Year: 2020

The Food and Drug Administration (FDA) may soon change its tune on hemp-derived CBD (Hemp CBD) thanks to a bill recently filed by chairman of the House Agriculture Committee, Rep. Collin Peterson (D-MN) and cosponsored by Reps. Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME).

HR 5587 is an Act “To amend the Federal Food, Drug, and Cosmetic Act [(FDCA)] with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances.” As of the time of this writing, the bill’s text is not available on Congress.gov but is provided by Marijuana Moment’s Kyle Jaeger, who wrote a great article on the bill.

If passed in its current form, HR 5587 would amend the FDCA’s definition of dietary supplement (21 U.S.C. 321(ff)(3)(B)) as shown below in bold:

The term “dietary supplement” does not include—

(i) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or

(ii) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

The bill would also amend the FDCA to clarify that federal law does not prohibit a person from introducing Hemp CBD into interstate commerce, as shown by the proposed amendments to 21 U.S.C. 331(ll):

The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 355 of this title, a biological product licensed under section 262 of title 42, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)[.]

This would be a significant change as the FDA has long held that Hemp CBD cannot be classified as dietary supplement because the FDCA’s definition of dietary supplement explicitly exempts any article that is approved or investigated as a drug unless the article was marketed as a dietary supplement or food prior to being publicly investigated as a drug. The FDA’s view is that Hemp CBD was not marketed as such prior to the investigation of CBD as a drug. The FDA could deal with this through regulation, as the FDCA does grant the FDA Secretary the authority to regulate around the definition of dietary supplement. That hasn’t happened, though, and it appears that the FDA is running out of time.

HR 5587, as currently drafted, only would apply to Hemp CBD, not other cannabinoids such as CBN or CBG. The 2018 Farm Bill encompasses all hemp-derived cannabinoids in its definition of “hemp,” so HR 5587 could encompass more than just CBD without having to amend the Farm Bill. It’s likely that this bill was drafted in light of the CBD craze over the last few years, so it isn’t all that surprising that CBD is the only cannabinoid listed. If HR 5587 picks up steam, it will be interesting to see whether the language is revised to encompass other, less popular cannabinoids, in order to prevent recurring problems.

In addition to removing obstacles related to making Hemp CBD a dietary supplement, the bill would also require the US Department of Agriculture (USDA), in consultation with other federal agencies, to submit to Congress a study on the following:

the costs and requirements for establishing and operating a hemp testing program, including the costs and requirements for operating or contracting with a laboratory approved by the Drug Enforcement Agency;
the costs and requirements for the destruction of hemp crops determined to be in excess of 0.3 percent delta-9 tetrahydrocannabinol or opportunities for remediation or alternative uses;
the feasibility of producer compliance with sampling timetables;
the feasibility of producer compliance with reporting requirements; and
other known or potential challenges by the participation of States or producers in the domestic hemp production program.

It’s probably too early to tell whether this HR 5587 has a chance to become law. It was presented with bipartisan support, but the legislative process can be unpredictable. Even if this bill does eventually become law, it will likely be subject to significant changes along the way. We simply don’t have enough information at this point to know what will happen.

We do know, however, that HR 5587 sends a clear message to the FDA, and to a lesser extent to the USDA, that lawmakers are not pleased with the treatment of hemp. For the FDA, this seems to be based on the agency’s continued hostility towards Hemp CBD. For the USDA, it seems that lawmakers have heard the backlash against the USDA’s testing requirements including the need to test for total THC at DEA-certified labs.

Remember, federal agencies only exist because of federal lawmakers. They are creatures of statute, statutes that were crafted by lawmakers in Congress. If agencies fail to interpret a statute in the way the legislature wants, it has the unique power to amend the statute. That’s what is happening here.

This may seem like an outright rebuke, but in all fairness to the FDA, former commissioner Dr. Scott Gottlieb has told Congress that a legislative change may be needed in order for the FDA to regulate Hemp CBD in a timely manner. In addition, the USDA has publicly stated that testing hemp for THC content has proved challenging.

We’ll keep an eye on HR 5587 and all things Hemp CBD. 2020 is likely going to be another big year for cannabis, especially at the federal level. Stay tuned.

