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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rx-promotion

  

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

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



UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: support@rx-drugs-support.com
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: October 8, 2010
 

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 (FFDCA). More specifically, the websites listed below offer unapproved and misbranded new drugs for sale in violation of sections 301(a), 301(d), and 505(a) of the FFDCA [21 U.S.C. §§ 331(a), 331(d), and 355(a)]. We request that you immediately cease marketing violative drug products to United States consumers.
 

Unapproved New Drugs
 

Certain products you offer for sale through your websites are drugs within the meaning of section 201(g) of the FFDCA [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 FFDCA [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 FFDCA (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 FFDCA [21 USC §§ 355(a) and 331(d)].
 

As a few examples, your firm offers for sale through your websites “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Acomplia,” “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. Similarly, Acomplia (rimonabant) is well-known as the name of a drug previously approved in the European Union. It has never been approved by FDA, and 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,” “Cialis,” and “Acomplia” causes products such as “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Acomplia,” “Cialis Professional,” and “Viagra Soft” to be subject to regulation as drugs under Section 201(g) of the FFDCA 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 FFDCA (21 USC § 355) are in effect for these products. Your offering these products for sale without approved applications violates the FFDCA.
 

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 FFDCA [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 FFDCA [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 FFDCA.
 

In addition, your websites offer Accutane (isotretinoin) for sale. Accutane is a potentially dangerous prescription drug that should only be taken under the close supervision of a healthcare professional and pharmacist. Because isotretinoin has serious risks, FDA-approved drugs containing isotretinoin are available in the U.S. only under specially created safety controls. More specifically, among other requirements, patients and 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 FFDCA [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 FFDCA (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 and effectiveness 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. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for new drug approval and labeling 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.
 

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

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Sincerely,

/S/
Michael M. Levy, Jr., Esq.
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
 

cc:
Rx-Promotion
Marianne Knowles
Suite 2, Portland House
Glacis Rd, GI
 

Alex James
Internet Marketing Pro's LLC
domain486@gmail.com
3422 Old Capitol Trail
Wilmington, DE 19808-6192
 

Annette Goldi and Annette Cirino
domain486@gmail.com
Landerbrook Drive
Cleveland, OH 44023
 

Hardy, Anthony
anthonythardy@aol.com
11306 Kettering Terrace
Largo, MD 20774
 

Nexton Limited
Ryabov Sergey
director@climbing-games.com
Scherbakova st., 6-38
Saint-Petersburg, 197375
RU
 

Aiden Aibo
doctoraibo@yahoo.com.au
219 Macquarie Street
Sydney 2000
AU
 

Brian Tracy
dzz1234567890qwertyuiopfckjff@gmail.com
Baloboo 13-66
NY, 12345
US
 

Roman Vozhev
50 Let Pobedi, 1/275
Lisichansck, 93103
UA
 

Said Umarik
enot.spec@gmail.com
pl. Mustakillik 5
Tashkent, 700078
UZ
 

Smartsol Inc.
Jorge Smark
hellmanh@gmail.com
Strawinskylaan 1221
Amsterdam, 1077
NL
 

Spik Janot
enot.spec@gmail.com
st. Lenina 25
Novosibirsk, 630209
RU
 

Igor Avramenko
igorlord6969@mail.ru
Ak.Koroleva 83.1 apt.43
Odessa 65122
UA