New hemp-derived CBD regulations in Colorado

The Colorado Department of Public Health and Environment (CDPHE) has finalized state testing requirements for hemp. The new regulations take effect on October 1 and include all hemp-derived goods intended for human consumption, including hemp-infused CBD products.

“We don’t want to burden the industry,” Jeff Lawrence, CDPHE director of environmental health and sustainability, told Westword. “But what we’ve learned is that there are things in hemp products that we obviously need to be considerate of. Since the inception of hemp, Colorado has been a leader in this industry. This will provide some better guidance.”

Testing will screen for things like pesticides, heavy metals, and residual solvents.

Hemp-infused products like foods, drinks, nutritional supplements, cosmetics, and pet products will be subject to the new testing requirements. Industrial hemp products like textiles, fuel, and building materials, are excluded from the testing requirements. Hemp-derived smokable products, including those with modified cannabinoids like Delta-8 THC, are also excluded from the new regulations.

“Ultimately, this is a public-health issue. In 2018, when, statutorily, these products were allowed, we said it would be treated like every other food and dietary supplement requirement,” Lawrence said.

DEA-approved medical marijuana research facility coming to Denver

A Denver-based marijuana research and cultivation firm received approval from the Drug Enforcement Agency (DEA) to begin federally-approved medical marijuana studies.

The research license will allow MedPharm to study all of the molecules known to be made by the cannabis plant—more than 400 so far. The company will also be studying the interaction between phytocannabinoids and different brain cells.

“Access to the diversity of chemicals produced by cannabis has never been greater, and we are excited to unlock the medical potential of these compounds,” said Dr. Tyrell Towle, MedPharm’s director of chemistry and research.

Although MedPharm is licensed to grow medical marijuana for research purposes at the city and state levels, they’re still waiting on the DEA to approve federal licensing. That means that the company won’t be using its own marijuana for research. Currently, the University of Mississippi is the only federally licensed medical marijuana research supplier.

Colorado Cannabis Business Office focuses on social equity

Governor Jared Polis announced the creation of a new office aimed at supporting cannabis businesses and promoting social equity.

The Cannabis Business Office (CBO) was created as part of a bill passed earlier this year. $4 million was set aside for the program for the 2022-’23 fiscal year from the state Marijuana Tax Cash Fund.

According to the CBO, the office will:

• Provide loans to social equity licensees for seed capital and ongoing business expenses;
• Offer grants to social equity licensees to support innovation and job creation and organizations that support marijuana businesses to be used to support innovation and job creation of social equity licensees; and
• Support cannabis business owners with technical assistance, prioritizing social equity licensees who have been awarded a loan or grant through the program.

“This office will offer tools like technical help and improve access to money for businesses. Where the federal government has fallen behind, Colorado will lead. Colorado is, and always has been, the best place to live, work, grow and sell cannabis,” Polis said in a press release.

This week the U.S. Department of Agriculture (USDA) released draft rules for hemp regulation. There will be a 60-day public comment period before the rules are finalized.

“At USDA, we are always excited when there are new economic opportunities for our farmers, and we hope the ability to grow hemp will pave the way for new products and markets,” said Secretary Perdue in a press release. “We have had teams operating with all-hands-on-deck to develop a regulatory framework that meets Congressional intent while seeking to provide a fair, consistent, and science-based process for states, tribes, and individual producers who want to participate in this program.”

The USDA drafted the regulations as a result of the 2018 Farm Bill that descheduled and legalized hemp. Under the draft rules, the THC content must be under 0.3%, and any hemp found to exceed that amount would be destroyed. Other key elements of the new regulations include:

• Industrial hemp must be tested in a Drug Enforcement Administration-registered laboratory.
• Hemp flower must be tested by a USDA-approved sampling agent 15 days before the anticipated harvest.
• Guidelines for licensing, locations where hemp can be grown, and testing procedures.
• A 10-year ban on participation in the hemp industry by “key participants” with a direct financial interest in the business who have felony drug convictions.

