Do you have feelings about how the federal government is handling the regulation of CBD products? Now you can share those thoughts—along with studies, data and other important information—with the Food and Drug Administration (FDA).
On Wednesday, the agency published an official notice announcing a public hearing for next month on its approach to regulating products, including dietary supplements and foods, that contain cannabidiol.
But you don’t have to participate in the meeting itself to make your voice heard. In conjunction with the May 31 event, regulators have also opened up an official docket to take feedback on the issue. The public comment period is open through July 2.
Specifically, FDA is requesting information related to health and safety risks, manufacturing and product quality and the way in which products containing cannabis or cannabis-derived compounds are marketed and sold.
As the agency writes in its notice: “While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.”
Broadly, the FDA wants to see information concerning the notion that hemp-derived CBD is safe to consume in food, what kind of standards need to be put into place to ensure product quality and consistency and what information needs to be included on labels to ensure consumers know exactly what risks they’re taking, if any.
Other questions include:
- What levels of cannabis and cannabis-derived compounds cause safety concerns?
- How do cannabis and cannabis-derived compounds interact with other substances (e.g., drug ingredients)?
- What validated analytical testing is needed to support the manufacturing of safe and consistent products?
David Mangone is the director of government affairs at Americans for Safe Access (ASA). He told Marijuana Moment that submitting comments to the FDA is an opportunity for the general public to help shape policy—and that every comment is read.
“The federal government is anywhere from 10 to 15 years behind the American public and the state-level politics on this issue,” he said in a phone interview. “It’s important for people to be able to use their voice,” and this is one way to do that.
If you’re planning to submit a public comment on the issue, here are a few things to keep in mind:
Be thoughtful about your comment.
“When you see comments particularly on this issue from the general public, you see a lot of brief comments that are very opinionated,” Mangone said.
Last month, another cannabis-related docket was opened to gauge public interest in how the United States should vote on World Health Organization recommendations to reschedule cannabis and its compounds. Nearly 2,000 comments were filed, and an overwhelming number of them support marijuana reclassification.
But, Mangone pointed out, many of those comments were brief, boiling down to “Legalize it” or offering stories about how medical cannabis helps people who are struggling with debilitating conditions.
“That’s not really what the FDA is ever looking for,” he said. “I wish we could sway federal policy with patient stories—and, to a degree, we can on Capitol Hill—but with a regulatory body like the FDA, they’re looking for very specific answers to very specific questions.”
As such, Mangone suggested picking one question from the public notice document on CBD and focusing on it.
Include scientifically sound research.
“This is not a popularity contest. It’s not like an up/down vote on how many comments in favor and how many comments against [CBD products],” he explained. “It’s based off the quality and content of the comments.”
That’s why including studies and data in your submissions is so important. Start by looking for scientific studies that include a large number of people in the sample. Pay attention to who it was conducted by (a university or international body is ideal) and whether or not the authors have a financial interest in the outcome of the study, Mangone said.
Remember who your audience is.
“You’re writing to a government regulatory body that for the past 40 to 50 years has worked actively against allowing CBD—and cannabis largely—as a medicine,” Mangone said. “You have to be respectful in your comments, but you also can’t leave anything on the table.”
Photo courtesy of Rick Proctor.
Marijuana Legalization Measure Advances One Step In South Dakota
South Dakota’s attorney general filed an official explanation of a proposed ballot measure to legalize marijuana on Friday.
While separate organizations are working to get a medical cannabis-focused initiative on the state’s 2020 ballot, activists behind this measure are hoping to incorporate recreational legalization, medical marijuana reform and hemp into one package.
Adult-use legalization would be accomplished through a constitutional amendment under the initiative, which would separately require the legislature to pass legislation creating rules for medical cannabis and hemp.
South Dakota Attorney General releases explanation on proposed constitutional amendment to legalize, regulate, and tax marijuana; to require passage of laws regarding hemp as well as laws regarding marijuana for medical use. Read it here: https://t.co/k33buSKjIJ pic.twitter.com/pEG0RxbDj9
— SD Attorney General (@SDAttorneyGen) August 16, 2019
“The constitutional amendment legalizes the possession, use, transport, and distribution of marijuana and marijuana paraphernalia by people age 21 and older. Individuals may possess or distribute one ounce or less of marijuana,” Attorney General Jason Ravnsborg (R) wrote. “Marijuana plants and marijuana produced from those plants may also be possessed under certain conditions.”
The South Dakota Department of Revenue would be responsible for issuing licenses for cannabis cultivators, manufacturers, testing facilities and retailers. Individual jurisdictions would be able to opt out of allowing such facilities in their areas.
“The Department must enact rules to implement and enforce this amendment,” the explanation states. “The amendment requires the Legislature to pass laws regarding medical use of marijuana. The amendment does not legalize hemp; it requires the Legislature to pass laws regulating the cultivation, processing, and sale of hemp.”
