Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435675.htm
Timestamp: 2019-04-24 09:07:54+00:00

Document:
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.
“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’”.
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.
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].
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.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331