Inspections, Compliance, Enforcement, and Criminal Investigations

NanoBiotech Pharma 2/26/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

FEB 26, 2015

WARNING LETTER
 
 
VIA EXPRESS MAIL
 
Gary S. Mezo
NanoBiotech Pharma, Inc.
7512 Dr. Phillips Blvd.           7932 West Sand Lake Road
Suite 50-240                            Suite 106
Orlando, FL 32819                 Orlando, FL 32819
 
 
RE: 446481
 
 
Dear Mr. Mezo,
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses http://www.nanobiotech.us, http://www.nanobiotech.squarespace.com, and http://www.nanobiotechpharma.com in December 2014 and has determined that you take orders there for the products NanobacTX and Urobac, which the websites promote for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims on your websites, http://www.nanobiotech.us and http://www.nanobiotechpharma.com, that provide evidence that your products are intended for use as a drug include:
 
Under the “NanobacTX” tab:
  • “NanobacTX is a patented non-prescription oral nanobiotic compound shown in published cardiology studies to reverse/regress atherosclerosis, calcified coronary artery plaque volume … and eliminate heart disease symptoms. NanobacTX is the only product ever shown to dissolve, eradicate and regress calcified arterial plaque and calcification deposits in blood vessels, organs, and tissues.”
  • “NanobacTX decreases coronary artery plaque volume, heart disease symptoms, angina … alleviates the inflammation, coronary artery calcification and improves coronary blood flow and vascular flexibility.” 
Under the “Urobac” tab
  • Urobac is a…nanobiotic compound shown in published clinical trials to eradicate Nanobacteria (CNPs) infection…”
  • “Urobac is designed to reduce inflammation and calcification that occurs throughout the urogenital system including dissolving kidney stones, Polycystic Kidney Disease (PKD) stones & cysts, prostate stones, BPH, chronic prostatitis, Interstitial Cystitis (IC) and Gallstones.”
Your websites also contain evidence of intended use in the form of personal testimonials recommending or describing the use of NanobacTX and Urobac for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
Under the “Testimonials” tab:
  • “Nanobiotech’s researchers have performed a pilot study of 91 patients using NanobacTX for three months: Of the 91 participating patients, the mean decrease in their coronary artery calcification scores was 58.5% after treatment with NanobacTX for three months. Interestingly, in 19 of those 91 patients 100 percent of coronary artery calcification was eradicated.”
  • “With NanobacTX, We Typically see, and now EXPECT to see: Decrease or resolution of angina, even in patients with closed bypass grafts or restenosis following angioplasty or stent Reduction in the HeartScan … coronary artery calcium (CAC) scores … LDL cholesterol falls … abnormal heart pumping function and filling characteristics improve, elevated blood pressure often falls and medication requirements decrease.”
  • “We treated a group of patients with Urobac that had calcified prostate stones and long-standing Chronic Prostatitis IC/CPPS symptoms that were unresponsive to all conventional therapies. Urobac is designed to eliminate stone forming CNP (Nanobacteria) and found that 80% had a significant improvement in symptoms after only 3 months. The Clinical Study population represented a … group of patients in whom all multiple previous therapies had failed, including antibiotics, phytotherapy, a-blockers, neuromuscular therapies and prostatic massage.”
  • “Prior to his treatment, he had a HeartScan calcium score of 343 … We treated him with NanobacTX and the follow up score was … 26 … Again he is angina free and had his cardiac meds reduced by approximately 2/3rds.”
  • “On continuing the NanobacTX treatment my peripheral neuropathy went away and my cardiac arrhythmia totally resolved!”
  • “NanobacTX could probably replace half the stent, bypasses and heart surgeries taking place…”
 
Examples of some of the claims on your website, http://www.nanobiotech.squarespace.com, that provide evidence that your products are intended for use as a drug include:
 
On your home page:
 
Under the “NanobacTX – the first Nanobiotic” heading:
  • “In 1996, we invented NanobacTX to reverse Coronary Artery Disease. NanobacTX is designed specifically to eradicate atherosclerotic calcified artery plaque, amyloid & inflammation in the coronary arteries…”
  • “Our NanobacTX is specifically designed to reverse heart disease and coronary arteriosclerosis.”
  • “‘I know of no other treatment that is so successful.’-Cardiologist, Stephen Sinatra, MD (‘NanobacTX – Major Breakthrough in Arterial Health’ – The Sinatra Report)” 
Under the “UROBAC – the second Nanobiotic” heading:
  • “UROBAC is designed for urinary tract CNP infections: BPH, PKD, Chronic Prostatitis, Interstitial Cystitis, & Kidney Stones.”
  • “UROBAC was shown in published urology research studies at Cleveland Clinic to be effective in the treatment of enlarged prostate/BPH and chronic prostatitis.”
  • “‘We treated a group of patients with prostatic stones and long-standing CP/CPPSIII symptoms unresponsive to conventional therapies with UROBAC … and found that 80% had a significant improvement in symptoms (and stones dissolved)…” 
On your “PURCHASE” tab:
 
