同时还查到了FDA给他们的警告信。 % g0 n1 x' t; i3 r/ m, ]
http://www.fda.gov/iceci/enforcementactions/warningletters/ucm182243.htm
9 X; Z+ D6 `8 S' M; J1 dEFT Inc 8/19/09| | |  Department of Health and Human Services | Public Health Service, b" m0 E* a2 Q) ~/ c
Food and Drug Administration | | | Los Angeles District Office
4 z4 ^3 U$ n3 q19701 Fairchild( S Z ^& R& G9 H5 S
Irvine, CA 92612 - 25069 @0 y/ V# a4 H$ w( G% @! }/ ?
Telephone: 949-608-2900 c& C% c/ q6 Q$ {* @3 E
FAX: 949-608-4415 |
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WARNING LETTER " q) t7 Z v2 e6 }$ I
CERTIFIED MAIL- G0 y9 J% L9 @# r* [/ c3 L! S
RETURN RECEIPT REOUESTED
. ?) m6 ]/ ]# m' ~August 19, 2009
! F9 w( V, c2 h) Y h: ?W/L 27-09
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Mr. Jack Qin/ d8 G# w- p3 x, @5 F% f
President7 S/ a0 k2 h7 Q/ b9 @2 b
EFT Biotech Holdings Inc.
* u( q) N( s. v% E( t3 F# g: J929 Radecki Ct.
% T* Y/ N- ~9 t+ Z4 kCity of Industry, CA 91748-1132 . _, D6 i+ A9 p3 c" l1 ?, |' A
Dear Mr. Qin:
+ C# j s' h/ j' l& @ p w: F: }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.
- D" p0 }) @: R2 T2006 Celprotect l:
$ C$ [0 P; d7 tYour 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. P4 f5 M8 P, h' e; ]* s& o C& P" ~
Dietary Supplements with Therapeutic Claims: - }2 E" h G: B1 H7 x% e$ x4 z
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. " i( X, A3 e! [/ F3 s
Examples of claims observed on your website include:
4 p4 D% g6 n: L0 @: B2006 Celprotect I
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• "Broad spectrum anti-viral (protects and helps eliminate viruses)."
9 z. f1 g8 D9 d4 w. {8 H7 V• "Helps diminish painful cold sores." , [4 e5 W+ k$ j! w4 V
2007 CelProtect II Bullet Points
# m& V( l* H& T+ K2 @• "Can eliminate food poisoning within minutes"
# M6 w- X2 H2 \& m0 g: d6 K; oColostrum #3008
* p1 Y, S4 Z8 U1 l d$ G2 [& N• "Maintain Blood-sugar balance"6 v9 `& T" [. k
• "Fight viral, bacterial & fungus infections"
$ U Z" r! F# M# P; D• "Improve well being of arthritis sufferers"+ [! K% _8 c; ?5 [1 x
• "Relieve pain"
7 I# @; }( ~+ c5 P3 N• "Fight gum disease"
6 `- W0 h: P7 h$ l5 d. a, YColloidal Silver #2003
9 V( m& d2 O) P• "Research has demonstrated that Colloidal Silver is effective over a broad spectrum of bacterial, fungal and even viral species. Not only less costly then available3 E( ]& o! q5 |2 I6 Z2 u2 r( [$ H6 w
antibiotics and anti-viral agents, Colloidal Silver use does not result in mutations of resistant species.". O8 A$ m P# [2 z8 y( b" v, J2 W
• "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
1 P6 ^ B% K% }than 650 different disease causing pathogens including viruses."
+ n& w$ ~3 s8 ^% Y7 t• "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]; q; q2 e4 {3 w9 y
that is not killed by #2003 in six minutes or less ...."* g- h w8 Q- {' h& t% p& V
• "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."- p: w) B; \$ }
• "In addition to its anti-microbial properties, 'EFT' silver solution is also a powerful anti-inflammatory agent."
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SuperCal #3015 ) ^+ c6 j- f% N, g6 |# d
• "Calcium [an ingredient in the product] ... help to prevent the risk of degenerative diseases."4 H, h/ @3 o5 b0 ?2 I8 E1 L$ L
• "[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."/ N( u' Z* N- O! I' U0 V
• "Other medical men of wisdom have also discovered that calcium supplements, such as SuperCal Spray, could indeed reverse cancer."
9 @- A6 p8 Z1 S D• "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'."
x$ r K6 s1 v( g) sMSM # 3003 + Ionic Minerals
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• "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."
) q6 ?) s$ K; S2 h* F0 V2 l( W h• "Its benefits are legendary: ... relief of muscle cramps, mental normalcy, anti-bacterial/inflammatory/parasitic effect ... and relief of muscle spasms and joint pain!"
+ f/ t; ^: w+ w7 J9 ?Re-Live Again #3004
# q. E$ J; c9 Z6 _9 X8 m7 b• "Zinc [an ingredient in the product]: [T]his essential mineral has been useful in the treatment of dwarfism and retarded growth in children."
