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FDA Chief Warns CBD Rulemaking Could Take Years Without Congressional Action

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The outgoing head of the Food and Drug Administration (FDA) suggested on Tuesday that it would take several years for the agency to come up with rules around allowing hemp-derived cannabidiol (CBD) in food products—unless Congress steps in.

At a Brookings Institution event, FDA Commissioner Scott Gottlieb recognized that there’s strong interest among the cannabis industry and lawmakers in developing a regulatory framework through which CBD from hemp could be extracted, sold and introduced into the food supply. The problem is that “CBD didn’t previously exist in the food supply, and it exists as a drug under the statute.”

“It can’t just be put into the food supply,” he said, arguing that current law only allows the FDA to “contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.”

That rulemaking process can take two to three years for conventional products, and so because CBD is “more complex”—due to its association with marijuana—and has already been approved by the FDA as a drug to treat epilepsy (in the form of Epidiolex), it could theoretically take much longer to develop those regulations.

“We’ve never done this before,” Gottlieb said. “It would be a highly novel rulemaking process.”

In the meantime, the FDA is putting together a “high-level work group” that will work to identify “some potential legislative pathways might be to create a framework for allowing CBD into the food supply.”

Gottlieb said he expects the group to release some recommendations by the summer, as Business Insider first reported.

The commissioner said the work group will be formally announced within the next week and would involve a public meeting to solicit comments from stakeholders.

While Congress might have intended to permit the marketing of hemp-derived CBD through the 2018 Farm Bill, the commissioner indicated that additional legislation that specifically addresses CBD regulations would be necessary to allow the ingredient in the food supply. He said there’s precedent for such actions, citing legislation around human growth hormone and fish oil.

“I think you need to come up with a framework that defines concentration levels, where you would create some kind of cut off, and that would be up to the agency to do,” he said. “Congress would obviously give directions to the agency to do that.”

“CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe—I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value. But this is a process that the agency would have to work through. I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD.”

Gottlieb made similar comments in response to questions from members of a House Appropriations subcommittee last month, where he announced that the agency would hold a public meeting in April to gather input from stakeholders on CBD regulation.

In the new comments, the commissioner also added that he felt the Drug Enforcement Administration (DEA) would have to “formally de-schedule” hemp-derived CBD before moving forward with regulatory changes, in spite of the fact that the agriculture legislation shifted regulatory responsibility for the crop and its derivatives from the Justice Department to the U.S. Department of Agriculture.

“I think the prevailing view is that the plain language of the statute [of the Farm Bill] intended for that, but I’m not sure that DEA has done that yet,” he said. “But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”

The desire for clarity around CBD’s legality post-Farm Bill passage has been widespread. For example, the U.S. Postal Service issued an advisory earlier this month spelling out rules for mailing hemp-derived CBD. Representatives from state agriculture departments also heard talk about “alternative approaches” to regulating the compound at a conference last month.

In his remarks at Brookings, Gottlieb announced that the CBD work group would be co-chaired by Amy Abernethy, FDA’s principal deputy commissioner, and Lowell Shiller, the agency’s acting associate commissioner for policy.

In the meantime, it is clear that lawmakers want FDA to move on the issue.

“Every meeting I go into on Capitol Hill, almost every meeting, I get asked about this,” Gottlieb said.

U.S. Postal Service Issues Advisory On Mailing Hemp-Derived CBD

Photo courtesy of YouTube/Brookings Institution.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

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Idaho Medical Marijuana Activists ‘Likely’ To Seek Signature Gathering Relief After Court Ruling

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A campaign to legalize medical marijuana in Idaho is preparing to potentially collect signatures again, as they are likely to seek the same relief that a federal court recently granted a separate campaign that found its petitioning efforts crippled by the coronavirus pandemic.

The judge said activists behind Reclaim Idaho, which is pushing an initiative on school funding, can start collecting signatures in-person and electronically for 48 days starting July 9. While the Idaho Cannabis Coalition wasn’t involved in that case, they feel the ruling will apply to them and they’re actively monitoring the situation.

“We are in the process of working with the local medical marijuana campaign to assess whether Judge Winmill’s order provides a route for the medical marijuana initiative to still qualify for the November ballot,” Tamar Todd, legal director for the New Approach PAC, which is lending support to the state cannabis effort, told Marijuana Moment.

