An office that serves President Donald Trump is reviewing a draft cannabis guidance document from FDA—possibly signaling progress in the public health agency’s examination of whether and how to regulate the market for CBD in dietary supplements and other products, though some advocacy groups expressed skepticism that the document is related to the latter issues.
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 received the document May 28, approximately one year after FDA held a widely publicized public meeting about products containing cannabis.
It's not clear whether, and to what extent, the document relates to FDA's examination of a regulatory framework for CBD.
Nathan Arnold, an FDA spokesman, said the agency could not comment on the guidance until it is published. OMB, whose job is to help the president meet “his policy, budget, management and regulatory objectives and to fulfill the agency’s statutory responsibilities,” did not respond to a request for comment on the substance of the guidance or its timing for reviewing the document and sending it back to FDA.
Michael McGuffin, president of the American Herbal Products Association (AHPA), a trade group representing the herbal products industry, said his organization assumes the "guidance will be focused only on what it is labeled to address—that is 'quality considerations for clinical research.'"
"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.”
In reviewing the title of the document before OMB, the leader of Vote Hemp, a grassroots nonprofit organization, reached a similar conclusion as McGuffin.
“Obviously, there’s a little bit of guess work involved there,” Eric Steenstra said in a phone interview, but the document is “likely related to drug development—not dietary supplements—based on the title.”
He acknowledged people won’t know for certain the contents of the document until it’s published in the Federal Register.
OMB’s pending review of the guidance comes at a time when two industries that have converged—the hemp and dietary supplement industries—have grown increasingly frustrated with the lack of a national regulatory regime for products containing hemp-derived CBD.
“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), a trade group representing the dietary supplement industry, said in a recent interview.
Despite thousands of CBD products sold in the U.S., "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.”
While not commenting specifically on the draft guidance document, Arnold said his agency recognized “substantial public interest in marketing and accessing CBD for a variety of products.”
“We are working toward a goal of providing additional guidance, and have made substantial progress,” he said in an emailed statement. “There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence. Our first priority needs to be to protect the health and safety of Americans.”
Garrett Graff, managing attorney in Denver with Hoban Law Group, which advises many companies in the hemp industry, said the statement of “substantial progress” by FDA was “somewhat promising insofar as how slow progress has been to date and given the ongoing pandemic.” He said he was anxious to learn further details about the timing of the release of the document pending before OMB, its “substantive content” and other details.
McGuffin of AHPA, which has a committee devoted to cannabis issues established in 2010, addressed FDA's statement that it has made "substantial progress."
“If we’ve got 140 miles to go, it doesn’t matter where they are," he explained. "All that’s going to matter is the day that they say, ‘Here’s the regulatory pathways.’ Maybe, there’s some comfort in that, but does that mean we’ve made substantial progress, and so it will only take us another three years, or we’ve made substantial progress, and you should see proposed regulations sometime in June? Because that’s not stated, maybe we should feel a little good, but it would be naïve to think that we should relax and wait.”
Calls for federal oversight
While Streenstra said it's "great to hear" FDA is making progress following its May 2019 public meeting, he had hoped the agency would be overseeing the market by now.
Many brands are not following GMPs (good manufacturing practices), making their products in facilities registered with FDA or properly testing their products for contaminants, he said.
"And that’s not to say there aren’t a lot of great products on the market," Streenstra added. "There are. But how does a consumer distinguish without FDA doing its job?”
Many prominent marketers of CBD products also have called for FDA to oversee the market. “We want to be regulated,” Joseph Dowling, CEO of CV Sciences Inc. in San Diego, said in a recent interview. “We’re in a group of companies that feel strongly that regulation will actually help the industry establish greater credibility [and] transparency—and both those things will help grow the space.”
Jane Wilson, director of program development for AHPA, said her group "strongly supports the establishment of prompt, rational federal oversight of the CBD market."
"We continue to work with other dietary supplement trade associations and industry partners to advocate for legislative or regulatory proposals that may accelerate the establishment of such a framework," she said in an email. "We also look forward to reviewing the upcoming guidance document issued by FDA, and providing comments as appropriate."
Manufacturers of food and beverages also are eager for FDA to create a regulatory framework. Betsy Booren, Ph.D., senior vice president of regulatory and technical affairs with the Consumer Brands Association, formerly known as the Grocery Manufacturers Association, suggested a federal framework for CBD is crucial.
“Having a clear federal framework for CBD products is really necessary because safety isn’t changed when you cross state lines,” she said in a recent interview. “That has really been the genesis of how we’ve gotten engaged in this, and our members—trusted brands—cannot play in this space until they have that clear federal framework.”
Meanwhile, hemp advocates in Washington, D.C. continue to speak to lawmakers on legislative solutions that would clear the way for CBD to be lawfully marketed in supplements and perhaps conventional food as well. Jonathan Miller, general counsel of the U.S. Hemp Roundtable, a coalition of companies and organizations in the hemp industry, is among those meeting with members of Congress and their staff at a time when the hemp industry, especially farmers, have struggled with financial woes, including a spate of bankruptcies.
“We’re really trying to work with our friends in Congress to force the FDA to act because that really is the lynchpin behind any recovery,” Miller said in a recent interview. “We are cognizant that the FDA has its hands full with COVID right now, but even before COVID struck, the FDA was moving in real baby steps, and we’ve got to get them to act.”
He expressed hope that CBD legislation could be incorporated at some point in a must-pass bill. A standalone CBD bill was introduced early this year by Rep. Collin Peterson (D-Minnesota), but Miller suggested getting such a piece of legislation through Congress would be extremely difficult, especially during the current economic crisis and COVID-19 pandemic.
“While I don’t anticipate the Peterson bill in its current form passing Congress and getting signed by the president, I’m hoping at least parts of it wind up in omnibus legislation,” he said, referring to legislation that packages several measures from diverse topics in a single bill.
Arnold, the FDA spokesman, said his agency “continues to explore potential pathways for various types of CBD products to be lawfully marketed.”
“An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform our consideration of potential regulatory frameworks for CBD, while maintaining the FDA’s rigorous public health standards,” he added. “We remain steadfast in our effort to obtain research, data, and other safety and public health input to inform our approach and to address consumer access in a way that protects public health.”