Department of Health and Human Services' logo 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

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

WARNING LETTER

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 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.

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:

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

This page was posted on January 31, 2010.

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