Under the “NanobacTX” link:
  • “Coronary Artery Disease + Alzheimer’s Disease Testimonial: ‘My sister was treated with NanobacTX for her heart disease for 4 months. Not only did her heart disease status improve, but so did her Alzheimer’s Disease! She had been confined to a nursing home for her Alzheimer’s … but after 4 months of NanobacTX, she … was able to return to her home and live by herself successfully’”.
Under the “Urobac” link:
  • “Testimonial: ‘I received my UROBAC (FOR CHRONIC PROSTATIS & BPH) … I have been taking the UROBAC for about ten days now. I feel a big improvement already!”
  • “Testimonial: … My symptoms of chronic prostatitis have diminished dramatically …in my 5th week of UROBAC … Also the calcified plaque on my teeth is completely gone!”
On your “RESEARCH” tab:
 
Under the “RESEARCH CHRONOLOGY” link:
  • “2002 Mezo’s NanobacTX-ACESII-Cardiology Trial … testing NanobacTX begin to show … results that severe heart disease patients have sustained substantial reductions in heart disease parameters, symptoms and markers after treatment with NanobacTX … the first substance ever shown to reduce coronary artery plaque, effectively reversing heart disease.”
  • “2003 … Mezo’s NanobacTX is safe & effective in structurally & functionally eversing [sic] Coronary Artery Disease.”
Further, your websites cite articles regarding the use of your NanobacTX and Urobac products to treat diseases. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use as a drug: For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
 
The following reference citations on your websites, http://www.nanobiotech.us and http://www.nanobiotechpharma.com, are among those used to market NanobacTX and Urobac for disease treatment and prevention:
 
Under the “NanobacTX” tab:
  • Maniscalco, B.S., Mezo, G.S. Calcification in coronary artery disease can be reversed. Intl Journal of Pathophysiology. 11(2): 95-101
Under the “Urobac” tab:
  • Shoskes, D., K. Thomas, E. Gomez. CLEVELAND CLINIC. Antinanobacterial therapy in men with chronic prostatitis/chronic pelvic pain syndrome and prostatic stones. Journal of Urology. 173: 474-477.
  • Ciftcioglu, N., et al. “Nanobacteria: An infectious cause for kidney stone formation.” Kidney International. 56:1893-1898.
These reference citations and other claims quoted above are supplemented by metatags used to bring consumers to your websites through Internet searches. The metatags are “CAC,” “CAD,” “coronary artery disease,” “has heart disease been cured,” “Heart Disease,” “Calcification,” “chronic prostatitis,” “kidney stones,” “glaucoma,” “amd” [age-related macular degeneration], “bph” [benign prostatic hyperplasia], “IC,” “interstitial cystitis,” “cataracts,” “ED” [erectile dysfunction].
 
In addition, claims for NanobacTX and Urobac made on your Facebook page, https://www.facebook.com/NanobiotechPharma, which has a link to your website at http://www.NanoBiotechPharma.com, where the products can be purchased directly, provide further evidence that these products are intended for use as drugs:
  • On December 4, 2014: “[Y]ou cannot have a heart attack if you do not have coronary artery plaque. NanobacTX reverses the plaque volume.”
  • On December 2, 2014: “REVERSING CORONARY ARTERY DISEASE CAN BE DONE …. The agent that caused reversal of calcified CAD plaque & Anginal symptoms? NanobacTX….”
  • On October 24, 2014: “NanobacTX ... Lower CAC score, Eliminate & reverse coronary artery plaque … & eliminate angina.”
  • On October 8, 2014: “Atherosclerosis and the underlying pathologies can be reversed with NanobacTX…”
  • On September 16, 2014: “Vascular Dementia and symptoms can be reversed as well as Atherosclerosis of the brain. …We have clinical trials planned in Vascular Dementia & Alzheimer’s with our non-prescription NanobacTX.”
  • On June 11, 2014: “Use NanobacTX for 6-12 months until symptoms/presence of AD [Alzheimer’s Disease]/Dementia subside or are eradicated… Vascular Dementia & Alzheimer’s Disease. Our hypothesis is that NanobacTX either rescues cognition, or prevents further decline.”
  • On October 15, 2013: “Many scholarly articles connect the persistent state of inflammation with chronic diseases such as cancer, heart disease, Lyme, Fibromyalgia…[I]nflammation can be stopped and reversed with our Nanobiotics: NanobacTX, Urobac…”
  • On August 28, 2013: “Our Urobac is shown … to eliminate … the calcification, biofilm and inflammation in the prostate that cause BPH.” 
Moreover, claims for NanobacTX and Urobac made on your LinkedIn page, https://www.linkedin.com/company/nanobiotech-pharma, which also has a link to your website at http://www.NanoBiotechPharma.com, where the products can be purchased directly, provide additional evidence that these products are intended for use as drugs:
  • “NanobacTX … shown in published clinical trials by cardiologists & radiologists to 1) regress Coronary Artery Disease Plaque … 2) to Stop Angina Chest Pain…”
  • “Urobac for Kidney Stones, PKD, Chronic Prostatitis & BPH.” 
Your products NanobacTX and Urobac are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act, 21 U.S.C. § 355(a); see also section 301(d) of the Act, 21 U.S.C. § 331(d). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your NanobacTX and Urobac products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use, 21 U.S.C. § 352(f)(1). The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, 21 U.S.C. § 331(a).
 
This letter is not meant to be an all-inclusive review of your websites and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which each such item will be corrected.
 
If you need additional information or have questions concerning any products distributed through your websites, please contact the FDA. You may respond in writing to Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.
 
 
Sincerely,
/S/
William A. Correll
Director                                                                                                                                              
Office of Compliance
Center for Food Safety   
     and Applied Nutrition

Page Last Updated: 03/02/2015
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