KALY – Kali-Extracts Receives Proposal To Certify Its CBD Extract As OTC Drug Under FDA Requirements
GlobeNewswire•September 4, 2019
DALLAS, Sept. 04, 2019 (GLOBE NEWSWIRE) -- via OTC PR WIRE -- Kali-Extracts, Inc. (Kali, Inc. dba/Kali-Extracts, Inc.) (KALY) (“KALY”) today announced the company has received a formal proposal to take one or more of its proprietary CBD extracts derived from the company’s U.S. Patented Extraction Process through a Current Good Manufacturing Practices (cGMPs) certification process for the purpose of certifying the extract as an Over-The-Counter (OTC) drug under the requirements prescribed by the U.S. Food and Drug Administration. “Current Good Manufacturing Practices (cGMPs) represent the U.S. Food and Drug Administration's extensive requirements that over-the-counter and dietary supplement manufacturers must follow.” Management indicates this is a major undertaking and not to be considered lightly. The proposal is being actively discussed and negotiated. A decision is expected next week on if and how to proceed.
