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Food and Drug Administration

USDA Hemp Producer License – Do the Opportunities Outweigh the Risks?


Posted on January 27, 2020 in HR Insights for Health Care

Published by: Hall Render

The USDA Hemp Producer License Rule and Framework On October 31, 2019, the United States Department of Agriculture (“USDA”) published an interim final rule[1] with request for comments in the Federal Register regarding hemp production (“USDA Hemp Rule” or the “Interim Final Rule”).[2] The USDA Hemp Rule establishes a federal hemp producer license and... READ MORE

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The Practice of Medicine vs. Protecting Patient Safety: Groundbreaking Court Ruling in Support of the FDA’s Regulation of Certain Stem Cell Therapies


Posted on June 11, 2019 in Health Law News

Published by: Hall Render

On Monday, June 3, the United States District Court for the Southern District of Florida (the “Court”) ruled that the Food and Drug Administration (“FDA”) has the authority to regulate certain stem cell-based treatments offered by U.S. Stem Cell Clinic, LLC (the “Clinic”) and U.S. Stem Cell, Inc. After the Clinic failed to heed... READ MORE

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FDA Clarifies Position on CBD After Passage of 2018 Farm Bill


Posted on January 18, 2019 in HR Insights for Health Care

Published by: Hall Render

The United States Food and Drug Administration (“FDA”) issued a statement (the “Statement”) clarifying its position on cannabidiol (“CBD”) products in the wake of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”) signed December 20, 2018.¹ The 2018 Farm Bill is a broad piece of legislation that regulates agricultural programs ranging from income support... READ MORE

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