Marijuana Advocates Are Celebrating This Small Victory

A Bloomberg report revealed President-elect Donald Trump's likely pick for Food and Drug Administration (FDA) commissioner, on Wednesday — and it is giving marijuana legalization advocates a glimmer of hope.

Jim O'Neill — an associate at Peter Thiel's Mithril Capital Management and legalization activist, who served as a founding member of the Coalition for Cannabis Policy Reform — could potentially head the federal agency, which plays a central role in shaping the government's cannabis policy.

"Jim O’Neill, the Thiel associate, hasn’t been officially selected, according to the people, who asked to remain anonymous because the decision process is private, and the Trump team could still go in another direction," Bloomberg reported.

AP/BRANDON MARSHALL - APIMAGES.COM

The FDA is responsible for determining the medical value of drugs and conducting scientific research that informs the Drug Enforcement Administration (DEA) drug scheduling decisions. Earlier this year, the FDA concluded that marijuana has a "high potential for abuse" and "no currently accepted medical use in treatment," as Marijuana.com reported. That determination led the DEA to maintain its current classification of cannabis as a Schedule 1 drug, the most restrictive category under federal law.

A public records request submitted by ATTN: revealed that FDA leadership has raised questions about the DEA's scheduling system and recommended revising the regulatory framework in order to "encourage appropriate scientific research into the potential therapeutic benefits of marijuana and its constituents."

If O'Neill is nominated and confirmed, the position would presumably allow him to push for these reform measures and order a reevaluation of marijuana's medical value, according to cannabis policy experts.

AP/EVAN VUCCI - APIMAGES.COM

"If O'Neill were to be confirmed as head of the FDA it would, at the very least, provide a voice of support in favor of marijuana law reform within an administration that is appearing to largely be made up of anti-marijuana appointments," Danielle Keane, communications associate at the National Organization for the Reform of Marijuana Laws (NORML), told ATTN:. But Keane also noted that the FDA "is just one small part of the puzzle when it comes to federal action on marijuana law reform."

The marijuana community has responded to the potential nomination of O'Neill with tepid optimism in light of the fact that Trump has also nominated several anti-legalization cabinet members.

Reform advocates have voiced concern about Trump's Attorney General pick, Sen. Jeff Sessions (R-Al.), due to his staunch anti-legalization position, for example.

"Seeing Jim’s name floated gives us reason for a little optimism in the midst of so many old school drug warriors being tapped for other key posts," Marijuana Majority founder Tom Angell told ATTN:. "I feel confident that if he becomes the next FDA commissioner, we will be in very good position to finally reschedule marijuana."

Mike Liszewski, the director of government affairs at Americans for Safe Access, agreed. He told ATTN: that O'Neill's prospective nomination "could bring about significant changes to medical cannabis policy" and "potentially address the regulations that have prevented medical cannabis research."

"Such reforms could ultimately lead to cannabis being removed from Schedule I of the Controlled Substances Act," Liszewski said. "However, whatever progress on cannabis at FDA under the Trump Administration should not be used as justification for cracking down on state medical cannabis programs, as there are more than 2 million patients who rely on these programs for safe and legal access to their medicine."

That said, O'Neill's prospective appointment as FDA commission has raised some concern among health care experts. He lacks a "strong scientific background" and has "proposed that the FDA only require companies to prove drugs are safe before they are sold — not that they actually work," STAT News reported.

O'Neill has also worked alongside Trump advisor Peter Thiel for "over a decade," according to Bloomberg, serving on the board of a controversial ventures such as the Seasteading Institute, which is designed to establish new societies in the ocean, beyond government reach. Before joining Thiel at Mithril Capital Management, O'Neill worked as the principal associated deputy secretary at the U.S. Department of Health and Human Services under former President George W. Bush.

http://www.attn.com: Marijuana Advocates Are Celebrating This Small Victory

DEA Set to Rule on Crucial Rescheduling of Marijuana

If the DEA reschedules marijuana, the industry could be welcomed into the mainstream economy.

BY WILL YAKOWICZ

Staff writer, Inc.@WillYakowicz

The U.S. Drug Enforcement Agency is about to make a decision that could have wide-ranging implications on the state-sanctioned marijuana industry: to reschedule or not to reschedule marijuana's position as an illegal substance.

Since 1970, marijuana has been on the list of Schedule I drugs, which defines chemicals under the Controlled Substances Act as a drug with high potential for abuse and no medical benefits. Marijuana, heroin, and LSD are Schedule I drugs, while cocaine, methamphetamine, and oxycodone are Schedule II. Drugs are rescheduled often, but marijuana has been deemed a Schedule I substance for 46 years, which makes it illegal to grow, possess, use, or distribute under federal law.

The DEA has already received the Food and Drug Administration's recommendation on the rescheduling, which is a key part of the rescheduling process stipulated by the Controlled Substance Act, says Russell Baer, a special agent at the DEA's office of public affairs. Baer won't reveal what the recommendation was. The DEA will now conduct its own eight-factor analysis to study the drug's potential for abuse, the current state of medical and scientific knowledge, the history and pattern of abuse, and other considerations. Once that is complete, the DEA's administrator, Chuck Rosenberg, makes the final call.

