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Senate Schedules Second Cannabis Hearing For Next Week

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A key Senate committee will hold a hearing next week to discuss hemp production, featuring witnesses from the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA).

In the months since hemp and its derivatives were federally legalized under the 2018 Farm Bill, there’s been strong interest in developing USDA and FDA regulations for the crop and its compounds such as CBD, and lawmakers have repeatedly pressed the agencies to speed up the rulemaking process to unlock the industry’s potential.

While the hearing notice doesn’t go into detail about what will be discussed, the meeting’s title—”Hemp Production and the 2018 Farm Bill”—and list of witnesses indicate that the conversation will revolve around the development of federal guidelines for hemp businesses.

USDA Marketing and Regulatory Programs Under Secretary Greg Ibach, USDA General Counsel Stephen Vaden, FDA Principal Deputy Commissioner Amy Abernethy and EPA Assistant Administrator of Chemical Safety and Pollution Prevention Alexandra Dunn will appear before the Senate Committee on Agriculture, Nutrition, and Forestry on July 25.

Other invited witnesses include Kentucky farmer Brian Furnish, National Hemp Association Executive Director Erica Stark and Red Lake Band of Chippewa Indians Tribal Chairman Darrell Seki.

The Senate Agriculture Committee meeting will mark the chamber’s second cannabis-related hearing of the week. The Committee on Banking, Housing and Urban Affairs announced on Tuesday that it will meet to discuss marijuana banking issues on July 23.

FDA and USDA have both recently signaled that they were cognizant of widespread interest in creating regulatory pathways for hemp and its derivatives, with USDA stating that it planned to release an interim final rule on the products in August and FDA’s Abernethy writing that the agency is “expediting” its rulemaking process. FDA added that it hoped to release a report on its progress by early fall.

That said, heads of the departments have also tried to temper expectations. Agriculture Secretary Sonny Perdue said that USDA wouldn’t be expediting regulatory developments but that he expected them to be issued ahead of the 2020 planting seasons.

Former FDA Commissioner Scott Gottlieb, meanwhile, cited policy complications that would make it difficult for the agency to create an alternative regulatory pathway for hemp-derived CBD products to be lawfully marketed as food items or dietary supplements. He said that without congressional action, it may take FDA years to establish those rules.

Separately, officials from both FDA and USDA will participate in hemp conferences in August, where they’re also expected to update stakeholders on their progress.

Senate Schedules Hearing On Marijuana Business Banking Access

Photo courtesy of Brendan Cleak.

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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Feds Send Warning Letter To Another CBD Company Over Medical Claims

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The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a warning letter to a Florida-based CBD company on Tuesday, alleging that the business made several unsanctioned claims about the therapeutic benefits of their products.

The federal agencies accused Rooted Apothecary of unlawfully asserting that their cannabidiol products could treat symptoms of conditions such as ADHD, Parkinson’s disease, ear aches, ADHD and autism. Those claims appeared on the company’s website and social media accounts, they said.

Certain products appeared to be marketed as dietary supplements, which FDA currently prohibits as it works to develop an alternative regulatory scheme for CBD.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” Acting FDA Commissioner Ned Sharpless said in a press release. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”

“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” he said. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority.”

FTC’s complaint with the company is that it violated a law that requires businesses that advertise medical claims about their products to have “competent and reliable scientific evidence” to back them up, which could include human clinical trials. Making or exaggerating such claims through “a product name, website name, metatags, or other means” without proper evidence is also prohibited.

Rooted Apothecary must respond to the agencies within 15 working days to explain what steps it’s taking to resolve the issues. If the company fails to do so, it is subject to legal action, including the possible seizure of its products or an injunction. It may also have to compensate customers.

FDA emphasized that CBD products—other than the prescription medication Epidiolex, for the treatment of intractable epilepsy—are not currently allowed. But it also reiterated that the agency is in the process of developing rules that could allow for the lawful marketing of the compound.

In April, FDA sent warning letters to three other CBD companies that it said was making unauthorized claims about the medical benefits of their products. FTC also submitted warning letters to three separate CBD companies for allegedly advertising misleading statements about their products last month.

These letters are examples of the agency’s use of enforcement discretion. Former FDA Commissioner Scott Gottlieb, who recently suggested that the federal government should be involved in regulating state marijuana programs, clarified in March that the agency is only going after companies that make especially misleading claims about their products.

Senate Majority Leader Mitch McConnell (R-KY), who championed a provision of the 2018 Farm Bill federally legalizing hemp and its derivatives, has urged FDA to clear a path for the lawful marketing of CBD products by using enforcement discretion while it develops an interim final rule. A bipartisan group of lawmakers made a similar request in a letter sent to the agency last month.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” FDA Principal Deputy Commissioner Amy Abernethy said.

“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products,” she said. “We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

Hemp Regulations Will Be Issued Within Weeks, Top USDA Official Says

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GOP Senator Links Medical Marijuana Claims To Tobacco Industry Advertisements

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Sen. John Cornyn (R-TX) said on Tuesday that claims about the therapeutic potential of marijuana remind him of decades-old tobacco industry advertisements asserting that the product had medical benefits.

