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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Canadadrugs 9/21/12

  

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: troy@harwoodjones.com
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: September 21, 2012
 

WARNING LETTER

This revised warning letter supersedes the warning letter sent to you on September 18, 2012. The warning letter sent to you on September 18, 2012, is withdrawn.

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) 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(a), 502(f), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(a), 352(f), 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 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 U.S.C. § 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 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 a few examples, your firm offers for sale through your websites products such as “Viagra” and “Levitra,” which are the proprietary names of FDA-approved drugs well-known for their intended use(s) to treat disease, and as such are subject to section 505 of the FD&C Act [21 U.S.C. § 355]. However, your websites offer “Viagra” and “Levitra” that are manufactured by manufacturers that are not the subject of the FDA-approved applications, and accordingly, no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for the products your firm offers for sale. The 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].

In addition to the above-mentioned drug products offered for sale through your websites, your firm offers unapproved and misbranded domperidone. In 2004, amid safety concerns, FDA issued a consumer alert for breastfeeding women warning against the use of domperidone for increased milk production. Such reported safety concerns included cardiac arrhythmias, cardiac arrest, and sudden death. FDA concurrently issued warning letters to pharmacies that were compounding products containing Domperidone and to firms that supplied domperidone for use in compounding. Domperidone is not approved for any human use in the U.S., and it is currently subject to an import alert (61-07) instructing FDA personnel to detain and refuse entry of any shipments of this drug offered for importation to the US.

Misbranded Drugs

Because the above mentioned drugs are intended for conditions that are not amenable to self-diagnosisand 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 some of your products 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.

Furthermore, your websites offer unapproved Accutane (isotretinoin) for sale. FDA approved the new drug application (NDA) for Accutane in 1982, but withdrew the approval via a Federal Register Notice effective November 22, 2010. The Accutane product offered for sale on your websites is unapproved within the meaning of section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] in that this is a new drug without an approved application. The introduction or delivery for introduction into interstate commerce of unapproved drug products violates section 301 of the FD&C Act [21 U.S.C. § 331]. Moreover, your websites offer for sale misbranded drugs containing isotretinoin. Although isotertinoin is legally marketed under approved abbreviated new drug applications (ANDAs), FDA-approved drugs containing isotretinoin are available in the United States only under specially created safety controls. If these products are not taken under the close supervision of a healthcare professional and pharmacist, they can be a potentially dangerous prescription drug. Because isotretinoin has serious risks, patients, their doctors and pharmacists are required by FDA to register with the iPLEDGE program in order to receive this medication, among other requirements. 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. To offer isotretinoin for sale without the above-mentioned safety controls misbrands the product as it is false and misleading to the consumer and adequate warnings against use are not provided per sections 502(a) of the FD&C Act [21 U.S.C. § 352(a)] and 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], respectively.

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 those 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 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

