Tell the FDA What’s on Your Mind

By Zoe Sigman On June 05, 2019

The FDA is asking for input on how to regulate CBD and cannabis. Project CBD gave oral comments at last week’s public hearing, and we plan on submitting written comments and supporting documents to their public docket. You should, too.

You have until July 2 to share your thoughts on the best path forward. The FDA’s ask is a big one, and it concerns more than just CBD (the full prompt is attached below). Whatever regulation is coming will shape not only CBD regulation, but that of cannabis and cannabinoids more generally.

In their announcement, the FDA clearly states that they’re looking for information about 1) health and safety risks; 2) manufacturing and product quality; and 3) marketing/labeling/sales. Each category is broken into specific queries, all aimed at seeking input on how they should regulate cannabis and cannabis-derived products.

The FDA is faced with the challenge of crafting regulation in a way they’ve never done before. Both THC (Marinol, Syndros, Nabilone) and CBD (Epidiolex) have been approved by the FDA for the treatment of specific diseases. This means that the FDA has, until this point, regulated single-molecule cannabinoids just like any other pharmaceutical. Now the FDA is tasked with regulating those same compounds for general consumption as food supplements and nutraceuticals. But the FDA is not generally in the business of approving the same plant compound both as a prescription medication and an over-the-counter food supplement – there is little precedent to draw upon.

Given the enormous public interest in cannabis and the huge demand for CBD products, the FDA says they’re willing to listen. So, tell them your story. Write about how CBD has helped (or not helped) you and your family (including your dog!). If you’ve researched how cannabis and CBD can impact a particular medical condition, share the data with the FDA. If you are involved in manufacturing hemp or cannabis products, tell the FDA how that’s working in your state.

DO:

  • Read the entire prompt that the FDA has provided. The FDA is looking for specific information about a broad range of topics related to cannabis. It was apparent that some of the people who spoke at the public hearing hadn’t taken into account the information the FDA already has. The FDA knows about Epidiolex, the pharmaceutical version of CBD. They approved it as a drug and are aware of the high-dose hepatotoxicity data from clinical trials.
  • Submit data and studies to support the information in your comments. Be specific. If you know of a study that backs up your experience with managing a specific condition, cite it and provide the article. One of the FDA’s most frequent requests at the recent public hearing was for more data to support claims.
  • If possible, include dosage amounts (in milligrams of cannabinoids) when sharing stories about how cannabis or CBD has helped you or those you care for.
  • Read the FAQs.
  • Submit your comments by 11:59 PM EST on July 2, 2019.

DO NOT:

  • Do not try to address the entire FDA prompt. Address the areas that directly apply to your experience or body of expertise.
  • Don’t use profanity or casual, lingo-laden language. You’re speaking to government officials, after all. The more formal, specific, and detailed, the better. Personal stories are wonderful, but make sure to support your story with specific dosages so that the FDA has some data to work with.
  • Do not make up data. If there isn’t data to support your experience, state that plainly and encourage the FDA to facilitate crucial research in that area.

Zoe Sigman is Project CBD’s Program Director.


Copyright, Project CBD. May not be reprinted without permission.

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Americans Spent as Much on Cannabis as Taco Bell Last Year

It’s official: The Crunchwrap is losing ground to the blunt wrap.

With the opening of more and more state-legal markets, cannabis sales are quickly catching up with that of more established products, brands, and services. New data compiled by Marijuana Business Daily shows that Americans spent an estimated $10.4 billion on cannabis last year–about as much as they dropped at the country’s sixth-largest fast food chain, Taco Bell.

Just two years ago, cannabis sales in the US stood at about $6.7 billion.

That $10.4 billion in sales, which combines medical and adult-use markets, was nearly $2 billion more than in 2017. It was also nearly three times the $3.6 billion that Americans spent on e-cigarettes in 2018.

As the industry continues to expand–Illinois is poised to become the 11th state to legalize adult-use cannabis, and Texas just OK’d a massive expansion to its medical marijuana program–it seems only a matter of time until cannabis eclipses other sectors of the American economy. Already there are more legal cannabis-industry employees in the US than there are steelworkers.

