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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pure Prescriptions Inc. 9/30/08

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506

 

WARNING LETTER
 
 
 
CERTIFIED MAIL 
RECEIPT REQUESTED
 
September 30, 2008 
  W/L 23-08
 
Mr. Devin Ryerson
Pure Prescriptions Inc
5671 Palmer Way, Suite K
Carlsbad, CA 92010-7256
 
Dear Mr. Ryerson: 
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.pureprescriptions.com and has determined that the products “Ellagic Defense,” “Immpower,” “Pau d’ Arco Extract,” “Prostate Elements II” and “N-Tense” are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the 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 violates the Act. 
 
Examples of some of the claims observed on your web site include:
 
Ellagic Defense
 
·  “Slowing the growth of abnormal cells in humans.”
·  “Promotes apoptotic growth (natural death) of cancer cells.”
 
Furthermore, the “References” section of the Ellagic Defense page of your website cites a number of articles about studies. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about a disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
 
The following are examples of reference citations used to market Ellagic Direct for disease treatment and prevention on your website:
 
· Narayanan BA, Re GG (2001) Anti cancer Res. Jan-Feb, 21 (1A): 359-364
· Narayanan B.A., Geoffroy O., Willingham MC., Re.GG, Nixon DW. (1999) cancer Lett Mar1, 136(2): 215-221
 
Immpower
 
· “The effects of Active Hexose Correlated compounds as a cancer treatment has been documented in case studies, laboratory experiments and one double blind study.”
 
 
Pau d’ Arco Extract
 
· “[I]t is used to treat……cancer…….”
· “[I]t is used in Brazilian herbal medicine for many conditions including cancer, …….”
· “In North American herbal medicine, pau d’ arco is considered ……to have anticancerous properties.”
· “It is used for…….cancer, ….”
· “Pau d’ arco also is employed in herbal medicine systems in the United States for……leukemia, …..Hodgkin’s disease……”
· “Its use with (and reported cures for) various types of cancers fueled much of the early research in the early 1960s.”
· “In a 1968 study, lapachol demonstrated highly significant activity against cancerous tumors in rats.”
· “In a small, uncontrolled 1980 study of nine human patients with various cancers (liver, kidney, breast, prostate, and cervix), pure lapachol was reported to shrink tumors and reduce pain caused by them – and three of the patients realized complete remission.”
 
Prostate Elements II
 
Under ingredients:
 
· “LycomatoTM – Lycopene is perhaps the most important antioxidant carotenoid with respect to the prostate since dietary consumption of lycopene is associated with a lowered risk of prostate cancer.”
· Boron – Researchers have noted a relationship between boron consumption and prostate cancer.”
 
N-Tense
 
· “The plants in this formula have been independently documented around the world with anti-tumorous, ….anti-cancerous,…..properties…”
 
Your products are not generally recognized as safe and effective for the above referenced conditions 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 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 “Ellagic Defense,” “Immpower,” “Pau d’ Arco Extract,” “Prostate Elements II” and “N-Tense” are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
 
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your web site, we noticed that you promoted other products for disease treatment and/or prevention. For example, the unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
 
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 §§ U.S.C. 332 and 334]. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
 
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:
 
  [Redacted]
  Acting Director, Compliance Branch
  Food and Drug Administration
  19701 Fairchild
  Irvine, CA 92612-2445
 
If you have any questions regarding this letter, please contact [Redacted], at 949-608-[Redacted].
 
Sincerely,
/S/ 
Alonza E. Cruse
Director
Los Angeles District