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美国专业直饮净水器森乐全屋净水系统
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[其他] 分享一个蒙人的品牌-美国EFT-主营保健品

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发表于 2014-5-16 10:13 | 显示全部楼层 |阅读模式
因为在美国出差,朋友让帮着带EFT的胶体银保健产品,结果没找到在哪里有卖,于是顺手查了一下相关信息,发现是一个注册在美国的蒙中国人的邮购公司。
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我个人的建议是:不要购买这个品牌的任何产品。从安全性上说他们的产品可能还不如国内的假货。' k" F  k7 I2 p" `# i2 W( C
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在几年前已经有人查到这个企业是蒙人的,并在网上发了贴子。我在网上看了一些资料,2007年和2009年的两个揭露他们信息都是正确的。他们目前仍然在用同样的方法 骗人: T& Q6 O% i2 z& [
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http://bbs.tianya.cn/post-100-696916-1.shtml4 v! H! j# m5 T
首先请看转载:* k+ k6 t, o% O5 H: `) ?& c7 Z
  借名行网络传销 提醒市民提防“EFT” & p- J! a* s& R* E# O
  www.LN.XINHUANET.com   2007年04月05日 09:07:12  来源:大连日报
1 t7 ~9 T1 K& D. P   近几个月来,一个叫做EFT的邮购公司经常被部分市民提起,有人声称通过该公司邮购产品就可获得巨额收益,然而,因听信了这一流言而感觉上当的市民也不断出现。昨日,经本报记者深入调查,发现这家EFT邮购公司竟然已被我国工商总局定性为涉嫌传销。" h" \3 l- ^. T% ]% v- H
  
1 n5 c1 h5 n5 y  D7 e( _   当天市民林先生告诉记者,几天前有人向其母介绍,一家名为EFT的公司是一家大型电子商务公司,专做邮购业务,总部设在美国,只要加入该公司就可获得巨额奖励,但前提是必须购买其产品。老人经不住诱惑,以2300元的价格买了一套号称能根治糖尿病等多种疾病的“神水”,并成为其“会员”。此时老人才得知,所谓获利就是需要“会员”发展别人购商品,从中提取回扣。- Z* }) L5 q6 H! H
   记者按照林先生所提供的网址登录了EFT公司的网站,发现上面写的话漏洞百出:“2006年3月经中国消费者维权联合会评审,授予EFT高科技口喷系列保健品为《2006年度保健品“3•15”诚信推广品牌》,另经中国中轻产品质量保障中心审核,美国EFT开发经营的系列高科技保健品、护肤品、汽车保养品为《国家合格评定质量信得过产品》……”此外,还有一个所谓的“答记者问”,“EFT公司并未在中国登记注册,其属于国际化的邮购公司,不用在中国国内注册。”显然,这是一个骗局,既然没有在我国注册,其产品怎么可能获得我国消费者权益部门评选的奖项呢?
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   按照该网站的介绍,记者逐渐了解到EFT公司的销售模式:申请者 A得用250美元加邮费(可折合为人民币)订购一套产品,这个时候 A便成了这个公司的消费者,有资格推荐其他消费者,也就是发展下线。然后, A必须直接发展两个下线,再分左右下线组织网络,此时开始积累套装消费奖金,奖金按周结算。直接发展的下线越多,或是下线发展的下线越多, A的奖金就越高。: Y8 ^. a4 h% L" F$ s- n" I/ d
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   这家公司称其“能够规避一个国家的管理风险”,记者就此咨询市工商局的有关人员,市场处的工作人员指出:“如果EFT公司在中国运营的直销企业脱离了政府的监管,那它算‘偷渡’还是‘空降’?如果EFT公司能够规避一个国家的管理风险,那么消费者的权益还能得到有效保障吗?这不是典型的钻政府管理空子的投机公司吗?”1 o' ~0 t+ c: o) @/ Y3 G
  
