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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Randek l-warez

   

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: I-warez
Randek
Kirov 12-10
Kostroma
Kostromskaya oblasty, 420045
RU

prj2005@hotmail.com

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: I-warez


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 website at thewomantour.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, "Xanax (Generic)," "Valium (Generic)," "Viagra (Brand)," "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," and "Herbal Ambien." 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:

Unapproved New Drugs

Your firm offers many unapproved new drugs including, but not limited to "Acomplia (Brand),"
"Acomplia (Generic)," "Rimonabant," and "Herbal Ambien." 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, the "Acomplia (Brand),' "Acomplia (Generic)" and "Rimonabant"
dispensed through your website are "new drugs,' as defined by section 201(p) of the Act, 21
U.S.C. § 321(p).

You also offer "Herbal Ambien" on your website. Ambien is an approved drug well known for its intended use to treat disease. Therefore, including the drug name causes "Herbal Ambien" to be subject to regulation as drugs under Section 201 (g) of the Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, "Herbal Ambien" is a new drug 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 but not limited to "Acomplia
(Brand)," "Acomplia (Generic)," and "Rimonabant" without approved applications violates these
provisions of the Act.

Misbranded Drugs

Your website offers several products, including but not limited to "Xanax (Generic)," "Valium
(Generic)," and "Viagra (Brand)," for sale without requiring that the products be dispensed under
a prescription from a duly licensed practitioner. Some of the products available on your website
are also controlled substances; the sale of these products is particularly concerning because of
the potential for abuse and dependency. 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, your website offers products for sale and states that they 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.

In addition, you offer "Herbal Ambien" for sale. This drug is misbranded under section 502(a) of
the Act, 21 U.S.C. § 352(a), because the labeling of the drug is false and misleading. The
labeling is false and misleading because it erroneously suggests that the product contains
Ambien, which is the proprietary name for the FDA-approved product containing the active
pharmaceutical ingredient zolpidem. Regardless of whether your product contains Ambien, the
product you are offering for sale is not manufactured by the sponsor of the approved application
for the product, and it is false and misleading to suggest that your product is manufactured by that sponsor.

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 FDAlnternetPharmacvTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA's Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.qov or (301) 796-3110.

Sincerely,
/S/

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