的产物是药品，您的产物标签和/或炊事填补剂妥帖。术语“炊事填补剂“的定义是在第201（法郎该法[21 ）南加州大学§ 321（法郎）] 。该PerformPlus ＃ 3006产物成分在您的网站名单公布雄烯二酮（除其他名称，也被称为4 -雄烯二酮或4 -雄甾烯- 3， 17 -二酮为原料） 。 2007年第二要点Celprotect产物的成份在您的网站列表声明为原料腐殖酸和富里酸。 2006年Celprotect声明为我的产物标签上的成分腐殖酸和富里酸。

　　既然你有一个炊事填补剂标签为那些产物，我们假设你有一个的根底上得出结论，雄烯二酮，腐殖酸，黄腐酸和“饮食成分“根据第201（法郎）（ 1法[ 21）南加州大学§ 321（法郎）（ 1）] 。假设雄烯二酮，腐殖酸，黄腐酸和“饮食成分“，他们也将“新炊事成分条“ 413（ 1 ）（ 2）法[21南加州大学§ 350b （ 1 ）（ 2）]和21 CFR 190.6 ，为此，通知是必须的。

　　根据该法第[21 413联邦法典§ 350b ] ，饮食填补剂，此中包罗一个新的炊事成分（即饮食成分没有在美国销售10月15日前，1994年）应被视为掺假402条（六）该法[21南加州大学§ 342（ f）条] ，除非它契合两项前提之一：

　　（ 1）炊事填补剂仅包罗已在食物中利用，做为一个在该食物没有化学改变的形式，逐条目前炊事成分的食物赐与;或

　　（二）有利用或成立的炊事成分的前提下利用时，定见的平安或其他证据的汗青标签的定见

　　炊事填补剂的合理预期将是平安的，而至少75天前被引进或进进州际商业，造造商或炊事成分或营养填补剂经销商介绍交付美国FDA供给的材料，包罗任何已颁发的文章引用，那是在其造造商或代办署理商已得出结论，炊事营养填补剂含有那类成分的合理预期将是平安的根底。

　　美国FDA没有发现任何证明雄烯二酮，腐殖酸信息晓得，黄腐酸是合法的，在美国销售的炊事成分10月15日前，1994年。也不是FDA的任何证明材料展现，那些成分已在目前的粮食赐与做为粮食利用的物品中，此中食物没有化学改变的形式。在如许的信息，雄烯二酮，胡敏酸的情状下，和黄腐酸是根据第一个新的炊事成分受通知的规定， 413（ 1 ）（ 2）法[21南加州大学§ 350b （ 1 ）（ 2）]和21 CFR 190.6 。因为你没有供给所要求的通知， PerformPlus ＃ 3006 ， 2007 Celprotect第二要点，2006年Celprotect我是根据第402（搀杂六） （ 1 ）（ B）和413 （一法[ 21）南加州大学§ 342 （六）（1 ）（ B）及350b （一）] 。

　　即便已提交通知要求的根底上，我们如今晓得，我们晓得没有证据，证明你的产物不掺假。在一个利用或成立那一雄烯二酮，黄腐酸，胡敏酸或当利用平安的前提下，没有其他证据的汗青，定见或在您的产物标签的定见，将合理预期是平安的，一个产物含有雄烯二酮，黄腐酸，胡敏酸是掺假或21岁以下的南加州大学§ 342 （六）（1 ）（ B）和350b （一）做为饮食的填补，此中包罗一个新的炊事成分，目前有关该。信息不敷，供给合理的包管，那种成分并没有显着或生病或受伤的不合理的求助紧急。如许的产物介绍到州际商业制止21岁以下的南加州大学§ 331（ a）及（五）。 FDA是不利用或成立的雄烯二酮，黄腐酸，胡敏酸的平安或其他证据的汗青意识，就会合理地估量可做为饮食成分的平安。在对利用或平安的其他证据，如汗青的情状下，你的产物将被视为掺假，即便你提交了一份通知。

　　那封信是不是要成为你的产物和标签都宽大审查。那是你的责任，以确保贵公司销售遵守该法及其施行条例的所有产物。

　　我们要求你们敏捷摘取动作，纠正那些行为。假设不立即停行上述以及其他违背该法所列的产物，产物的分配可能会招致美国FDA ，恕不另行通知在执法动作。该律例定，违规产物，对造造商和分销商强逼充公违规产物，以及对人形成违背该法的负责刑事造裁。

　　请通知本处，以书面形式，在15 （15 ）工做的那封信后日内，以您所摘取的详细步调纠正上述违法行为，并确保不发作类似的侵权行为。包罗任何需要的证明文件更正已经到达。假设纠正办法未能在15个工做日内完成，阐明理由挈延和在此中的更正将被完成的时间。

　　你的书面回答应寄往：

　　詹姆斯Stumpff

　　代办署理主任，合规部

　　食物和药物治理局

　　19701新时代

　　尔湾，加利福尼亚92612-2506

　　假设您有任何疑问那封信，请949-608-4439联络Marco伊斯特芙，监察主任。

　　热诚的，

　　与/ S /

　　阿尔萨大肠杆菌克鲁斯

　　董事

　　洛杉矶区

　　抄送：杰夫法拉尔，数字电压表，博士，公共卫生硕士

　　处处长，食物和药物科

　　加州公共卫生署

　　1500卡皮托尔大街- 微软7602

　　P.O.盒997413

　　萨克拉门托，加利福尼亚95899-7413

　　 以上是FDA对EFT公司发出的警告信，看了令人不冷而栗！

　　EFT公司总裁在香港声称 新产物2005 2006 2007 对肝病有特效疗效；快则7天转印慢着半年！可至今一切都是假的；FDA竟然发现新产物还有重金属成分，对人体有毒副感化的！恐惧！

　　 该公司2001称为超等神水。产物手册鼓吹其2001原理是美国氢弹之父艾瓦雷特创造的。可是！在糊弄人啊！撒下弥天大谎！

　　 美国的氢弹之父并非艾瓦雷特呀 而是另有其人，不知EFT为何编造如许的谎话？令人不解！

　　 各人醒醒了。。EFT的诸多疑问，有待各人切磋！