Business
House Panel Calls On FDA To Regulate CBD For Foods, Beverages
Lawmakers and witnesses called on the FDA to regulate CBD for use in foods, beverages and dietary supplements at a House subcommittee hearing last week.
Hemp advocates and industry leaders last week called on the federal government to ease access to cannabidiol as a House of Representatives subcommittee held a hearing to investigate the U.S. Food and Drug Administration’s refusal to regulate CBD as an ingredient in foods, beverages and dietary supplements.
At Thursday’s hearing of the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services, lawmakers and witnesses criticized the FDA’s refusal to regulate CBD and noted how the agency’s inaction on the subject has impacted individuals and families eager to take advantage of the cannabinoid’s health and wellness benefits.
“Lack of a federal framework has led to the proliferation of unregulated products, some of which raise significant quality, safety, and other consumer protection concerns,” Jonathan Miller, general counsel for the industry group the U.S. Hemp Roundtable, told the members of the subcommittee.
In opening remarks prepared for the hearing, Republican Representative Lisa McClain, the chair of the subcommittee, noted that “if you buy a CBD consumer product off the shelf today, in many cases there’s no way for the average consumer to verify its purity or even the amount of CBD in it, or rely on FDA’s enforcement of regulations.
“In fact, one study that tested almost 3,000 CBD products showed that only one-quarter of brands test their CBD products for purity and only sixteen percent of products tested contained exclusively what was stated on their labels,” McClain continued. “That’s because FDA hasn’t regulated CBD as a dietary supplement or food additive in the five years since hemp was legalized.”
Hemp Legalized In 2018
Congress legalized hemp agriculture and commerce five years ago with the passage of the 2018 Farm Bill. But since then, the FDA has refused to regulate hemp-derived CBD for use in foods, beverages and dietary supplements, and in January announced it would not do so without further legislation from Congress.
“This announcement has led to confusion and uncertainty in the market, which has suppressed the ability for good faith manufacturers to sell CBD products,” she said. “It only benefits bad actors who capitalize on the confusion and the flood of the market with potentially unsafe products. The FDA must do better and use their already existing authority to regulate how derived products you know actually do the job they were signed up to do.”
Witnesses also emphasized how the lack of a regulatory framework for hemp-derived CBD from the FDA has also contributed to the proliferation of products containing intoxicating cannabinoids, most prominently delta-8 THC, which are being sold in unregulated products, sometimes to minors. While none of the witnesses called for the criminalization of these products, they called for strict safety regulations to keep them out of the hands of children.
“In many states, including Kentucky, most delta-8 THC products are sold through unregulated market sources like convenience stores, smoke shops, gas stations, and even can be ordered online. These products are not reliably tested and have been found to contain many impurities,” said Richard A. Badaracco, president-elect of the Kentucky Narcotic Officers Association and a retired Drug Enforcement Administration agent. “Assuming these products remain legal, the optimal approach is following the lead of Kentucky, whose General Assembly this year passed legislation unanimously to strictly regulate these products and keep them out of the hands of minors.”
Paige Figi, founder of the Coalition for Access Now, has been an outspoken advocate of CBD for more than a decade after discovering it significantly reduced the seizures suffered by her daughter Charlotte, who died in 2020 at the age of 13 following a nearly lifelong battle with intractable epilepsy. After watching last week’s hearing from her home in Colorado Springs, Figi called on the FDA to ease access to CBD for families across the country.
“We have been united with families, athletes, seniors, veterans, and others who rely on the benefits of CBD for almost a decade. Today’s hearing shows that common sense, bipartisan reform to push the FDA to do its job and regulate hemp-derived CBD as a dietary supplement is close,” Figi wrote in an email to High Times. “The 45 million Americans who rely on the benefits CBD for their chronic conditions are encouraged that members of Congress will stand up for their constituents to pass legislation that will support access for patients now.”
Source: https://hightimes.com/health/cbd/house-panel-calls-on-fda-to-regulate-cbd-for-foods-beverages/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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