canadadrugs.com
cheapodrugs.com
ecprx.com
jandrugs.com
petdrugs.com
ukmedicine.co.uk
usdrugs.com
isaverx.com
libertycarerxmail.com
scriptsfromcanada.com
worldrxgroup.com
cpsmeds.com
ehealthpharmacy.com
smartchoicepharmacy.com
pharmacy.com                                                         canadadrugs.com
canadadiscountrx.com                                               canadadrugs.com
cornerdiscountdrugs.com                                  canadadrugs.com/concord
dependablerxofcanada.com                               canadadrugs.com/concord
familyrxofcanada.com                                     canadadrugs.com/concord
medoutletcanada.com                                      canadadrugs.com/concord
medsforamerica.com                                       canadadrugs.com
PayLessMeds.com                                           canadadrugs.com/medsforamerica
petdrugs.ca
rx1.biz                                                          canadadrugs.com
rxadvantageofcanada.com                                canadadrugs.com/concord
rxnorth.com
rxofcanada.com                                              canadadrugs.com/concord
smartmed.ca                                                           canadadrugs.com/medsforamerica
mthcs.us
universalfulfillment.com
worlddrugs.com                                              canadadrugs.com
canadadrugsit.com
rockleyventuresltd.com
globaldrugsupply.com
dumb.biz
gdslink.webs.com
rximagehosting.com                                                  JanDrugs.com
secrx.com
canadausarx.com
canadausdrugs.com
canadausdrugstore.com
canadausmeds.com
canadauspharmacy.net
canadausrx.com
canadausrx.net
canadavaluepharmacy.com
canadavaluerx.com
canadawebpharmacy.com
canadawholesalemeds.com
canadawiderx.com
canadawortdpharmacy.com
canaddrug.com
canaddrugs.com
canaddrugstore.com
canadepharmacy.com
canadian-apothecary.com
canadian-chemist.com
canadian-chemists.com
canadian-drug.biz
canadian-drus.net
canadian-drug.org
canadian-druggist.com
canadian-drugmart.com
canadian-drugs-online.com
canadian-druss.co
canadian-druas.com
canadlan-druas.net
canadian-druastore.com
canadian-druastore.info
canadian-drugstore.net
canadian-drugstore.org
canadian-drugstores.com
canadian-generic-pharmacy.com
canadian-med.net
canadian-med.org
canadian-medical.com
canadian-medicals.com
canadian-medicament.com
canadian-medication.com
canadian-medications.net
canadian-medicine.com
canadlan-medicine.net
canadian-medicine.org
Onlinepharmacy.com
1-800-can-drug.com
123diabeticsupplies.com
123drugsonline.com
1800candrug.com
1800usdrugs.com
1855buymyrx.com
1855getmyrx.com
1877aptecha.com
1canadadrugs.com
1canadadrugstore.com
1canadapharmacy.com
1canactianpharmacy.com
1clickpharmacy.com
1stdiscountrx.com
24hourmeds.net
24hourpharmacy.net
24hourspharmacy.com
24hrdrugstore.com
2yourdrugstore.com
2yourpharmacy.com
855buymyrx.com
855getmyrx.cam
a-kce.com
a-zonlinedrugs.com
a-zpharmacy.com
aaadrugstore.com 
aaadrugstore.net
aameds.com
abapharmacy.com
abc-meds.com
abcdrugstore.net
abcmeds.com
ABCpharmacyonline.com
abdrugs.com
ablemeds.com
abonlinepharmacy.com
aboutmymeds.com
accesscanadianmeds.com
acidrefluxmedicine.net
aciphexdrugmart.com
acnadadrugs.com
acnadadrugstore.com
acnadameds.com
acnadapharmacy.com
acnadiandrugs.com
acnadianmeds.com
acnemedicationonline.com
adaliledrug.com
aemricanameds.com
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affordablecanadadrugs.com
affordablecanadameds.com
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affordabledrugmart.com
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affordabledrugstore.com
affordablegenericdrugstore.com
affordablemedicinecanada.com
affordablemedsofcanada.com
affordablerxofcanada.com
affordableusmeds.com
africadrugstore.com
africameds.com
africanmedicines.com
aiddrug.com
aids-medicatian.com
aidsdrugs.org
aidsmart.com
aidsmedscanada.com
aisandrugs.com
aisiandrugs.com
albertameds.com
albertarx.com
allamerican-rx.com
allamerican-rx.net
allcanadadrugs.com
allcanadarx.com
allergy-meds.com
allmedsrx.com
allpharmacycanadian.com
alphacanadapharmacy.com
alphacanadiandrugs.com
alprazolamdrug.com
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alzheimermedicine.net
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amcarerx.com
ameicanameds.com
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ameri-canadianrx.com
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america-medication.com
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american-drug.com
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american-druastores.com
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american-medicines.com
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american-pharmaceuticals.com
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amencan-prescnption.com
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anadinpharmacy.com
anti-psychoticmedication.com
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antidtarrhealdruss.com
antidiarrhealmedication.com
antigoutdrugs.com
antivirusmedicine.com
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aptedcha.com
aptecha.net
arabdrug.com
arthritis-meds.com
aspenparkrx.com
assuredmeds.com
asthmadrug.com
asthmadrug.net
atorvsa,tatin.com
attarvastatin.com
ausmedsupplies.com
aussiedrugs.com
aussiemed.com
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australia-discount-pharmacies.com
australia-meds.com
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australiadiscountdrusstore.com
australiadiscountdrugstores.com
australiadiscountpharmacies.com
australiadiscountpharmacy.com
australiadrugstore.com
australiadrugstores.com 
australiamedication.com
australiamedlcations.com
australiameds.com
australian-discount-pharmacies.com
australlan-pharmacies.com
australiandiscountdrugstore.com
australiandiscountdrugstores.com
australiandiscountpharmacies.com
australiandiscountpharmacy.com
australiandrua.com
australiandruastore.com
australiandrugstores.com
australianmedicatlon.com
australianmedications.com
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australianonlinedrugstore.com
australianonlinedrugstores.com
australianonlinepharmacies.com
australianpharmaceuticals.com
australia-pharmacy.net
australianprescriptions.com
australianrx.com
australiaonllnedrl!gstore.com
australiaanliMedrugstores.com
australiaonlinepharmacies.com
australiapharmacy.net
autodiscover.habit.com
availabledrugs.com
azdrugstore.com
azmeds.com
bangaloredrugs.com
barbadosdrugservice.com
barbadaspharmacy.com
barbadosrx.com
bargain-drugs.com
bargain-pharmacy.com
bargaindrug.net
bargaindrugs.net
bargaindrugsframcana_da.com
bargainmeds.net
bargainprescription.com
bargainrxdrugs.com
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bcdrugstore.com
beautymedical.com
beneficialdrugs.com
bestbuycanadadrugs.com
bestbuyglobalrx.com
bestcanadadrugs.com
bestcanadarx.com
bestcanadianmeds.net
bestcanmeds.net
bestcanmedsrx.com
bestdealcanadadruas.com
bestdrugsofcanada.com
bestearthmeds.com
bestgenericrx.com
bestwebdrwas.com
bipolardrugs.net
birth-control-drugs.com
birthcontrolpharmacy.net
bodydruas.com
border-pharmacy.com
bordermeds.com
bordermeds.net
bordermedsforless.com
bordertownpharmacy.com
britain·chemist.com
brltain·chemists.com
britain·chemistshop.com
britain-drug.com
britain-drugstore.com
britain-med.com
britain-medication.com
britain·medications.com
britain·medicine.com
britain-medlcines.com
Britain-pharmacies.com
britain-prescriptions.com
britain-remedies.com
britain-remedy.com
britainchemist.com
britainchtmists.com
britaindlscountdruastore.com
britaindiscountdrugstores.com
britaindiscountpharmacies.com
britaindiscountpharmacy.com
britaindrug.com
britaindruastore.com
britaindruastores.com
britainmed.com
britainmedication.com
britainmedications.com
britainmedicine.com
britainmedicines.com
britainmeds.com
britainonlinedrugstore.com
britainonlinedrugstores.com
britainonlinepharmacies.com
britainonlinepharmacy.com
britainpharmacies.com
britainprescription.com
britainprescriptions.com
britainremedies.com
britainremedy.com