Conroe Law Office John E Choate, Jr
Call for FREE Consultation 936.441.2999

https://www.cnn.com/2020/01/02/business/cannabis-breathalyzers-are-coming-to-market/index.html

As a growing number of states legalize cannabis, health officials are increasingly sounding the alarm for technology that can quickly determine when drivers are stoned.A solution for measuring alcohol intoxication has existed since 1954: the Breathalyzer. No such technology yet exists for cannabis, but several tech startups and university scientists say they’re close to commercializing something resembling a cannabis breathalyzer. Still, others are quick to caution the answer is not that simple. Critics note the technology must detect recent cannabis use and also prove that cannabis in a person’s system impaired his or her driving. A cannabis breathalyzer that does both of those things has proven elusive, because, unlike alcohol, cannabis can stay in people’s bodies long after their “high” has worn off. Cannabis’ largest trade show is pretty ordinary, and that’s what the industry wants“We’re applying the alcohol rules to a substance that doesn’t play by them,” said Nick Morrow, a retired Los Angeles Sheriff’s Department narcotics investigator who now serves as an expert witness in areas such as drug symptomology and field sobriety testing.

Some legalization advocates and lawmakers want cannabis to be regulated like alcohol and a handful of states have established “per se” limits making it inherently illegal to drive with specific concentrations of the psychoactive cannabis compound delta-9-tetrahydrocannabinol (THC) in one’s system. Although the effects of alcohol have been extensively researched, the same can’t be said for cannabis.Some studies have shown that cannabis consumption can affect response times and motor performance; however, research remains limited and there isn’t conclusive evidence of how cannabis affects people and how to classify impairment. “The National Transportation Safety Board has advised that ‘about two alcoholic drinks’ within an hour will cause a 160-pound male to experience decline in visual functions and in the ability to perform two tasks at the same time,” wrote David Randall Peterman, Congressional Research Service transportation analyst, in a May 2019 report on cannabis use and driving. “Based on current knowledge and enforcement capabilities, it is not possible to articulate a similarly simple level or rate of marijuana consumption and a corresponding effect on driving ability.”

How cannabis can be detected in breath

Yet several companies and scientists say they’re close to a breakthrough: They’ve made advancements in detecting and capturing THC in breath, where it can linger for two to three hours. In July, Clinical Chemistry published the findings of a University of California-San Francisco study that showed THC could be detected in breath for up to three hours after smoking and that there’s a correlation between THC concentrations and blood concentrations for that initial period. The study was sponsored by Oakland, California-based Hound Labs, a venture capital-backed company that has raised $65 million to develop a dual alcohol and THC breathalyzer.

Hound Labs’ THC breathalyzer After a person blows into the handheld Hound device for two minutes, the cartridge is read in a separate bay that acts like a mini mass spectrometer, which can measure the mass and concentration of specific molecules. If THC is detected, the word “warning” will display on the screen. The Hound device is intended to capture and measure tiny particles of THC in human breath to help determine if someone consumed cannabis in the two-to-three hours prior to testing. “We aren’t measuring impairment, we’re measuring THC in breath where it lasts a very short period of time, providing objective data about THC in breath to law enforcement and employers to use in conjunction with other information they have gathered,” said Hound Labs founder Mike Lynn, an emergency room doctor, reserve deputy sheriff and venture capitalist.

The problems with testing drivers for cannabis

Cannabis compounds, notably THC, don’t behave like alcohol does in the body. Alcohol is classified as a depressant that can slow down the nervous system. It’s quickly absorbed in the blood and metabolized quickly, according to the CRS report.Cannabis has a complex interplay with the body’s endocannabinoid system, and its effects can be either immediate or delayed depending on the form of consumption. THC potency can vary in strains and in products. Hybrid strains can be bred to enhance certain effects such as pain relief, anxiety reduction and muscle spasticity, Morrow said, adding that people can have different reactions to cannabis’ effects.Minimal research exists on how cannabis affects driving. Although some of the most notable cannabis research has occurred in Israel, there are longstanding complaints that federal research in the US has been hindered by low-potency and poor-quality cannabis samples. It’s yet to be determined exactly how the hundreds of other compounds in the cannabis plant could potentially affect the testing processes. Further complicating matters are attitudes that it’s safer to drive while high than it is drunk.It’s been difficult to detect and capture THC in breath, leading to some skepticism about the accuracy of the early stage breathalyzers. A battery of peer-review studies showing the devices in action would go a long way, said Brian Clowers, an associate professor of chemistry at Washington State University. The elephant in the room remains that the devices do not determine impairment. Someone could conceivably use or consume a small dose without being high, yet still could have THC detected in their breath. Because pass-fail tests do not prove impairment, that can create problems for patients in the more than 30 US states where cannabis is a legal medicine, said Benton Bodamer, an M&A, private equity and cannabis attorney at Dickinson Wright’s office in Columbus, Ohio.”That’s a recipe for a public health disaster,” he said. “There’s not a pass/fail opioid breathalyzer, so why would some different rules apply in the context of medical cannabis?” Additionally, even the seemingly tried-and-true drug and alcohol tests haven’t been completely foolproof and some states have tossed driving-under-the-influence convictions for technology failures such as poor calibration.An alcohol giant cut bait on a big craft beer holding. What’s next for its even bigger cannabis investment?“Scientific precision requires the absence of bias, for example,” he said. “One look at the mass prosecution, conviction, and incarceration of communities of color for simple non-violent drug possession shows how that particular story ends.”And the issue of impairment is not limited to cannabis.”Anybody who believes you’re going to look at alcohol or other drugs in a vacuum is mistaken,” said Sheriff Justin Smith, of Larimer County in northern Colorado. Smith said that his office continues to see more incidences in which suspects were under the influence of multiple drugs. Some polydrug tests have been increasingly adopted following cannabis legalization. That’s been the case for healthcare company Abbott’s SoToxa rapid mobile drug screening test. The handheld device, which analyzes a saliva sample in five minutes, is being used in Canada, Spain and US states such as Michigan, Alabama and Oklahoma, said Fred Delfino, Abbott’s senior law enforcement liaison.”Because marijuana isn’t the only drug that can cause impairment, Abbott has engineered SoToxa to detect if someone has also recently used cocaine, opiates, benzodiazepines, amphetamines, and methamphetamine, in addition to marijuana,” he said via email.Colorado and other states that legalized cannabis are also turning to Drug Recognition Experts, law enforcement officers that undergo special training to help determine if a person is too impaired to drive.

