| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993-0002 |
TO: firstname.lastname@example.org; VisitSupportPage@hotmail.com; Jennaiyyek@hotmail.com; email@example.com
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: June 26th, 2013
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(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)].
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:
rxmall-checkout.net for checkout process
link to canadianhealthandcaremall.com
Office of Drug Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research
Email: firstname.lastname@example.org; VisitSupportPage@hotmail.com; Jennaiyyek@hotmail.com; email@example.com
 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.