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Lawmakers Introduce Bipartisan CBD Regulation Bill

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A bipartisan group of lawmakers has introduced legislation that would allow the FDA to regulate hemp-derived CBD as an ingredient for foods, drinks and dietary supplements.

A bipartisan group of lawmakers on Thursday introduced a bill to ensure hemp-derived CBD products are regulated by the U.S. Food and Drug Administration, while on the same day, a Republican representative announced a hearing to examine the agency’s refusal to regulate the cannabinoid following the legalization of hemp five years ago.

In 2018, Congress legalized hemp agriculture and commerce with the passage of that year’s 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.

On July 20, U.S. Representative Earl Blumenauer and Senators Ron Wyden and Jeff Merkley, all Oregon Democrats, joined Kentucky Republican Senator Rand Paul to introduce the Hemp Access and Consumer Safety Act, a bill that would direct the FDA to regulate hemp-derived CBD as an ingredient for foods, beverages and dietary supplements. In a joint statement, the bipartisan group of lawmakers characterized the development as “an action that is essential to protecting consumer safety and treating hemp producers fairly.”

“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Wyden said in a joint statement from the lawmakers. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”

Federal Law Limits CBD Uses

Currently, the Federal Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition but has not yet exempted hemp-derived CBD, despite congressional action to legalize the production and sale of the cannabinoid. By exempting hemp-derived CBD from the prohibition, the Hemp Access and Consumer Safety Act would allow the FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods and beverages.

If passed, the legislation would give hemp-derived CBD products an opportunity to be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act. The bill also includes provisions that prioritize consumer safety by requiring manufacturers to comply with all existing federal regulations for products that contain CBD and ensure such products are properly labeled.

Paul, who had a career as an ophthalmologist for more than 15 years before being elected to the Senate, noted many consumers are already using CBD products for their reputed health and wellness benefits.

“Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement,” said Paul. “The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants.”

The bipartisan bill is supported by stakeholders in the hemp and CBD industries, including the Oregon Farm Bureau, Wine and Spirits Wholesalers Association (WSWA), Vote Hemp, American Herbal Products Association (AHPA), Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA), Veterinary Cannabis Society, Midwest Hemp Council, Colorado Hemp Association, Kentucky Hemp Association, Georgia Hemp Association, iHemp Michigan, and the Virginia Hemp Coalition.

“This bill provides a much-needed pathway for FDA to establish a clear and consistent framework for the production, marketing, and sale of hemp-derived CBD to ensure consumer safety while fostering a thriving, regulated market,” said Jonathan Miller, general counsel of the industry group the U.S. Hemp Roundtable. “We look forward to supporting his efforts and appreciate his longtime commitment to unlocking the full potential of the hemp industry.” 

Michigan Lawmaker Schedules Hearing

Also on Thursday, Michigan Republican Representative Lisa McClain, the chair of the House Subcommittee on Health Care and Financial Services, scheduled a hearing to investigate the FDA’s refusal to regulate CBD for use in dietary supplements, foods and drinks. The hearing, titled “Hemp in the Modern World: The Yearslong Wait for FDA Action,” will take place at the Rayburn House Office Building on Thursday, July 27.

“The FDA has failed for too long to do its job to ensure the safety of legalized hemp-derived products,” McCain said in a statement on Thursday. “Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market. We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction. We need to ensure that the FDA is not setting what would be a dangerous precedent and using this as an opportunity to seek more authority and resources from Congress.”

Source: https://hightimes.com/news/lawmakers-introduce-bipartisan-cbd-regulation-bill/

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New Mexico cannabis operator fined, loses license for alleged BioTrack fraud

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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:

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/

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Marijuana companies suing US attorney general in federal prohibition challenge

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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.”

Source: https://mjbizdaily.com/marijuana-companies-suing-us-attorney-general-to-overturn-federal-prohibition/

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Alabama to make another attempt Dec. 1 to award medical cannabis licenses

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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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