Medical Cannabis Use Associated With Reduced Opioid Use In Pain Patients, Finds Study

The use of medical cannabis for at least a month is associated with reduced opioid use in pain patients, according to a new study.

The study, titled Opioid dose reduction and pain control with medical cannabis, was published by the Journal of Clinical Oncology. It was conducted by researchers at the Kymera Independent Physicians medical group.

For the study, “A retrospective cohort was evaluated to understand the pattern of care and QOL [quality of life] outcomes with MC [medical cannabis] use across rural multidisciplinary practices in New Mexico. ” QOL questionnaire included a graded pain scale, and “morphine equivalent (ME) dose was used to estimate changes in opioid dose.” ODR was defined “as any reduction of baseline opioid dose.” A chi-square was performed to evaluate associations.

“A total of 133 patients were identified between Jan 2017- May 2017. (M/F) 65/68; median age of 53 (range 20 – 84)”, states the study. “Nineteen percent (25/133) had a cancer diagnosis. Pain score improved in 80 % of patients with cancer and in 75% (64/89) of non-cancer patients (x2 0.24 p = 0.62).”

Opioid dose reduction (ODR) was achieved in 41% of all patients using medical cannabis. Of these, “63% (34/54) had a 25% ODR and 37% (20/54) had 26% or more ODR (x2 12.8 p = 0.002). In cancer patients, a 25% ODR was achieved in 73% (x2 0.51 p = 0.771).”

Researchers state that “All patients (15/15) using MC and high dose opioid (morphine equivalent ≥ 50 mg/day) had some ODR. Co-adjuvant NSAIDs [nonsteroidal anti-inflammatory drug] with MC improved pain score in 67% of all cases vs 33% among non-NSAID cohort (x2 10.7 p = 0.001). ODR was achieved in 32% of patients with active depression vs 68% of patients without (x2 0.044 p = 0.83).”

The study concludes by stating that “In this rural cohort, MC use led to ODR in 41% of all patients.”

Click here for more information on this study.

The post Medical Cannabis Use Associated With Reduced Opioid Use In Pain Patients, Finds Study appeared first on TheJointBlog.

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What the 2018 Farm Bill Could Mean for CBD in California

The federal 2018 Farm Bill is likely to become law in the very near future. If it does, it will redefine the hemp industry nationwide. We intend on writing more in the near future as to the specifics of the 2018 Farm Bill, but one interesting question is what effect it will have on California’s industrial hemp and CBD policies.

As anyone in the California hemp business knows, the Department of Public Health (“CDPH”) issued a FAQ policy guideline over the summer which took the position that industrial-hemp derived CBD in food products is unlawful. The FAQ justified this position in part because the federal Controlled Substances Act included industrial hemp as a Schedule I drug, and in part because the federal Food and Drug Administration (“FDA”) had concluded that it was unlawful to place THC or CBD into food products.

The 2018 Farm Bill, if it passes, will essentially amend the Controlled Substances Act to take industrial hemp out of the definition of marijuana. In essence, this would make industrial hemp derived products lawful products. The question then is: Will the 2018 Farm Bill negate the FAQ?

The answer is probably not. Even though the Controlled Substances Act may be amended and some of the underlying support for the FAQ may be undermined, that won’t change the fact that the FDA has not concluded that CBD in food products is lawful. While the CDPH certainly could change its position, the de-scheduling of industrial hemp won’t necessarily change the FDA’s positions right away. In the meantime, it’s safe to conclude that the FAQ still stands.

Ultimately, the 2018 Farm Bill is likely to have far-reaching impacts throughout the industrial hemp industry. We’ll make sure to keep you updated along the way.

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Study: Marijuana Stores Associated With Increased Home Values

Medical and recreational marijuana dispensaries are associated with a significant increase in home value, according to a new study published by the journal Contemporary Economic Policy.

(Photo: DenverHomeLender.com).

For the study, titled The effect of marijuana dispensary openings on housing prices, researchers evaluated “the effect of medical and recreational dispensary openings on housing prices in Denver, Colorado.” Using an “event study approach”, they found that “the introduction of a new dispensary within a half‐mile radius of a new home increases home prices by approximately 7.7% on average.”

The study notes that this effect “diminishes for homes further from new dispensaries but is consistent over time.” Researchers conclude by stating that “Our results provide important and timely empirical evidence on the socioeconomic impacts of marijuana legalization.”

More information on this study, conducted by researchers at Colorado State University, can be found by clicking here.

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U.S. Congress Approves Bill to Legalize Hemp, Sending it to President Trump

Both the U.S. House of Representatives and Senate have passed the 2018 Farm Bill, which includes a provision to legalize hemp throughout the country.

