A Senate committee has approved language on CBD that will not protect consumer access to CBD supplements. Action Alert!
Two weeks ago, we reported on efforts to preserve consumer access to therapeutic levels of CBD oil in supplements. The US Senate Appropriations Committee has approved report language for FY 2020 that falls far short of protecting consumers, and we must act again to save affordable CBD.
The language approved by the Committee would give the FDA the authority to determine allowable levels for CBD in food and supplements. The language also instructs the FDA to develop an enforcement discretion policy on hemp while the agency “establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product.”
This is a huge problem. As we argued previously, we fear that if the decision is left to the FDA, the agency will protect the interests of pharmaceutical manufacturers and severely limit the amount of CBD allowed in supplements such that it becomes impossible, or extremely difficult, to get any therapeutic effect.
The language requiring notifications and safety studies also seems to relegate CBD in supplements to the new dietary ingredient (NDI) notification process—a process which the FDA has not yet completed. Recall that one of the main problems with the FDA NDI guidance that we’ve previously discussed is that it isn’t practical for supplement companies to conduct expensive safety studies on supplements; supplements are typically natural compounds that cannot be patented, and thus the cost of these safety studies cannot be recuperated like they can in the pharmaceutical industry.
Requiring notifications and safety studies on CBD supplements also defies logic. CBD was apparently studied sufficiently for the FDA to approve it as a drug. A World Health Organization report that critically reviewed CBD characterized it as “generally well-tolerated with a good safety profile.” Why would CBD supplements be required to submit additional studies?
“Enforcement discretion” for certain products containing CBD will presumably allow the sale of some CBD products free of FDA intrusion, which is a positive step, but it is not nearly enough. We must fight for an exemption for CBD supplements at a dosage level up to 100mg.
Action Alert! Write to Congress, calling for an amendment that exempts CBD from FDA rules and allows CBD in food and supplements at a dose of up to 100 mg. Please send your message immediately.