Bipartisan Lawmakers Slam ‘Completely Insufficient’ FDA Response To Hemp Bill Request And Lack Of CBD Regulations

Bipartisan congressional lawmakers recently sent a pointed letter to the head of the Food and Drug Administration (FDA), complaining about the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.

After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said late last month in a letter that was released on Wednesday.

FDA’s response “does not address provisions of our bill drafted specifically to address product safety, and is a completely insufficient response at this moment when cannabidiol (CBD) products are proliferating around the country,” Reps. Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-MN) and Dan Crenshaw (R-TX) wrote.

Despite being given regulatory authority over hemp and its derivatives under the 2018 Farm Bill, “FDA has refused to act on that authority, allowing a marketplace where dangerous products, like those containing delta-8 THC, are often indistinguishable from products that meet strict standards for quality, dosage, packaging, and sale established by state regulators who have stepped in to fill the regulatory void.”

The lawmakers are asking FDA to go back to the drawing board and provide revised technical assistance that more specifically addresses these concerns and directly speaks to the relevant provisions of their bill.

Because FDA has so far declined to take action to allow the marketing of hemp derivatives in food and beverages, states have increasingly stepped in to fill the regulatory gap, with about two dozen having enacted rules for the cannabinoids that are widely available in markets across the country.

“These state regulations are a direct result of FDA’s inaction, lack of clarity, and refusal to engage meaningfully on this issue,” the August 24 letter to FDA Commissioner Robert Califf says. “However, we believe that FDA can and should reverse course and learn from these state governments—working with them to determine how a federal framework could be designed to eliminate the unsustainable and inefficient patchwork of state regulations.”

The @HempRoundtable applauds @RepKathleenRice@RepAngieCraig@RepMGriffith & @RepDanCrenshaw for a clear, comprehensive critique of the @US_FDA's TA on H.R. 6134! We hope it prompts the @US_FDA to act on the establishment of a regulatory framework for #hemp-derived #CBD products. https://t.co/fOTttIwn0t

— US Hemp Roundtable (@HempRoundtable) September 15, 2022

At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.

He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”

“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”

But as more months have gone by without an update, the bipartisan lawmakers have grown increasingly frustrated—and they demanded answers from FDA within 30 days of receiving the letter, which would put the deadline at the end of next week. They said, at a minimum, the agency should be providing enforcement guidelines for the hemp cannabinoid market.

The lawmakers said that they “worked hard to craft a bill that would provide the agency with tailored authorities to address the concerns FDA has raised in order to establish a workable, responsible framework for the regulation of hemp-derived CBD in conventional food products.”

Under their bill, FDA would be required to develop rules and hold a public comment period on the maximum amount of hemp-derived CBD that could be added to a food item or beverage per serving, labeling and packaging requirements and the “conditions of intended use,” according to the text of the legislation.

—Marijuana Moment is tracking more than 1,500 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.—

“We were genuinely hopeful that, even if some in the agency disagreed with the particulars, you, as Commissioner, would have viewed our legislation as an opportunity to jumpstart a productive dialogue and make up for lost time,” the sponsors wrote.

Here’s what the lawmakers asked FDA to produce by next week:

1. A new [technical assistance, or TA] document that addresses the actual text and construct of our bill.

2. A redline to our legislative language, or new legislative language, that establishes a pathway for CBD to be legally marketed in food products and provides the appropriate safety considerations.

3. A public charge to the Reagan Udall Foundation that, as part of the internal review of CFSAN they are conducting per your request, TA processes (including clearance processes) be assessed as part of the report, using CBD as an example.

4. An update on any ongoing work at the agency to develop an enforcement discretion policy articulating specific circumstances in which the agency will prioritize enforcement actions against CBD products. If no work is ongoing, please provide an explanation for why not.

5. Answers to the following questions:

a. What are the specific discrete scientific questions FDA is seeking answers to before issuing regulations to permit CBD in food and other products?

i. What actions has FDA taken to present these questions to the scientific community?

ii. What other actions has FDA taken to obtain answers to these questions?

iii. Does FDA have answers to these questions for every other food ingredient and dietary supplement ingredient on the market? If not, please explain the difference in standards.

b. Has FDA spoken with any state and international regulators to learn about the information and policy considerations used to set regulations for CBD-containing food products in these jurisdictions? If so, please provide the participants and dates of these meetings and the agendas. If not, please provide the rationale for not doing so.

Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. U.S. Hemp Roundtable, which posted the letter, launched an online portal for supporters to send messages to their representatives about the need to enact the bipartisan CBD bill.

With respect to the lawmakers’ request that FDA provide, “at a minimum,” enforcement guidelines for the marketplace, the agency has taken some modest actions against certain CBD companies in recent years.

In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unsanctioned claims about the medical benefits of CBD products they’ve marketed for animals.

FDA also recently warned consumers about marijuana-infused copycat food products that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.

The agency separately issued its first set of warnings to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.

It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.

In May, a top Republican on a key congressional committee also called on leadership to schedule a hearing to hold FDA accountable for its lack of action to set regulations for CBD and delta-8 THC products.

Read the letter to FDA about CBD regulations below: 

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Minnesota Governor Tours Hemp Facility After New THC Edibles Law Takes Effect

“When you see a processing facility [breaking] ground for more expansion, this sends a signal to the market that Minnesota is ready to lead on this.”

By Baylor Spears, Minnesota Reformer

As a high school teacher and football coach not that long ago, Gov. Tim Walz (D) was no doubt on the lookout for students under the sway of mind-altering substances.

As governor in the middle of a reelection campaign, Walz on Monday found himself at Hemp Acres, now one of the largest cannabis processing facilities in the nation after opening their third operation, a 37,000-square-foot facility 35 miles west of Minneapolis.

Walz and local and company officials celebrated the opening of the new plant on Monday, offering it up as a shining example of agricultural innovation and diversification.

“When you see a processing facility [breaking] ground for more expansion, this sends a signal to the market that Minnesota is ready to lead on this,” said Walz, whose likely GOP opponent Scott Jensen once flirted with cannabis legalization as a state senator before backing off.

Walz said he hopes more Minnesota producers enter the industry and begin growing hemp.

I visited Hemp Acres in Waconia today to hear about their booming business. Agriculture is a pillar of Minnesota's economy and our rapidly growing hemp industry will add to the foundation of our farming tradition while also expanding our economy. pic.twitter.com/ytBZtAGhyQ

— Governor Tim Walz (@GovTimWalz) July 19, 2022

Hemp Acres buys raw hemp from local farmers across Minnesota and the Midwest and processes it into a bevy of ingredients like Cannabidiol, or CBD, hemp seed oil, fiber and protein powder. These are then supplied to companies in industries like food manufacturing, construction and supplements.

Hemp Acres is trying to restore what was once a thriving industry before a moral panic over marijuana led to the plant’s prohibition. As the company’s website says, “The Midwest was once known as the hemp belt of America, and during the brief re-legalization of hemp in the 1940’s to help support the war efforts, one of the largest hemp processing mills in the world of its time was located just one hour west of the Hemp Acres facility.”

Company founder Charlie Levine, the state’s first licensed hemp processor, said the company wants to use the entire plant to exploit its many practical applications. “We specialize in processing every aspect of the hemp plant all the way from the grain to the stock.”

And the green rush is just starting, following a new Minnesota law in effect July 1 legalizing hemp-derived THC—the stuff that gets people high—in 5-mg increments of edibles and drinks.

Margaret Wiatrowski, Hemp Acre’s general manager, said the law caused an explosive increase in demand, as more people are looking for hemp-derived THC products. She said the company is looking to help meet that demand.

“It’s caught everyone unaware, but we are probably in the best position to be able to make those products and make them safe,” Wiatrowski said. “But it’s going to take time.”

.@GovTimWalz, joined by MDA’s hemp team, helped cut the ribbon on Hemp Acres new processing facility in Waconia. The facility will be able to process all parts of the hemp plant & up to 50,000 acres in several years, giving MN farmers better opportunities for the #hemp market. pic.twitter.com/1MFewYm7sB

— MN Agriculture Dept (@MNagriculture) July 18, 2022

Hemp Acres started small, as an early participant in the state’s industrial hemp program, which was created after a 2014 federal farm bill that allowed state agriculture departments to begin cultivating hemp for research purposes. The law was liberalized further in the 2018 farm bill.

The facility expansion is launching a new phase for the company. Over the next five years, Levine said the goal is to process 30,000 to 50,000 acres of hemp across the Midwest.

Despite the sunny outlook, however, the number of licensed hemp growers has actually fallen in recent years. In 2020, Minnesota reached a high of 461 licensed growers, falling to 348 in 2021. Anthony Cortilet, supervisor of the state Department of Agriculture’s industrial hemp program, said there are 300 hemp licenses and 2,000 acres in production this year. He said the department wants to get the state up to 7,000-10,000 acres planted.

