This week an FDA spokesman has said his agency is “working toward a goal of providing additional guidance” related to marketing CBD for various products and has “made substantial progress.”
The document, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” is pending before the White House’s Office of Management and Budget (OMB).
OMB helps the president meet “his policy, budget, management and regulatory objectives and to fulfill the agency’s statutory responsibilities.”
The office received the document on May 28.
Nathan Arnold, an FDA spokesman, said the agency could not comment on the guidance until it is published.
Speaking to Natural Products Insider via e-mail, Michael McGuffin, president of the American Herbal Products Association (AHPA) said, “That’s what it says it is,” he said in a phone interview. “That’s what we assume it is. Our expectation is that this is guidance related to drug discovery, and since it has ‘quality considerations’ in the title, we assume it will likely focus on CMC/chemistry manufacturing and controls—that’s the term of art—as these quality parameters relate to cannabis drug discovery.”
“Unless FDA has deliberately buried the lead, we think it’s very unlikely that the guidance will have much, if any, direct relevance to foods and dietary supplements that contain cannabis-derived ingredients,” McGuffin added. “Nor do we see issuance of this particular guidance as a necessary step in the process in FDA’s development of a regulatory pathway for hemp and CBD in foods and supplements.”
“We do not see movement by the agency, and we’re very disappointed that we have not seen constructive progress in a year,” Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).
The “FDA has failed to do its job and assert regulatory authority over the existing market,” Steenstra said. “The reality is they’re not protecting consumers from products that are made without following existing dietary supplement regulations.”
