A bipartisan group of lawmakers introduced a bill on Thursday that’s meant to promote federally authorized research into marijuana and its derivatives like CBD. It was one of several pieces of new congressional cannabis legislation to be filed on the same day.
Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI) and Chuck Grassley (R-IA) are leading the bill, which would streamline the application process for researchers interested in studying the plant, encourage the development of Food and Drug Administration (FDA)-approved drugs derived from marijuana and clarify that doctors can discuss the benefits of cannabis with patients.
It would also require the U.S. Department of Health and Human Services (HHS) to submit a report on the health benefits and risks of marijuana, as well one on barriers to cannabis research and how to overcome those obstacles.
The bill, at 22 pages, covers a lot of ground, and that’s partly because it combines legislation previously filed by the sponsors.
“Many parents have had success treating their children with CBD oil, particularly for intractable epilepsy, but there are still too many unknowns when it comes to the medical use of marijuana and its compounds,” Feinstein said in a press release. “Current regulations make medical marijuana research difficult and stifles the development of new treatments.
“Our combined bill streamlines the research process and paves the way for marijuana-derived medications that are FDA-approved to keep consumers safe,” she said.
Many parents have had success treating their children with CBD oil, particularly for epilepsy, but current regulations make medical marijuana research difficult. Our bill streamlines the research process and paves the way for marijuana-derived medications that are FDA-approved. pic.twitter.com/T3ZZb5jAVV
— Sen Dianne Feinstein (@SenFeinstein) June 27, 2019
Grassley added that research “is necessary to determine the potential medical value of cannabidiol, and wherever possible, the government should help facilitate the scientific research needed to give these parents the answers they need.”
The first section of the bill concerns the application process for institutions seeking federal authorization to research marijuana. The U.S. attorney general would be given a 60-day deadline to either approve a given application or request supplemental information from the applicant. It would also create an expedited pathway for researchers who request larger quantities of Schedule I drugs.
Another provision addresses applications to become a federally authorized cannabis manufacturer for research purposes. Currently, only one such facility exists nationwide, at the University of Mississippi. The legislation would give the Justice Department a similar 60-day deadline to approve such applications or ask for more information.
The second major section of the bill is about FDA approval of marijuana-derived drugs. One way to encourage such developments is through allowing “accredited medical and osteopathic schools, practitioners, research institutions, and manufacturers with a Schedule I registration” to cultivate their own cannabis for research purposes.
The Drug Enforcement Administration would get a mandate to approve applications to be manufacturers of marijuana-derived, FDA-approved drugs under the bill. Manufacturers would also be allowed to import cannabis materials to facilitate research into the plant’s therapeutic potential.
“The medical community agrees that we need more research to learn about marijuana’s potential health benefits, but our federal laws today are standing in the way of that inquiry,” Schatz said. “Our bill will remove excessive barriers that make it difficult for researchers to study the effectiveness and safety of marijuana, and hopefully, give patients more treatment options.”
There’s another section of the legislation on doctors discussing marijuana with patients. A summary of the bill states that it would allow physicians to talk about cannabis derivatives like CBD with children if their legal guardian consents and also generally allows them to “discuss the potential harms and benefits of both marihuana and its derivatives with adult patients.” Federal courts have already ruled that discussing and recommending medical cannabis is a right guaranteed by the First Amendment, though, so it’s not clear how it would have an impact beyond providing legislative clarification and assurances.
Finally, a fourth section would require HHS to look at the health benefits and risks of marijuana as well as policies that are inhibiting research into cannabis that’s grown in legal states and provide recommendations on overcoming those barriers.
“In addition, it encourages the federal government to facilitate more medical research on marihuana and its components, including the potential therapeutic effects on serious medical conditions,” a summary of the legislation states.
In a statement for the Congressional Record, Feinstein said that “anecdotal evidence suggests that marijuana and its derivatives, like cannabidiol, commonly known as CBD, may be helpful in treating serious medical conditions.”
“However, anecdotal evidence alone cannot be the basis for developing new medications. Rather, medication development must be based on science,” she said. “Unfortunately, marijuana research is subject to burdensome regulations which may unintentionally inhibit research and medication development.”
“I have heard from many parents who have turned to CBD as a last resort to treat their children who have intractable epilepsy… I have heard similar stories from people who use marijuana to treat various other medical conditions.
“But a common concern echoed in many of these conversations is that there is a lack of understanding about the proper delivery mechanism, dosing, or potential interactions that CBD or marijuana may have with other medications. Some also worry because these products aren’t well regulated or factory sealed, and often are labeled incorrectly. Without additional research, our ability to adequately address these concerns is limited and uninformed…
“I firmly believe that we should reduce the regulatory barriers associated with researching marijuana and CBD. If and when science shows that these substances are effective in treating serious medical illnesses, we should enable products to be brought to the market with FDA approval.”
