Oasis Consumer Healthcare, LLC – FDA Warning Letter

The FDA issued a Warning Letter to Oasis Consumer Healthcare, LLC, regarding the marketing of their product, Halo, on their website, Twitter, Facebook, and in a press release. The FDA determined that Halo is an unapproved new drug and is misbranded.

Halo is marketed with claims such as "protect[ion] from airborne germs for up to six hours," "kill 99.9% of infectious germs," and "help prevent the flu this season." These statements indicate the product is intended to prevent, treat, or cure disease, or affect the body's structure/function, classifying it as a drug under section 201(g)(1) of the FD&C Act.

Although Halo includes a Drug Facts panel for "first aid to help prevent infection in minor oral irritations" (consistent with the OTC Human Use Tentative Final Monograph for Oral Antiseptic Drug Products), its marketing claims extend beyond these uses. Consequently, Halo is considered a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its labeled uses.

The sale of Halo without an FDA-approved application violates sections 301(d) and 505(a) of the Act. Furthermore, since the product is offered for conditions not amenable to self-diagnosis and treatment by laypersons, adequate directions for its intended uses cannot be written, rendering it misbranded under section