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Colorado’s Hemp Program Must Change to Fit USDA Rules

Most hemp farmers across the country got a big boost when the United States Department of Agriculture released its first round of industrial hemp regulations earlier this week; the new rules took effect today, October 31.

“I applaud the USDA for moving forward on hemp rulemaking and recognizing hemp production as an agricultural activity,” Senator Cory Gardner said in a statement after the regulations were announced. “Legalized hemp has the potential to be a major boon to agricultural communities across Colorado, giving farmers another viable and profitable option for their fields.”

But for farmers in states like Colorado, where hemp has been an established crop for almost five years, the new rules might not seem so progressive.

The language of last year’s Farm Bill, the measure that legalized hemp, permits states to submit plans for their own hemp regulations, follow the USDA’s regulations, or ban hemp production altogether. While the Colorado Department of Agriculture has indicated that it will submit a new hemp plan to the USDA in 2020, the state ag department had already implemented its own plan long before hemp was legalized federally late last year, and under that plan, Colorado became of the largest hemp-producing states in the country.

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Shawn Hauser, a hemp attorney with Vicente Sederberg, says that Colorado will have to alter some of its hemp regulations to align more closely with the USDA regulations, and that could mean tighter rules for this state’s farmers. Under the new, USDA-approved regulations, Colorado hemp farmers are likely to face stricter testing requirements for THC levels, she says, and have less opportunity to mitigate hot hemp, or plants that test above the federal government’s maximum allowable level of THC (0.3 percent) in industrial hemp.

“The way the federal regulations are set up, they’re going to affect every state significantly. Testing and sampling, specifically, are different from what most states have in practice,” Hauser explains. “Federal rules are pretty strict with requiring hot hemp to be destroyed by a DEA agent. There is no opportunity for remediation or correction.”

The new FDA rules do allow a “measurement of uncertainty” for farmers, which could let plants reach as high as 0.5 percent THC and still be considered acceptable by the USDA. However, industry supporters and farmers alike have been pushing for a 1 percent THC limit for some time.

Colorado farmers are currently given a couple of weeks to lower plants’ THC levels if they test too high, but hemp’s legalization and close connection to marijuana has spurred concerns of increased black market marijuana activity among law enforcement in certain states. Hauser suggests that states like Colorado and Oregon — both of which have legal and established marijuana industries — are better prepared to deal with such concerns, but she adds that more evolved markets are better prepared to roll with federal changes, too.

“Colorado and other states, because they’re mature and have gone through these trials, kind of understand there is a need for remediation,” she adds. “But because Colorado has one of the most mature industries, some of the hemp markets have anticipated these changes.”

Federal hemp regulations that mandate 100 percent of hemp harvests to undergo THC testing would likely require more CDA staff, Hauser says, as this state’s agriculture department only has enough bandwidth to test about 25 percent of hemp crops right now. Further, the USDA rules call for such testing to take place at labs certified by the Drug Enforcement Administration — and there aren’t many.

And if hemp farmers lose their crops because of high THC levels, there’s little that could help them in the form of insurance, as the new federal crop insurance program for hemp isn’t likely to cover high THC levels, according to industry representatives.

Although the USDA rules are officially implemented today, the rules are only for the interim and will be replaced in two years; states have a year to either comply or send in their respective proposals for hemp regulations. The CDA’s Colorado Hemp Advancement and Management Plan (CHAMP), a committee created by Governor Jared Polis to advance hemp policy in Colorado, will send the state’s hemp proposal to the USDA within the next few months in hopes of fully complying with the USDA by the 2020 farming season, according to Hauser.

“There are some areas for improvement, especially around testing, disposal and sampling,” Hauser says. “There is a public comment period — it’s incredibly significant for legalized hemp farmers — so it’s more important than ever to engage with the industry.”

One of Colorado’s largest hemp brands doesn’t see the USDA’s changes as a hindrance, welcoming the long-awaited federal guidance. According to Derek Thomas, vice president of business development for Veritas Farms, the USDA’s regulations will usher in a more defined and legal marketplace nationwide, which in turn will help Colorado’s hemp industry grow.

“Inside of the Colorado ecosystem, not much is going to change. Colorado has had a very robust legislative framework from the onset, and a lot of states have replicated that model,” he says. “Not a lot in Colorado will change too much. However, outside of Colorado, things like interstate commerce will see a lot less restriction from the federal government.”

