In a letter (READ HERE) 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.
“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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