Public Health Service
Food and Drug Administration
Silver Spring, MD 20993-0002
TO: eyal@pronet-ltd.com
FROM:Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: September 18, 2012
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), 502(a), 502(f), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(a), 352(f), 353(b), 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 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 “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. Including drug names such as “Viagra,” “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 [21 U.S.C § 355] are in effect for these products. Your offering these products for sale without approved applications violates the FD&C Act.
In addition to the above-mentioned drug products offered for sale through your websites, your firm offers unapproved antiviral drug products such as Tamiflu and Baycip TZ. Your websites promote generic Tamiflu, which is both unapproved and misbranded because there is no FDA-approved generic Tamiflu and the website and promotional labeling for this product mislead the consumer to believe they are purchasing an FDA approved drug product. Moreover, Baycip TZ is an unapproved drug product for which there is no FDA approved generic or brand drug product in the US.
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,” “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 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 any of 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
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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: Eyal Bar Oz
Max Brod Street 11
Tel Aviv, Israel
PRONET Ltd.
Keren Hayesod 19
Herzylia, Israel
Email: eyal@pronet-ltd.com
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