With the USDA nearing completion of its hemp regulations, Thomas says the next domino that must fall is held by the Food and Drug Administration, the federal body responsible for regulating products with CBD and other cannabinoids derived from hemp. Currently, the FDA views CBD as an illegal ingredient for products meant for human and animal consumption, but admits that the agency lacks resources to enforce the policy as the largely unregulated CBD industry booms.

Veritas has deals with national drugstore chains to sell its CBD-infused lotions and topicals (products that are legal under FDA standards), but Thomas says that finding national carriers to sell its CBD tinctures and edibles is much harder in the current landscape.

“The big piece that is lingering now from the federal government is the FDA,” he says. “Most national chains are sticking to the wait-and-see model for guidance form the FDA, but we’ve seen a lot of regional retailers take interest in CBD ingestibles as we wait.”


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Stricter Rules Loom Over THC Vape Products in Colorado

The recent outbreak of lung illnesses connected to THC vaporization products is pushing the Colorado Marijuana Enforcement Division to implement new regulations that could include the prohibition of certain vaping additives in the regulated marketplace.

New rules banning the production and sale of cannabis vape products containing polyethylene glycol (PEG), vitamin E acetate and medium chain triglycerides (MCT oil) were proposed by the MED on October 7, according to the agency, with the proposed rules up for public discussion on Tuesday, October 15.

The proposed regulations also include additional labeling requirements for concentrates or products intended to be inhaled through a vaporizer or metered dose inhaler, according to MED rule-making documents, mandating that vaping additives be listed on the label, which would also be required to include the statement “Not approved by the FDA.”

Although most members of the pot industry expect the ban to be approved, MED spokesperson Shannon Gray notes, “These are proposed rules, which are not in effect until adopted and signed by the State Licensing Authority.”

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After weeks of reports of lung illnesses suffered by consumers of nicotine and THC oil vaping products, public health officials face more pressure to react — but a definitive cause of the problems hasn’t been identified. On Friday, October 11, Centers for Disease Control and Prevention Deputy Director Anne Schuchat announced that 1,299 cases across the country, 26 of them ending in death, have been linked to vaping since the outbreak began, but health officials continue to look for exactly which chemicals or devices are leading to the health issues.

Most of the deaths and hospital visits are linked to THC vaping products obtained on the black market, made with the additives in the MED’s crosshairs as well as toxic pesticides and other harmful chemicals. As of October 2, nine reported hospitalizations in Colorado have been linked to vaping, with some patients reporting THC use and others citing nicotine. While the vast majority of hospitalizations for THC products have been linked to black-market cartridges with traces of harmful pesticides and additives, at least one death was reportedly connected to a legal product purchased from a dispensary in Oregon.

The chemicals banned by the MED haven’t been explicitly fingered as the culprits, but some cannabis business owners and health officials aren’t waiting until they are. In late September, Medicine Man dispensaries announced that its stores would no longer sell pre-filled vape cartridges containing vitamin E or PEG. The dispensary chain’s parent company, Medicine Man Technologies, was a leading force pushing the MED’s proposed ban.

“That’s just a start. It’s a good start, but they should also ban propylene glycol and vegetable glycerin,” says MMT chemistry director Dr. Tyrell Towle. “They’re not necessary to be used with cannabis for vaporization. You can create products for vaporization that don’t have these additives.”

According to Towle, the Colorado Department of Public Health and Environment’s cannabis science and policy work group — which comprises public health officials and industry stakeholders — had been trying to define potentially dangerous vaping additives and ingredients over a year ago, but “it wasn’t as pressing at the time, and there was a lot of pushback from industry members who still used some of those ingredients,” he notes.

“We can always bring them back if we can get the research funding and do eventually find out these are safe, although I doubt they are,” Towle adds.

The proposed vaping restrictions are part of a much larger set of new regulations that have been part of MED rulemaking throughout the summer and fall, including requirements for social consumption business licenses and dispensary delivery services. 


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‘Lion King’ Rules Overseas Box Office, $300M+ Weekend Expected

Adding in Thursday’s take, Jon Favreau/Disney’s beast of a summer blockbuster The Lion King has come up with $ 130.5 million at the box office — including $ 76.6M from China, where it opened last week, and $ 53.9M from 42 other overseas markets which opened Wednesday and Thursday such as Brazil and Russia. The film has scored the No. 1 spot in all its Thursday opening zones.