This story was first published by Minnesota Reformer.

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GOP Congressman Requests Hearing On FDA’s Failure To Set CBD And Delta-8 THC Regulations

The top Republican on a key congressional committee is calling on leadership to schedule a hearing to hold the Food and Drug Administration (FDA) accountable for its lack of action to set regulations for CBD and delta-8 THC products.

Rep. James Comer (R-KY), ranking member of the House Oversight and Reform Committee, said in a letter to Chairwoman Carolyn Maloney (D-NY) that purpose of the meeting should be to “examine the failure of [FDA] to develop a regulatory regime that effectively oversees the sale of hemp-derived extracts such as cannabidiol (CBD).”

He said that the current lack of regulations has led to mislabeling, contaminated products and advertising that targets children.

“We must hear directly from the FDA to ensure the agency has a plan to institute a regulatory solution that can effectively monitor the sale of hemp products and protect the health of children,” he wrote.

The federal legalization of hemp under the 2018 Farm Bill was a bipartisan effort, and members across the aisle have since been pushing for further reforms to create a regulatory framework for products that are derived from the crop. FDA is cognizant of the complaints, but it’s so far declined to enact rules providing for the marketing of legal cannabinoids in food products.

“The FDA’s failure to establish a regulatory regime for hemp is enabling mislabeled products that contain more THC than the legal limit to be sold,” Comer said, referencing the 0.3 percent THC limit per dry weight for legal hemp items. “Unfortunately, mislabeled products have caused many adverse health events in children.”

While the GOP congressman seems to be supporting regulations that would correct issues on mislabeling and contamination of CBD products, he also brought up the fact that companies are increasingly marketing items containing delta-8 THC, an intoxicating cannabinoid commonly synthesized using CBD that falls into an especially grey legal area because it’s not expressly prohibited under federal law.

Longtime #hemp champion + Ranking Member of the House Committee on Oversight & Reform @JamesComer is calling for a hearing in his committee to examine @US_FDA's failure to develop a regulatory regime overseeing sales of hemp-derived extracts such as #CBD👉https://t.co/rc35At87Jhpic.twitter.com/JF8KU0qaMU

— US Hemp Roundtable (@HempRoundtable) May 4, 2022

“It is troubling that the product contains intoxicating chemicals, giving users the ‘high’ feeling of federally illegal marijuana,” he wrote in the letter, which was highlighted by the U.S. Hemp Roundtable on Wednesday. “The production and sale of Delta-8 THC undermines the congressional intent of the 2018 Farm Bill. The bill was intended to legalize non-intoxicating hemp products, not a synthetic alternative to marijuana.”

“The newly confirmed FDA commissioner, Robert Califf, has not publicly expressed an official position on this critical issue. We respectively request that the Committee hold a hearing in order for the FDA to explain how it plans to resolve the serious issue of mislabeled CBD products. By doing so, we will empower good-faithed hemp farmers and protect American consumers—especially children—from intoxicating cannabis.”

To be sure, Califf, who previously served a short stint as the FDA head under the Obama administration, hasn’t been especially vocal about marijuana issues. But at a 2016 federally hosted research summit on cannabis, he recognized various therapeutic applications for the plant and its components and emphasized that the agency is interested in promoting research and development.

He also said that he’s personally prescribed a cannabinoid drug as a doctor.

For his part, Comer has been a key ally for the hemp industry, touting his state’s burgeoning industry and even bringing CBD products to a congressional hearing in 2019.

But while FDA has taken steps to issue warningsagainst select CBD and delta-8 THC companies that are peddling products with allegedly misleading medical claims, the agency has yet to implement specific marketing regulations for the cannabinoids.

For what it’s worth with respect to delta-8 THC, the Drug Enforcement Administration (DEA) has conceded that the cannabis component is generally unregulated because current statute only bans cannabis products with more than 0.3 percent delta-9 THC by dry weight.

FDA, meanwhile, had repeatedly said it is exploring regulatory pathways to allow for CBD commerce, and bipartisan lawmakers haveintroduced legislation session to force a change.

FDA was mandated under appropriations legislation enacted in 2019 to provide an update on its regulatory approach to CBD, and it did so in 2020. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”

Read the letter from Comer on holding a committee hearing on FDA and cannabis below:

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