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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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EvaPharmacy 6/26/13

  

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:         support@customersupportglobal.com; VisitSupportPage@hotmail.com; Jennaiyyek@hotmail.com; viviyanrydky@hotmail.com
 
FROM:    Food and Drug Administration Internet Pharmacy Task Force
 
RE:        Internet Marketing of Unapproved and Misbranded Drugs

DATE:     June 26th, 2013
 
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 in the attachment)[1] 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), 502(f), 503(b)(1), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(f), 353(b)(1), 355(a)]. We request that you immediately cease marketing violative drug products to United States consumers.
 
Unapproved New Drugs
 
As labeled, 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, as marketed through your websites, are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Based upon our information, no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 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 U.S.C. §§ 355(a) and 331(d)].
 
As two examples, your firm offers for sale through your websites “Levitra Super Force” and “Viagra Super Force,” which contain the brand names of FDA-approved drugs ( “Levitra” and “Viagra”). Your websites claim that Levitra Super Force and Viagra Super Force are “for the treatment of male impotence and premature ejaculation” and “for the treatment of male sexual problems,” respectively, both of which are intended uses to treat disease and, as such, are subject to section 505 of the FD&C Act [21 U.S.C. § 355]. In addition, Levitra Super Force and Viagra Super Force include dapoxetine, an active ingredient that is not the subject of an FDA-approved application. These two drugs your firm offers for sale without approved applications are in violation of section 505 of the FD&C Act [21 U.S.C. § 355]. Accordingly, their introduction or delivery for introduction into interstate commerce violates section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
 
Another example of an unapproved drug product offered for sale on your websites is “Generic Celebrex.” Generic Celebrex contains the brand name of the FDA-approved product Celebrex. While Celebrex is an FDA-approved drug product, there is currently no FDA-approved generic version of Celebrex. Your websites offer Generic Celebrex for the “treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation . . . symptoms,” which is an intended use to treat disease and, as such, is subject to section 505 of the FD&C Act [21 U.S.C. § 355]. This drug your firm offers for sale without an approved application violates section 505(a) of the FD&C Act [21 U.S.C. § 355]. Accordingly, its introduction or delivery for introduction into interstate commerce violates section 301(d) of the FD&C Act [21 U.S.C. § 331(d)]. 
 
Misbranded Drugs
 
Your websites offer clozapine, a prescription drug FDA-approved for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia, for sale without requiring that the drug be dispensed only upon a prescription from a practitioner licensed by law to administer such drug. Clozapine, marketed under the brand names Clozaril and Fazaclo, among others, is available only pursuant to a written prescription issued by a practitioner licensed by law to administer such drug. Despite the risks associated with this drug, your websites offer clozapine for sale directly to the consumer. By dispensing, without any prescription, a drug that is limited to use only under the professional supervision of a licensed practitioner, you cause this product, clozapine, to be misbranded per section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. 
 
Your firm also offers Avandaryl for sale directly to consumers through your websites. Avandaryl is the brand name of an FDA-approved rosiglitazone-containing drug product used to improve glycemic control in adults with Type II Diabetes. Clozapine and Avandaryl are subject to additional restrictions on their distribution based on their unique safety risk profiles. By selling these drug products online, you fail to observe such restrictions and do not adequately warn consumers against use of these drugs in the pathological conditions or within the methods, dosage, or duration of administration or application that are necessary for the consumers’ protection. For this reason, you further misbrand the drugs clozapine and Avandaryl per section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)]. Further, introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
 
* * *
 
FDA is taking this action against your firm because of the inherent risk in buying misbranded and unapproved new drugs.  FDA-regulated drugs offer protections that include rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. Unapproved new drugs do not have the same assurance of safety and effectiveness as do 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 as well as any other violations of the Act.  Failure to correct these violations promptly may result in regulatory action.
 
Please notify this office in writing within 10 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 10 working days, state the reason for the delay and the time within which the correction(s) will be completed.  Your response and any other inquiries concerning this letter should be sent to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov
 
Table of Websites:

URL
REDIRECT
 
 
awg-pharmacy.org
 
canadianfamilypharmacy.biz
 
canadian-familypharmacy.com
canadianfamilypharmacy.biz
drugsblast.com
 
mycanadianfamilypharmacy.com
canadianfamilypharmacy.biz
rxmall.net
rxmall-checkout.net for checkout process
rxmall-checkout.net
 
thecanadianfamilypharmacy.com
canadianfamilypharmacy.biz
buytramadolonline2.com
canadianfamilymeds.net
canadianhealthandcaremall.com
 
canadianhealthcaremallinc.com
canadianhealthandcaremall.com
canadianhealthcaremallonline.com
link to canadianhealthandcaremall.com
edpharmacydrugs.com
 
