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USDA Releases Interim Final Rule for Industrial Hemp Production, Requests Comments

The U.S. Department of Agriculture (USDA) has issued an Interim Final Rule (IFR) for the establishment of a domestic hemp production program. By publishing the rule in the form of an IFR, USDA is able to issue guidance before...more

FDA Considering Changes to Regulation of CBD Products - Agency Holds Public Hearing on Cannabis to Gather Input from Stakeholders,...

• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed. • The...more

FDA Issues Statement on Cannabis Regulation and Announces Public Hearing

On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more

FDA Open to “Alternative Approaches” to Regulating CBD

FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products. The announcement came as Commissioner Scott Gottlieb spoke on the...more

Hemp is Now Legal, But What Does That Actually Mean?

With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC)—less than 0.3 percent on a dry weight...more

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more

FDA Commissioner Speaks Out on Compliance and Enforcement

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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