( O3 S0 {% h' f9 H3 n2 J2 m   记者在采访中还了解到,目前这家EFT公司已经在我市等一些地区发展了一批会员。早在2004年,国家工商总局曝光和查处十大传销和变相传销案件中,“美国EFT公司”就已经赫然在目。对此市工商部门表示,希望市民能提高警惕,尤其是要提防利用“特许加盟”和互联网进行的非法传销活动,切莫上当,必要时可向当地工商部门进行咨询或举报。1 |1 G3 l  X% p. [2 P1 y
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   孙亮 记者谷国强3 a* d2 F/ d1 [9 ^
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7 y* w! \" I/ F2 N: l7 J  这里还有: 已经被查了, 大家千万不要再上当了呀!
% T' y! ~3 s  d$ t  看这个: http://paper.people.com.cn/scb/h ... ontent_35730140.htm* G: M$ i* V0 h7 W5 K7 W, g
  http://www.people.com.cn/GB/paper53/12743/1144869.html7 ?; M8 X; g  b% ~; \
  http://www.people.com.cn/GB/paper1787/12691/1140194.html
! Q$ Y2 I$ v. U* x5 j  http://www.pxyy.org/ss/html/07/207-1203.html
. R  H3 |( E% Y6 g  大陆好多人在卖这个产品,千万别轻信哦!!
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# H: W/ P+ t' t8 ]+ e+ U下面是当时发贴的人写的:(本文主要针对想购买EFT公司产品的重症患者,请仔细阅读。) . ]& H1 L+ X: g4 O
  该公司创办人秦杰好像很出名,一个杰出的商人,这也意味着难改商人的本性!由于有朋友得了重病,他们听人极力介绍推销接触到其公司EFT的产品,一个疗程要7000元,需要10个疗程。这对一般大陆的家庭来说可不是小数目。于是才接触到他们公司的网站 http://www.eftb.us/about_company.php?language=en, 于是才得知秦杰此人。
& V) p0 {/ b) k* D  这是一个网上邮购公司。4 q$ d1 j( T0 j+ ?
  