Explosive Growth

A number of interconnected factors fueled the industry’s growth in 2018. Perhaps most notably, regulated adult-use sales began in California, making it the largest legal market in the country–perhaps the world. Meanwhile, Utah and Oklahoma opened their doors to medical cannabis, and the latter already has more registered patients than New York state.

As Leafly reported earlier this year, the cannabis industry added 64,000 jobs in 2018 alone, bringing the total number of legal cannabis workers up to nearly a quarter million. On the finance side, investors poured in nearly $10 billion.

“The gradual legalization around the world of a plant which humans have been happily consuming for millennia is creating one of the largest industry-growth phenomena in history,” said Tom Adams, the managing director and principal analyst at BDS Analytics. He’s not exaggerating: Just two years ago, cannabis sales in the US stood at about $6.7 billion.

Goldfish Crackers Today, NFL Tomorrow

The MJBiz analysis made a few other striking comparisons to help contextualize what $10 billion in sales looks like. For instance, it’s about 10 times the roughly $900 million that Americans forked out for Goldfish crackers. It’s just a sliver of the $72.2 billion spent on wine. And it’s more than twice what Americans paid to play the popular video game Fortnite.

Some of the most interesting data points in the report highlight the industries that cannabis is likely to surpass next. The NFL generated $15 billion in 2018, for example. Cannabis is almost guaranteed to blow past that figure in the next few years.

Online food deliveries, meanwhile, added up to $17 billion in 2018. Whether cannabis will pull ahead there remains to be seen–in part because more legal cannabis may in fact lead to more online food deliveries…

Whether cannabis will ever surpass the king of fast food, McDonalds ($36 billion), pizza ($46 billion) or alcohol ($254 billion!) remains to be seen. But no matter how the numbers play out, they tell us that when legal cannabis becomes available, people want it. A lot.

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Congressional Report Raises Questions About Whether Marijuana Impairs Driving

Concerns expressed by lawmakers that marijuana legalization will make the roads more dangerous might not be totally founded, a congressional research body said in a recent report. In fact, the experts tasked by the House and Senate with looking into the issue found that evidence about cannabis’s ability to impair driving is currently inconclusive.

While law enforcement has well-established tools to identify impaired driving from alcohol, developing technology to do the same for cannabis has proved difficult. Not only is the technology lacking, but questions remain as to how THC affects driving skills in the first place and what levels of THC should be considered safe.

“Although laboratory studies have shown that marijuana consumption can affect a person’s response times and motor performance, studies of the impact of marijuana consumption on a driver’s risk of being involved in a crash have produced conflicting results, with some studies finding little or no increased risk of a crash from marijuana usage,” the Congressional Research Service (CRS) wrote.

What’s more, “studies have been unable to consistently correlate levels of marijuana consumption, or THC in a person’s body, and levels of impairment.”

Both advocates and opponents of marijuana reform strongly support finding a resolution to the impaired driving detection issue. But experts aren’t so confident that researchers will be able to develop something akin to an alcohol breathalyzer, as the most promising attempts have only been able to determine whether a person has smoked within recent hours.

What’s striking about the report from Congress’s official research arm is that it repeatedly states it’s not clear that cannabis consumption is associated with an increased risk of traffic accidents. In general, the issue has been treated as something of a given in congressional hearings, with some lawmakers arguing that loosening federal cannabis laws would lead to a spike in traffic deaths.

That argument was echoed in a separate House Appropriations Committee report that was released on Monday. A section of the document described ongoing concerns about drugged driving “due to the increase in States legalizing marijuana use” and designated funds to help law enforcement identify impaired driving from cannabis.

The CRS report, which was published last month, signals that the problem isn’t quite as cut and dry as lawmakers might think.

Researchers have found on several occasions that traffic fatalities do not increase after a state legalizes marijuana.

Of course, that doesn’t change the fact that both opponents and supporters of legalization generally caution against driving under the influence.

