The FDA recently sent letters with a new emphasis towards companies selling delta-8 THC products with purported benefits. 

Some of the companies sold pet products containing CBD, the announcement highlighted hemp-derived delta-8 products, marketed for human consumption. This marks the first time individual companies have received such a letter warning about delta-8 THC.

Specifically, the FDA says the products are marketed in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), and most of the concern surrounds medical claims on the labeling. Per the announcement, any delta-8 THC product claiming to “diagnose, cure, mitigate, treat, or prevent diseases” is considered an unapproved new drug. 

The FDA sends continual reminders that it has not evaluated whether unapproved delta-8 THC products are effective for medical claims, which involves dosages, interactions, or whether they have potentially dangerous side effects. These products can be found just about everywhere including gas stations and CBD shops.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. 

“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.” 

The FDA recently published a consumer update giving a general warning to consumers about the potential health hazards of delta-8 THC products. 

“Several months ago, they came out with questions regarding delta-8 and made it clear that it was their opinion that ‘buyer beware,’ and that there are many unsafe delta-8 products here in the marketplace that are injuring people,” U.S. Hemp Roundtable’s General Counsel Jonathan Miller told High Times on the phone. “This is now step two in terms of sending out warning letters.” 

The U.S. Hemp Roundtable is a coalition of dozens of leading hemp companies and organizations committed to safer practices. The organization receives questions swirling around the murky topic of delta-8 THC regularly.

Should businesses that deal with delta-8 THC products be concerned? That depends. “I would not be surprised to see actual enforcement actions in the not-so-distant future. We’re seeing a tide of action right now at the state level, and I think that’s going to continue,” Miller said, but added that he expects the delta-8 THC market to continue to thrive in places such as adult-use markets. 

“The general consensus—maybe not from everybody—is that D8 products that use good manufacturing practices in adult-use marketplaces have a future,” Miller added. “I don’t think anyone’s talking about a ban of delta-8 products in the sense that delta-9 is banned, but I think those folks who are selling poorly manufactured products at gas stations without any controls should be forewarned that public policy is moving strongly against them.”

This applies to questionable psychoactive products that are sold in stores that are generally not authorized to do so. “Stop making medical claims, use good manufacturing practices and sell them in adult-use marketplaces,” he said.

Regarding hemp products, the FDA went on to remind that Epidiolex alone has been fully approved at all levels for medical claims. Even Charlotte’s Web full-spectrum CBD extract was denied FDA approval as a dietary extract. 

The FDA issued individual warning letters to the following companies:

ATLRx Inc.
BioMD Plus LLC
Delta 8 Hemp
Kingdom Harvest LLC
M Six Labs Inc.

Businesses involved with delta-8 THC products should take note about the pattern the FDA is taking.

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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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