“The medical marijuana campaign is similarly situated to the Reclaim Idaho campaign and will likely ask for a similar extension of time and permission to collect signatures electronically from the Secretary of State, and if necessary, from the District Court,” she said. “I don’t know the exact timeline as there are a number of moving pieces but it will be quick.”

On June 23, U.S. District Judge B. Lynn Winmill gave the state two options: either allow electronic signature gathering for 48 days or simply place the Reclaim Idaho initiative on the ballot regardless of the signature requirement. The state chose neither and proceeded to request that the ruling be stayed.

The judge denied the state’s request to stay the order, so the signature gathering for the school funding campaign can proceed on July 9. The state has since filed an emergency motion with the U.S. Court of Appeals for the Ninth Circuit to challenge the lower court’s ruling.

“The district court order severely and unquestionably disrupts Idaho’s election,” the state deputy attorney general wrote in the motion.

The deadline to submit 55,057 signatures to qualify the cannabis initiative passed on May 1, shortly after the group announced it was suspending petitioning activities because of the health crisis and the stay-at-home social distancing measures the state enacted. The cannabis campaign said it has about 45,000 raw signatures on hand at this point, and they’re confident that can fill the gap if they get the deadline extension and electronic petitioning option.

Under the proposed measure, patients with qualifying conditions could receive medical cannabis recommendations from physicians and then possess up to four ounces of marijuana and grow up to six plants.

While advocates say passing medical marijuana in one of the remaining states without such policies on the books would be a victory for patients in its own right, it could also have outsized federal implications. A House-passed bill to protect banks that service state-legal cannabis businesses from being penalized by federal regulators is currently sitting in limbo in a Senate committee chaired by a senator who represents the state.

Creating a medical marijuana program in Idaho, which is one of small handful of states that don’t yet even have limited CBD laws, could put additional pressure on Senate Banking Committee Chairman Mike Crapo (R-ID) to move the financial services legislation in Congress.

Summer Dreams Of Marijuana-Infused Slushies Are Melted By Oklahoma Regulators

Photo elements courtesy of rawpixel and Philip Steffan.

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Summer Dreams Of Marijuana-Infused Slushies Are Melted By Oklahoma Regulators

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Bad news for Oklahoma medical marijuana patients trying to beat the summer heat with a marijuana-infused slushy: State regulators say the icy beverages “are unlikely to meet requirements set forth in Oklahoma statutes and rules” for cannabis products.

As the weather heats up, THC-infused slushy machines have been popping up at more and more Oklahoma dispensaries. Made by companies such as Glazees, which offers flavors such as watermelon and blue raspberry, the THC-infused drinks sell for about $12-$15.

But despite their popularity with some patients, regulators say the slushies fail to comply with a number of state rules, such as a requirement that products be packaged in child-resistant containers. Dispensaries themselves also “are not allowed to alter, package, or label products,” regulators said.

State rules further require that all medical marijuana products be tested in their final form. “In this instance, the finished product is the slushy mixture to be dispensed to patients/caregivers, not the syrup,” regulators said. “If water, ice, or any other substance is added to the product, additional testing is required to ensure the product is safe for consumption and final-product labeling is accurate.”

Regulators didn’t specify how adding water or ice to cannabis products could affect consumer safety, however.

The Oklahoma Medical Marijuana Authority (OMMA) issued the update on Thursday in what it called a “slushy-machine guidance” memo. The office said it had received “multiple inquiries regarding the processing and dispensing of marijuana-infused slushies on-site at medical marijuana dispensaries.”

The memo was silent, however, on the likelihood of enforcement. As of Friday morning, slushies still appeared on menus for some Oklahoma dispensaries.

It’s not the first obstacle encountered by Oklahoma marijuana businesses, which began popping up across the state voters passed a medical marijuana law in 2018.

Earlier this year, lawmakers passed a wide-ranging medical cannabis expansion bill, which would have allowed out-of-state residents to obtain temporary licenses, permitted licensed businesses to deliver marijuana to customers and eliminated jail time for for first-time possession convictions. But Gov. Kevin Stitt (R) then vetoed the bill, and lawmakers didn’t hold a vote to override the action.

Oklahoma activists also filed a proposed marijuana legalization ballot measure in December, but it’s unlikely the campaign can gather enough signatures to put the measure before voters this November. Their signature-gathering was largely delayed due to the coronavirus pandemic, and only last week did the state Supreme Court rule that the campaign could initiate petitioning. Supporters now have about 90 days to gather nearly 178,000 signatures from registered voters.