The 2018 Farm Bill was passed by the House today by a vote of 369 to 47. The vote comes a day after the Senate approved the same bill 87 to 13. Now that it’s been passed by the full Congress it will be sent to President Trump, who has said he will sign it into law once given the opportunity.

The legislation is a wide-reaching bill that covers many facets of the farming industry. A provision in the measure, put forth by Senate Majority Leader Mitch McConnel, removes hemp from the federal list of controlled substances. This effectively legalizes it throughout the country, allowing farmers to grow it as they can any other agricultural commodity such as tomatoes.

Once the law takes effect hemp will become legal for the first time in decades.

According to congressional research, the hemp market consists of over 25,000 various products ranging from textiles to food products. Despite its cultivation being illegal, the United States imports roughly half a billion dollars in hemp each year from other countries.

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Breaking News: Industrial Hemp Legalization is Happening!

At long last, it’s finally happening: The 2018 Farm Bill has made it out of conference and been approved by the Senate. It currently awaits approval from the House, which is expected this week. If Donald Trump signs the 2018 Farm Bill before the current legislative session ends on December 21, industrial hemp will be legal under U.S. federal law. Though we still are likely a few years out from full marijuana legalization, it appears that 2019 is going to be the “Year of Hemp” if Washington D.C. can make this happen before the deadline. Now, we’ll turn to the long awaited hemp-related text of the 2018 Farm Bill, as agreed to by the House and Senate. A copy of the full 2018 Farm Bill is available, via the U.S. Hemp Roundtable, here.

Some key provisions of the 2014 Farm Bill remain. “Industrial hemp” still means parts of the cannabis plant, whether growing or not, with less than 0.3% THC on a dry weight basis. Cannabis with more than 0.3% is still considered marijuana and is still classified as a schedule I substance. Additionally, the 2014 Farm Bill’s hemp provisions will continue for a year after the 2018 Farm Bill is signed. That means that the agricultural pilot programs that we know and love will stick around for a little bit longer.

However, the new version of the Farm Bill differs significantly in that industrial hemp is explicitly defined to include “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers” of industrial hemp. Technically, this isn’t necessarily a change in the sense that industry stakeholders (including yours truly) have long interpreted the 2014 Farm Bill to make derivatives and cannabinoids from industrial hemp legal. Now that interpretation has been codified into US law.

The CSA will also explicitly exempt “hemp” from the definition of marijuana. That means that the CSA will acknowledge two different types of cannabis, hemp and marijuana. Hemp is an agricultural commodity. Marijuana is a controlled substance. The problems that plague the marijuana industry including the lack of access to banking, bankruptcy, and federal intellectual property protections should no longer impact businesses dealing solely in industrial hemp. This distinction will also likely lead to increased research by the FDA and other agencies, and remove any question as to whether industrial hemp producers are subject to IRC 280e, which prohibits the taking of deductions related to the trafficking of Schedule I or II controlled substance.

The questions of the interstate transfer of industrial hemp is also addressed. Section 10114 of the 2018 Farm Bill states the following:

TRANSPORTATION OF HEMP AND HEMP PRODUCTS. — No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (as added by section 10113) [the provisions on industrial hemp] through the State or the territory of the Indian Tribe, as applicable.
This is a major development as the 2014 Farm Bill did not require states to make any distinction between hemp and marijuana. The new provision means that states that don’t adopt an industrial hemp program cannot interfere with the transportation or shipment of industrial hemp. Though this may not go so far as to require each state to allow the sale of industrial hemp or hemp products, including Hemp-CBD, it does prevent states from interfering with the distribution of industrial hemp.

The 2018 Farm Bill also gives Indian tribes the authority to regulate industrial hemp. This is an important change as the Menominee tribe, who’s territory falls within the state of Wisconsin had its initial hemp crop destroyed by DEA agents. A Federal Court ruled that the 2014 Farm Bill required that hemp be cultivated in compliance with state law and therefore, because Wisconsin had not implemented an agricultural pilot program to research industrial hemp, that the Menominee tribe could not legally cultivate hemp. The 2018 Bill explicitly gives tribes the ability to implement programs allowing the cultivation of industrial hemp.

One of the reasons the 2014 Farm Bill’s hemp provisions have been so murky is that no federal agency was given regulatory authority over hemp. The 2018 Farm Bill addresses this by appointing the United States Department of Agriculture (USDA). The USDA will oversee a state or tribe’s regulatory authority over industrial hemp. The state or tribe will submit a plan to monitor and regulate the production of industrial hemp and the USDA will have 60 days to review the plans. Plans must track the land where hemp is cultivated, procedures for testing hemp and disposing of non-compliant hemp, and indicate how the state will enforce against violations of the 2018 Farm Bill.