: s, b6 @0 Q; u1 `" f( J# _7 S9 W  -秦杰秦杰生于中国上海,毕业于江西工学院机械制造专业,1988年到美国堪萨斯州ESU大学(什么野鸡大学?反正我没听说过,我请教的老美也没听过)攻读MBA学位。他没有任何生物知识背景,网上所列公司合作人无一人生物背景或者是Science背景,都是搞市场的,搞传销的。看来,Biotech 高科技生物,纳米技术,真是什么人/公司都能套用!只要会宣传会广告,卖什么不重要,能卖出才重要!!!
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  -他们主要针对大陆消费者,公司在美国加州,利用邮购手段卖出产品。提几个疑问,大家自己动脑经思考:
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  -请大家自己上他们网站,http://www.eftb.us/about_company.php?language=en,自己看一看,是不是很像一个兜售信息的垃圾网站?很程式化的套用来的图片,一些加粗的字体?当然这个知识感觉,我们继续往下看。
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  -为什么主要消费群是中国大陆的?他们有详而又详的简体繁体中文介绍,而英文介绍却错误百出,语法,拼写错误等等,甚至写得让人觉得搞笑?这一点,大家可以像我一样找英文母语的人帮忙,我被告之的是,这一定是业余英文爱好者写的。再问一遍,为什么针对中国百姓呢?想想,一般大陆的中国老百姓听到美国高科技,生物公司,进口药材会作何感想?看到网站上有英文介绍却又似懂非懂对一般的老百姓有没有说服力?下面给个例子:
+ t4 j7 N% W6 g$ M; d. X  h  http://www.eftb.us/product_info.php?cPath=&products_id=47 (以下是胶银 #2003的部分描述)
, H  v4 t# q6 ?5 h- H6 R  “        #2003contains no free radicals, as the silver acts only as catalyst, and is stabilized. #2003 is not a chemical compound containing silver, but pure metallic silver of submicroscopic clusters of just a few atoms, held in suspension in pure water, by the tiny electric charge on each atom. It is absolutely non-toxic( except to one celled plants and animals), and non-addicting.
- \9 X8 u. M' P- P          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. To top it off, #2003 is virtually non-toxic, making it safe for both children and adults, as well as pets. In short, anything bigger than a one cel animal seems to like it.
. t: m) p3 R4 c$ \7 P1 I          Nor does one have to worry about the FDA( Food and Drug Administration) fox being put in charge of this hime remedy hen house. #2003 is a pre-1938 healing modality, making it exempt from the FDA jurisdiction un der the grandfather clause.”
# ]3 c+ |/ U" }! c8 Z  特意请教了一个老外,只说了bogus(胡说八道)! 顺便说一句,上面文字里提到银,银食入过多也是会中毒的。' e6 q8 A7 u  Q1 t
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  -网站上英文介绍,甚至有错误的描述。比如他们称他们的产品“colloidal silver”是antibiotic(抗生素),而美国食品和药物管理局(FDA)早就否定了这点。再如,http://www.eftb.us/product_info. ... =71&language=en,他们关于“超级喷雾钙 #3015”产品描述里,写到该产品含有coral calcium。而参照Wikipedia网站, 查询coral calcium, (http://en.wikipedia.org/wiki/Coral_calcium#Health_claims)上写“coral calcium has been identified by the United States Food and Drug Administration as a "Fake Cancer ’Cure’ Consumers Should Avoid”(美国食品和药物管理局(FDA)确认,消费者应该避免购买coral calcium,这是一种假的抗癌药。)5 Y4 U- C$ m$ |& o: d+ b
  所以,类似的例子,请大家开动脑子,如果真的花大钱买药,得先做个明白人,多做做调查研究。请教一下身边读生物的人士等等,盲信,盲从都是不可取的,尤其是现在国内那么多假冒伪劣产品,你怎么知道国外就没有呢?况且是个既懂中国行情又懂英文的中国人呢?顺便说一下,不要动不动就说是华人的骄傲,靠,不说他是华人的败类就不错了!不是有了钱有了名就不用考虑他做的什么勾当的!
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! h1 ~0 X  k$ Z* c1 V, Q  -很好听,他们公司上市了,但是请教了老外,说,“Their particular stock is ’pink slips’, and they aren’t subject to the normal SEC regulations for companies listed on stock exchanges”,“Their company is traded on a market that is notorious for extremely risky stocks”。大概是说,一般的上市公司都受SEC规章调控,而他们公司不属于这类,他们公司在美国一个臭名昭著的高风险股票市场上交易。懂的人可以帮着介绍一下。当然这样一来,他们公司听上去就更可信啦。怪不得这个秦杰这么有名,吼吼,连凤凰卫视,还有什么江苏卫视都采访他,还到北京大学做演讲,拜托,以后先调查清楚他是干嘛的再说,现在说的好听,以前的说法,就是一卖假药的,披着现代的高科技衣服。" r5 S# Q/ b  y5 S8 b* f* i
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  -哇,还有美国授予他的荣誉。好厉害!美国人懂嘛中国药材,他们包装出售的中药性质(一些诸如灵芝,绿茶等)的补品,大部分又都销到国内,美国人只要你公司赚了钱他们,给美国纳了税,就是好样的!大家想想,一个患者花7到8万买他的东西,在大陆通过人传人的销售方式,随便都能赚好多啊,公司能不发吗?秦杰能不成为成功人士吗?我写这个,只是想站在大陆普通消费者的角度,因为绝望所以愿意花大价钱买这些他们并不清楚来龙去脉的“名不副实”的补品,呼吁大家要小心,尤其是重症患者,捞他们的钱,实在让人愤慨。如果有人看到这个留言,请一定相走告之。或者如果能静下心来,客观的仔细的看一下他们产品的介绍,自己做一下研究,就会发现很多可疑点。) b/ y/ m8 k2 X" E2 V" u' O
  
