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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Edrugnet.com/1accutane.com 09-Sep-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Rockville, MD 20857


By Federal Express & Faxed to (775) 414-9344

& (0870) 139-8938

Warning Letter

September 9, 2003

Mr. Eric Kaiser
Registrant
Edrugnet.com
1accutane.com
Accutane-ance-treatments-medication.com
3508 Van Teylingen Dr.
Apt. D
Colorado Springs, CO 80917

Dear Mr. Vincent:

The Food and Drug Administration (FDA) has learned that, through the websites Edrugnet.com, Accutane-acne-treatments-medication.com and 1accutane.com, you are selling “Accutane” to United States (U.S.) consumers. Accutane is the trade name for a prescription drug approved for marketing in the United States under an approved new drug application by Roche Pharmaceuticals, Nutley, New Jersey. Accutane products approved for marketing in the United States are capsules for oral ingestion. Even though Edrugnet.com, Accutane-acne-treatments-medication.com and 1accutane.com order forms state that the product offered for sale is “Accutane (brand) Roacccutane,” the label of the actual product shipped states that it is “Roaccutane lsotretinoin 10 mg tablet.” “Roaccutane” does not have an approved new drug application, and may not be legally marketed in the United States.

You sell “Roaccutane” from your website without a prescription, and these orders are sent to the American consumers from Thailand. The customer may order on-line over the Internet, or print the order form, then fax it to (775) 414-9344 (U.S.A. number) or 0870139-8938 (U.K. number). As discusssed ingreater detail below, these actions violate the Federal Food, Drug and Cosmetic Act (FD & C Act or Act), 21 United States Code (U.S.C.) 301 et seq.

The “Roaccutane” product sold through your websites is contains 10 mg of Isotretinoin which is packaged in a box containing 3 strips of 10 individually wrapped capsules labeled in part, "Roaccutane***Isotretinoin 10 mg.. ***Roche***Attention: Adhere strictly to precautions! Pregnancy forbidden! Risk of malformation***. The box containing the three strips was labeled in part, “‘Roaccutane***Isotretinoin 10 mg ***Attention ***Roche *** 30 capsules***insert *** Thai Reg No 1C 230/41 *** Made under license from F. Hoffmann-La Roche Ltd, Basel, Switzerland by R.P. Scherer GmbH, Eberbach, Germany.”

Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part.
“Accutane must not be used by females who me pregnant...must be prescribed under the System to manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,“ (meaning special training has been given to the prescribin, tr licensed practitioner and the patient) “and no telephone or computerized prescriptions are permitted. ” The approved Accutane is for oral ingestion. FDA has not approved a topical gel version of Accutane or any other isotretinoin drug.

Because it has serious risks, isotrctinoin is available in the U.S. only under specially created safety controls. These safety controls are bypassed when this drug is purchased from foreign sources or over the Internet, placing patients who use this imported drug at higher risk.

The isotretinoin dispensed through medicapharma.com is also "new drug” as defined by section 201(p) of the Act. Under Section 505(a) of the Act, a “new drug” may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug, The continued distribution of this product into the U.S. without an approved NDA is a prohibited act as set forth in Section 301 (d) of the Act.

The isotretinoin dispensed through medicapharma.com is also misbranded under section 502(f)(1) of the Act because its labeling fails to bear adequate directions for the uses for which it is being offered and it is not exempt from this requirement (See 21 CFR 201.115).

This drug is also misbranded pursuant to section 503(b)(1) of the Act because it is dispensed without a prescription.

False statements are being made by you on www.edrugnet.com, that are aimed at and accessible to American consumers stating in part, ***Order legally*** offering a huge selection of medications based on brand name and generic name which are approved by FDA***.False statements again are being made by you on www.accutande-ance-treatments-medication.com and www.1accutane.com that are aimed at and accessible to American sonsumers stating "FDA Approved Products" are available on your website. The product was then packaged and in Thailand. Inside the package was a U.S. Customs Declaration stating in part, "***I am United States Citizen***None of these Medication which I must have access to are for treating a life threatening or debilitating condition***." These false and misleading statements on your Internet site and Packaging labeling cause the drugs you distribute to be misbranded pursuant to section 502(a) of the Act.

This letter is not intended to identify all of the ways in which your activities might be in violation of United States Iaw. For example, in addition to isotretinoin, your pharmacy also offers for sale and shipment to U.S. consumers numerous other prescription drugs.
FDA believes that virtually ail shipments of prescription drugs imported from non-U.S. pharmacies will violate the Act. It is your responsibility to ensure that all drug products dispensed and distributed by you and your website into the United States are in
compliance with applicable legal requirements.

The agency has taken steps to warn our residents that drugs sold via the Internet, from foreign sources, may not be approved for marketing in this country, and may not be legally imported. With copies of this Ietter, we are advising regulatory officials of the State of Colorado, The United Kingdom and Thailand of these potential violations, In addition, we are advising the Bureau of Customs and Border Protection through an Import Alert, that shipments offered for importation into the U.S. as a result of your activities may be detained and subject to refusal of entry.

You are instructed to cease these practices, and you are requestcd within fifteen (15) days of your receipt of this letter, to describe the actions you are taking to assure that your operations are in full compliance with United States law. Please address your
correspondence to Mr. Melvin F. Szymanski. Compliance Officer, at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance. HFD-310, 5600 Fishers Lane, Rockville, MD 20857.

You should be aware that violations of the FD&C Act could result in seizure, injunction, and/or prosecution without further notice.

 

Sincerely,

/s/

David J. Horowitz, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research