The bill’s original cosponsors include Sens. Dick Durbin (D-IL), Thom Tillis (R-NC), Tim Kaine (D-VA), Joni Ernst (R-IA), Kevin Cramer (R-ND) and presidential candidate Amy Klobuchar (D-MN).
The proposal has been endorsed by mainstream medical organizations like American Academy of Pediatrics, American Medical Association, American Psychological Association and American Society of Addiction Medicine, as well as pro-legalization groups such as Americans for Safe Access, Multidisciplinary Association of Psychedelic Studies and NORML.
For no apparent reason, Thursday was especially active for congressional marijuana legislation. Rep. Earl Blumenauer (D-OR) and Sen. Ron Wyden (D-OR) filed bills that would allow for the interstate commerce of cannabis products, and Sen. Cory Booker (D-NJ), another presidential candidate, introduced a proposal to protections immigrants from being deported for marijuana. Legislation concerning cannabis businesses’ access to Small Business Administration programs was also filed.
Read the text of the new marijuana and CBD research bill below:
Photo by Sam Doucette on Unsplash.
Former FDA Chief Wants Federal Government To Regulate State Marijuana Markets
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said on Monday that the federal government should regulate state marijuana programs.
In his clearest comments on the issue to date, Gottlieb said in a CNBC appearance that the rise in vaping-related lung injuries underscores the need for a federal regulatory scheme that would empower agencies to impose industry standards on aspects of legal cannabis markets such as THC potency and allowable forms of consumption.
Previously, the official had been ambiguous about the extent to which the federal government should get involved, broadly arguing that vaping issues reflect a consequence of conflicting state and federal laws without specifically saying what his preferred policy fix would be. However, in an editorial for The Wall Street Journal published last week, he provided some clarification—hinting that federal drug scheduling laws should be reformed for cannabis—but still left room for interpretation.
But now, he is beginning to lay out specific details of a regulatory agenda.
Gottlieb said during the TV interview that enforcing prohibition is no longer “politically practicable” and that Congress should pass “a federal law that actually can be enforced and allow federal regulatory authorities to impose appropriate supervision.”
While he said he’s not in favor of adult-use legalization and would “like to see the recreational uses shut down entirely,” the reality is that many states have made that decision and so any federal regulatory scheme would have to include “some accommodation of that.”
“I think the time has come that we need to grapple with this at a federal level. We can’t ignore it any more.”
Asked whether states are capable of providing the types of regulations he’s calling for, Gottlieb said no because there’s a patchwork of policies across the country and states “don’t have the capacity to both police what’s being sold in their so-called legal dispensaries as well as shut down the black market.”
“I think you’re going to need federal authorities in there to do that,” he said.
Under the regulatory model Gottlieb is envisioning, FDA and other agencies such as the Drug Enforcement Administration (DEA) “could regulate what’s being sold for the potency, for the manufacturing, for the ingredients, for the claims that are being made.”
“Even if we were to federalize it and allow some form of recreational use, we could limit what can be sold, the potency of what could be sold, the forms in which it can be sold,” he said, adding that he doesn’t think vaping THC products should be allowed.
Federal agencies could impose “tighter controls on the medical claims, holding them to a higher standard and allowing some form of recreational use, probably for products that are lower concentration, that are only delivered in forms that pose less harm than vaping e-liquids,” he said.
“There’s a way to have a compromise where you allow some form of recreational access in the states that want to allow it but something that looks far different than what you have today, something that’s far less permissive than the state laws,” he said. “That’s not a great outcome in my view from a public health standpoint, but what we have now is far worse where you have a federal government not enforcing the law at all—barely enforcing the law—because they know the existing law isn’t practical, and the states not imposing any supervision because they’re incapable of doing it or they don’t want to step in in a vigorous way.”
Photo courtesy of YouTube/CNBC.
Scotland’s Ruling Party Unanimously Backs Drug Decriminalization Measure
Delegates of the Scottish National Party (SNP) unanimously approved a resolution calling for the decriminalization of drug possession and consumption on Sunday.
At a conference in Aberdeen, lawmakers representing Scotland’s largest party and the third largest in the UK Parliament argued that removing criminal penalties for drug offenses and treating addiction as a public health issue would combat an ongoing overdose crisis.
The proposed amendment to the 1971 Misuse of Drugs Act stipulates that the current law is “not fit for purpose in 21st Century Scotland” and would add a provision “to allow for decriminalization of possession and consumption of controlled drugs so that health services are not prevented from giving treatment to those that need it.”
— Alison Thewliss (@alisonthewliss) October 13, 2019
Members of Parliament Tommy Sheppard, Ronnie Cowan and Alison Thewliss of the SNP introduced the measure.
