| Public Health Service Food and Drug Administration |
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Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-42
September 16, 2011
Mr. Matthew Barry
Algonot, LLC
5111 Ocean Blvd.
Suite C
Sarasota, FL 34242
Dear Mr. Barry:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.algonot.com in June 2011 and has determined that your "Algonot-Plus,""CystoProtek," "ProstaProtek," and "NeuroProtek" products are promoted for conditions that cause these products 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 claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. The marketing of your products with these claims violates the Act.
Examples of some of the claims observed on your website at www.algonot.com include:
From the "Products" link under a heading titled "Algonot Plus":
• "Algonot-Plus ... designed to give long-term relief from arthritis."
• "Algonot Plus will ... reduce the swelling caused by inflammatory diseases such as osteoarthritis, rheumatoid arthritis, interstitial cystitis, and prostatitis."
• "Algonot Plus is a unique formulation that. " Relieves osteoarthritis related inflammation and swelling"
From the "Products" link, under the heading, "CystoProtek":
• "CystoProtek® ... effective in reducing the pain and improving the overall symptoms in patients with [Interstitial Cystitis]."
From the "Products" link, under the heading, "ProstaProtek":
• "ProstaProtek® is ... developed to reduce the symptoms and pain associated with Prostatitis."
From the "Products" link, under the heading, "NeuroProtek":
• "NeuroProtek® ... may reduce symptoms of gut and brain inflammation and nerve damage."
• "[T]en children diagnosed with autism were orally administered ... NeuroProtek® for a period of 4-6 months. At the end ... parents of the patients observed a significant improvement of core autism symptoms, such as poor communication skills and social interactions. [T]wo children ... who prior to treatment were unable to speak, could not identify words, would get upset when asked to repeat a task ... after treatment were able to answer simple questions, could make words with block letters ...."
Your website also contains disease claims in the form of personal testimonials, including:
• "I would like you to know that I have had promising results with your product. I have been diagnosed with IC since 2002. Since that time, I have taken medications such as Elmiron, Atarax, Urised, Pyridium, and various pain medications - along with bladder instillations of Rimso. I have seen little results with any of these drugs.
At the advice of my Urologist, I began taking your CystoProtek last fall. I took it for 4 months and was feeling better. After the 4 months, I was not sure if I really "needed" the supplement, so I quit taking it. Wow, did I notice a difference. My symptoms became much worse for a month. I couldn't pinpoint the cause of the increase in symptoms - until I remembered I quit taking CystoProtek. So, I ordered another supply right away. Since I began taking it again, I have noticed a drastic change in my symptoms. The pain is still there, but much less debilitating.
I am pleased with the results of CystoProtek. I definitely would recommend it to any IC patient."
In addition, 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. 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 to be 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 are examples of reference citations used to market your products for disease treatment and prevention on your website and are thus evidence of your products' intended use as drugs:
• "Middleton E Jr, Kandaswami C, Theoharides TC. The effects of plant flavonoids on mammalian cells: implications for inflammation, heart disease, and cancer. Pharmacol Rev. 2000 Dec;52(4):673-751."
• "Kempuraj D, Tagen M, Iliopoulou BP, Clemons A, Vasiadi M, Boucher W, House M, Wolfberg A, Theoharides TC. Luteolin inhibits myelin basic protein-induced human mast cell activation and mast cell-dependent stimulation of Jurkat T cells. Br J Pharmacol. 2008 Dec; 155(7): 1076-84."
Your "Algonot-Plus," "CystoProtek," "ProstaProtek," and "NeuroProtek" products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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 "Algonot-Plus," "CystoProtek," "ProstaProtek," and "NeuroProtek" 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, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. 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 and 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 fifteen (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 state the date by which the corrections will be completed.
Please send your reply to the attention of Carla Norris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding any issue in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/S/
Ronnie E. Jackson
Acting Director, Florida District
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