The initiative calls for a 15 percent excise tax on marijuana sales. That revenue would be used to fund the Department of Revenue’s implementation and regulation of the legal cannabis system, with remaining tax dollars going toward public education and the state general fund.
Ravnsborg said that judicial clarification of the amendment “may be necessary” and notes that marijuana “remains illegal under Federal law.”
The attorney general issued a similar explanation of a proposed constitutional amendment to legalize medical cannabis earlier this month.
This latest move comes one day after advocacy organization New Approach South Dakota announced that their medical marijuana initiative was certified, enabling them to begin the signature gathering process.
Several other cannabis initiatives are in the process of being certified in the state, according to the attorney general’s website. In order to place constitutional amendments on the ballot, activists must collect 33,921 valid signatures from voters.
South Dakota is one of the last remaining states in the U.S. that has not legalized marijuana for any purposes.
Photo courtesy of Brian Shamblen.
Elizabeth Warren’s Plan For Indian Tribes Includes Marijuana Legalization
Sen. Elizabeth Warren (D-MA) unveiled a plan on Friday that’s aimed at holding the federal government accountable for following through on its obligations to Native American tribes, and that includes ensuring that tribal marijuana programs are protected against federal intervention.
The plan emphasized Warren’s support for a bill she filed earlier this year that “would protect cannabis laws and policies that tribal nations adopted for themselves.”
The 2020 Democratic presidential candidate, who has faced criticism over claims of Native American heritage, pointed to federal reports showing that tribal programs generally have not received adequate funding and said it is imperative that legislation be enacted to “provide resources for housing, education, health care, self-determination, and public safety” for those communities.
To that end, Warren is planning to introduce a bill called the “Honoring Promises to Native Nations Act” alongside Rep. Deb Haaland (D-NM), co-chair of the Congressional Native American Caucus. Before filing, however, the lawmakers are soliciting input on how best to draft the legislation, and are accepting written testimony until September 30.
While the proposed legislation itself doesn’t currently include marijuana-specific provisions, a press release and blog post on the topic address the senator’s sponsorship of the Strengthening the Tenth Amendment Through Entrusting States (STATES) Act, which would allow tribal communities and states to set their own cannabis policies without Justice Department interference.
In order to provide economic opportunities to Native people, that “requires streamlining and removing unnecessary administrative barriers that impede economic growth on Tribal lands, respecting tribal jurisdiction over tribal businesses, and promoting forward-looking efforts to ensure full access to new and emerging economic opportunities.”
“For example, while not every tribe is interested in the economic opportunities associated with changing laws around marijuana, a number of Tribal Nations view cannabis as an important opportunity for economic development,” Warren’s campaign blog post states.
“I support full marijuana legalization, and have also introduced and worked on a bipartisan basis to advance the STATES Act, a proposal that would at a minimum safeguard the ability of states, territories, and Tribal Nations, to make their own marijuana policies,” she wrote.
.@RepDebHaaland & I invite feedback about this proposal & look forward to working closely with tribal nations & citizens, experts, & other stakeholders to advance legislation in Congress that honors the United States’ promises to Native peoples. https://t.co/qc1fkBGb3I
— Elizabeth Warren (@SenWarren) August 16, 2019
A separate press release on Warren’s Senate website also touts her support for the STATES Act, saying she “worked hard to ensure” that it included tribal protections.
“It’s beyond time to make good on America’s responsibilities to Native peoples, and that is why I’m working with Congresswoman Haaland to draft legislation that will ensure the federal government lives up to its obligations and will empower tribal governments to address the needs of their citizens,” Warren said of the overall tribal plan. “We look forward to working closely with tribal nations to advance legislation that honors the United States’ promises to Native peoples.”
In an email blast to her campaign list, Warren included “a set of additional ideas to uphold the federal government’s trust and treaty obligations with Tribal Nations and to empower Native communities,” which includes her marijuana proposal:
“New economic opportunities: We also need to respect tribal jurisdiction over tribal businesses and promote forward-looking efforts to ensure full access to new economic opportunities. For example, a number of Tribal Nations view cannabis as an important economic opportunity. I support full marijuana legalization and have advanced the STATES Act, a proposal that would safeguard the ability of Tribal Nations to make their own marijuana policies.”
There’s increased interest in ensuring that Native populations receive the same benefits and protections as states as it concerns cannabis legislation.
In June, the House passed a spending bill that included a rider stipulating that Native American marijuana programs couldn’t be infringed upon by the Justice Department. And a GOP representative filed a bill in March that would provide similar protections.
FBI Seeks Tips On Marijuana Industry Corruption
The Federal Bureau of Investigation (FBI) is actively seeking tips on public corruption related to the marijuana industry, it announced on Thursday.
“States require licenses to grow and sell the drug—opening the possibility for public officials to become susceptible to bribes in exchange for those licenses,” FBI Public Affairs Specialist Mollie Halpern said on a short podcast the bureau released. “The corruption is more prevalent in western states where the licensing is decentralized—meaning the level of corruption can span from the highest to the lowest level of public officials.”
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)