In a speech on the Senate floor, Cornyn discussed a hearing that the International Narcotics Control Caucus, which he co-chairs, will hold on Wednesday to explore the public health impacts of cannabis. He said it was especially important to hear from experts about the subject as more states legalize marijuana and members of Congress, as well as Democratic presidential candidates, push to end federal prohibition.

The senator made clear he’s skeptical about marijuana’s health benefits.

“There’s no shortage of people who claim that marijuana has endless health benefits and can help patients struggling from everything from epilepsy to anxiety to cancer treatments,” he said. “This reminds me of some of the advertising we saw from the tobacco industry years ago where they actually claimed public health benefits from smoking tobacco, which we know as a matter of fact were false and that tobacco contains nicotine, an addictive drug, and is implicated with cancers of different kinds.”

“We’re hearing a lot of the same happy talk with regard to marijuana and none of the facts that we need to understand about the public health impact of marijuana use,” he said.

While Cornyn recognized there’s significant support for cannabis reform, he said that ” for the number of voices in support of legalization, there are even more unanswered questions about both the short- and long-term public health effects.”

He expressed concern about increased levels of THC concentration in cannabis products and stated that it’s “true that for some people that marijuana can indeed be addictive.”

“There’s simply a lack of scientific evidence to determine the link between marijuana and various health risks, and that’s something I would think Congress and the American people would want to know before we proceed further down this path,” Cornyn said. “We don’t know enough about how this could impair cognitive function or capacity or increase the risk of mental illness or perhaps serve as a gateway for other drugs that are even more damaging to the health of a young person.”

The senator made similar remarks during a conversation with a former White House drug czar in August. He said it was important to address the public health impacts of cannabis before moving forward with legislation that would protect banks that service marijuana businesses from being penalized by federal regulators.

“With increasing use and a growing number of states giving the green light for marijuana use, we need better answers,” he said.

The surgeon general and the director of the National Institute on Drug Abuse, along with several academics, are scheduled to testify at Wednesday’s hearing.

Senate Hearing To Focus On Marijuana And Health This Week

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Michael J. Fox Parkinson’s Foundation Urges Congress To Pass Three Marijuana Research Bills

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A leading advocacy group that’s dedicated to finding treatment options for Parkinson’s disease is backing three pieces of marijuana research legislation in Congress.

The Michael J. Fox Foundation (MJFF)—named after the actor, who has Parkinson’s and established the nonprofit—said last week that lifting barriers to cannabis research, including rescheduling the plant under the Controlled Substances Act (CSA), is necessary to promote studies verifying marijuana’s potential therapeutic benefit for conditions such as Parkinson’s patients.

“The MJFF supports increased access to cannabis for medical research. Congress has begun to recognize this need, and there are several bills in the U.S. House and Senate designed to remove barriers that impede safe and legal access to cannabis by medical researchers,” the foundation said on its website. “The MJFF public policy team is tracking these bills and working to educate members of Congress and their staff on their importance to the Parkinson’s community.”

MJFF said it’s in favor of three marijuana bills, which would accomplish the following: 

Medical Cannabis Research Act

—Require the Justice Department to approve additional manufacturers for research-grade cannabis.

—Protect research institutions that conduct studies on marijuana.

—Authorize the U.S. Department of Veterans Affairs (VA) to inform patients about opportunities to participate in federally authorized cannabis studies.

VA Medicinal Cannabis Research Act

—Require VA to conduct studies into the therapeutic potential of marijuana in the treatment of various conditions that commonly afflict veterans such as chronic pain and post-traumatic stress disorder.

Expanding Cannabis Research and Information Act

—Reschedule marijuana from Schedule I to Schedule III under the CSA.

—Free up universities to conduct studies on cannabis by removing certain regulatory requirements.

In a letter to the Senate sponsor of that last piece of legislation, Sen. Dick Durbin (D-IL), in June, the foundation stated that marijuana’s current classification under federal law and the inadequate quality of cannabis grown at the only federally authorized manufacturing facility has meant that “researchers do not have the proper materials to conduct the necessary research.”

The foundation noted that it has submitted comments to the Food and Drug Administration arguing in favor of rescheduling in 2018 and 2019. It also applauded the Drug Enforcement Administration for announcing that it would take steps to approve additional federal cannabis farms for research.

“Current policies hinder comprehensive medical research on cannabis, making it difficult to generate the evidence needed for clear recommendations,” Andrew Koemeter-Cox, MJFF’s associate director of research programs, said. “This is especially problematic when some products may be unsafe for human use and have the potential for adverse interactions with other medications.”

Ted Thompson, the nonprofit’s senior vice president of public policy, said that removing barriers to research “is one way in which Congress can help scientific researchers determine what the benefits of medical cannabis might be for Parkinson’s disease.”

“Our role on the public policy team is to work with Congress and the administration to ensure there is access and funding for research and care initiatives that can benefit people living with Parkinson’s and, right now, that includes access to medical cannabis for research,” he said.

Senate Hearing To Focus On Marijuana And Health This Week

Photo courtesy of Brian Shamblen.

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.
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