A new comprehensive study of more than 1,000 people has confirmed the safety of orally-ingested cannabidiol products and provides data that addresses the U.S. Food and Drug Administration’s concerns about the safety of CBD. The two-part study found that daily consumption of CBD across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels, or daytime drowsiness.

To conduct the study, the research firm Validcare contracted with 17 CBD companies to study safety concerns previously expressed by the FDA. Validcare acted as the contract research organization, which included obtaining feedback from the FDA on the research protocol, conducting the study and publishing the results.

“The data in this study looks really good; it’s highly significant, and the chances of it being wrong are very, very small,” Dr. Robert Kaufmann, director of research for Validcare and a former professor at Southern Illinois University School of Medicine, said in a statement from the U.S. Hemp Roundtable. “I am very hopeful that this data will allow the FDA to regulate these popular CBD products.”

The first cohort of the study, which was peer-reviewed and published in Cannabis and Cannabinoid Medicine last year, studied how CBD products from 12 different manufacturers affected the liver function of 839 study participants. The second cohort included 222 additional individuals taking CBD products produced by five additional companies. The participation of the additional study subjects strengthened the statistical reliability of both the liver safety results and achieved statistical relevance for both sleep and testosterone results, according to the researchers.

The participants in the research were all adults aged 18 to 75 who had been taking oral CBD products for at least 30 days. Participants were recruited by the 17 CBD companies involved in the research for the decentralized observational study. The companies provided participants with their standard CBD regimen during the study period. All product companies supplied a third-party certificate of analysis (COA), which was confirmed by a neutral third party to ensure the composition of the supplied product matched both the label and the supplied COA.

FDA Still Has Not Regulated CBD

After hemp was legalized with the signing of the 2018 Farm Bill, the FDA recognized the “clear interest of Congress in fostering the development of appropriate hemp products” and noted that the agency “has the authority to issue a regulation,” which would allow for the legal marketing of CBD as a dietary supplement. The FDA said it would work to further clarify a regulatory approach for CBD products, “using science as our guide and upholding our rigorous public health standards.” However, the agency has not taken any substantial steps to regulate CBD, claiming that it needs more real-world data to move forward.

In March 2020, the FDA released a congressional report and public statement on potential regulatory pathways for the sale of hemp-derived CBD products, listing liver injury as the top concern for consumer safety, along with “male reproductive toxicity, or damage to fertility in males or male offspring of women.”

“We are excited to report that the ‘real-world data’ that FDA has been soliciting addresses the agency’s safety concerns,” stated Jonathan Miller, general counsel to the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization. “The time has come for FDA to regulate CBD and other hemp derivatives.”

The results of the study have renewed calls from CBD producers and the hemp industry for the FDA to expedite the regulation of CBD products.

“Participating in this study has allowed us to help provide regulators, scientists, product formulators, and other stakeholders with the evidence needed to prove the safety profile of CBD,” said Blake Schroeder, CEO of Medical Marijuana Inc. and its subsidiary, Kannaway, one of the companies that participated in the research. “We hope that this, in addition to our other research efforts in Brazil and Mexico, will not only help break the stigma around CBD but that it will also help legislators understand the importance of free, legal access to the entire cannabis plant.”

If the FDA still does not act to regulate CBD products, the U.S. Hemp Roundtable is calling on Congress to pass relevant legislation. There are currently three pending bills, H.R. 841, H.R. 6134 and S. 1698, that would require the FDA to develop regulatory pathways for the sale of hemp extracts such as CBD in ingestible form.

“We are proud to have participated in this ground-breaking study on CBD products and feel verified in our products’ excellent results in the testing. These results bode very well for supporting the hemp industry against the fears that FDA had previously stated which had been a hurdle in their regulatory process,” said Vince Sanders, the owner CBD American Shaman. “We are excited they can now rely on this study in verifying CBD products as safe for the human liver, have no effects of day-time drowsiness, and no negative effect on low testosterone levels or reproductive harm of male participants or the male offspring of women in the study.”

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Hemp production was legalized at the federal level under the 2018 Farm Bill—but endless red tape and regulatory demands make it next to impossible to thrive in the industry. Growers and processors say the THC thresholds in particular make the industry unbearable.

But fortunately, a potential legislative fix to some of those problems is underway. In particular, the bill would raise the THC limit to a reasonable one percent during cultivation and processing, saving some farms from ruin over hot crops and other hiccups.

On February 8, Congresswoman Chellie Pingree (D-Maine) introduced the Hemp Advancement Act of 2022 with the goal to improve the 2018 Farm Bill’s hemp provisions and provide greater clarity and flexibility to hemp growers and processors. 