“Cannabis inhalation in a dose-response manner may influence certain aspects of psychomotor performance, particularly in those who are more naive to its effect,” Paul Armentano, deputy director of NORML, told Marijuana Moment. “But this influence is typically short-lived and is far less acute than the psychomotor effects associate with alcohol.”

“By contrast, THC’s unique absorption profile and prolonged detection window in blood makes it so that–unlike as is the case with alcohol–the detection of THC in blood is not necessarily indicative of either recency of use or behavioral impairment,” he said.

The congressional report discusses the limitations of technology in detecting active impairment from cannabis and details previous studies on traffic trends in states that have reformed their cannabis laws. It also lays out legislative options for Congress to “aid policymaking around the issue of marijuana and impairment.”

As it stands, states have generally enforced impaired driving laws through one of two processes. Some states “require that the state prove that a driver’s impairment was caused by the substance or behavior at issue” while others have per se laws asserting that “a driver is automatically guilty of driving while impaired if specified levels of a potentially impairing substance are found in his or her body.”

But it’s significantly easier to prove impairment for alcohol however you cut it, the report explains.

“Detecting impairment due to use of marijuana is more difficult. The body metabolizes marijuana differently from alcohol,” the authors wrote. “The level of THC (the psychoactive ingredient of marijuana) in the body drops quickly within an hour after usage, yet traces of THC (nonpsychoactive metabolites) can still be found in the body weeks after usage of marijuana.”

Further there is “as yet no scientifically demonstrated correlation between levels of THC and degrees of impairment of driver performance, and epidemiological studies disagree as to whether marijuana use by a driver results in increased crash risk.”

Detecting impairment from cannabis is additionally complicated by another extraneous circumstance: variation in THC potency. The THC concentration conundrum is exacerbated by the fact that the only source of federal, research-grade cannabis “is considered by some researchers to be low quality,” the report stated, referring to studies showing that the government’s marijuana supply does not chemically reflect what’s available in state-legal commercial markets.

CRS also looked at the “inconsistent” results of studies examining the effects of cannabis use on traffic incidents. While some have indicated that consumption poses an increased risk on the road, the report argues that some may be conflating correlation and causation.

“Relatively few epidemiological studies of marijuana usage and crash risk have been conducted, and the few that have been conducted have generally found low or no increased risk of crashes from marijuana use,” CRS wrote.

After going through several other related issues, CRS laid out a couple of choices for Congress when it comes to dealing with the impaired driving issue. Those options include “continued research into whether a quantitative standard can be established that correlates the level of THC in a person’s body and the level of impairment” and compiling “better data on the prevalence of marijuana use by drivers, especially among drivers involved in crashes and drivers arrested for impaired driving.”

One of the last elements the report specifically focused on was federally mandated drug testing for individuals in “safety sensitive” jobs in the transportation sector. Interestingly, CRS seemed to suggest that, given the issues they outlined with respect to difficulties identifying active impairment from THC, the government should reevaluate whether suspensions for testing positive should be permanent.

“CRS could not identify any data on how many safety-sensitive transportation employees have lost their jobs as a result of positive tests for marijuana use,” the report states. “Considering the length of time that marijuana is detectable in the body after usage, and the uncertainty about the impairing effect of marijuana on driving performance, Congress and other federal policymakers may elect to reexamine the rationale for testing all safety-sensitive transportation workers for marijuana usage.”

“Alternatively, Congress and federal policymakers may opt to maintain the status quo until more research results become available,” the report advised.

Armentano, of NORML, said that legislators should be way of enacting policies focused on levels of THC or metabolites in drivers.

“As more states consider amending their cannabis consumption laws, lawmakers would best served to avoid amending traffic safety laws in a manner that relies solely on the presence of THC or its metabolites as determinants of driving impairment,” he said. “Otherwise, the imposition of traffic safety laws may inadvertently become a criminal mechanism for law enforcement and prosecutors to punish those who have engage in legally protected behavior and who have not posed any actionable traffic safety threat.”

Marijuana Legalization Not Linked To Increased Traffic Deaths, Study Finds

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