Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|College Park, MD 20740|
FEB 26, 2015
VIA EXPRESS MAIL
David Mouser, CEO
Twin Falls Bio Tech, LLC
18 Margarita Court
Hilton Head Island, SC 29926
Hilton Head Island, SC 29926
Dear Mr. David Mouser:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address www.arisitol.com in November 2014 and has determined that you take orders there for the product Arisi-Tol, which you also refer to as ArisiTol, Arisitol and Arisi-tol. FDA also reviewed literature that accompanies the sale and shipment of your product and has determined that your website and the literature promote Arisi-Tol for conditions that cause the product to be a drug 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 website and in promotional literature establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introduction 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 observed in the literature titled “Read Before Taking” that accompanies the sale and shipment of “Arisi-Tol” and provide evidence that your product is intended for use as a drug include:
- “ … Case studies have shown it even reduces or inhibits cancer cell growth in six cancers with breast cancer leading the list.”
- “Over 2/3rds of the 300 individuals, suffering from many forms of Arthritis, tested our formula and reported it worked!”
- “I developed walking pneumonia. A cough developed effecting [sic] my bronchial tubes, they became sore and inflamed….So, instead of taking cough syrup with codeine, I chewed up three Arisi-tol tablets. In less than an hour, no more burning or inflammation! The inflammation never returned as I continued taking three tablets a day.”
- “[T]he knowledge CBD inhibits growth of cancer cells, is why I continue to take one tablet of Arisitol daily.”
- “If you suffer from Arthritis...try chewing up some Arisi-Tol.”
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
On the webpage titled, “United Patients Group Explains Top 5 Cannabinoids that Help Medical Cannabis Patients Heal”:
- “Cannibidiol (CBD) [sic]: …CBD helps with cancer, multiple sclerosis…diabetes, arthritis, dystonia, Chrohn’s [sic] disease…”
On the webpage titled, “CEO Editorial: Looking for Natural Alternatives and Dealing with Aging, Memory Loss, Arthritis and Pain Management”:
- “If you or someone you know is looking for a safer alternative treatment option for MS, RA, OA,…ArisiTol is made just for you.”
On the webpage titled, “ArisiTol – Order Now for Inflammation and Pain Relief”:
- “Arthritis, Arthritis Pain, RA, Rheumatoid Arthritis, Severe Arthritis…Cancer, Cancer Cure, Cancer Remedies...MS… Multiple Sclerosis…Theiler’s murine encephalomyelitis virus, Theiler’s murine encephalomyelitis virus-induced demyelinating disease…parkinsons [sic]…”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 product is 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 this drug safely for its intended purposes. Thus, “Arisi-Tol” is misbranded within the meaning of section 502(f)(1) of the Act, in that its 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)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. 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 as to 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 website, please contact the FDA You may respond in writing to 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, 2C-047). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition