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What Causes Seizures?

Book cover of Foundational Concepts in Neuroscience: A Brain-Mind Odyssey by David E. Presti.

A variety of different things may happen as a result of a seizure, depending upon the region of the brain that is affected. There may be sudden changes in sensory perception, such as visual disturbances or the smell of an unusual odor. There may be rapid and inexplicable emotional or cognitive changes. There are often involuntary muscle movements, and sometimes even complete loss of control over the movement of one's body. Obviously, this could lead to serious consequences if someone has a seizure while, for example, driving a car.

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What Causes Seizures?

Book cover of Foundational Concepts in Neuroscience: A Brain-Mind Odyssey by David E. Presti.

A variety of different things may happen as a result of a seizure, depending upon the region of the brain that is affected. There may be sudden changes in sensory perception, such as visual disturbances or the smell of an unusual odor. There may be rapid and inexplicable emotional or cognitive changes. There are often involuntary muscle movements, and sometimes even complete loss of control over the movement of one’s body. Obviously, this could lead to serious consequences if someone has a seizure while, for example, driving a car.

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Hemp-CBD Across State Lines: Alaska

alaska hemp cbd

The Agriculture Improvement Act of 2018 (“2018 Farm Bill”) legalized hemp by removing the crop and its derivatives from the definition of marijuana under the Controlled Substances Act (“CSA”) and by providing a detailed framework for the cultivation of hemp. The 2018 Farm Bill gives the US Department of Agriculture (“USDA”) regulatory authority over hemp cultivation at the federal level. In turn, states have the option to maintain primary regulatory authority over the crop cultivated within their borders by submitting a plan to the USDA. This federal and state interplay has resulted in many legislative and regulatory changes at the state level. Indeed, most states have introduced (and adopted) bills that would authorize the commercial production of hemp within their borders. A smaller but growing number of states also regulate the sale of products derived from hemp.

In light of these legislative changes, we are presenting a 50-state series analyzing how each jurisdiction treats hemp-derived cannabidiol (“Hemp-CBD”). Each Sunday we will summarize a new state in alphabetical order. Last week was Alabama. This week we turn to Alaska.

In April 2018, Alaska enacted Senate Bill 6 (SB 6), “An Act Relating to the Regulation and Production of Industrial Hemp.” SB 6 was passed before the 2018 Farm Bill, in compliance with the 2014 Farm Bill. Under SB 6, “industrial hemp” is defined as “all parts and varieties of the plant Cannabis sativa L. containing not more than 0.3 percent delta-9-tetrahydrocannabinol.” SB 6 defines “cannabidiol” oil as the “viscous liquid concentrate of cannabidiol extracted from the plant (genus) Cannabis containing not more than 0.3 percent delta-9-tetrahydrocannabinol.” SB 6 does not address the processing of industrial hemp into Hemp-CBD products

The Alaska Department of Natural Resources (“DNR”), which is a part of the Alaska Division of Agriculture, has regulatory authority over industrial hemp. According to the Alaska Journal, Alaska’s hemp program has been off to a slow start as DNR took time to work with law enforcement to come up with a regulatory plan for hemp.

On May 31, 2019, DNR issued proposed industrial hemp rules. These rules are extremely detailed and are not yet final. This post will summarize some of the highlights including cultivation, processing, sales, and hemp-derived products. The proposed rules also provide a detailed outline of industrial hemp transportation and testing, including procedures for quarantining and destroying non-compliant hemp and hemp products.

Under proposed rules, DNR will issue three “classes of industrial hemp registration for participation in the [Alaska Industrial Hemp Pilot Program],” for growers, processors and retailers.

Grower registration. A registered grower may grow, store, and transport industrial hemp. A grower may also sell raw industrial hemp to another grower or to a processor or sell industrial hemp “to persons who are not required to be registered by this chapter, including consumers in the state, if the hemp will not be further processed[.]” A grower cannot sell industrial hemp that has been processed unless it holds a processor registration as well. Growers must retain records of the source of all industrial hemp seeds and propagules. Industrial hemp cultivation is only allowed in a registered “grow area,” which cannot be a residence and cannot be within 3,230 feet of a marijuana grow. Growers must submit planting report to DNR 30 days after planting or replanting hemp seeds and propagules. Pesticides are only to be applied by an Alaska Department of Environmental Conservation certified applicator. Growers cannot harvest hemp until it has been tested by DNR unless DNR gives express permission allowing a post-harvest test. In either scenario, industrial hemp must be tested before a grower may sell it.

Processor registration. A registered processor may process industrial hemp in its raw form into any other form or product. Processors may purchase, store, and transport raw hemp. Processors may sell processed hemp or hemp products to retailers. Processors must comply with all applicable health and safety standards. Processors may only create hemp-based extracts using the following methods:

  • Non-hydrocarbon extractions, including: cold or hot potable water filtration; isopropyl alcohol or isopropanol; ethyl alcohol or ethanol; carbon dioxide; dry ice; or dry shifting or sieve.
  • Hydrocarbon extractions, including: n-butane; isobutene; propane; or heptane.

Processors may only use solvents in the extraction process that are food grade or at least 99% pure. and Solvent-based extraction must be “completed in a commercial, professional grade, closed loop system capable of recovering the solvent used for extraction.”

Processed hemp products intended for human or animal consumption must be tested for cannabinoid concentration and profile, residual solvents, microbials, pesticides, and heavy metal concentrations. Testing must be performed by DNR or a testing facility authorized by DNR. Processors must retain records and prepare an annual report on the quantity of industrial hemp processed, identification of lot and batch numbers processed, disposition of all raw and processed industrial hemp, and records of all persons who received all raw or processed industrial hemp.

Retailer registration. A registered retailer may sell processed industrial hemp or industrial hemp products to consumers. In addition, retailers may import, store, and transport processed industrial hemp and industrial hemp products. Retailers must ensure that all products are labeled properly and must display a placard from DNR showing that it is a registered retailer. When applying for registration, a retailer applicant must provide a description of the type of store or operations of the retailer, a location or list of locations where industrial hemp will be offered for retail sale, and a list of products intended for sale. Like processors, retailers must keep records and submit annual reports to DNR.

Hemp Product Endorsement. In addition to registering growers, processors and retailers, DNR is also imposing regulations on all hemp products in Alaska. DNR must endorse “any hemp product processed beyond its raw form” that is intended for human or animal consumption before it is “transported in the state or offered with or without compensation to a consumer.” Retailers and processors can apply for an endorsement on an application provided by DNR. Endorsement applicants must provide the following:

  1. A color copy of the product’s proposed label;
  2. A copy of the laboratory test results of each product or batch of product;
  3. A copy of the processor’s DNR registration under or a copy of the processor’s registration or license from other states or qualifying entities that have implemented an industrial hemp pilot under the 2014 Farm Bill;
  4. A copy of the terpene analysis if required under the proposed rules; and
  5. An endorsement fee.

No processed industrial hemp product intended for human or animal consumption may contain more than 50 milligrams of delta-9 THC per individual product. Such products must also include the following items on their label:

  1. The product name;
  2. A batch and lot number for the product;
  3. An expiration date;
  4. The total quantity of the product by weight or volume;
  5. The serving size or recommended dose;
  6. A list of all ingredients;
  7. A statement that the product has not been approved by the Food and Drug Administration or the Alaska Department of Environmental Conservation.
  8. The industrial hemp pilot program from which the hemp originated;
  9. The industrial hemp pilot program that authorized the processing or testing of the industrial hemp in the product; and
  10. If the product conducts any delta-9-THC, the statement “warning: contains THC”.

Bottom Line. At this time, it is unclear when the DNR will start issuing registrations or will start endorsing products.

The most striking thing about the new rules is the endorsement and registration required for the sale of hemp products intended for human consumption, which almost certainly includes Hemp-CBD. On June 20, 2019, the DNR updated a “Questions and Answers” page on its website which indicates the scope of this registration:

Q: Are big stores such as GNC, Natural Pantry, all the gas stations going to have to get retail
licenses?
A: Yes. Except for a grower or processor selling raw industrial hemp, all retail sales of hemp and hemp products will require retail registration.

This may preclude the online sale of consumable Hemp-CBD in Alaska as retailer applicants must list the locations where they will sell hemp products and display a placard from DNR in their stores. Online retailers who sell directly to consumers won’t be able to comply with these location-based requirements.

Finally, these rules are focused solely on the 2014 Farm Bill and make no reference to the 2018 Farm Bill. That may need to change as a majority of states are going to be operating under the 2018 Farm Bill next year.

Interested stakeholders should carefully review these rules if they want to make any changes. DNR will be accepting public comments on the rules until 5:00 PM on Tuesday July 3rd, 2019. Comments can be submitted by email to industrialhemp@alaska.gov or online at http://notice.alaska.gov/, and using the comment link.

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Oregon Hemp: ODA’s New “Total THC” Standard is a KEY Operations and Contract Issue

total thc oregon hemp
Get it right with Total THC testing requirements.

In the past few months, many of our Oregon hemp clients have asked us to clarify the testing requirements imposed by the Oregon Department of Agriculture (“ODA”). Unlike other jurisdictions that only test for tetrahydrocannabinol (“THC” or “delta-9 THC”) concentration, the ODA rules provide that any industrial hemp product sold to consumers must contain no more than 0.3 percent “Total THC.”

Under Oregon hemp law, “Total THC” means “the molar sum of THC and THCA [tetrahydrocannabinolic acid].” This creates some very important considerations for hemp farmers and related parties, and, as explained below, failing to account for this issue in production and sale agreements creates serious exposure. But first, some background on the “Total THC” standard.

THC and THCA are two compounds commonly found in the cannabis plant. As its name indicates, THCA is an acidic cannabinoid, whereas THC is a neutral cannabinoid, meaning it possesses active (psychoactive) proprieties. While these compounds are present in different forms, they are linked in that when exposed to heat or lights THCA converts into THC. This conversion process naturally occurs over time but can also be enhanced through a chemical reaction called decarboxylation. Specifically, decarboxylation removes a carboxyl group of THCA and releases carbon dioxide which turns the large 3-D shape of the THCA molecule into a THC molecule, which is smaller and can fit into a body CB1 (cannabinoid) receptors.

A while back, the ODA suggested in one of its public announcements that the “Total THC” testing requirements aimed to align with the 2018 Farm Bill. The 2018 Farm Bill defines “hemp” as, in part, “acids, […] with a delta-9 tetrahydrocannabinol [(“THC”)] concentration of not more than 0.3 percent on a dry weight basis.” (Emphasis added). Consequently, the ODA posits that because THCA is an acidic cannabinoid that “contains” THC, it must be added to the THC concentration to ensure that their total concentration does not exceed 0.3 percent. However, opponents of the “Total THC” approach have described this rational as flawed in that THCA and THC are separate and distinct molecules. As such, THCA does not “contain” delta-9 THC. Instead, a chemical process converts a THCA molecule into a delta-9 THC molecule.

States like Oregon also support the “Total THC” position because the 2018 Farm Bill provides that States and Native American Tribes that wish to hold primary regulatory authority over the production of hemp within their borders must submit a plan that includes, among other things, “a procedure for testing, using postdecarboxylation or other similarly reliable methods, delta-9 tetrahydrocannabinol concentration levels of hemp produced in the State or territory of the Indian tribe[.]” Although there is no “postdecarboxylation” testing method per se, the congressional intent was apparently to refer to a testing method known as gas chromatography (“GC”).

