Cti Science Inc – FDA Warning Letter, Mar 13, 2012

This FDA Warning Letter (CIN-10-107927-14) dated June 17, 2010, addresses CTI Science, Inc.'s marketing of "OSR#1" on its website, www.ctiscience.com. The FDA determined that OSR#1 is marketed in violation of the Federal Food, Drug, and Cosmetic Act.

The product, marketed as a dietary supplement, does not meet the definition of a dietary supplement under section 201(ff) of the Act because its only listed ingredient, N1,N3-bis(2-mercaptoethyl)isophthalamide, is not a defined dietary ingredient.

Furthermore, claims on the website, such as "helps maintain a healthy glutathione level" and "scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity," classify OSR#1 as a drug under section 201(g)(1) of the Act. It is also deemed a new drug under section 201(p) as it is not generally recognized as safe and effective. The sale of OSR#1 without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

The product is also misbranded under section 502(f)(1) because claims linking it to "Thyroid conditions, hypertension, and