Virginia Lawmakers Announce Plans To Legalize Marijuana, One Day After Decriminalization Takes Effect

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Virginia Lawmakers Announce Plans To Legalize Marijuana, One Day After Decriminalization Takes Effect

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Only a day after a new marijuana decriminalization law took effect in Virginia, top state lawmakers are announcing that they’re already looking ahead to full legalization.

A group of Democratic legislators on Thursday announced plans to introduce a bill to legalize and regulate a commercial cannabis market in the state. While the measure isn’t set to be filed until next year, lawmakers framed legalization as necessary in the fight for social and racial justice.

“Decriminalizing marijuana is an important step in mitigating racial disparities in the criminal justice system, but there is still much work to do,” House Majority Leader Charniele Herring (D) said in a press release. “While marijuana arrests across the nation have decreased, arrests in Virginia have increased.”

Other lawmakers backing the broader legalization push include Sens. Adam Ebbin (D) and Jennifer McClellan (D), as well as Del. Steve Heretick (D).

On Wednesday, the state’s new marijuana decriminalization policy took effect. The law, approved by lawmakers earlier this year and signed by Gov. Ralph Northam (D), removes criminal penalties for low-level marijuana possession. Under the change, having up to an ounce of cannabis is now punishable by a $25 fine and no threat of jail time or a criminal record.

Prior Virginia law punished simple marijuana possession with up to 30 days in jail, a $500 fine and a long-term criminal record.

“This bill will prevent low-level offenders from receiving jail time for simple possession while we move toward legalization with a framework that addresses both public safety and racial equity in an emerging market,” Herring said of the new law, which she sponsored in the House of Delegates and Ebbin led in the Senate.

The decriminalization measure also contains a provision to study future legalization. It requires a bevy of executive agencies, including “the Secretaries of Agriculture and Forestry, Finance, Health and Human Resources, and Public Safety and Homeland Security,” to convene an expert working group to study the matter. That panel’s report is due in November.

A separate legislative agency, the Joint Legislative Audit and Review Committee (JLARC), is also studying the impacts of possible legalization as the result of yet another resolution approved by lawmakers this year.

Lawmakers said on Thursday that the JLARC report, which is due in December, would inform how they shape legalization legislation they expect to file in 2021.

“Elements of the JLARC study include review of best practices from states such as Illinois that have developed a legal framework, testing and labelling recommendations, and measures to reduce illicit sales,” according to a press release from Ebbin’s office. “The study will also examine how best to provide redress and economic opportunity for communities disproportionately impacted by marijuana prohibition, and recommend programs and policies to reinvest in affected communities.”

The Virginia Legislative Black Caucus doesn’t want to wait for the results of the two reviews, however, and is pushing fellow lawmakers to take up cannabis legalization during a special session in August. In addition, the caucus has said its members intend to file bills to implement automatic expungement, ban no-knock warrants, require courts to publish racial date on people charged with low-level offenses and enact other sweeping criminal justice reforms.

Jenn Michelle Pedini, development director for the legalization advocacy group NORML and executive director of the group’s Virginia chapter, said the organization, which has worked with lawmakers on past reforms, looks forward to continuing to bring evidence-based cannabis policy to Virginia.

“For far too long, young people, poor people, and people of color have been disproportionately impacted by cannabis criminalization, and Virginia must take immediate steps to right these past wrongs and undo the damage that prohibition has waged upon hundreds of thousands of Virginians,” Pedini said. “It is time to legalize and regulate the responsible use of cannabis by adults in the Commonwealth.”

Ebbin said that despite the meaningful step of decriminalization, the state still has a long way to go.

“Today Virginia is taking an important first step in reducing the harm caused by the criminalization of cannabis,” he said in a statement. “The prohibition of marijuana has failed and the consequence of this failure has been felt overwhelmingly by Virginians of color, but it has not ended. It will only end when it is replaced by a regulated adult-use market that emphasizes equity—making whole those who have been burdened most by making sure they have a seat at the table and access to the marketplace. We are looking forward to doing the hard work needed to get this right.”

In the meantime, the Senate Democratic Caucus has announced it will pursue a bill during the special session next month to end law enforcement searches of people or vehicles based solely on the smell of marijuana, which critics say is a recipe for discriminatory enforcement. The group also noted that the chamber approved legislation during the regular legislative session that would have expunged certain marijuana charges and convictions, but that those bills didn’t make it to the governor’s desk.

Austin Police Will Stop Marijuana Possession Arrests And Citations

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