Rockville, MD 20857 |
Via Express Mail/Return Receipt
& Faxed to (775) 924-4501
Warning Letter
September 9, 2003
Mr. David Anderson
Registrant
2bbrands
P.O. Box 0798
Manhattan Beach, CA 90266
Dear Mr. Anderson:
The Food and Drug Administration (FDA) has learned that, through the websiteswww.2bbrands.com and ww.mexican-drugstore.com, you are selling “Accutanetopical gel” to United States (U.S.) consumers. Accutane is the trade namefor a prescription drug approved for marketing in the United States under anapproved new drug qdication submitted by Roche Pharmaceuticals. Nutley, MewJersey. The only approved Accutane products approved for marketing in the UnitedStates are capsules for oral ingestion. Even though the the mexican-drugstore.comorder form states that the product offered for sale is Accutane topical gel,”the label of the actual product shipped states that it is “ISOTEX ISOTRENINOINAGEL 0.05%. The labeling for this product is in Spanish. Neither “Accutanetopical gel” nor “Isotrex” has an approved new drug application,and they may not be legally marketed in the United States.
You sell “Accutane topical gel" without a prescription to the Americanconsumers from a Mexican pharmacy. As discussed in greater detail below, theseactions violate the Federal Food, Drug and Cosmetic Act (FD & C Act or Act),21 United States Code
(U.S.C.) 301 Et seq.
When a U.S. resident logs onto the Internet site, www.2bbrands.com/drugstorethey are automatically taken to that states in part, “***US Corporationenables you to purchase medicines from Mexico***Privately delivered to youraddress Medicines in Mexico are made from the same quality ingredients, madeby the same companies *** in compliance with all U.S. and international laws***” Your firm packages the dispensed prescription and mails it directly tothe resident in the United States.
The “Accutane” product sold through your web site is labeled in part,“ISOTREX ***ISOTRETlNOINA GEL 0.05 %***Tuba con 30 g Formila: Cada 100g contiene: Isotretinoina 0.05g Excipiente c.b.p. 100 g. ***Hecho en Mexicopor STIEFEL MEXICANA, S.A. DE C.V., Eje Norte Sur. No. 11, Nuevo Parques Industrial,San Juan del Rio Qro., C.P. 76809. Segun Formula y bajo licencia de: STIEFELLABORATORIES. INC.,. Coral Gables, FL 33134 ***Late. 130002F428 CAD. 15/JUN/2004***.”
Accutane (isotretinoin) is a systemically administered retinoid approved in1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significantpotential risks, including that it may cause severe birth defects. The approvedAccutane labeling states in part.
“Accutane must not be used by females who me pregnant...must be prescribedunder the System to manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellowAccutane Qualification Sticker must be on each prescription,“ (meaningspecial training has been given to the prescribin, tr licensed practitionerand the patient) “and no telephone or computerized prescriptions are permitted.” The approved Accutane is for oral ingestion. FDA has not approved a topicalgel version of Accutane or any other isotretinoin drug.
Because it has serious risks, isotrctinoin is available in the U.S. only underspecially created safety controls. These safety controls are bypassed wbcn thisdrug is purchased from foreign sources or over the Internet, placing patientswvho use this imported drug at higher risk.
The isotretinoin dispensed through mexcian-drugstore.com is a "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 intointerstate commerce unless an FDA-approved new drug application (NDA) is ineffect for such drug, The continued distribution of this product into the U.S.withoul an approved NDA is a prohibited act as set forth in Section 301(d) ofthe Act.
The isotretinoin dispensed through mexican-drugstore.com is also misbrandedunder section 502(f)(1) of the Act because its labeling fails to bear adequatedirections for the uses for which it is being offered and it is not exempt fromthis requirement (See 21 CFR 201.115). The drug is also not allowed to bearthe required informarion solely in Spanish because it is not distributed solelyin the commonwealth of Puerto Rico or in a U.S. Territory where the predominantlanguage is Spanish (See 21 CFR 201.15(c)).
This drug is also misbranded pursuant to section 503(b)(1) of the Act becauseit is dispensed without a prescription.
In addition, faisc promotional statements are being made by you on www.2bbrands.comand www.mexican-drug.store.com, such as, “All items arc shipped *** incompliance with all U.S. and international laws.” You are giving the incotrectimpression that all the drugs sold on your website are approved and/or legalto be sold and shipped to U.S. residents. This is a false and misleading statementon your Internet site causing the drugs you distribute to be misbranded pursuantto section 502(a) of the Act.
This letter is not intended to identify all of the ways in which your activitiesmight 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 otherprescription drugs.
FDA believes that virtually ail shipments of prescription drugs imported fromnon-U.S. pharmacies will violate the Act. It is your responsibility to ensurethat all drug products dispensed and distributed by you and your website intothe 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, andmay not be legally imported. With copies of this Ietter, we are advising Mexican,New York, and
California drug regulatory officials of these potential violations, In addition,we are advising the U.S. Custom’s Bureau, through an Import Alert, thatshipments offered for importation into the U.S. as a result of your activitiesmay bc 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 takingto 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. Foodand Drug Administration, Center for Drug Evaluation and Research, Office ofCompliance. 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
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