“Our law enforcement agencies are focused on the weak and vulnerable at the bottom of the pyramid, when they should be focused on the organized criminals at the top,” Sheppard said.
He added that if the UK government declines to pursue the reform move, it should “give Scotland the ability to do it instead, because we will take the steps necessary.”
As SNP back decriminalisation to address the drug-death crisis, we spoke to @TommySheppard MP on the need for urgent action to save lives. If Westminster won't act, Scotland must. #SNP19 #skotia pic.twitter.com/zoUWeVYkIZ
— Skotia (@TheSkotia) October 13, 2019
Cowan noted that many people suffering from addiction have experienced some form of trauma and are self-medicating.
“Decriminalization demystifies drugs and places them firmly in the health arena,” he said. “Drug policy is about a mindset. Decriminalization changes the mindset and by changing that you can treat people as human beings and we can start a recovery process.”
As Common Space reported, previous SNP conferences have also seen the passage of progressive drug reform amendments, including one that would establish safe consumption sites to prevent overdoses and help people transition into treatment. Advocates have expressed frustration that the UK Parliament has generally resisted such harm reduction policies.
The Labour Party announced last month that it would launch a Royal Commission dedicated to reviewing the country’s drug laws if elected to the majority.
“The UK government’s cavalier attitude towards Scotland’s drugs emergency is simply appalling,” Thewliss said. “People are dying on our streets and the risk to the general public from discarded needles and transmission of blood borne diseases is very real—yet the Tories at Westminster sit on their hands.”
Glasgow Councillor Mhairi Hunter said at the conference that “challenging the stigma around addiction means challenging the laws that criminalize addiction.”
Over in the U.S., lawmakers remain primarily focused on reforming federal marijuana laws, but talk of broader decriminalization is growing. A survey released earlier this month found that a majority of Americans (55 percent) support the policy change.
Dietary Supplement Industry Pushes Congress To Allow CBD Product Sales
Four trade associations representing the dietary supplement industry signed a letter urging federal lawmakers to take action to provide for the lawful marketing of CBD products while the Food and Drug Administration (FDA) develops its regulations.
The American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition and United Natural Products Alliance said Congress should “pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria.”
To do that, the groups recommended granting a limited waiver that would exempt CBD products from a provision of the Food, Drug and Cosmetic Act that would allow companies to sell CBD as dietary supplements as long as the products are derived from hemp and meet health and safety standards.
“Given the rapidly growing marketplace of products, it is crucial that Congress take quick action to clarify the legal status of hemp-derived CBD dietary supplements,” the letter states. “At the same time, it is equally essential for FDA to have the resources it needs to protect the public from unsafe CBD products.”
A united supplement industry is urging Congress to take swift action on CBD to assure consumer protection and a clear regulatory framework. See what CHPA, @AHPAssociation, @CRN_Supplements, and @unpafrank have to say, here: https://t.co/pUBGSpXFQf
— CHPA (@CHPA) October 10, 2019
“These actions are urgent given the strong consumer interest in CBD, the growth in products and sales, and the need for clarity among consumers, retailers, and manufacturers about the legal status of these products,” the groups said.
Congressional action is needed, they argued, because FDA officials have indicated that the rulemaking process for CBD could take up to five years. They also expressed appreciation for agriculture spending legislation approved by a the Senate committee that would allocate $2 million to FDA to support their efforts to develop cannabidiol regulations.
“We urge Congress to go even further to include substantial new resources to enable effective FDA oversight of this fast-growing category, including funding for efficient and timely review of new dietary ingredient notifications and enforcement of existing laws governing the safety, manufacturing, and labeling of dietary supplements containing CBD,” the letter continues. “We urge that you work with FDA to determine a level of funding adequate to assure effective regulation of the CBD marketplace that does not detract from other agency enforcement priorities.”
“This is the best, most efficient, and most timely way to both set a clear regulatory framework for the marketplace and better assure consumer protection. While we can appreciate the FDA’s deliberative interest in making sure that consumers have access to safe CBD products, we are concerned that continuing to leave the marketplace without clarity and adequate oversight for an extended period of years will both endanger consumers and the bright future of the hemp-derived products they seek. Since it appears FDA is unlikely to provide a timely and effective resolution to this challenge, Congress must act.”
The dietary supplement industry is far from alone in its call for an expedited process to allow CBD products to be marketed.
A bipartisan coalition of senators—and notably, Senate Majority Leader Mitch McConnell (R-KY)—have also urged FDA to clear a path to allow for the lawful marketing of CBD products while the agency continues to develop regulations.
Read the full CBD letter from the dietary supplement industry groups below:
Photo by Kimzy Nanney.