Innovative Biodefense Inc. – FDA Warning Letter

On June 30, 2015, the FDA and FTC issued a Warning Letter to Innovative Biodefense Inc. regarding its Zylast antiseptic product line (Zylast XP Antiseptic, Foaming Soap, and Lotion). The agencies reviewed claims on product labels and the company's website, www.zylast.com, including linked social media pages.

The Zylast products are deemed unapproved new drugs under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], making their introduction into interstate commerce prohibited under Section 301(d) [21 U.S.C. § 331(d)].

Violations include: - **Unapproved New Drug Charges:** Despite being labeled as topical "antiseptics," the products' labeling and promotional claims on websites (www.zylast.com, www.zylastdirect.com), Twitter, and Facebook indicate intended uses as drugs for specific serious-disease-related pathogens (e.g., Ebola, MRSA, H1N1, norovirus, HIV, herpes, influenza, rhinovirus, rotavirus). Zylast XP Antiseptic Lotion is also marketed as a leave-on product. These uses are not covered by any ongoing OTC monograph rulemaking, nor are they generally recognized as safe and effective. The products require FDA-