New details have been released on the CBD-focused meetings taking place at the White House, on which Cannabis Wire first reported last month. The topic of discussion? The US Food and Drug Administration’s forthcoming guidance on CBD products.
On July 22, the FDA submitted to the White House Office of Management and Budget (OMB) its “Cannabidiol Enforcement Policy; Draft Guidance for Industry; Availability.” This is the last step in a winding, months-long process that began following the passage of the 2018 Farm Bill, which legalized cannabis plants with .3% THC or less, and all non-THC cannabinoids within the cannabis plant. Once the OMB signs off on these guidelines, the published policy will place guardrails around the growing, but mostly unregulated, CBD industry.
(Cannabis Wire has been closely covering the FDA’s deliberations on CBD policy. Read all of our original reporting and analysis here.)
Already, as Cannabis Wire reported, three entities met with White House on CBD: on July 30, the US Hemp Roundtable; on July 31, the National Industrial Hemp Council; on August 3, Ziese Farms, a hemp farm in Washington state.
Now, several new names have appeared on the meeting schedule. Two of those meeting dates have passed: attorney Jessica Wasserman was joined by Steve Bevan, a founder of GenCanna Global and a founding chair of US Hemp Roundtable, who met with the White House as an individual, and by Ron Conyea of Conyea Farms, on August 6; and the American Herbal Products Association, on August 4. Forthcoming meetings have been scheduled with: Tami Wahl, former council of the American Herbal Products Association for Monday, August 11; Vote Hemp for August 13; dietary supplement company Pharmavite LLC for August 14; and Geoff Whaling for August 17.
Whaling joined Canadian cannabis giant Canopy Growth in 2019 to help with their US hemp operations, but left following the ousting of founder and CEO Bruce Linton, who had brought Whaling on board. Now, Whaling has joined Linton’s latest hemp effort in the US, Collective Growth Corp. Whaling is also a longtime hemp advocate, and chair of the National Hemp Association.
“We need to build the trust back with farmers, so that they will take on [this] crop,” Whaling told Cannabis Wire. “I hope that we can ask [federal officials] to recognize that this was probably one of the very first times in the history of our country that states have been allowed, through temporary regulations, research regulations,” to build the hemp industry. “We need to find a compromise to be able to bring everyone together to build this industry.”
Bevan, whose White House meeting has passed, called the meeting a “good interaction.”
“We hope that CBD, and all cannabinoids for that matter, can be quickly included into the US food supply, because it’s our clear understanding that these substances are safe,” Bevan told Cannabis Wire.
AHPA President Michael McGuffin told Cannabis Wire that if the FDA’s current policy of “acting against blatant claims” and “occasional enforcement on post-market analysis of CBD or THC levels” continues, it would be a “disservice to consumers, leave industry without clarity on how to proceed and hurt American hemp farmers.”
“We need to see FDA’s enforcement policy be the same as its enforcement policy for all other herbs, such as chamomile and burdock and echinacea. FDA could then promptly initiate enforcement of very basic regulatory issues, such as food facility registration, current good manufacturing practice rules, proper labeling (nutrition, allergens, etc.), and pre-market safety obligations, among others,” McGuffin added.
On the note of Canopy, more details have been released about those three initial White House meetings, in which Canopy participated. Now we know who from the company was there: Kelly Fair, Canopy’s US director of legal, and David Culver, Canopy’s vice president of US government and stakeholder relations. Also listed as part of Canopy’s team is Liz Breckenridge, though her role with the company is unclear; Cannabis Wire has reached out to Canopy to learn more.
Canopy had appeared as part of the broader National Industrial Hemp Council meeting. Additional new names listed as part of the NIHC meeting include: Rasma Zvaners from the American Bankers Association, Nick Caezza from multistate operator Columbia Care, and Jay Noller from Oregon State University.
The US Hemp Roundtable meeting included the following guests, in addition to Jonathan Miller, general counsel for the Roundtable: from OMB, Julie Wise, Elizabeth Ashley, April Kluever, and Joanne Davenport; from the White House Office of Science and Technology Policy, Mark Bicket joined the call; from the Office of National Drug Control Policy, Christine Kourtides; from the Department of Health and Human Services, Ekaterini Malliou; and from the Food and Drug Administration, Diane Seery and April Alexander. Attorney Ashish Talati, who represents clients in the hemp and CBD industries joined, as well as attorney Rend Al-Mondhiry, who focuses on dietary supplement, food, beverage, and cosmetic companies, and federal regulatory matters.
In a document submitted to the White House, the US Hemp Roundtable noted that the passage of the 2018 Farm Bill, during which members of Congress lent strong support for the production and sale of hemp and hemp products, brought great excitement among farmers, but was followed by confusion and regulatory gray areas that have stifled the industry’s growth.
“Public statements by FDA officials arguing that it is illegal to sell ingestible hemp-derived CBD products have taken their toll on the industry. While the agency has primarily taken action against companies that have made improper disease claims, and while FDA officials have announced that they are investigating a regulatory pathway for CBD products, CBD commerce and investment have been chilled due to the absence of federal regulation, impairing economic opportunity for farmers and small businesses,” the USHRT document reads.
The USHRT document also points out that Atalo Holdings, GenCanna Global, and Elemental Processing have all filed for bankruptcy, due in part to regulatory uncertainties, and that the COVID-19 pandemic has hit many in the hemp industry hard, though some are experiencing a rise in online CBD sales. Another barrier for hemp companies is that major payment processors like Chase and PayPal are reluctant to bring hemp and CBD companies on board, “citing regulatory uncertainty.”
“Some, like Visa, are even levying significant penalties against financial services providers that process hemp and CBD transactions, which has caused merchants’ accounts to be suspended. As a result, farmers and hemp companies are being left without critical financial and merchant services, further compromising their farms and businesses,” the document highlighted.
Further gobbling up available funds is a “disturbing trend in hemp-related litigation across the country,” USHRT noted in their document. “More than a dozen class action lawsuits regarding CBD have been filed, citing FDA’s public statements as grounds for injury. Even more cases have been brought by farmers against processors for non-payment and breaching hemp contracts.”
This story has been updated with comments from AHPA President Michael McGuffin.