Adding to Lion King’s pride were milestone openings in several countries on Wednesday, including the 2nd highest debut of the year in France ($ 4.8M, Disney’s 2nd biggest live-action open behind Avengers: Endgame), Germany and S. Korea — more than double the opening results for live-action Beauty and the Beast and The Jungle Book revamps.

The roaring new release is now in U.S. theaters, and is expected to surpass $ 300M globally through Sunday, which will mark 10 days in release in China.

[Source: Deadline]

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Tough E-Cig Rules Might Push Folks Back to Smoking

By Steven Reinberg
HealthDay Reporter

TUESDAY, July 16, 2019 (HealthDay News) — Banning flavors and lowering nicotine levels in electronic cigarettes is a strategy that could backfire, a new study suggests.

Without those draws, many people would vape less and smoke more tobacco cigarettes, researchers claim.

“Some regulations on e-cigarettes, like making safer batteries, would benefit the general public,” said study author Lauren Pacek. She’s an assistant professor of psychiatry and behavioral sciences at Duke University School of Medicine in Durham, N.C.

But others, like reducing nicotine, might prompt adults to cut down or quit e-cigarettes and smoke more tobacco cigarettes, Pacek said.

The U.S. Food and Drug Administration has taken steps in the past year to try to make e-cigarettes less appealing to youth, following a huge surge in teen use of the devices.

For this new study, which was funded by the U.S. National Institutes of Health, Pacek and her team surveyed 240 young adults aged 18 to 29 who used both e-cigarettes and tobacco cigarettes.

In the online survey, participants were asked what they would do if the sale of flavored e-cigarettes were limited; if e-cigarettes didn’t contain nicotine, and if they couldn’t adjust the amount of nicotine or the temperature of the vapor.

If nicotine was not in e-cigarettes, 47% of the participants said they wouldn’t use them as often and would smoke more tobacco cigarettes.

If the ability to customize e-cigarettes was no longer available, 22% said they would use e-cigarettes less and smoke tobacco cigarettes more. About 17% said if e-cigarette flavors were limited to tobacco and menthol, they would do the same.

Pacek said that the FDA is now looking at reducing the level of nicotine in tobacco cigarettes to a very low level. Nicotine cannot be eliminated entirely, because that’s beyond the FDA’s authority, she explained.

“The level would be so low that smokers cannot smoke enough cigarettes to get the amount of nicotine that they’re craving,” she said.

Pacek has taken part in large trials in which people used low-nicotine cigarettes. Contrary to what you might expect, people actually smoked fewer cigarettes, she said.

Continued

It’s possible that if nicotine was reduced in tobacco and e-cigarettes, people would seek their nicotine fix elsewhere, Pacek said.

On the positive side, Stanton Glantz, director of the Center for Tobacco Control, Research and Education at the University of California, San Francisco, said that removing flavors and nicotine reduces the use of e-cigarette, which is a plus.

Because this study is so small and the questions hypothetical, its ability to predict an actual increase in smoking tobacco cigarettes isn’t firm, said Glantz, who had no part in the research.

“Flavors are absolutely crucial to attracting kids to e-cigarettes,” he said. “The evidence on adult use of flavors is very limited.”

Glantz believes that flavor bans on e-cigarettes and tobacco cigarettes would result in people using both these products less.

Studies of reduced nicotine cigarettes have found that people tend to quit rather than smoke more, Glantz said. “Reducing the nicotine levels in cigarettes looks like it would lead more people to quit,” he said.

San Francisco has banned e-cigarettes and flavors in all tobacco products including menthol, Glantz said. He thinks this will result in more people giving up tobacco altogether.

The ban on e-cigarettes will remain in effect only until the FDA’s regulations on e-cigarettes are enforced, he said.

The report was published July 15 in the journal Substance Use & Misuse.

WebMD News from HealthDay

Sources

SOURCES: Lauren Pacek, Ph.D., assistant professor, psychiatry and behavioral sciences, Duke University School of Medicine, Durham, N.C.; Stanton Glantz, Ph.D., professor, medicine, Center for Tobacco Control, Research and Education, University of California, San Francisco; July 15, 2019,Substance Use & Misuse

Copyright © 2013-2018 HealthDay. All rights reserved.

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