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In the nearly four years since the 2018 Farm Bill legalized hemp with a 0.3% THC limit in the United States, the country’s CBD market has seen its fair share of highs. and down. At this time, the United States Food and Drug Administration (FDA) has not established regulations for the production, marketing and sale of CBD.

This lack of regulation has hampered the industry’s growth trajectory and will continue to do so, say industry members Cannabis timeand data company Brightfield group indicated in a semi-annual report in July.

Kim Stuck is CEO and Founder of Allai Consulting and one of the nation’s first hemp and cannabis regulators who previously worked at Denver’s Department of Public Health and Environment. She notes that the industry is not achieving the same level of growth as with FDA regulation and that the lack of regulation allows companies to sell dangerous products.

“It’s really disconcerting to me that this even happens in a country like the United States,” Stuck says.

Jonathan Miller, General Counsel of the American Hemp Roundtable (USHR), says, like Stuck, that some companies do 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 have a number of companies that are a minority…that don’t use [proper] practical, coming out of their bathtubs or their garages. They use battery acid and other harmful materials.

Miller continues, “Then there are companies selling products that don’t have what they claim to have. They will have a different level of CBD than what is stated on the label. They will have high levels of THC and will make you intoxicated unintentionally. So all of these challenges will 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 said the agency likely needs the US Congress to grant more regulatory authority, according to USHR.

“They’ve had the power to regulate this all along, and they just haven’t put any regulations in place, 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 preliminary results showed no evidence of liver toxicity.

Miller says the lingering safety issues with CBD aren’t about CBD itself, but about the fact that it’s sometimes improperly manufactured and producers are unregulated.

Stuck says, “I hope they do more studies on CBD and toxicity and all that, just so we have more ammunition to say, ‘Yeah, sure.'”

In late July, USHR vice president and Kentucky-based Ecofibre CEO Eric Wang testified before the U.S. House Agriculture Committee subcommittee on biotechnology, l horticulture and research to urge Congress to regulate CBD and other hemp-derived products in the 2023 Farm Bill. Members of the committee and subcommittee were responsive to these requests from Wang and the Commissioner of Agriculture of Kentucky, Ryan Quarles, CCT Previously reported.

Miller outlines bills that would explicitly grant more authority to the FDA if included in the 2023 Farm Bill.”[H.R.] 841 would establish a regulatory pathway for the sale of CBD as a dietary supplement. HR 6134 would establish a regulatory pathway for CBD as a food and beverage additive. On the Senate side, S. 1698 would do both — it would have regulations on hemp and CBD as both a dietary supplement and a food additive,” Miller said.

Because Congress is so polarized, Miller says the U.S. Hemp Roundtable is working to ensure that HR 841, HR 6134, and/or S. 1698 will be included in the 2023 Farm Bill, which must be passed by the Congress.

“What often happens is that you collect your language and try to insert it on a bill that you know has pass,” Miller says. “The Farm Bill, every five years, must pass or you won’t get the food stamp program [Supplemental Nutrition Assistance Program], you don’t get relief for farmers. It would be devastating for all farmers. So it will pass. »


While CBD companies wait for federal regulations, they can work and earn Good Manufacturing Practices (GMP) certification, which Stuck says is “the next best thing after being regulated by the FDA.”

GMP-certified companies must follow processes that ensure they produce safe products, and they are audited by accredited auditors, Stuck says.

“It’s also a huge risk mitigation factor – fewer recalls and disposals are happening – and it prepares you for FDA regulations,” Stuck says. “Obviously, if regulations come out, if they decide on cannabis-specific regulations, there might be adjustments here and there that they might have to make. But for the most part, they will follow the FDA food code. .

“So they won’t be shocked or shut down right away if the FDA shows up. They have enough sinks and floor drains, and their facility is built the way it’s supposed to be, which reduces cross-contamination. They use an appropriate disinfectant. They train their staff. This is all part of the GMP certification. »

And hemp organizations work to ensure that CBD companies meet certain standards. For example, the National Industrial Hemp Council of America launched a verification program this week in partnership with the standards organization ASTM. Companies can also self-regulate through the US Hemp AuthorityMiller points out.

Simple but impactful

Any potential 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 security is food security. And they can take regulations that are already written, apply them to this industry, much like many small health departments have done and have been successful, and then write a very small chapter that talks about testing standards and handling the cannabis plant and what type of disinfectants they can use, … what type of extraction methods they are allowed to use, that sort of thing. I don’t think it would be that difficult. »