5 k+ {" j0 u$ ]+ k! d( u  -他们公司的产品都是一些在美国市场上被称为“supplements(补品)”的药,没有任何一种药是由真正的药厂支撑的,也没有任何一种药是需要通过美国食品和药物管理局(FDA)检验来证明它的药效或者不含有害成分的。换一种话说,FDA也没有说这些“药”就是假的了,你只能说,这些东西并没有被证明可以治疗任何疾病。也许这些‘补品’是可以让病人感觉好些,你听听它们的名字,“有机神奇茶”,“极品灵芝喷剂”,“超级神水”等等,一瓶就30-50美元不等,他们的消费者可是中国的普通百姓,很多还是病人!就是这样模棱两可,似是而非的“补品”,叫人半信半疑,吃了死不了人,不吃信不信由你。很贵的哦,越贵越有人上。' v8 [; k# V, `# }- c* }& F& v+ [  d
  
. R3 O( e) f* `  如果不是偶然原因,也不会去研究这样一个公司。由于没有阅读他们公司其他的“护肤美容,汽车环保,居家日用”产品的介绍,此文只针对欲购买其保健食品的大陆重症患者,作为参考。
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   “我最大的快乐就是看到EFT不仅为大家带来健康 更为大家带来创造财富的机会。” ——秦杰
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  (我想他的意思是,“我最大的快乐就是看到EFT不仅没有为大家带来健康 更为我秦杰带来创造财富的机会!); b* q7 R% b* M0 U  o9 {3 P
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 楼主| 发表于 2014-5-16 10:14 | 显示全部楼层
同时还查到了FDA给他们的警告信。  
6 B0 G0 G7 t7 |8 vhttp://www.fda.gov/iceci/enforcementactions/warningletters/ucm182243.htm$ l  O( Q7 W) ^
EFT Inc 8/19/09
Department of Health and Human ServicesPublic Health Service
7 F9 D7 K+ `! V  IFood and Drug Administration
Los Angeles District Office
, O! s+ j- \9 U19701 Fairchild
2 l' Y. K- h' F# h0 Q, ^. {Irvine, CA 92612 - 2506
* c' S3 h3 {8 g; t+ l8 ]( ^. MTelephone: 949-608-29007 e! l+ N. V' C' q* c
FAX: 949-608-4415

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, R: J  r. |$ a9 g4 |% Q, zWARNING LETTER

* c% [: ?3 `5 ^7 l+ CCERTIFIED MAIL
6 ~0 ^% b' g% i6 C: {6 _RETURN RECEIPT REOUESTED
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August 19, 2009
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- W7 @, T+ P& e8 o( {4 ]Mr. Jack Qin6 p9 {" [' T' J9 ^2 A7 T* Y% k
President
/ A. |* N1 L6 i5 R7 e2 p" ~& qEFT Biotech Holdings Inc.. H# C; O6 ^; k0 M
929 Radecki Ct.
- N# G9 [* W9 N9 l6 N" bCity of Industry, CA 91748-1132

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Dear Mr. Qin:
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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 http://www.eftb.us in July 2009. Our analysis of your product sample and our review of your website found numerous violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet web site at
http://www.fda.gov.
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2006 Celprotect l:
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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.
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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.

3 q' w8 ?* E, H5 w# X. \Dietary Supplements with Therapeutic Claims:
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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.
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Examples of claims observed on your website include:

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9 J2 a2 m& \" v6 X• "Broad spectrum anti-viral (protects and helps eliminate viruses)."8 X( J  Z, d9 G" L
• "Helps diminish painful cold sores."
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2007 CelProtect II Bullet Points
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• "Can eliminate food poisoning within minutes"
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Colostrum #3008

  C% z! [( i# B9 e! G• "Maintain Blood-sugar balance"
( g9 g* J: C6 E$ m$ G( C% t1 P• "Fight viral, bacterial & fungus infections"( a- O$ E: b; i' O; V7 q
• "Improve well being of arthritis sufferers"
2 a: ?# P7 ^" E+ E6 O' n• "Relieve pain"7 ~5 t; B2 W/ h9 d; N( G
• "Fight gum disease"
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Colloidal Silver #2003