The 2018 Farm Bill covers penalties for violations of approved state or tribal plans and breaks them into the following categories:

  • Negligent Violations occur when a hemp producer unintentionally violates a state or tribal plan for hemp cultivation by failing to provide a legal description of the land where hemp will be cultivated, failing to obtain the required license or authorization from the state or tribe, or produces cannabis with more than 0.3% THC. Producers who commit a negligent violation shall enter into and comply with a plan established by a state or tribe to correct the violation. The corrective action plan must include a date by which the producer corrects the violation and require that the producer periodically report to the state or tribe on compliance for no less than two years. Producers who commit negligent violations will not be subject to criminal or civil enforcement action beyond agreeing to submit to a corrective action plan. However, if a producer commits three negligent violations within a five-year window
  • Other violations occur when a hemp producer acts with a “culpable mental state greater than negligence.” Other violations could cover things like intentionally growing THC-rich marijuana under the guise of industrial hemp or completely disregarding the industrial hemp rules. Other violations will be referred to the Department of Justice or the “chief law enforcement officer of the State” where the industrial hemp is grown.

The 2018 Farm Bill will prohibit “any person convicted of a felony relating to a controlled substance” under state or federal law before, on, or after the date when the Farm Bill passes to produce hemp under the 2018 Farm Bill or participate in a state or tribal hemp program for a period of 10 years following the date of conviction. This prohibition will not apply to any person lawfully growing hemp with a license, registration, or authorization under a 2014 Farm Bill agricultural pilot program prior to the 2018 Farm Bill enactment. In addition, anyone who makes a false statement on an industrial hemp application will also be banned from the industry.

Finally, the 2018 Farm Bill would also extend federal crop insurance coverage to industrial hemp, meaning that the feds will actually insure a cannabis crop. Hemp producers can also apply for USDA certification and grants, as with other agricultural commodities.

Expect us to write more on this in the near term. This is an important day in the history of cannabis reform and will have a major and positive impact on the cannabis industry.

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Colorado Supreme Court to hear arguments in case that will decide future of pot-sniffing police dogs

On Wednesday, the Colorado Supreme Court will hear oral arguments in a case that will set standards for the use of police dogs’ drug-detection skills in this state — and could have repercussions across the country.

The post Colorado Supreme Court to hear arguments in case that will decide future of pot-sniffing police dogs appeared first on The Cannabist.

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Six alleged illegal retail pot shops busted in Colorado Springs; $1.375M seized, police say

Business was booming at several Colorado Springs marijuana shops, despite local ordinances that prohibit the retail sale of marijuana and pot products. Following a lengthy investigation, multiple executed search warrants, an arrest and additional arrest warrants issued, police on Tuesday said cash seized from the alleged illegal businesses came out…

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New Zealand Legalizes Medical Marijuana

New Zealand’s parliament on Tuesday passed legislation to legalize medical marijuana through its third and final vote.

The legislation will now go through Royal Assent (a formality for a measure to become law), and will take effect the following day. Rules to regulate licensing and quality standards will be established in the next 12 months, reports the Marijuana Business Daily. The bill also removes cannabidiol as a controlled drug, instead making it a prescription medicine.

The initial bill would have allowed for cannabis use by anyone with a diagnosed terminal illness – which would have greatly limited its application. That was broadened in the final months of debate to include any patient requiring palliation.

Health Minister Dr. David Clark said that will open the door to medical marijuana use for approximately 25,000 New Zealanders.The expansion allows patients to “procure, possess, consume, smoke or otherwise use any plant or plant material of the genus cannabis or any cannabis preparation,” according to the Misuse of Drugs (Medicinal Cannabis) Amendment Bill.

A certificate from a medical practitioner or nurse practitioner will be required.

According to the law, the regulations “must not require that the variety of cannabis contained in the product was brought into New Zealand with authorization, if the variety is established in New Zealand at the time the product is manufactured or produced.”

In other words, medical cannabis strains currently used in New Zealand illicitly will have a path to be brought into the legal market.

“People nearing the end of their lives should not have to worry about being arrested or imprisoned for trying to manage their pain,” Clark said. “So as a compassionate measure we are also creating a statutory defense for people eligible to receive palliation so that they can use illicit cannabis without fear of prosecution.

“These medicinal products will be available on prescription. This will be particularly welcome as another option for people who live with chronic pain.”

In 2019, the Ministry of Health plans to consult the public on the quality standards, licensing system and regulations required as part of New Zealand’s medical cannabis scheme.

The post New Zealand Legalizes Medical Marijuana appeared first on TheJointBlog.

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CBD Companies Should Prepare Now for Product Liability Claims

We counsel our cannabis (and non-cannabis) clients extensively on product liability issues, and have warned them that the federal illegality of their products will not shield them from the same products liability risks faced by companies in other industries. We extend the same warnings to our cannabidiol (CBD) clients, who, if they are operating outside of a state-run cannabis licensing regime, are actually in a position of even greater risk. Lack of regulation in the CBD space is to the detriment of consumers, who often cannot be certain what ingredients the products they purchase actually contain, or whether those products are safe and free of contaminants.

