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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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: Michael Trinidad
tvforever
2325 East Kivett Drive
High Point, NC 27260
info@tvforever.com

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


TO: Michael Trinidad


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
michaelpharmacy.com, mywebmarquee.com, pharmazero.com, and pharmalove.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, "Accutane," "Acomplia,"
"Zimulti," "Valium," "Xanax," "Ativan," "Vicodin ES," "Lunesta," and "SleepWell (Herbal Xanax)."
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," "Zimulti," and "SleepWell (Herbal Xanax)." 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" and "Zimulti" dispensed through your websites are
"new drugs" as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).

You also offer "SleepWell (Herbal Xanax)." Xanax is an approved drug, well-known for its
intended uses to treat disease. Therefore, including the drug name causes "SleepWell (Herbal
Xanax)" to be subject to regulation as a drug under Section 201 (g) of the Act because it is
intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Moreover, this products 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 "Acomplia," "Zimulti," and
"SleepWell (Herbal Xanax)" without approved applications violates these provisions of the Act.

Misbranded Drugs

Your websites offer numerous products, including but not limited to "Accutane," "Valium,"
"Xanax," "Ativan," "Vicodin ES," and "Lunesta," 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).

Your firm offers Accutane (isotretinoin) for sale on your websites. Isotretinoin is a potentially dangerous prescription drug that should only be taken under the close supervision of a healthcare professional and pharmacist. Because it has serious risks, isotretinoin is available in the U.S. only under specially created safety controls. More specifically, patients and their doctors and pharmacists are required by FDA to register with the iPLEDGE program in order to receive this medication. In addition, your websites fail to warn of the dangers of serious mental health problems, such as suicide, that may occur in patients who use Accutane. These safety controls are bypassed when this drug is purchased from foreign sources or over the Internet, placing patients who use this drug at risk. Therefore, the Accutane offered for sale on your websites is misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that labeling for the drug fails to bear adequate directions for use.

In addition, you offer "SleepWell (Herbal Xanax)" 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
Xanax, which is the proprietary name for an FDA-approved product containing the active
pharmaceutical ingredient alprazolam. Regardless of whether your product contains Xanax, the
product you are offering for sale is not manufactured by the sponsor of the approved application
for Xanax 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 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