medsmedicaretax.com
 
mybestdrugs.com
 
pillstoronto.net
 
rxinternational.net
 
thecanadianhealthcaremall.com
canadianhealthandcaremall.com
canadian-health-care-mall.org
 
canadian-neighbor-pharmacy.net
canadian-neighbor-pharmacy.biz
canadian-neighbor-pharmacy.biz
 
canadianneighborpharmacyonline.com
canadian-neighbor-pharmacy.biz
cheapcanadianpharmacy.net
 
healthfeeling.com
 
rxedmeds.com
 
thecanadianneighborpharmacy.com
canadian-neighbor-pharmacy.biz
mexicanpharmacyprices.com
 
erxbid.com
 
mytrustedmeds.com
 
wiki-pharmacy.org
 
antibioticsdrugstore.com
 
torontodrugstore.org
 
toronto-drug-store.org
 
torontoonlinepharmacy.com
 
bordoctor.ru
 
doctoraccor.ru
 
doctorada.ru
 
doctoraft.ru
 
doctorarch.ru
 
doctoratt.ru
 
doctorattr.ru
 
doctorband.ru
 
doctorbank.ru
 
doctorbat.ru
 
doctorbeac.ru
 
doctorbill.ru
 
doctorbric.ru
 
doctorbui.ru
 
doctorbuil.ru
 
doctorbutc.ru
 
doctorcabl.ru
 
doctorcapi.ru
 
doctorcapit.ru
 
doctorcher.ru
 
doctorcler.ru
 
doctorcoal.ru
 
doctorcomf.ru
 
doctorcoug.ru
 
doctorcove.ru
 
doctorcred.ru
 
doctorcut.ru
 
doctorcyli.ru
 
doctordead.ru
 
doctordeer.ru
 
doctordele.ru
 
doctoreag.ru
 
doctoreas.ru
 
doctoredu.ru
 
doctoreduc.ru
 
doctoreuro.ru
 
doctorfact.ru
 
doctorfigh.ru
 
doctorfis.ru
 
doctorfork.ru
 
doctorfrog.ru
 
doctorfron.ru
 
doctorgird.ru
 
doctorgoat.ru
 
doctorgra.ru
 
doctorhar.ru
 
doctorharm.ru
 
doctorhell.ru
 
doctorholi.ru
 
doctorhood.ru
 
doctorhygi.ru
 
doctorike.ru
 
doctorimpr.ru
 
doctorjame.ru
 
doctorlath.ru
 
doctorlathe.ru
 
doctorlum.ru
 
doctormapl.ru
 
doctormemo.ru
 
doctornove.ru
 
doctornum.ru
 
doctoroni.ru
 
doctorpack.ru
 
doctorpai.ru
 
doctorparr.ru
 
doctorpart.ru
 
doctorpass.ru
 
doctorpeac.ru
 
doctorpeli.ru
 
doctorpent.ru
 
doctorperu.ru
 
doctorpicc.ru
 
doctorplan.ru
 
doctorplay.ru
 
doctorpoe.ru
 
doctorpos.ru
 
doctorpref.ru
 
doctorpurp.ru
 
doctorroa.ru
 
doctorrose.ru
 
doctorsail.ru
 
doctorsala.ru
 
doctorsatu.ru
 
doctorsau.ru
 
doctorseed.ru
 
doctorslo.ru
 
doctorsnow.ru
 
doctorspec.ru
 
doctorstop.ru
 
doctorsugg.ru
 
doctorsurg.ru
 
doctorsys.ru
 
doctortemp.ru
 
doctortip.ru
 
doctortouc.ru
 
doctortown.ru
 
doctortram.ru
 
doctorwalr.ru
 
doctorwis.ru
 
doctorwit.ru
 
doctorwood.ru
 
doctorwool.ru
 
doctorwork.ru
 
doctoryach.ru
 
doctorzinc.ru
 
dradoctor.ru
 
geldoctors.ru
 
leydoctor.ru
 
orydoctor.ru
 
raldoctor.ru
 
bitdoctors.ru
 
doctoracq.ru
 
doctoraun.ru
 
doctorbag.ru
 
doctorboa.ru
 
doctorcd.ru
 
doctorcre.ru
 
doctormagi.ru
 
doctorox.ru
 
doctorpail.ru
 
doctorwhis.ru
 
ewsdoctor.ru
 
medicexper.ru
 
oamdoctor.ru
 
ongdoctor.ru
 
oomdoctor.ru
 
paldoctor.ru
 
reydoctor.ru
 
bcheste.pl.ua
 
cockpitch.pl.ua
 
amedoctors.com
 
atoesmedic.com
 
bmpharmacy-discount.com
 
canadianpharmacyrebills.com
 
canadianpharmacyrefills.com
 
doctoradva.com
 
doctorarg.com
 
doctorbloc.com
 
doctorchee.com
 
doctorclos.com
 
doctorcol.com
 
doctorcupb.com
 
doctorcycl.com
 
doctordivi.com
 
doctorend.com
 
doctorequi.com
 
doctorfear.com
 
doctorfelo.com
 
doctorfoun.com
 
doctorfowl.com
 
doctorfrec.com
 
doctorgrou.com
 
doctorhyac.com
 
doctorinno.com
 
doctorjanu.com
 
doctorkeyb.com
 
