US Senate Appropriations Subcommittee on Agriculture will “mark up” language submitted by Senator McConnell that would require the FDA to halt enforcement of anti-CBD guidance.

Specifically, the language  would require FDA to:

  • 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 US Hemp Roundtable writes

This morning, Senate Majority Leader Mitch McConnell – after consulting closely with the US Hemp Roundtable — has introduced legislation that would require the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.

As discussed more fully last week, a primary policy challenge facing the hemp CBD industry has been FDA’s guidance that it is illegal for CBD to be introduced into interstate commerce as a food additive or dietary supplement. While the FDA has announced that it will unveil its timetable to take action toward full legalization this fall, it could be many months before they issue a formal regulation.

Today, 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. Specifically, the language in the document

McConnell-Language

 

Would require FDA to:

  • 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.

In the short run, the McConnell language would help lift the current regulatory cloud that’s been discouraging financial institutions to work with CBD companies, and that’s encouraged some local government officials to suggest that CBD is illegal in their state.  In the long run, it would set forward a fair and expeditious path for hemp CBD products to be formally recognized as safe and legal as a matter of federal law.

The bill will be marked up by the full Senate Appropriations Committee on Thursday, and could go to the full Senate soon.

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