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Council for Federal Cannabis Regulation (CFCR) Urges Biden Administration to Allow FDA to Regulate US Cannabis Market

CFCR has called upon the Secretary of Health and Human Services (HHS) to address an escalating public health and safety crisis in the US affecting children, vulnerable populations, and the general population.

CFCR has called upon the Secretary of Health and Human Services (HHS) to address an escalating public health and safety crisis in the US affecting children, vulnerable populations, and the general population.

“Even though cannabis products are fully legal in some states and are regulated by those jurisdictions, there are still thousands of products shipped interstate every day that urgently require oversight,” said Orlowitz.

“Even though cannabis products are fully legal in some states and are regulated by those jurisdictions, there are still thousands of products shipped interstate every day that urgently require oversight,” said Orlowitz.

CFCR urges government to address urgent risks to public health and safety toward ultimate goal of establishing a well-regulated pathway for cannabis industry.

It is critical that this Administration work to overcome the Drug Exclusion Rule (DER) which the (FDA) continuously points to as the regulatory barrier preventing it from regulating CBD.”
— Sheri Orlowitz, CFCR Board Chair
WASHINGTON DC, UNITED STATES, December 14, 2021 /EINPresswire.com/ -- The Council for Federal Cannabis Regulation, (CFCR), a non-profit organization dedicated to fostering common-sense federal directives and regulations applicable to cannabis, has called upon the Secretary of Health and Human Services (HHS) to address an escalating public health and safety crisis in the US affecting children, vulnerable populations, and the general population.

In a letter delivered on Sunday, December 12th, to the Hon. Xavier Becerra, Secretary of HHS, CFCR Board Chair and former Department of Justice lawyer Sheri L. Orlowitz stated, “It is critical that this Administration work to overcome the Drug Exclusion Rule (DER) which the Food and Drug Administration (FDA) continuously points to as the regulatory barrier preventing it from regulating CBD and products containing CBD." The DER prohibits a molecule used in a drug to be sold as a food or dietary supplement unless the molecule was marketed as same before the FDA approved it as a new drug or began the IND investigation. The CBD molecule is the active ingredient contained in Epidiolex, a drug used to treat seizures. This is the required and critical first step to creating a national marketplace.

The letter emphasized that:

• This regulatory barrier has permitted psychoactive substances, including Delta-8 THC, Delta-9 THC (hemp derived), to be introduced into food, drink, tincture, and other products, and sold with no restrictions.

• These products range from gummy worms that are virtually indistinguishable from other children’s candy to “soft” drinks, both containing psychoactive ingredients that produce intoxication. These can be found in convenience stores, gas stations, and many other storefronts, making these products easily available to children and other vulnerable populations.

CFCR, whose Board, committee chairs and advisors, are a who’s who of leading industry experts, both domestic and international, as well as former federal agency leaders, has requested a meeting with HHS to amplify the concerns expressed in the December 12th letter and to share its strategies to support federal agencies and make this a ‘win-win’ for the Administration, the legal cannabis sector, and above all, the American public. CFCR also proposes to provide FDA access to ongoing confidential toxicology studies being conducted by a well-respected research organization to support safety requirements for CBD products in the European Union and the United Kingdom. CFCR believes this information can accelerate FDA’s ability and timeline to regulate CBD, but not without first obtaining an Administration waiver of the DER to allow the FDA to proceed.

“Even though cannabis products are fully legal in some states and are regulated by those jurisdictions, there are still thousands of products shipped interstate every day that urgently require oversight,” said Orlowitz.

For additional information, please visit uscfcr.org.

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ABOUT CFCR
The Council for Federal Cannabis Regulation (CFCR) is 501(c)(3) non-profit based in Washington, DC. The mission of CFCR is to assist the government, and specifically federal regulatory agencies, to rethink, develop, and implement evidence-based cannabis regulations. Our overarching goal is the de-stigmatization, normalization, and legitimization of cannabis on behalf of consumers, the professions, organizations, and businesses who support and serve them. We do this by serving as a conduit for informed scientific research, inclusive education, and by mainstreaming the best practices that enable the industry to maximize its potential. For additional information please visit www.uscfcr.org and follow us on social media @USCFCR.

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Sarah Chase
Executive Director, Council for Federal Cannabis Regulation
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