FDA WARNING_LETTER - Algonot, LLC

On September 16, 2011, the FDA issued a Warning Letter to Algonot, LLC, following a June 2011 review of their website, www.algonot.com. The FDA determined that Algonot's "Algonot-Plus," "CystoProtek," "ProstaProtek," and "NeuroProtek" products are promoted for conditions that classify them as 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 violations stem from numerous claims on the website, including product descriptions and personal testimonials, asserting the products' efficacy in the cure, mitigation, treatment, or prevention of diseases such as arthritis, osteoarthritis, rheumatoid arthritis, interstitial cystitis, prostatitis, gut and brain inflammation, nerve damage, and autism symptoms. The letter also cited the commercial use of scientific publications on the website as evidence of intended drug use.

These products are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval as required by section 505(a) [21 U.S.C. § 355(