McConnell Pushes FDA To Act On CBD Guidance

According to the U.S. Hemp Roundtable,  Majority Leader Mitch McConnell (R-KY) introduced language on the Agriculture Appropriations bill that would require the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.  The FDA had suggested it would take them 3-5 years to decide on rules and regulations for CBD.

The group’s website posted that the US Senate Appropriations Subcommittee on Agriculture will “mark up” language submitted by Senator McConnell that would require the FDA to formally stand down on any enforcement of its troublesome anti-CBD guidance. The notes are as follows:

• Within 90 days, provide Congress a report outlining its efforts to develop an enforcement discretion policy on hemp CBD;

• Within 120 days, issue its formal enforcement discretion policy on hemp CBD;

• Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and

• Ensure that going forward, CBD manufacturers would be able share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.

The group also added that the bill will be marked up by the full Senate Appropriations Committee on Thursday, and could go to the full Senate soon. The Hemp Roundtable said that last week, Reps. Chellie Pingree (D-ME) and James Comer (R-KY) sent all members of the US House of Representatives a “Dear Colleague” letter, asking them to co-sign a letter that urges the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.

One of the biggest complaints following the passage of the 2018 Farm Bill that legalized hemp was that the product remained in a legal quagmire. Some states have outlawed hemp-derived CBD products, while others have no problems. Banks aren’t sure how to address CBD customers and even e-commerce has struggled with the issue. Shopify only just announced on Tuesday that it began working with CBD merchants, while Google refuses to allow CBD advertising.

The letter said, “However, FDA’s current regulatory approach on CBD has created significant regulatory
and legal uncertainty for participants in this quickly evolving industry. FDA maintains that food products
containing CBD remain illegal under the FDCA because it is the active ingredient in an epilepsy drug,
Epidiolex, that is undergoing clinical trials. Although the agency is exploring alternative regulatory
pathways, the FDA claims that a rulemaking process could take the agency anywhere between 3-5 years
to complete.”