: @. |: z% z! X/ |/ Y# {• "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
* c/ P  E% J) k/ w& g$ lantibiotics and anti-viral agents, Colloidal Silver use does not result in mutations of resistant species."
) C- i. ~( \4 c4 T• "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 more4 h6 c. s0 o/ P0 d# O; m
than 650 different disease causing pathogens including viruses."3 P  m. P, Q7 s0 V! Q# j! Y8 R) q1 V
• "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]2 u: Z- C' o4 v+ S
that is not killed by #2003 in six minutes or less ...."/ n- m* C2 n, t, a
• "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."
) ?/ b7 F% J' s4 \6 {6 R/ ^9 g• "In addition to its anti-microbial properties, 'EFT' silver solution is also a powerful anti-inflammatory agent."

6 n' k1 r3 W' H7 G1 o  _SuperCal #3015

7 G( W  k8 D6 s9 N• "Calcium [an ingredient in the product] ... help to prevent the risk of degenerative diseases."
+ C: G. H+ A3 M• "[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."
8 t& @% p" z1 t: Z• "Other medical men of wisdom have also discovered that calcium supplements, such as SuperCal Spray, could indeed reverse cancer."
! j- E  B2 n, e• "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'."

& W& _# e2 _6 j; R$ tMSM # 3003 + Ionic Minerals

8 X3 U! \. B* r  |! D• "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."- ?' F7 L3 _  {, F; _
• "Its benefits are legendary: ... relief of muscle cramps, mental normalcy, anti-bacterial/inflammatory/parasitic effect ... and relief of muscle spasms and joint pain!"
4 j) H8 s( `# }) \$ l
Re-Live Again #3004
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• "Zinc [an ingredient in the product]: [T]his essential mineral has been useful in the treatment of dwarfism and retarded growth in children."

8 l3 D5 F( }/ w) H9 l' aGlucoBalance #3017 (describing ingredients in the product)
5 O$ H1 k0 L" M: b8 B% x
• "Bitter Melon - Researchers have found that Bitter Melon helps improve glucose tolerance and can help lower blood sugar levels."7 b5 a* L( ^3 h
• "Barley Sprout - Barley extract is another traditional medicine that scientists have found may significantly help normalize blood sugar levels."' `* o4 b; N& Z6 H
• "Gymnema - Helps lower blood sugar levels ...."
' U# T7 I( U1 Q- x. F* {• "Cinnamon - Scientists have found that Cinnamon extract contains compounds that help maintain healthy blood sugar levels by enhancing insulin activity in body."
) Z- Q3 X) r: l/ l8 C# [$ [
Cardio Support #3019 (describing ingredients in the product)
: K$ Q, Q5 p$ ]5 C
• "Vitamin B3 ... helps reduce levels of 'bad' LDL cholesterol and triglycerides (fats)."0 ~4 k% `0 M! [2 \5 J
• "Ginger - inhibits abnormal platelet clumping and helps protect against abnormal blood clots that can clog arteries."  Q3 ~: j; F/ S) H1 T! I# T
• "Green tea ... may help to lower blood pressure and reduce elevated cholesterol.". _/ f) K2 ^; Z. o, B% U! `+ a. Z
• "Salvia (Dan Shen) - supports . . . reduced platelet clumping for optimal cardiovascular health."
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PerformPlus #3006