doctorkitc.com
 
doctorkitt.com
 
doctorkni.com
 
doctorlaur.com
 
doctorlute.com
 
doctormicr.com
 
doctormust.com
 
doctornarc.com
 
doctornbs.com
 
doctororn.com
 
doctorperi.com
 
doctorplas.com
 
doctorposs.com
 
doctorseap.com
 
doctorsfre.com
 
doctorsist.com
 
doctorskil.com
 
doctorslas.com
 
doctorsmus.com
 
doctorspo.com
 
doctorsurp.com
 
doctorverm.com
 
doctorviol.com
 
doctorwhis.com
 
edandmore-discount.com
 
eradoctor.com
 
goalmedic.com
 
heronmedic.com
 
icianmedic.com
 
medicchief.com
 
mediccoke.com
 
medicjoin.com
 
medicjudo.com
 
medickilo.com
 
medicrobi.com
 
medicsmin.com
 
medicterr.com
 
doctorcate.com
 
doctorcod.com
 
doctorcrop.com
 
doctordanc.com
 
doctorenc.com
 
doctorenq.com
 
doctorethe.com
 
doctorfrid.com
 
doctorgeor.com
 
doctorhima.com
 
doctorosu.com
 
doctorpeen.com
 
doctorptr.com
 
doctorpurc.com
 
doctorqsx.com
 
doctorscal.com
 
doctorsforworlds.com
 
doctorshal.com
 
doctorshie.com
 
doctorsken.com
 
doctorsmem.com
 
doctorsmul.com
 
doctorsocc.com
 
doctorwate.com
 
elpdoctors.com
 
iftdoctors.com
 
ilydoctors.com
 
istdoctor.com
 
iumdoctor.com
 
medicarmen.com
 
medicbeard.com
 
medicbench.com
 
medicbush.com
 
mediccana.com
 
mediccapp.com
 
mediccart.com
 
mediccat.com
 
mediccoll.com
 
mediccomma.com
 
mediccond.com
 
mediccrown.com
 
medicden.com
 
medicdenti.com
 
medicdista.com
 
medicdomai.com
 
mediceast.com
 
medicedger.com
 
medicenem.com
 
medicfahr.com
 
medicfirem.com
 
medicfish.com
 
medicflam.com
 
medicflar.com
 
medicfloc.com
 
medicgeol.com
 
medicglidi.com
 
medicgood.com
 
medicgren.com
 
medichali.com
 
medichand.com
 
medicjelly.com
 
medickitch.com
 
mediclibra.com
 
medicllama.com
 
mediclyoce.com
 
medicmagi.com
 
medicmotor.com
 
medicnapk.com
 
medicnorw.com
 
medicnotif.com
 
medicphysi.com
 
medicplat.com
 
medicprod.com
 
medicprodu.com
 
medicrand.com
 
medicregr.com
 
medicrhino.com
 
medicsagi.com
 
medicsilk.com
 
medicslipp.com
 
medicsmel.com
 
medicstart.com
 
medicstopw.com
 
medicstov.com
 
medicsund.com
 
medictanke.com
 
medictimpa.com
 
medictrian.com
 
medicuten.com
 
medicverdi.com
 
medicwaite.com
 
nimdoctor.com
 
oindoctors.com
 
onydoctor.com
 
ormdoctor.com
 
othdoctors.com
 
owndoctors.com
 
rxtrand.com
 
syrupmedic.com
 
tchdoctor.com
 
temdoctor.com
 
ukmedixonline.com
 
vendoctor.com
 
vsdoctors.com
 
waydoctor.com
 
wqdoctors.com
 

Sincerely,
/S/
Thomas Christl
Director
Office of Drug Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research
 
Email: support@customersupportglobal.com; VisitSupportPage@hotmail.com; Jennaiyyek@hotmail.com; viviyanrydky@hotmail.com


[1] We note that some of the website domain names listed are already the subject of seizure proceedings in a United States District Court, while some are not. Moreover, the list may not include all websites that you operate as part of your network, and of course, the list does not include website domain names that you may operate in the future as part of your network. Nonetheless, the FD&C Act violations set forth here are applicable to all website domain names that market violative drug products to United States consumers.