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Kali-Extracts Receives Proposal To Certify Its CBD Extract As OTC Drug Under FDA Requirements

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Kali-Extracts, Inc. 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.

 

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