What’s next for CBD products, for both humans and animals, and the future of cannabis policy?
These questions were in focus at the Food and Drug Law Institute’s two-day conference last week titled “Legal and Practical Issues in Cannabis Regulation.”
Speakers included: Norman Birenbaum, senior public health advisor for the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research; Gillian Schauer, executive director of the Cannabis Regulators Association; Damian Fagon, chief equity officer for the New York State Office of Cannabis Management; Bill Bookout, founder and board chair of the National Animal Supplement Council; and Charlotte Conway, deputy division director for Division of Animal Food Ingredients at the FDA’s Center for Veterinary Medicine (CVM).
Birenbaum gave the keynote speech and also spoke on another panel. The backdrop for his remarks was President Joe Biden’s announcement in October that he would direct the Secretary of Health and Human Services and the Attorney General to conduct a review of how the federal government classifies cannabis. Birenbaum fielded questions on this topic, but didn’t give any new updates to a potential timeline related to the review.
“We understand this is a priority. There’s not much more that we can say about the timing of the work that will need to be done,” Birenbaum said.
He also answered questions about the FDA’s announcement in January that it would not craft regulations to guide the booming CBD industry in the U.S., but would instead turn to Congress.
“What could be part of a new way forward and a new pathway? Ultimately, this will be up to Congress,” Birenbaum said, adding that regulations are likely to include efforts to ensure consistent and contamination-free products with clear labels, and to prevent accidental youth ingestion.
“There is a great opportunity before us right now,” Birenbaum said. “Unlike what we see with the state adult use and medical programs, the hemp industry is not all that entrenched. It’s still relatively new. That’s not to say that they’re not digging in their heels and becoming more entrenched, in terms of various products and practices and distribution patterns. But now is an opportunity to course correct.”
Animals
A new regulatory pathway could also include CBD products meant for animals, too, Birenbaum said.
Some context: the FDA Center for Veterinary Medicine published an opinion in the Federal Register in 1996 that laid out that Congress didn’t intend for the Dietary Supplement Health Education Act to extend to animals. So, most products marketed as supplements for animals that aren’t part of the human food chain are done so as unapproved drugs, as long as companies don’t make false claims and follow good manufacturing practices. Some state agencies like in Texas and Kentucky also regulate these products, said Bookout, the founder and board chair of the National Animal Supplement Council.
Bookout said that the industry for supplements for cats and dogs is roughly a $2.4 billion industry, which is fairly “recession-proof,” he said.
“The animal industry is a fast-follow industry almost without exception. Whatever happens on the human side, you will see products and companies start to show up on the animal side,” Bookout said.
There’s a firm distinction between hemp that could be for companion animals and those for animals that could be food. Currently, CBD is an unapproved ingredient for use in any animal food, Bookout said, and the FDA has been “very consistent in that position.”
“I don’t know of a single circumstance where CBD would be acceptable or allowed for a food chain animal and, in my opinion, I don’t think it ever will be,” Bookout said. “And the reason that I say that,” he continued, is “I have not seen any studies that would substantiate CBD as being acceptable in animal food.”
Conway, deputy division director for Division of Animal Food Ingredients at the FDA’s Center for Veterinary Medicine (CVM), is also the animal products lead on the agency’s Cannabis Products Committee.
“I think it’s clear that we don’t have the resources to take every product on the market out of distribution. But we have tried to share the potential risks associated with using these products,” Conway said.
The biggest questions looming over the space, Conway said, are: what kind of impacts do cannabinoid ingredients have on human food safety? Are the meat, milk and eggs produced from these animals safe? And what level of exposure to cannabinoids does or doesn’t develop residues?
“We do know that CBD and other cannabinoids can form residues in the edible tissues like meat, milk and eggs,” Conway said. “But because these products aren’t approved, what we don’t know is what these results bring to the American consumer. And so with these unknowns, we’re especially concerned about the CBD products for food producing species.”
Conway added that one of the “roadblocks” has been a lack of “adequate analytical methods” for these cannabinoids in the complex contexts of meat, milk, eggs and other tissues.
“Luckily, we are seeing work done in this space and so hopefully we will have some questions answered soon,” she said.
Conway said that the FDA sees “great potential” for hemp seed ingredients to be used like other oilseed ingredients, as long as they’ve been processed correctly.
“One thing to keep in mind for animal foods is that because animal feed animals are typically fed the same ingredient every day for the majority of their lives, we need to look at safety maybe a little bit differently,” Conway said.
Equity
Fagon, the chief equity officer for New York’s Office of Cannabis Management, highlighted the ways in which New York has strived for an equitable launch of its adult use industry.
Fagon said that he and his team have crunched data to start to “identify those communities that were most targeted with police activity around marijuana arrests” before lawmakers passed the Marihuana Taxation and Regulation Act in 2021.
When those communities are fully identified, people who lived and currently reside in those neighborhoods will be prioritized for licensure and other technical assistance programs.
“A big thing that we’re focused on is not committing to one path when it comes to social equity. If something’s not achieving the results we want it to, we will pivot. We will iterate different versions of our social equity programing to achieve different outcomes,” Fagon said.
Christina Sava, a lawyer with Troutman Pepper Hamilton Sanders LLP, covered litigation related to equity programs, many of which target residency requirements and allege violation of the Dormant Commerce Clause of the Constitution. These types of cases have cropped up in California, Washington, Ohio, Missouri, Michigan, New York, and Maine, Sava said.
Most of the federal district courts that have taken up this specific issue have held that the Dormant Commerce Clause applies to the cannabis industry, ultimately determining that residency rules are in violation, Sava said.
“This is a big deal because it means your local industry is now open to players from out of state,” Sava said.