States and American Indian tribes will have some say in setting their own hemp regulations (as long as they don’t violate USDA guidelines), and the USDA must evaluate these plans within 60 days of submission. In states where hemp production is illegal, such as South Dakota, farmers will not be able to cultivate hemp unless state law changes.

Not everyone is happy with the proposed rules. Hemp farmers say that the USDA regulations will make producing high-quality CBD impossible.

“We’re going to be forced, if we want to continue farming CBD, to be harvesting in week four to week six of flower time, where we’re typically not starting our harvest until seven or eight,” Phoenix-based hemp farmer Adam Harris told KTVL News10.

Hemp farmers say that the window between testing, receiving results, and harvesting is too narrow and will hurt the quality of their harvest.

“Most scientific research to date is indicating that the most medicinal benefits are with that full-spectrum CBD. These new USDA regulations make it so we can’t even take in the harvested material to take in those full-spectrum extracts the way that we have been,” said Mitra Sticklen of Om Farms LLC, a hemp company based in Jacksonville.

Senate Majority Leader Mitch McConnell and other members of Congress are urging the Food and Drug Administration (FDA) to speed up its guidance on hemp-derived CBD products. Specifically, Congress wants the FDA to issue formal “enforcement discretion” regarding CBD.

Hemp was legalized last year thanks to the 2018 Farm Bill, which made CBD legal as well. However, without guidance from the FDA, hemp and CBD are in a regulatory gray area. Lawmakers say that the FDA’s current approach to CBD has “created significant regulatory and legal uncertainty for participants in this quickly evolving industry.”

Currently, the FDA prohibits adding CBD to food or drinks marketed beyond a single state or to be added to food as a dietary supplement. Because of the regulatory confusion, some local governments have insisted that CBD is illegal in their state.

“Given the widespread availability of CBD products, growing consumer demand, and the expected surge in the hemp farming in the near future, it’s critical that FDA act quickly to provide legal and regulatory clarity to support this new economic opportunity,” lawmakers wrote.

The FDA has said it could take years to finalize CBD regulations. Congress isn’t waiting, and the US Senate Appropriations Subcommittee on Agriculture is working on guidelines to submit to the FDA. According to U.S. Hemp Rountable, Congress is working on rules that would require the FDA to:

• Within 90 days, provide Congress a report outlining its efforts to develop an enforcement discretion policy on hemp CBD;
• Within 120 days, issue its formal enforcement discretion policy on hemp CBD;
• Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and
• Ensure that going forward, CBD manufacturers would be able share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.

While the end of marijuana prohibition is spreading across the U.S., there are still some states that are reluctant to enter into the brave new world of cannabis. But data compiled by Marijuana Business Daily shows even in states with restrictive cannabis laws, there are still signs of progress–especially when it comes to CBD.

• In Virginia, Gov. Ralph Northam (D) dropped the list of qualifying conditions for low-THC cannabis, instead allowing physicians to recommend cannabis for any ailment. Before Northam signed the legislation, medical practitioners were only allowed to prescribe cannabis for the treatment or to alleviate the symptoms of intractable epilepsy.
   
• A bill that would regulate the distribution and sale of CBD oil was approved unanimously in the Utah Senate and passed in the state House on a 49-20 vote. The House sponsor of the bill, Brad Daw (R), said, “This bill solves an immediate problem where we have a lot of fake product on the shelves right now. I think this bill fulfills our duty to protect consumers, and make sure what they are buying is what they think they are buying.”
   
• Gov. Eric Holcomb (R) is expected to sign a bill that would legalize CBD oil in Indiana. When the bill is signed into law, it will expand CBD access from patients with epilepsy to all adults. While cannabis advocates say the bill is a win for cannabis, many of them are frustrated that the bill requires burdensome labeling that they say will prevent manufacturers to sell their products in the state.
   
• In Iowa, seven companies have applied to sell low-THC medical cannabis at 21 separate locations. The state is expected to approve licenses for five locations next month. Iowa’s medical marijuana program is in its infancy, and existing rules prohibit marijuana products from being smoked or eaten, and THC potency is limited to 3%.
   

While access to CBD and cannabis is still quite limited in a number of states, there is movement and incremental change.