• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Lorna Hillier

   

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: Lorna Hillier
24/1 South Esplanade
Glenelg, South Australia 5045
Australia

lulu@safe-mail.net

 

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

 

TO:    Lorna Hillier

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 buyonlinemedications.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, "Generic Valium Anxiety Medication," "Ambien Sleeping Pills," "Cialis (Brand)," "Acomplia (Generic) New Weight Loss Pill," "Rimonabant Weight Loss," "Herbal Xanax," and "Herbal Viagra." 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 (Generic) New Weight Loss Pill," "Rimonabant Weight Loss," "Herbal Xanax," and "Herbal Viagra." 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 (Generic) New Weight Loss Pill" and "Rimonabant
Weight Loss" 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 Xanax" and "Herbal Viagra" on your website. Xanax and Viagra are
approved drugs well-known for their intended use(s) to treat disease. Therefore, including the
drug names causes "Herbal Xanax" and "Herbal Viagra" to be subject to regulation as drugs
under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease. Moreover, these products 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 but not limited to "Acomplia
(Generic) New Weight Loss Pill," "Rimonabant Weight Loss," "Herbal Xanax," and "Herbal Viagra"
without approved applications violates these provisions of the Act.

Misbranded Druqs

Your website offers several products, including but not limited to "Generic Valium Anxiety
Medication," "Ambien Sleeping Pills," and "Cialis (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 Xanax" and "Herbal Viagra" for sale. These drugs are misbranded
under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs are false
and misleading. The labeling are false and misleading because they erroneously suggest that
the products contain Xanax and Viagra, which are the proprietary names for FDA-approved
products containing the active pharmaceutical ingredients alprazolam and sildenafil citrate.
Regardless of whether your products contain Xanax or Viagra, the products you are offering for
sale are not manufactured by the sponsors of the approved applications for Xanax or Viagra, and
it is false and misleading to suggest that your products are manufactured by those sponsors.

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