“The 2018 Farm Bill laid a legal pathway for hemp production but created overly complicated regulations and hardship for farmers and small businesses in the process. I am introducing The Hemp Advancement Act of 2022 to eliminate unworkable testing requirements, set reasonable THC thresholds for producers and processors while protecting consumers, and end the discriminatory policy that bans people with drug convictions from growing legal hemp,” said Congresswoman Pingree. 

She continued, “My bill takes a commonsense, straightforward approach to correct these unintended implementation problems and works to make the hemp industry more profitable and more equitable. My bill also provides a clear path forward for this industry and will support a thriving hemp economy.”

Congresswoman Pingree highlighted three fixes to the 2018 Farm Bill that The Hemp Advancement Act of 2022 would implement:

• Raise the allowable THC threshold for hemp and in-process hemp extract to make the rules more workable for growers and processors while ensuring that final hemp products sold to consumers aren’t intoxicating.
• Remove the requirement that hemp testing occur in DEA-registered laboratories, which is a particular challenge in Maine where there currently aren’t any of these facilities.
• End the 10-year ban on people with drug-related felony convictions receiving a hemp license, which disproportionately excludes communities of color from participating in this emerging market.

Congresswoman Pingree’s Hemp Advancement Act of 2022 is officially supported by about a dozen hemp organizations including The U.S. Hemp Roundtable—proudly representing the industry’s major national hemp grassroots organizations.

“The 2018 Farm Bill, while well-intended, left some challenges,” Jonathan Miller, General Counsel of the U.S. Hemp Roundtable told High Times on the phone. “The USDA has done a terrific job of responding to farmer concerns, but there are certain issues that have to be changed in the law to reduce the burdens on U.S. farmers—the first is the THC level.” 

Unlike other industries, hemp growers face much higher fiscal risks because of these particular regulations.

“What’s happening is that we are constantly hearing that farmers—through no fault of their own, largely due to the weather or the soil or seed quality—will grow a field of hemp,” Miller said. “And it will be tested to be slightly above the point of 0.3 percent THC level, and they’ll have to burn their entire field or major parts of their field—losing all of the dollars that went into those crops. So we believe that if we can raise it to a level of 1.0, it will provide a lot more flexibility, and at the same time, what Congress was intending by that 0.3 [THC limit], was that people would not consume intoxicating hemp products. So while the testing in the field is 1.0, the testing in the final product has to still remain under 0.3 percent THC so that the intoxicating products are limited to adult-use markets and not sold as hemp at gas stations and vape stores.”

The 10-year ban on felons is particularly frustrating, given that hemp by definition is the non-drug form of cannabis. “It was something that got inserted at the last minute—over our strong objections […],”  Miller said.”

“Hemp is a legal crop, and if you’ve done your time for an offense, you should be able to grow a legal crop,” Miller said. “There are no prohibitions on ex-felons for growing corn or soybeans or you name it.”

In Congresswoman Pingree’s home state of Maine, hemp production is at a standstill because it can’t be tested or due to other regulatory setbacks. While over 2,000 acres of hemp were planted in Maine in 2019, only 111 farmers received licenses to grow hemp in 2020, accounting for just 211 acres. 

Hemp—which is grown in every Maine county—is highly useful as a textile, food or fuel. 

Congresswoman Pingree reaffirmed her support for the nation’s hemp farmers and hemp-derived CBD businesses—that face burdens unique to the industry. 

Earlier this year, Pingree joined her colleagues in reintroducing the bipartisan Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, with a goal to provide a regulatory pathway for the legal sale of hemp-derived cannabidiol (CBD) as dietary supplements. 

Congresswoman Pingree also led a bipartisan effort in 2019 to push the Food and Drug Administration to establish a regulatory pathway for food products containing hemp-derived CBD. She also voted to pass the Marijuana Opportunity Reinvestment and Expungement Act of 2021 (MORE) Act in December 2020, which would decriminalize cannabis and end prohibition at the federal level.

This bill is supported by the following:

• U.S. Hemp Roundtable
• American Herbal Products Association
• Americans for Safe Access
• Association of Western Hemp Professionals
• Friends of Hemp
• Hemp Alliance of Tennessee
• Hemp Industries Association
• iHemp Michigan
• Realm of Caring Foundation, Inc.
• U.S. Hemp Authority
• U.S. Hemp Building Association
• Veterinary Cannabis Society
• Virginia Hemp Coalition
• Wisconsin Hemp Alliance

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