The GC testing method consists of heating up a hemp sample to separate out its compounds and measure them. This method is powerful enough to decarboxylate THCA in a sample, which means that GC generates the very molecule it is measuring, and thus, calculates the “totality of THC concentrations” found in a hemp sample. Many in the hemp industry have criticized this method, as it tends to increase the THC concentration in the hemp sample and pushes it over the 0.3 percent limit. This, in turn, limits the type of strains farmers can work with and gives farmers in jurisdictions that only require the testing of THC a competitive edge.

But regardless of which position is most meritorious, Oregon hemp farmers and processors are obliged to comply with these ODA rules. As we have highlighted in several of our blog posts (here and here), hemp players must strategically and carefully plan when entering into a hemp-related contract. This careful approach mitigates their risks of financial loss and litigation. Consequently, Oregon hemp farmers and processors should account for the “Total THC” testing requirements in their transactional documents with the assistance of experienced hemp attorneys. For more information on hemp-related contracts and Oregon’s testing requirements, do not hesitate to contact our team of CBD attorneys.

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Hemp Contracts: What Business Can Learn from Oregon State’s New Research Facility

hemp research Oregon contracts
More hemp research makes for better hemp contracts.

Last Thursday, Oregon State University (“OSU”) officials announced plans to launch the Global Hemp Innovation Center (“Hemp Center”). The Hemp Center will be based in OSU’s College of Agricultural Sciences and intends to serve “as a research hub connecting faculty and researchers engaged in plant research, food innovation, pharmacy, public health, public policy, business and engineering.” You can read all about it here.

This is good news for folks in the hemp industry for a number of reasons as highlighted in this article about the Hemp Center by the Oregonian. The article notes the lack of standard units of measurement and seed certification programs, noting a case where Oregon farmers purchased hemp seeds having THC levels too high to be legal hemp. Professor of Crop and Soil Science, Jay Noller, who will head the Hemp Center, points out other goals that will benefit industry such as “how to efficiently and sustainably grow hemp for seeds, for hemp fiber materials that can be used in textiles and construction materials, including as an alternate to gravel in concrete, for hemp essential oils that have popular health and wellness uses, and for hemp grain for use in foods and feed.”

Let me add a few more reasons why the hemp industry should be thrilled about the Hemp Center. As regular readers know, we are writing more and more posts about hemp litigation and we have started publishing a 50-state survey of Hemp-CBD laws (first post: Alabama). Underlying these posts is our view that boilerplate contracts don’t work for hemp, just like they don’t work for marijuana. In our view, the work contemplated by the Hemp Center may lead to better hemp-CBD contracts, including on the issues such as:

  • What are best farming practices?
  • What is the quality of the seed?
  • What kinds of hemp have less than .3% THC?
  • What kinds of hemp have less than .3% “total THC”? (This is not a repeat.)
  • What CBD content might one expect at harvest from a particular strain?
  • What is a reasonable estimate for the cost per acre of cultivation for a particular hemp strain, in a particular geographic region?

These are not just research issues, but contract issues. Other hemp-related contract issues we’ve mentioned include, to name a few:

  • Who is responsible for maintaining the hemp chain-of-custody?
  • Who is responsible for procuring insurance (if any)?
  • Who is responsible for testing of hemp for human consumption or hemp items for other industries and to what standards?
  • Who bears what risk of regulatory changes?

Alright … the Hemp Center may not solve every contract issue 😊 Lastly, I think an exciting part about the Hemp Center is the promise of strategic global research and that the future of hemp looks even brighter with its launch. Kudos to Oregon State for being a first mover in this very promising space.

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CBD for Brain-Damaged Babies?

Father kissing and cuddling his newborn baby.

Giving medical cannabis to infants is a difficult taboo to shift, but new research is paving the way. The launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.

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Congress Lays Out Expectations for FDA on Hemp-CBD in Budget Report

hemp cbd report congress

The House Appropriations Committee (the “Committee”) publishes reports to accompany annual spending bills. One such report, released on June 3, provided insight on hemp-derived CBD (“Hemp-CBD”). The Committee’s report on didn’t get much coverage in the media, outside of some ace reporting from the folks at Marijuana Moment. Despite that, it’s kind of a big deal because it outlines Congress’ expectations for the Food and Drug Administration (“FDA”) when it comes to Hemp-CBD.

