In the last two weeks, two powerhouse companies met with the White House to talk about the future of cannabidiol, or, CBD: GW Pharmaceuticals and General Nutrition Centers (GNC).
Aside from a desire for better regulation in the world of CBD, these two companies—one, the first to obtain FDA approval for a pharmaceutical product extracted from cannabis, and the other, aiming to sell CBD alongside other common supplements—have little in common.
More than a dozen companies have met with the White House in recent weeks to discuss the US Food and Drug Administration’s forthcoming enforcement policy on CBD products. The long-awaited industry guidance was sent to the White House Office of Management and Budget for approval in July, a final step before publication. (Catch up on Cannabis Wire’s coverage of previous meetings.)
This is the final stage in a months-long waiting game 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. The legislation also tasked the FDA with determining whether and how certain CBD products will be allowed—for humans and animals, for food and cosmetics, and just about everything in between. Once the OMB signs off, the published policy will provide the first glimpse into how these already-mainstream products will be regulated from coast-to-coast.
UK-based GW Pharmaceuticals, through its US subsidiary Greenwich Biosciences, has an extensive lobbying footprint in the United States. As Cannabis Wire first reported, Greenwich Biosciences is lobbying in all 50 states and at the federal level.
Lobbying firm Marshall & Popp and law firm Covington & Burling represented GW at the OMB meeting, as did: Mark Bolton, senior director of US public policy for Greenwich Biosciences and senior legal council at GW Pharmaceuticals; Douglas Snyder, GW’s chief legal officer; and Deborah Walter, senior director for US federal policy and advocacy for Greenwich Biosciences.
“GW Pharmaceuticals recently met with OMB to reiterate that scientific evidence must form the basis of cannabinoid medications developed for serious illnesses and should similarly determine which cannabinoid products are safe in consumer goods,” Stephen Schultz, vice president of investor relations for GW Pharmaceuticals, told Cannabis Wire.
“We support a comprehensive regulatory framework that encourages more research and development of FDA-approved, cannabis-derived medicines; provides adequate safety protections for consumers ingesting foods and dietary supplements; and distinguishes FDA-approved medicines from consumer-focused products. This approach will ensure that patients have access to medicines that are proven safe and effective for specific medical conditions,” Schultz added.
Lobbying firm Parry, Romani, DeConcini & Symms also met with the White House, representing GNC, the CBD Industry Association, and Plexus International. Romano Romani, president of the firm, told Cannabis Wire that because the meeting was on the topic of proposed guidance that they’ve never seen, “you’re really talking more in generalities about what you’d like to see happen.”
Romani said that the entities that he represents want to see “the FDA to withdraw its position that that CBD violates the exclusionary clause.”
The FDA has long reiterated that, under the Federal Food, Drug, and Cosmetic Act, “if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved … or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.” The same, generally, applies to adding CBD to foods.
This is the crux of the problem for Romani’s clients, including GNC, Romani told Cannabis Wire, calling the exclusionary clause “unnecessary.” He feels that it is “designed, in this case, to protect GW Pharmaceuticals, to protect their product Epidiolex from competition from supplement makers,” he said.
He added that while the FDA has “made CBD as a supplement, and as a food, illegal, they have not tried to enforce that illegality because, you know, there are hundreds, if not thousands of CBD products on the market.”
Romani said he met with the FDA several weeks ago in a similar capacity as the White House OMB meeting. Essentially, these are listening sessions, he said, where officials take in the information, but don’t interact much.
“It’s a kind of crazy situation where GNC and a lot of other major companies would like to get into this market. But they don’t want to sell an illegal product. They want a regulated product. And that’s what we were pitching primarily, is that the FDA needs to get back in there and regulate this marketplace,” Romani told Cannabis Wire.