britainrx.com
british-drug.com
british-drugs.com
british-drugstore.com
british-meds.com
british-pharmacies.com
british-pharmacy.com
british-rx.com
britishdiscountdrugstore.com
britishdis~ountdrugstores.com
britishdiscountpharmacies.com
britishdrug.com
britishdrugs.com
britishdrugstores.com
britishmedlcal.net
britishmedication.com
britishmedications.com
britishmedicines.com
britishmeds.com
britishonHnedrugstore.com
britishonllnedrugstores.com
britishonlinepharmacies.com
britishonlinepharmacy.com
britishpharmacies.com
britishpharmacyonline.com
britishrx.com
budgetmeds.net
bugdetmedicines.com
budgetmedication.com
buy-canada-drugs.com
buy-canadian-medicine.com
buyamericandruas.com
buycanadacheapdrusstore.com
buycanadadirectmeds.com
buycanadarx.net
buycanadianmedicines.com
buycanadianprtscriptiondrug.com
buycanadianpresc:rlptiondrugs.com
buycheapcanadiandruas.com
buyc:heapmedsonline.com
buydiabetlesuppties.net
buydirectmedical.com
buydrugsfromcanada.com
buydrugsfrommexico.com
buyinacanadiandruss.com
buyonlirutmedicine.com
buyotcdrugs.com
buyovernightrx.com
buypillsforless.com
buyprescriptiondruas.net
buyritedruas.com
buyrxfromcanada.com
buyusadruas.com
buyusameds.com
ca-medicine.com
caadadrugs.com –
caadadruastore.com
caadameds.com
caadarx.com
caandadrugs.com
caandadrugstore.com
caandarx.com
cadrug.com
cadruas.net
cadruas.org
caraarydruastore.com
calgarymeds.com
camadadrugstore.com
camadianpharmacy.com
cameds.net
cameds.org
can-amrxexpress.com
can-drug.com
can-drug. net
can-drug.org
can-drugs.com
can-drugs. net
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can-pharm.com
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canaadrug.com
canaadrugs.com
canaadrugstore.com
canaameds.com
canaapharmacy.com
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canada-apothecary.com
canada-chemist.com
canada-chemists.com
canada-drug.com
canada-drug.info
canada-drug.net
canada-drug.org
canada-druggist.com
canada-drugmart.com
canada-drugs-rx.com
canada-drugs.co
canada-drugs.com
canada-druas.info
canada-drugs.org
canada-drugs.us
canada-drugstore.com
canada-drugstore.net
canada-drusstore.org
canada-med.com
canada·medical.com
canada-medicals.com
canada-medicament.com
canada-medication.com
canada·medications.com
Canada-medicine.biz
canada·medicine.com
canada-medicine.info
canada-medicine.us
canada-medicines.com
canada-meds-for-less.com
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canada~meds.net
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Sincerely,
/S/
Thomas Christl
Director
Office of Drug Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research
 

cc:

24 Terracon Place
Winnipeg, Manitoba, Canada, R2J 4G7
14 Terracon Place
Winnipeg, Manitoba, Canada R2J 4G7
Email: troy@harwoodjones.com