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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pro West Marketing Ltd., 11/16/09

   

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

Public Health Service
Food and Drug Administration
  Silver Spring, MD 20903

 

 

From: FDA Center for Drug Evaluation and Research 

           FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov

Date: November 16, 2009

TO:        Pro West Marketing Ltd, Rue de
             L'arc 45, Road Town, Tortola,
             BVI VG1110

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

 

 

TO:    Pro West Marketing Ltd

FROM: Food and Drug Administration Internet Pharmacy Task Force

RE:     Internet Marketing of Unapproved and Misbranded Drugs

DATE:  November 16, 2009


WARNING LETTER

The United States Food and Drug Administration (FDA) has reviewed your websites at doctorphentermine.com, trusted-tabs.us, online-pharmacy-no-prescription.com, 365pharm.com, approved-pharm.com, value-drugstore.com, cheapphentermine.com, rx-giant.com, 4cheaprx.com, preferredpharma.com, prescriptionsintl.com, aprixe.com, buycanadianpharmacy.net, terameds.org, dragon-rx.com, first-refill-c1ub.com, bestrxpharm.net, pharma-direct.com, buy-canadian-pharm.com, easy-pharm.com, licensed-medical.com, my-refilldrugstore. com, refill-rx-now.com, rxcalm.com, top-hotpills.com, top-uspharm.com, my-pill.com, smsrx.net, total-pharma.com, pharma-discounts.com, and rxontv.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic): and "Levitra (Brand)." We request that you immediately cease marketing violative products.

These products are drugs under section 201(g) of the Act, 21 U.S.C. § 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:

Unaporoved New Drugs

Your firm offers many unapproved new drugs including, but not limited to "Acomplia (Generic)," "Acomplia (Brand)," and "Rimonabant." FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.

Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, "Acomplia (Generic)," "Acomplia (Brand)," and "Rimonabant" dispensed through your websites are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321 (p).

Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including "Acomplia (Generic)," "Acomplia (Brand)," and "Rimonabant" without approved applications violates these provisions of the Act.

Misbranded Drugs

Many of your websites sell products, including but not limited to "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)" without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k). 

Further, most of your websites state that your products are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331(a).

This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA's Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.

Sincerely,

/s/

Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research

Cc:
Protected Domain Services - Customer ID: NCR-1083643
125 Rampart Way, Suite 300
Denver, CO 80230
doctorphentermine.com@protecteddomainservices.com
doctorphentermine.com


Steven Rook
Regents Blvd
Union City, California 94587
redisonberg@gmail.com
trusted-tabs.us


Domains by Proxy, Inc., DomainsByProxy.com
15111 N. Hayden Rd., Ste 160, PMB 353
Scottsdale, Arizona 85260
United States
ONLINE-PHARMACY-NO-PRESCRIPTION.COM@domainsbyproxy.com
online-pharmacy-no-prescription.com
prescriptionsintl.com

WhoisGuard
8939 S. Sepulveda Blvd. #110 - 732
Westchester, CA 90045
US
365pharm.com
approved-pharm.com
value-drugstore.com
aprixe.com
buycanadianpharmacy.net

Scott Stiverson
XP Hosting and Design
1938 Eagle Crest Dr
Draper, UT 84020
US
info@xphostinganddesign.com
cheapphentermine.com

NameCheap.com NameCheap.com
8939 S. Sepulveda Blvd. #110 - 732
Westchester, CA 90045
6763d4f87c15430b92099daadd0d9f0a.protect@whoisguard.com
rx-giant.com

ESALES, LLC
One Commerce Center
1201 Orange Street, Suite 600
Wilmington, Delaware 19899
rampage76@cyber-rights.net
4cheaprx.com

Gregg Masters
MorMax, LLC
1644 Corte Verano
Oceanside, CA 92056
greggmasters@gmail.com
preferredpharma.com

Sergey Nikolaev
Chaykovskogo 28 apt 39
Nikolaev
Mykolaiv Oblast
54018
UA
nikolos00@gmail.com
terameds.org

Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
dragon-rx.com
bestrxpharm.net
pharma-direct.com
buy-canadian-pharm .com
easy-pharm.com
Iicensed-medical.com
rxcalm.com
top-hotpills.com
top-uspharm.com
smsrx.net
total-pharma.com


James Riley c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
my-pharm.com

PrivacyProtect.org
Domain Admin
contact@privacyprotect.org
first-refill-c1ub.com

Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
my-refill-drugstore.com
refill-rx-now.com
rxontv.com

Sergiy Nikolaev c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
my-pill.com

Janis Larsen c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
pharma-discounts.com