When cannabis breathalyzers will become available

Research is ongoing. Some scientists are looking at non-traditional and less-invasive roadside approaches to detect impairment from cannabis and other substances. “There’s a really strong push in the field to see what we can do to better determine impairment and behavioral function rather than just rely on fluid measures,” said Thomas Marcotte, the co-director of the Center for Medicinal Cannabis Research at UC-San Diego.In the state-funded study at UCSD, scientists are researching whether cognitive assessments on an iPad could aid in field sobriety tests for cannabis-impaired driving. Other clinical trials under way include the establishment of cannabis-specific field sobriety tests and the development of virtual-reality-enabled eye-movement sensors. Research takes time, but there’s a kneejerk reaction to want to implement newly created devices, said Morrow, the former narcotics investigator. Technology and toxicology are not always the answers, he said. “Under the influence signs are not necessarily proof of impairment. Use of marijuana is not a crime. You can drive with bloodshot eyes. You can drive smelling like marijuana. You can drive with an elevated pulse or slightly dilated pupils,” he said. “Under the influence signs along with clear evidence of physical and mental impairment sufficient to affect the operation of a motor vehicle are what is necessary to competently opine a person is impaired due to a particular substance.”If the Hound breathalyzers make their way to market early next year as announced, they initially could see more use on job sites than the roadside. Companies across a variety of industries — and especially those in which workers use vehicles or heavy machinery — expressed interest in the device, Lynn said. Hound Labs’ digital drug sniffer is touted as leading the pack, but other breathalyzer devices appear not to be far behind. Earlier this year, University of Pittsburgh researchers announced they advanced a technology previously used to analyze and identify breath biomarkers for asthma, halitosis and diabetes. Professors Alexander Star and Ervin Sejdic used carbon nanotubes and machine learning to ferret out THC molecules in breath.

Ervin Sejdic (left) and Alexander Star (right) hold the THC breathalyzer prototype they developed at the University of Pittsburgh.The handheld device is designed to measure the electrical resistance of semiconductor-enriched carbon nanotubes that are 100,000 times smaller than a human hair and are good at conducting electricity. THC and other compounds bind to the surface and change the electrical acoustics. A mathematical algorithm was applied to increasingly select THC over other more volatile components found within breath such as carbon dioxide, water and ethanol. The Pitt crew’s findings were published in the American Chemical Society’s ACS Sensors journal in July.”The device is more or less ready [for a company to commercialize it],” Sejdic said. Drug testing company Lifeloc Technologies (LCTC) earmarked real-time drug tests, notably a THC breathalyzer, as a top priority for research and development dollars. Dräger, an industry leader in the drug testing field, was watching closely as to how this area develops, Brian Shaffer, a company spokesman, told CNN Business last fall.And several breathalyzer technologies are under development in Canada, where adult-use cannabis was legalized in 2018. Nanotechnology is the backbone for startup SannTek Labs’ handheld breath test. Cannabix Technologies (BLOZF) is partnering with researchers at the University of Florida and the University of British Columbia to develop two THC breathalyzer devices, including one that that potentially could be 3D-printed.”It’ll likely be that there will not be one de facto technology,” said Rav Mlait, Cannabix’s chief executive officer.