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GlucoBalance #3017 (describing ingredients in the product) 4 Y: @# P! |( W6 o1 X
• "Bitter Melon - Researchers have found that Bitter Melon helps improve glucose tolerance and can help lower blood sugar levels."2 S, E( Z/ d& p i% g" ~1 X) X
• "Barley Sprout - Barley extract is another traditional medicine that scientists have found may significantly help normalize blood sugar levels."! B$ c4 l8 m4 H# v* Z2 u
• "Gymnema - Helps lower blood sugar levels ...."$ e5 R* u q" [2 P6 H
• "Cinnamon - Scientists have found that Cinnamon extract contains compounds that help maintain healthy blood sugar levels by enhancing insulin activity in body." + E6 |7 m/ k5 a7 p# ~
Cardio Support #3019 (describing ingredients in the product) 0 }9 I. r h/ ~3 s6 u9 _; E t0 ^
• "Vitamin B3 ... helps reduce levels of 'bad' LDL cholesterol and triglycerides (fats)."# o9 n! Z! w/ T: L% Z4 K6 S
• "Ginger - inhibits abnormal platelet clumping and helps protect against abnormal blood clots that can clog arteries."4 }) |* N% B) k4 J5 q
• "Green tea ... may help to lower blood pressure and reduce elevated cholesterol."
% [+ x4 w5 O' j' j• "Salvia (Dan Shen) - supports . . . reduced platelet clumping for optimal cardiovascular health." % P0 i! C; m! z. @, T4 T) |, w' n$ g! F
PerformPlus #3006
6 A- }6 W5 i" G% |6 x( b' Z) j6 |• "Sarsaparilla Extract (smilax officinalis) [all ingredient in the product]: This herb ... helps lower cholesterol ...."" F w, w: X! I0 P) C3 l" }. O
• "Ginkgo Biloba [an ingredient in the product]: This extract [is] helpful in cases of erectile dysfunction."
+ I" K. {! ]' K* S) q! S4 ` v• "Tribulus Terrestris [an ingredient in the product] ... In China, it has long been used for impotency in men, ..."
0 s" D5 `' o3 y2 V; v' J• "Schisandra [an ingredient in the product]: This herb has been used for centuries to improve ... staying power in men."
$ h% ~6 X; \. 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."" r$ ~ P$ T$ s1 L3 r o1 f7 T
VisionPlus #3012 (describing ingredients in the product)
* w: K, k1 S3 ?% C6 X• "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
+ c. @2 y" {) s' Adeterioration of vision."$ Q1 O5 ~% j0 o7 J. o' Q
• "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."
+ J q# [# ] f; M$ T• "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) d6 u* I0 b; [( Z/ `' B2 W7 o
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)."- D+ K! U0 n8 \$ h' O/ Q$ O
• "Zeaxanthin ... These yellow carotenes function in preventing oxidative damage to the macula and obviously play a central role in protecting against the development of; e7 U0 G( ~. @/ N
macular degeneration. Increasing the concentration of Lutein and/or Zeaxanthin may offer significant protective effects against the development of macular degeneration."
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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)]. ; j7 r3 r* {: l5 }4 j
Dietary Supplements Containing Androstenedione, Humic Acid, and Fulvic Acid: " F. ?4 l0 {3 v* l" X0 Y$ A% b- ?
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. 6 T. I* _1 X. N! ?! C$ E# v
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.
$ g% E* r' V% |( WUnder 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:
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(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
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' T0 u$ Z7 J8 ?(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+ P' x( C: c2 H. j! P
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.
/ e/ t |, l$ A. Q! zFDA 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)].
2 S: y- b2 v( R, }# KEven 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.
U. |; \9 r, R" N2 |1 ?% gThis 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.
3 x: ~- h0 C3 E* [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.
- G5 u8 U* j- D% a# K+ s7 d: _Your written reply should be addressed to:
6 ~8 @7 a6 p6 ~6 ?. S# t1 l+ ^# E
James P. Stumpff
; [, X/ u0 ^: V% C8 }Acting Director, Compliance Branch
6 M# S# L q: l% T; a, tFood and Drug Administration+ X+ s# @1 n, }0 c' R
19701 Fairchild) @7 S6 S. [) V) w* V, Z
Irvine, CA 92612-2506
" A, ^9 C7 r5 @! N4 XIf you have any questions regarding this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
2 |4 d" J# U7 m3 LSincerely,
/S/
3 Q1 c9 g3 E" }- Q- nAlonza E. Cruse8 ?# {' ^* A% Y' V1 G( K( q1 l
Director
; X) b P# S% o$ V$ QLos Angeles District " P7 B4 S0 t; r& I+ y
CC: Jeff Farrar, DVM, PhD, MPH
2 Y& [ P* K# I5 Z: `. F- GBranch Chief, Food and Drug Branch
; k4 A5 U; O# R4 K4 vCalifornia Department of Public Health% ]" e% {0 B. [. S
1500 Capitol Avenue - MS 7602. Q) p3 l1 B/ R5 D2 B* A2 r
P.O. Box 9974132 u1 ^: T8 X& }
Sacramento, CA 95899-7413
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