8 R& u* Y1 v5 l3 y, L• "Sarsaparilla Extract (smilax officinalis) [all ingredient in the product]: This herb ... helps lower cholesterol ...."
% W1 }3 G5 R4 T; Z, ^. K, m  ^0 y4 r• "Ginkgo Biloba [an ingredient in the product]: This extract [is] helpful in cases of erectile dysfunction."
$ ]9 p0 @, B+ |0 w; ?8 e2 x• "Tribulus Terrestris [an ingredient in the product] ... In China, it has long been used for impotency in men, ..."
) U4 h! S0 h! G( R9 e7 F• "Schisandra [an ingredient in the product]: This herb has been used for centuries to improve ... staying power in men.". G/ W% h" r7 v( _& V  |& K" L8 M
• "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."# \' h  q; x( P* E
VisionPlus #3012 (describing ingredients in the product)
9 U* s& i- j0 R
• "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+ L# K6 \- \4 b; p9 Z. A
deterioration of vision."
2 V0 K% p- H: ]• "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."
( Q2 c. H5 p+ }• "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 supplementation0 {3 S" W' W8 {; X- Q! @2 X
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)."6 n- c$ ^; v- B3 e
• "Zeaxanthin ... These yellow carotenes function in preventing oxidative damage to the macula and obviously play a central role in protecting against the development of& T1 Q5 T- f. Q; g* ~) t
macular degeneration. Increasing the concentration of Lutein and/or Zeaxanthin may offer significant protective effects against the development of macular degeneration."

, N" q2 a$ z* E! M6 zMoreover, 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)].

! l1 b; ^+ L: S6 M" sDietary Supplements Containing Androstenedione, Humic Acid, and Fulvic Acid:
) E% g: k  j% a
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.

: E, c( R( m) f3 N% E$ H: gGiven 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.

& k  [/ B) B0 m& z& ~* k; SUnder 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:
  G% B: g" v0 x$ I8 @1 k
(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* b' s3 b  l$ D: G3 j$ i0 F

4 o( f" i8 b( h6 `/ ](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
; J/ N5 S0 ?+ H2 z# M6 ythe 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.

/ S* h  i7 l; F: ]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)].

0 i! R& r$ U! R6 L! [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.
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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.
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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.

6 i6 L  x7 n1 W+ C7 w( R1 N; \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.

( w2 I6 x# L: rYour written reply should be addressed to:

- z+ c; M3 k! S7 oJames P. Stumpff: b2 b: [0 g7 B# |
Acting Director, Compliance Branch
; ?4 _* M, c0 |( Q3 s7 W* D0 {Food and Drug Administration  u8 ]% o+ _6 s$ {" {
19701 Fairchild9 I' a% k( @& R5 b/ {6 \! m
Irvine, CA 92612-2506
$ I- s6 F  }8 R  Y- c* l
If you have any questions regarding this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

: h1 O: y0 `# ?% t- ASincerely,
/S/
: N6 X3 ^1 R. a9 u8 V& s& r) dAlonza E. Cruse2 h/ G" F  V/ b. |- j# E$ t% |- t
Director; C  r, m6 {* l  z3 v: a' B' y
Los Angeles District

9 k* j4 P  b) B/ p8 F# p1 l$ XCC: Jeff Farrar, DVM, PhD, MPH
8 X0 @$ |& i, S5 N6 ?1 a9 kBranch Chief, Food and Drug Branch
: y! W# w7 ^/ t: \( r4 n$ sCalifornia Department of Public Health
& R$ D% m" g: f2 V1500 Capitol Avenue - MS 7602- J* R1 i7 W6 s. x5 i/ t) q3 c
P.O. Box 997413& S; Z) n7 D, O* q3 a
Sacramento, CA 95899-7413
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 楼主| 发表于 2014-5-16 10:26 | 显示全部楼层
如果一个消费品在amazon上根本查不到信息的话,就要小心了,基本上就可以确定这个产品有问题。如果他们宣传说做了很久,销量大、而且网络平台是主要方式,但amazon上没有,基本可以确定是假的。
; y2 b8 A1 P; T  U  i$ \! Y& s$ P8 o' j! W. L1 `
在国外有Colloidal Silver (胶体银?)类的产品在销售,都是归在保健品里面,不要当药来用也不要指望有药品的效果。) x1 P; P" g, l7 Q
例如下面这个: f; h; P" T% [8 t1 O$ C. Y6 ?
http://www.amazon.com/Natural-Pa ... 20&tag=c05f0-20  U  f. V  ^6 A& i: ]
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$ d  l* s. U( n3 n: j- O% b
8 r3 M, E* L% l, I9 \1 n1 z
发表于 2014-5-16 21:20 | 显示全部楼层
传销开到美帝去了。
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