In the nearly four years since the 2018 Farm Bill legalized hemp with a 0.3% THC limit in the U.S., the country’s CBD market has seen its fair share of ups and downs. In that time, the U.S. Food and Drug Administration (FDA) has not set forth regulations for the production, marketing and sale of CBD.
That lack of regulation has hindered the growth trajectory of the industry and will continue to do so, industry members tell Cannabis Business Times, and data firm Brightfield Group stated in a July mid-year report.
Kim Stuck is CEO and founder of Allay Consulting and one of the country’s first hemp and cannabis regulators who previously worked at the Denver Department of Public Health & Environment. She notes the industry isn’t achieving the same level of growth it would with FDA regulation, and that the lack of regulations allows companies to sell unsafe products.
“It’s really baffling to me that this would even happen in a country like the United States,” Stuck says.
Jonathan Miller, general counsel for the U.S. Hemp Roundtable (USHR), says, like Stuck, that there are companies doing their best to ensure they provide safe products with accurate labeling and dosing, but he notes the same issues.
Regarding product safety, Miller says: “You do have a number of companies that are a minority ... that don't use [proper] practices, that make it out of their bathtubs or their garages. They use battery acid and other harmful materials.”
Miller continues: “Then there are companies that sell products that don’t have what they say they have. They’ll have a different level of CBD than is on the label. They’ll have high levels of THC and will get you intoxicated unintentionally. So, all of these challenges are going to continue to exist until we have regulation.”
Next Steps?
Both Stuck and Miller say the FDA can regulate CBD now, but FDA Commissioner Robert Califf has stated that the agency likely needs the U.S. Congress to grant more regulatory authority, according to USHR.
“They've had the power to regulate this from the beginning, and they just haven't put together regulations, or at least decided where to put CBD,” Stuck says. “They keep saying, ‘We don't know if it’s safe. We don't know if it's safe.’ And I'm like, ‘Well, then, why are you even allowing it to be sold then?’”
The FDA commissioned a study by Validcare in which the preliminary results showed no evidence of liver toxicity.
Miller says ongoing safety issues with CBD are not with CBD itself but how it’s sometimes poorly manufactured and that producers are not regulated.
Stuck says, “I hope that they do more studies about CBD and toxicity and all of that, just so that we have more ammunition to say, ‘Yeah, this is safe.’”
In late July, USHR Vice President and CEO of Kentucky-based Ecofibre Eric Wang testified before the U.S. House Agriculture Committee Subcommittee on Biotechnology, Horticulture, and Research to urge Congress to regulate CBD and other hemp-derived products in the 2023 Farm Bill. Committee and subcommittee members were receptive to these requests from Wang and Kentucky Agriculture Commissioner Ryan Quarles, CBT previously reported.
Miller outlines the bills that would explicitly grant the FDA more authority if included in the 2023 Farm Bill. “[H.R.] 841 would establish a regulatory pathway for the sale of CBD as a dietary supplement. H.R. 6134 would establish a regulatory pathway for CBD as a food and beverage additive. Over on the Senate side, S. 1698 would do both—it would have regulations of hemp and CBD both as a dietary supplement and a food additive," Miller says.
Because Congress is highly polarized, Miller says the U.S. Hemp Roundtable strives to make sure H.R. 841, H.R. 6134 and/or S. 1698 will be included in the 2023 Farm Bill, which has to pass Congress.
“What often happens is that you get your language together and you try to insert it on a bill that you know has to pass,” Miller says. “The Farm Bill, every five years, has to pass or you don't get the food stamp program [Supplemental Nutrition Assistance Program], you don't get relief for farmers. It would be devastating to all farmers. So, it’s going to pass.”
In the Meantime…
While CBD companies await federal regulations, they can work toward and achieve Good Manufacturing Practices (GMP) Certification, which Stuck says is “the next-best thing to being regulated by the FDA.”
Companies that are GMP Certified must follow processes that ensure they produce safe products, and they undergo audits by accredited auditors, Stuck says.
“It’s also a huge risk mitigator—less recalls and disposals take place—and it’s preparing you for FDA regulation,” Stuck says. “Obviously, if regulations come out, if they decide on cannabis-specific regulations, there might be tweaks here and there that they might have to make. But for the most part, they will be following FDA Food Code.
“So, they’re not going to be shocked or shut down right away if the FDA shows up. They have enough hand sinks and floor drains, and their facility's built the way it's supposed to be built that reduces cross-contamination. They're using proper sanitizer. They’re training their staff. All of that stuff is part of GMP Certification.”
And hemp organizations are striving to ensure that CBD companies to follow certain standards. For instance, the National Industrial Hemp Council of America this week launched a verification program in partnership with standards organization ASTM. Companies can also undergo self-regulation via the U.S. Hemp Authority, Miller points out.
Simple But Impactful
All eventual federal regulatory actions for cannabinoids will be based on how the FDA handles CBD regulations, Stuck says.
“But for the most part, they don't need to reinvent the wheel here.” Stuck says. “Food safety is food safety. And they can take already-written regulations, apply them to this industry, much like many smaller health departments have done and been successful with, and then write a very small chapter that talks about the testing standards and handling of the cannabis plant and what kind of sanitizers they can use, … what kind of extraction methods they're allowed to use, that kind of stuff. I don't think it would be that difficult.”
Patrick Williams
Posted by Patrick Williams
