FDA WARNING_LETTER - Saferex Laboratories International Corporation

This FDA Warning Letter addresses Saferex Laboratories International Corporation's marketing of SlicPlus on www.slicplus.com. The FDA determined SlicPlus is an unapproved new drug, misbranded, and promoted with false and misleading claims.

SlicPlus is deemed a drug under section 201(g)(1) of the Act due to website claims indicating its intent to mitigate, prevent, treat, or cure diseases, specifically STDs. Examples include "Greatest STD Protection Without Condoms!" and "Destroys germs that lead to viruses, infections and STD's." As a new drug (section 201(p)), it lacks general recognition of safety and effectiveness, violating sections 301(d) and 505(a) of the Act by being introduced into interstate commerce without an FDA-approved application.

Furthermore, SlicPlus is misbranded under section 502(f)(1) because its intended uses are not amenable to self-diagnosis and treatment, thus lacking adequate directions for laypersons. The product is also misbranded under section 502(a) due to false and misleading promotional statements. These include claims of being "all FDA approved" and implying support from government agencies like the Department of Health and Human Services and the CDC, which is untrue.

Saferex Laboratories must take prompt action to correct these violations. Failure to do so may result in legal action, including seizure and