Baer says the decision will be in line with the current scientific and medical findings surrounding marijuana's status as a beneficial drug.

"We are bound by the FDA's scheduling recommendations," says Baer.

If the DEA recommends rescheduling marijuana to II, III, IV, or V, or removing it from the list of controlled substances, any change in designation will have big implications for the legal industry across 23 states and Washington, D.C., says Aeron Sullivan, the co-founder of Tradiv, an online wholesale marketplace for legal marijuana businesses to buy and sell marijuana. If pot is rescheduled, it could also open up the industry to import-export and help increase the potential for a nationwide, regulated market. In short, it could welcome marijuana into the mainstream economy.

But if the DEA decides marijuana is still a Schedule I drug, Baer says the agency will not be dropping down into Colorado, Washington, and Oregon from black helicopters and arresting everyone.

"Even if it remains a Schedule I substance, the DEA will continue to allocate its resources and time to the biggest and most violent drug traffickers," he says, explaining most of the agency's resources are being used to deal with the current opioid epidemic, which kills more people each year than auto accidents.

While the states are technically breaking federal law, the DEA is not going to waste its resources on regulated marijuana industries that have been approved by local voters, Baer says.

Baer wouldn't give a specific date for the decision, but he said the process is nearly complete and the agency is waiting to hear Rosenberg's decision whether marijuana is considered a medicine or if it's still a dangerous substance. 

While the DEA continues to deliberate the rescheduling of cannabis, the agency will continue to support increased medical and scientific studies on weed, says Baer.

According to the DEA, the total number of Schedule I researchers registered to study marijuana and its extracts, concentrates, and active compounds has increased from 161 in April 2014 to 344 in March 2016, an increase of more than 113 percent.

Baer said the DEA is also working to build an on-line application system for researchers to apply for a Schedule I researcher registration to make the application and review process easier and to promote more scientific and medical research on the plant.

Pot Advocates Want to Establish a 'Unit' of Weed So We Know How High We Are

WRITTEN BY GABE STUTMANApril 20, 2016 // 07:00 AM EST

Know how sometimes you take multiple bong rips and feel excellent, and then sometimes you take one hit of particularly potent dope and feel like you might die? Weed advocates and policy makers are trying to fix that.

At the Cannabis Science and Policy Summit at the NYU Marron Institute of Urban Management over the weekend, policy makers, academics and public health advocates discussed the challenges associated with portioning out proper dosages of THC to both recreational and medicinal users, prompting a discussion about whether a "unit" of weed should be identified, similar to one "standard” drink of alcohol.

In the US, one “standard” drink has been codified by the NIH and refers to approximately 14 grams of pure alcohol, which can be found in one 12-ounce beer at 5 percent alcohol by volume (ABV), one 5 ounce glass of wine at 12 percent, or one shot—a single ounce serving—of hard alcohol at 40 percent ABV.

“Understanding your dose is essential,” said George McBride, a former lawyer and current policy officer at the Beckley Foundation, a drug policy think tank based out of the UK. “Recommended units in alcohol is rife with problems, but at least it gives you a means to compare a shot of tequila with a pint of ale. Cannabis users have no way to compare a dab with a joint.”

The most important factor in determining the potency or psychoactivity of any given quantity of weed is its mass of THC, measured in milligrams. Generally 10 milligrams is considered one dose in both recreational and medicinal uses—however the manner in which it is ingested, say via edible, smoke or vape, can alter the effects, McBride said.

Complicating matters, weed strains can range in potency from today’s average of around 20 percent THC, to over 30 percent. This represents a stark contrast to the weed of the 1980s, which averaged around 4 percent THC concentration. So basically taking “one hit” today is a pretty opaque unit of measurement.

The debate around the weed industry’s regulatory scaffolding is going to heat up as four additional states could see recreational weed legalization measures pass this year

Though ingesting via smoking creates a gray area, regulating THC quantities in edibles is more doable; regulations went into effect in Colorado on February 1, 2015, that specified that edibles must be individually wrapped in servings of 10 milligrams of THC or fewer, and a single edible can’t contain more than 100mg of THC. This followed the death of a college student who jumped from a Denver balcony after eating a pot cookie, and a spate of incidents in which children accidentally ingested marijuana-infused food items.

However, the accurate labeling of edibles relies upon accurate measurements of THC concentration by weed sellers, which has proven elusive. In a damning report published in 2014 in the Denver Posts’ marijuana news website The Cannabist, a study of several marijuana-infused edibles showed that companies across the board misrepresent, most-likely unintentionally, the concentration of THC in their products.

The test was conducted by Steep Hill Labs, an independent marijuana research company based out of Berkely, and showed that nearly all of the products examined were significantly off in their THC levels. This is due to the fact that accurate proportionment of THC levels is difficult, and many argue that the regulatory framework is not in place to sufficiently hold companies accountable for misrepresenting their products.

