FDA Warns CTI Science on Drug Claims

CINCINNATIFDA issued a warning letter June 17 to CTI Science, Lexington, Ky., concerning the marketing of its product OSR#1. The product is positioned as a dietary supplement, marketed with claims touting its ability to promote a healthy glutathione level and scavenge free radicals; however, the labeled ingredient N1,N3-bis(2-mercaptoethyl)isophthalamide does not meet regulatory criteria as a dietary ingredient. Further, FDA noted the claims and positioning make the product a new drug.

The agency also raised concerns about the use of the product in addressing health conditions such as hypertension and diabetes, which also position it as a drug, not a dietary supplement. The CTI Science Web site also refers to certain animal studies in relation to product safety that report several side effects, which are not represented as a problem in Web site labeling.

CTI Science has 15 working days to respond to FDA with documentation on steps it is taking to address the cited violations. FDA noted failure to correct the violations could result in legal action including seizure and injunction.