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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SPHERE Inc. 9/21/11

  

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

Public Health Service
Food and Drug Administration
 Silver Spring, MD 20993-0002 

TO:      contact@erusu.com
FROM:  Food and Drug Administration Internet Pharmacy Task Force
RE:       Internet Marketing of Unapproved and Misbranded Drugs
DATE:   September 21, 2011

WARNING LETTER
 
The United States Food and Drug Administration (FDA) recently reviewed your websites (listed in the table located at the bottom of this letter) and has determined that your websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C ACT).  More specifically, the websites listed below offer unapproved and misbranded new drugs for sale in violation of sections 301(a), 301(d), 303(e), 502(f), 503(b), and 505(a) of the FD&C ACT [21 U.S.C. §§ 331(a), 331(d), 333(e) and 355(a)].  We request that you immediately cease marketing violative drug products to United States consumers.
 
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Unapproved New Drugs
 
Certain products you offer for sale through your websites are drugs within the meaning of section 201(g) of the FD&C 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.  These products are also new drugs as defined by section 201(p) of the FD&C ACT [21 USC § 321(p)], because they are not generally recognized as safe and effective for their labeled uses.  No approved applications pursuant to section 505 of the FD&C ACT [21 USC § 355] are in effect for these products.  Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 505(a) and 301(d)of the FD&C ACT [21 USC §§ 355(a), 331(d)].
 
As a few examples, your firm offers for sale through your websites “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Cialis Professional,” and “Viagra Soft,” “Viagra” and “Cialis” are the names of FDA-approved drugs well-known for their intended use(s) to treat disease.  In addition, your firm offers for sale Acomplia and Melanotan, both of which are unapproved new drugs in the United States. Acomplia (rimonabant) is well-known as the name of a drug previously approved in the European Union.  In June 2007, FDA’s 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.  Including drug names such as “Viagra” and “Cialis,” causes products such as “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Cialis Professional,” and “Viagra Soft” to be subject to regulation as drugs under Section 201(g) of the FD&C ACT because they are intended for use in the diagnosis, cure, mitigation treatment, or prevention of disease. As stated above, no approved applications pursuant to Section 505 of the FD&C ACT are in effect for these products. Your offering these products for sale without approved applications violates the FD&C ACT. In addition, for the reasons stated above, Melanotan II and Acomplia are drugs, as defined by Section 201(g)(1) of the FD&C ACT, and, without approved applications, violate the FD&C ACT.
 
Human Growth Hormone
 
Under the FD&C ACT, it is unlawful to knowingly distribute or possess with the intent to distribute human growth hormone for any use in humans other than for the treatment of a disease or other recognized medical condition, unless such use has been authorized by FDA under Section 505 of the FD&C ACT and the human growth hormone is distributed, or intended to be distributed, pursuant to the order of a physician. Distributing human growth hormone to customers in the United States without the order of a physician is in direct violation of Section 303(e) of the FD&C ACT [21 USC § 333(e)] and may be punishable by up to 10 years in prison and applicable fines. Your firm offers unapproved human growth hormone products for sale through your websites without the order of a physician. Improper use of human growth hormone can lead to long-term side effects such as increased risk of cancer, nerve pain, and elevated cholesterol and glucose levels.
 
Misbranded Drugs
 
Your websites offer prescription drugs – some of which include controlled substances, particularly concerning because of their potential for abuse and dependency – for sale without requiring that the drugs be dispensed only upon a prescription from a practitioner licensed by law to administer such drugs.  Therefore, the drugs are misbranded under section 503(b)(1) of the FD&C ACT [21 U.S.C. § 353(b)(1)].
 
Additionally, because the above mentioned drugs are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses.  Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C ACT [21 U.S.C. § 352(f)(1)].  Because your products, such as “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Acomplia,” “Cialis Professional,” and “Viagra Soft,” lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the FD&C ACT.
 
In addition, your websites offer misbranded Accutane (isotretinoin) for sale.  Isotretinoin, if not taken under the close supervision of a healthcare professional and pharmacist, can be a potentially dangerous prescription drug.  Because isotretinoin has serious risks, FDA-approved drugs containing isotretinoin are available in the United States only under specially created safety controls.  More specifically, among other requirements, patients, their doctors and pharmacists are required by FDA to register with the iPLEDGE program in order to receive this medication.  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.  The Accutane product offered for sale on your websites is misbranded within the meaning of section 502(f)(1) of the FD&C ACT [21 U.S.C. § 352(f)(1)] in that labeling for the drug fails to bear adequate directions for use.  The introduction or delivery for introduction into interstate commerce of misbranded products violates section 301 of the FD&C ACT [21 U.S.C. § 331].
 
* * *
 
FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs.  Unapproved new drugs from unregulated sources do not have the same assurance of safety, efficacy and quality as drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
 
This letter is not intended to identify all of the ways in which your activities might be in violation of law.  It is your responsibility to ensure that all products marketed by your firm are in compliance with the FD&C 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 FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.
 
Table of Websites:
 

 

 
 
Sincerely,
/S/
Michael M. Levy, Jr., Esq.
Director
Office of Drug Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research

 
cc: SPHERE Inc.
      Eugeniu Rusu
      1461A First Avenue, #360
      New York, NY 10021-2209
 
      SPHERE Inc.
      1461A First Avenue #360
      Panama City, Panama 10021-2209
 
      Tatiana Saldana/SPHERE Inc.
      Calle Primera
      Panama Viejo, House 496
      Panama City, Panama 0834-1987
 
      Tatiana Saldana/SPHERE Inc.
      8939 S. Sepulveda Blvd. #110-732
      Westchester, CA 90045
 
       Tatiana Saldana/SPHERE Inc.
       11400 W. Olympic Blvd.
       Suite 200
       Los Angeles, CA 90064
 
       Eugeniu Rusu
       326 Ave.
       New York, NY 11029
 
       Eugeniu Rusu/SPHERE In.
       Alecu Russo 61
       Ap.125
       Chisinau, MD 2044
 
Email: contact@erusu.com; rusuem@yahoo.com; sphereincorporated@yahoo.com