While the agency has consistently stated that it does not consider CBD to be a lawful dietary ingredient as it was first investigated as a drug, its enforcement activity has been focused on companies making egregious claims, prompting many players to wade into the market at their own risk.
However, several states have cracked down on firms selling hemp-derived CBD, and most larger companies are waiting for clarity from the FDA before introducing products into interstate commerce, although they fear a formal rulemaking and comment process could take years.
In draft language shared on Tuesday by the US Hemp Roundtable, a coalition of hemp companies representing every link of the product chain, the US Senate Appropriations Subcommittee on Agriculture would require FDA to:
- Provide Congress with a report outlining its efforts to develop an enforcement discretion policy on hemp CBD within 90 days;
- Issue its formal enforcement discretion policy on hemp CBD within 120 days;
- 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 Council for Responsible Nutrition commended Sen McConnell’s additions to the Senate Agriculture Appropriations bill, with president and CEO Steve Mister adding that, "The strong consumer interest in CBD, the burgeoning market for these products, and the vast differences in dosages between prescription drugs and supplements containing CBD all argue for the quick exercise of that discretion by FDA."
Once that regulatory pathway is created, added Mister, "CRN believes FDA should fully enforce all the legal and regulatory requirements on the books that currently exist for other dietary supplements."
In a letter to FDA acting commissioner Ned Sharpless signed by a bipartisan coalition of 26 House members on Thursday, the lawmakers noted: "Without a formal enforcement discretion policy, anyone participating in the growing marketplace for legal hemp-derived products will continue to face significant legal and regulatory uncertainty."
They went on to urge the FDA to: "promptly issue guidance announcing a policy of enforcement discretion that maintains FDA’s current risk-based enforcement approach towards hemp-derived CBD products” and also “consider issuing an interim final rule, pending issuance of a permanent final rule, to establish a clear regulatory framework for CBD as a dietary supplement and food additive.”