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U.S. Department of Health and Human Services

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Enforcement Actions

www.tob-one.com 7/15/13

  

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:                Fundacion Private Whois
                      Aptds. 0850-00056
                      Zona 15, Panama
                      abuse@privatewhois.net
 
                      www.bestcheapmedsonline.com
 
FROM:          United States Food and Drug Administration
                    Center for Drug Evaluation and Research
                    Office of Compliance
                    Office of Drug Security, Integrity and Recalls
                    Division of Supply Chain Integrity
 
RE:                Internet Marketing of an Unapproved and Misbranded Drug
 
DATE:           July 15, 2013
 
WARNING LETTER
 
The United States Food and Drug Administration (FDA) reviewed your website, www.bestcheapmedsonline.com. We have determined that www.bestcheapmedsonline.com offers products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the website offers misbranded and unapproved new drugs for sale in violation of sections 502(f)(1), 503(b)(1), and 505(a), of the FD&C Act [21 U.S.C. §§ 352(f)(1), 353(b)(1), and 355(a)], which are prohibited acts under sections 301(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(a) and 331(d)]. 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 website 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, namely diabetes mellitus. These products, as marketed through your website, 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 section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is a prohibited act under section 301(d) [21 U.S.C. §331(d)].
 
We purchased and received through your website, Januvia 25 mg Tablets, containing the active ingredient (AI) Sitagliptin Phosphate. We also received four free Sildigra 100 mg Tablets (AI Sildenafil Citrate). Sildenafil Citrate is the active ingredient in the FDA approved drug Viagra, well known for its intended use to treat erectile dysfunction. Sildigra is subject to regulation as a drug under section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, Sildigra appears to be a new drug within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled use. No approved application pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] is in effect for Januvia or Sildigra. Accordingly, their introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is a prohibited act under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
 
Your firm also sells through your website Exermet GM (AIs Glimepiride and Metformin Hydrochloride), Galvus (AI Vildagliptin), Nuzide (AI Gliclazide), and Triexer (AIs Glimepiride, Pioglitazone Hydrochloride, and Metformin Hydrochloride Extended Release), which are presented on your website under the heading “Antidiabetic.” These products 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, namely diabetes mellitus. Moreover, Exermet GM, Galvus, Nuzide, and Triexer appear to be new drugs within the meaning of 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. There are no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for any of these drug products.  Accordingly, their introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is a prohibited act under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
 
Misbranded Drugs
 
Your website sells Januvia without requiring that it be dispensed only upon a prescription from a practitioner licensed by law to administer such drug.  We purchased and received Januvia without a prescription even though the outer carton bears the “Rx” legend and the statement “WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.” By dispensing, without any prescription, a drug that is limited to use only under the professional supervision of a licensed practitioner, you cause Januvia to be misbranded under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], which is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
Because Januvia and Sildigra 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 within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because Januvia and Sildigra offered for sale through your website lack required approved applications, they are not exempt from the adequate directions for use requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as described in Title 21 of the Code of Federal Regulations (21 CFR) § 201.115. 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)].
 
* * *
 
Januvia is subject to refusal of admission pursuant to section 801(a)(2) of the FD&C Act [21 U.S.C. § 381(a)(2)] in that it is forbidden or restricted in sale in the country in which it was produced or from which it was exported. Januvia’s labeling states in part “For Sale in India only – Not for Export.” Therefore, Januvia is prohibited or restricted in sale and should not be sold outside of India.
 
FDA is taking 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 may not have the same assurance of safety, efficacy, and quality as drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, containing varying amounts of active ingredients, or containing 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 drug 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 FDA regulatory action, including but not limited to, seizure or injunction, without further notice.
 
Please notify this office in writing within 15 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 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
 
Sincerely,
 
/s/
 
Thomas Christl, Office Director (Acting)
Office of Drug Security, Integrity and Recalls
Office of Compliance
Center for Drug Evaluation and Research
 
 
 
cc:
 
New Global Enterprises
304 3rd Floor Ahilya Commercial Complex
Gandhibagh, Nagpur – 440002, Maharashtra, India
 
New Global Enterprises
No. 103 & 104-A, 1st Floor, G. M. Market,
Gandhibagh, Dawabazar, Nagpur – 440002, Maharashtra, India