FDA WARNING LETTER
Zona Health Inc.
MARCS-CMS 584676 — DECEMBER 06, 2019
Recently, Zona Health received a “Warning Letter” from the Food and Drug Administration (FDA) which detailed concerns that Zona Health’s website was marketing claims which exceeded our approval with the Agency. Their review identified a few areas on the Company’s website which the Agency requested be adjusted. Being a company based on a foundation of honesty and integrity, we immediately complied with their request, as we always have. Previously, we had undergone several complete compliance audits and had received the Agency’s clearance.
As noted on the FDA’s website, “Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.” In the spirit of full transparency, our formal response is available below. No further action has been required from the Agency, as we have fully complied.
In related news, Zona Health has been actively seeking full FDA approval and in 2019, submitted full IDE and test protocol for review. We currently await their approval for our full research study.View Zona Health's Response View FDA Warning Letter