It’s only a matter of time before harmed consumers start suing CBD companies alleging defective, dangerous, or mislabeled products (and Proposition 65 violations). Here are some posts we’ve written about product liability in the cannabis industry, which are highly relevant to CBD companies as well:

Recently, Vice published an alarming article about a new study that detected synthetic marijuana and a compound in cough syrup in one CBD company’s vape products. The article summarizes the findings of Michelle Peace, a toxicologist and vaping expert at Virginia Commonwealth University who evaluates how electronic cigarettes are being used for substances other than nicotine. Peace received a tip that a product supposedly containing only CBD had psychedelic effects for a consumer. Upon further testing, she discovered that out of nine products tested, four contained synthetic marijuana (5-fluoro MDMB-PINACA (5F-ADB)) and one contained dextromethorphan, an ingredient in cough syrup.

Unfortunately, these findings do not surprise us. We’ve long been wary of the proliferation of CBD products with very little regulation from federal or state governments. Some states have taken steps to combat these unregulated products. In July of this year, the California Department of Public Health’s Food and Drug Branch (CDPH) issued an FAQ on CBD in food products stating:

“[A]lthough California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.”

In California, CBD products derived from marijuana and produced by licensed cannabis manufacturers may be sold, but unregulated, industrial-hemp-derived products intended for consumption may not.

So, what should CBD companies be doing to protect themselves from consumer product liability claims? Of course, we recommend implementing robust testing protocols that are in line with those required by state agencies of cannabis manufacturers. The first step in protecting your company is ensuring that your products are safe. In the same vein, be sure that everything you state about your product is accurate.

And oftentimes, one of the best ways to mitigate against product liability claims is to institute a product recall, and having a product recall plan in place will facilitate this. In crafting that plan, below are some recommendations we’ve made before, which bear repeating:

  1. Create an overall recall strategy.
  2. As part of your recall plan, create definitions and standards for classes of recall and the depth and scope of any given recall. If your state or local laws do not provide basic recall standards for cannabis businesses, check out the FDA’s website under Guidance for Industry: Product Recalls, Including Removals and Corrections.
  3. Appoint a recall committee within your company, to be led by experienced personnel capable of evaluating and investigating product complaints to determine if a recall is warranted. This also entails your developing a product complaint form that will be utilized by customers. It is important to learn about product problems as early as possible.
  4. Develop a complaint receipt and evaluation method to ensure your product complaint processing and investigations are logical, efficient, and comprehensive. There are few things worse than receiving product safety complaints and then ignoring them until the situation is out of control.
  5. Truly ponder what your product complaint investigation will entail. What facts should your recall committee be gathering when seeking to determine if a product complaint is valid or if a recall is warranted? What should your recall look like, as based on the facts and circumstances and the threat your product may pose to consumers and vendors?
  6. Create a distribution list so your product recall committee can quickly and easily identify all affected products and product lots for disposition and potential destruction. The distribution list should — at minimum — include the names of all affected consumers and vendors, their contact information, and the dates on which the products were sold to them or consumed by them, and it should also include any side effects, injuries, or illnesses resulting from product use. Time is of the essence here. Our firm had a regional food client that inadvertently failed to issue a recall notice to one of many supermarket chains to which it sold its food. This supermarket chain was so angry about having been kept out of the loop that it refused ever to purchase our client’s product again. Then other supermarket chains learned of our client’s failure to notify this one supermarket company and they too ceased all of their purchasing. Needless to say, our client company no longer exists. Don’t let this sort of thing happen to you.
  7. Institute a method of stock recovery so all tainted product in inventory is effectively quarantined from sale and distribution.
  8. Generate your recall notice and be very careful with your wording in how you alert vendors and consumers to the recall. You want to effectively communicate that a product has been affected and how to deal with that, but you also want to minimize whatever liability your product problems may create for the company. On a case by case basis, consideration should also be given to drafting a press release to help the company’s PR. For this you absolutely need attorney help.
  9. Make sure to as quickly as possible (preferably in advance) alert your outside advisors (your lawyers, your insurance broker, etc.) regarding your recall.
  10. Set out in your recall plan your options for product disposition. Will you destroy a product? Cleanse and then repurpose it? Lay out your options in your plan now so you are not scrambling to try to figure out your possible options later, when you have no time to do so.
  11. Record everything you do. Document every effort you make and record all your communications with consumers and vendors. If there is a legal action later, you will want to be able to show the court that you took all reasonable steps to ensure consumer safety.

In addition to the foregoing, we also recommend regular compliance audits to ensure that your procedures are safe, legal and effective. It is only a matter of time before CBD product liability claims start to proliferate, and CBD companies should prepare for that reality now.

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