The Committee’s passage on Hemp-CBD starts by focusing on its concerns:

Cannabidiol Regulatory Pathway—The Committee is concerned about the proliferation of foods and dietary supplements marketed in violation of the Federal Food, Drug & Cosmetic Act (FFDCA), including products containing cannabis and cannabis-derived ingredients. Non-FFDCA-compliant products pose potential health and safety risks to consumers through unsubstantiated and misleading claims such as treating a wide-range of life-threatening diseases and conditions; excessive cannabidiol (CBD) concentrations that can result in harmful drug-drug interactions, somnolence, and elevated transaminases or liver toxicity; and the presence of significant levels of intoxicating compounds such as tetrahydrocannabinols (THC).

First, the Committee lays out its concerns over unregulated Hemp-CBD. These concerns echo the FDA’s statements on Hemp-CBD, especially the reference to unsubstantiated and misleading claims about CBD. Second, the Committee focused on the safety of CBD itself. This includes how CBD interacts with other drugs, somnolence (which according to Wikipedia is a fancy way to say sleepiness or drowsiness), and liver toxicity. FDA-approved Epidiolex, the epilepsy medication that contains CBD, includes a warning about liver damage. A recent study conducted and the University of Arkansas and published in Molecules found that large dosages of CBD damaged the livers of mice. Third, the Committee raised the issue of elevated significant levels of THC in products. Though hemp only has 0.3% THC, the Committee seems concerned about hemp-derivatives containing excess amounts of CBD or consumers ingesting large doses of THC. The 0.3% threshold is relative, after all and the Committee might be concerned about intoxicating effects in large doses.

The Committee went on to outline its expectations of the FDA:

The 2018 farm bill expressly preserves FDA’s public health authority to take appropriate actions regarding cannabis, including hemp and its derivatives. The Committee recognizes the FDA is considering a public regulatory process to evaluate the appropriateness, and possible parameters, of a regulatory pathway that would permit CBD in certain foods and dietary supplements. The Committee expects the FDA to assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways are consistent with protection of the public health. Such pathways may include necessary public health and safety parameters that will protect the public health, such as labeling requirements and limits on CBD or other cannibis-derived ingredients in products, based upon anticipated total exposure levels. The Committee also expects the FDA to preserve the integrity of its drug development and approval processes, which ensures that products marketed for drug uses have undergone a rigorous scientific validation process demonstrating quality, safety and efficacy. It is also imperative that any FDA regulation of foods and dietary supplements containing CBD or other cannibis-derived ingredients preserve incentives to invest in robust clinical study of cannabis, so its therapeutic value can be more fully understood.

The FDA’s marching orders are to figure out a safe way to allow CBD in foods and dietary supplements if that is possible to do while protecting public health. The Committee floats the idea of labeling requirements and limiting cannabinoids based on anticipated exposure levels. Remember that the FDA is a creature of statute. It exists because Congress wanted it to exist. Though the FDA is part of the executive branch, it must operate within the laws passed by Congress. The Committee doesn’t represent the entire legislative body, but it does seem to be in favor of a world where CBD is available in food and dietary supplements. That being said, the Committee also wants CBD in drugs. The FDA must also preserve incentives to research CBD’s health benefits. That research happens when companies go through the FDA’s drug approval process. The Committee doesn’t want to forego the medical benefits that come with CBD being approved for use in drugs.

The FDA has work to do. It recently held a listening session which allowed stakeholders to comment on the FDA’s approach to regulating Hemp-CBD. This latest report from the Committee only reiterates the prevailing expectation that Hemp-CBD will be available both as a drug and as a food/dietary supplement. It remains to be seen how the FDA will get to that point.

For more analysis on this “two-track” theory and the FDA’s position on CBD, check out the following posts:

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