Better regulations are being welcomed by consumers and weed sellers alike as a positive for consumers and for the industry as a whole.
“In clearly marking what the dose is, hopefully that will lead to more responsible use and public education,” said John Lord via interview with The Cannabist. Lord is the owner of LivWell, a company that has nine pot shops in Colorado. “It keeps us safe, and it provides uniformity for the product itself,” he said.

Many point to the absence of federal regulation by the Food and Drug Administration, which introduced guidelines for regulating alcohol such as ABV requirements, as leading to confusion, as each state scrapes together laws that would keep them safe from litigation, but are ultimately ineffective as informing consumers.

“Every single example of education in our society [has come] through the USDA, FDA, EPA,” said Rev. Dr. Kymron deCesare, Chief Research Officer at Steep Hill. “Suddenly when states are doing something different than normal, yeah it’s gonna confuse society.”

DeCesare, who researches the integration of marijuana into society as well as plant chemistry, said of the hodgepodge nature of current regulatory rules imposed by legal-weed states, “A lot of the ideas they come up with are interesting they work, a lot of them work miserably.”

The debate around the weed industry’s regulatory scaffolding is going to heat up as four additional states could see recreational weed legalization measures pass this year, in addition to the four and the District of Columbia that already have legalized.

As the legal weed industry grows nationwide, groups like the Steep Hill Labs, Inc., based out of Berkely, CA, are figuring as important thought leaders in establishing effective weed policy, emphasizing the integration of marijuana use into society via clear information for consumers and effective regulatory environments.
That said, consumers should not be relying upon the federal government to inform them on how to ingest weed anytime soon.


“Every patient has to be their own best advocate first,” said deCesare.

DEA to Allow Huge Increase in Marijuana Production to Meet Research Demands

POSTED BY: CANNABISACTIVISTNETWORK JUNE 17, 2015

The US Drug Enforcement Administration (DEA) has proposed a massive increase in the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced.

In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA)—a law which categorizes drugs in accordance with their risk of abuse and medical benefit.

For example, drugs regulated by DEA under Schedule II of the CSA may have a recognized benefit, but also a substantial risk of misuse or abuse. A Schedule V drug, meanwhile, may have a recognized medical benefit and a very small risk of misuse or abuse.

And then there are Schedule I drugs like cocaine and marijuana—drugs which DEA claims have no recognized medicinal purpose as well as a high risk of misuse or abuse.

But while these drugs might not have the approval of the US Food and Drug Administration (FDA) or DEA, that doesn’t mean they are totally banned in the US. Under the CSA, DEA controls the production of schedule I and II drugs, including for research purposes.

As a result, even drugs like cocaine are allowed to be manufactured and distributed under DEA’s Aggregate Production Quotas (APQs). Such quotas determine the exact amount of each drug that is permitted to (legally) be produced in the US each year for research or other official purposes.

In September 2014, DEA released its Established Aggregate Production Quotas for Schedule I and II Controlled Substances in the Federal Register. The document details the exact amount of each schedule I and II drug that can be produced in the US during 2015.

Among the drug substances included in DEA’s initial 2015 APQ is marijuana—spelled marihuana in the document—which is set at a production quota of 125,000 grams.

Then, in April 2015, DEA proposed a further and substantial increase for the APQ for marijuana, which it said should be increased to 400,000 grams.

The increase, DEA said, was in response to an elevated demand for cannabidiol, an active ingredient in marijuana, for research purposes.

“Since the establishment of the initial 2015 aggregate production quotas, the DEA has received notification from DEA registered manufacturers that research and product development involving cannabidiol, is increasing beyond that previously anticipated for 2015,” DEA explained in its notice. “The associated product development activities are related to process validation and commercialization activities, including qualification activities related to potential FDA submission support.”

In plain terms, several companies have been trying to obtain supplies of cannabidiol to test its medicinal properties. For example, two companies, Insys Therapeutics and GW Pharma, are seeking FDA approval for drugs to treat different types of epilepsy. Dozens of other studies are hoping to determine if the ingredient is helpful in treating schizophrenia, graft versus host disease, Dravet syndrome and more.

The boost in demand is also due, in part, to increased interest from the government. DEA said the National Institute on Drug Abuse (NIDA) has requested “Additional supplies of marijuana to be manufactured in 2015 to provide for ongoing and anticipated research efforts involving marijuana.”

But even a three-fold increase in the APQ is apparently not enough. DEA is now proposing to increase its production quota for marijuana even further.

In a Federal Register posting on 16 June 2015, the agency said upon further review of the quota, and inconsideration of comments received from the public, it will increase the production quota for marijuana to 658,000 grams—more than five times the amount permitted previously.

The new quota amount applies to all of fiscal year 2015, DEA said.

Source: Regulatory Affairs Professionals Society

DEA to Allow Huge Increase in Marijuana Production to Meet Research Demands