Month: February 2019

World Health Organization Expert Committee Calls For Changes In Cannabis’ International Classification

The World Health Organization’s (WHO) Expert Committee on Drug Dependence have proposed amending the classification of cannabis under international law.

According to reporting in the British Medical Journal, the WHO policy reversal “takes account of the growing evidence for the medical applications of the drug,” and marks the first time that the agency has reviewed its stance on cannabis in nearly 60 years.

The recommended changes, outlined in a letter by WHO Director-General Dr. Tedros Adhanom Ghebreyesus and reported on by NORML, call for cannabis to be removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs. Schedule IV is the most restrictive classification under the treaty. Instead, the committee advises that whole-plant cannabis and THC be designated as Schedule I controlled substances under international law.

“The current [international] scheduling of cannabis is as strict as that for heroin,” the BMJ summarizes. “[T]he Committee believes that keeping cannabis at that level of control would severely restrict access to and research on potential therapies derived from the plant.”

In a separate recommendation, the Committee reiterated its 2017 request that preparations containing “pure cannabidiol … and not more than 0.2 percent of delta-9-tetrahydrocannabinol” no longer be scheduled within the international drug conventions.

The Committee’s policy recommendations now await action from the 53 participating members states of the United Nation’s Commission on Narcotic Drugs. The Commission is anticipated to vote on the issue in March.

In October, NORML delivered over 10,000 public comments to the US Food and Drug Administration urging the agency to recommend that WHO reschedule cannabis internationally.

The post World Health Organization Expert Committee Calls For Changes In Cannabis’ International Classification appeared first on TheJointBlog.

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Exporting CBD Food Just Got Harder: The European Union Makes a Move

We’ve been writing a lot on this blog about the regulation and sale of cannabidiol (“CBD”) products at the state and federal levels. The United States is not the only international actor, however, that is concerned with regulating the sale of CBD products, including CBD-infused foods. The European Food Safety Authority (“EFSA”), the European equivalent of the U.S. Food and Drug Administration (“FDA”), recently changed guidance on cannabinoids, declaring that all new food products infused with the plant or its derivatives should receive a pre-market approval under the European Union “novel food” regulation.

Regulation 2015/2283, which is the latest food regulation adopted by the European Parliament and the European Union (“EU”), defines “novel food” as “food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of the Member States to the Union.”

The EU Novel Food Catalogue entry for CBD, which contains a non-exhaustive list of ingredients that inform member nations on whether a product will need an authorization under the Novel Food Regulation, now refers to a broader class of “cannabinoids” and provides that:

Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.

This new EFSA guidance drastically expands the categories of cannabinoids that would require pre-market approval–note, however, that hemp seeds, flour and seed oil remain permitted–and it suggests that CBD-infused food could be off the European market for some time. Generally, it takes 3 years for an ingredient to gain novel food status.

A handful of European countries such as Spain, Italy, and Austria have already taken enforcement actions against CBD products on the basis of being “novel foods.” As such, it seems likely that these EU member nations will adopt the new EFSA guidance and continue their efforts in regulating CBD-infused foods as “new foods.”

The EU or its affiliates are expected to provide further guidance on this issue; however, due to administrative procedures and time required for adequate data collection, such publication won’t likely be released until 2020.

This new EFSA guidance will further complicate U.S. CBD companies’ ability to export their products overseas. In addition to potential international law violations, CBD companies run the risk of FDA and Customs and Border Protection (“Customs”) enforcement actions. The FDA has yet to release guidelines on shipping CBD products to other countries; however, the main FDA inquiry for the purpose of exporting CBD would likely be whether the CBD products were adulterated or mislabeled due to the fact that they were not manufactured or labeled in compliance with the target country’s law. Another risk in exporting CBD products is that Customs agents may not have a sophisticated understanding of the difference between hemp and marijuana, as demonstrated in recent state enforcement actions. If such confusion were to occur, Customs would likely seize the CBD shipment and potentially involve the Drug and Enforcement Administration.

In light of those regulatory changes, CBD companies should remain informed on domestic and international shipping laws and consult with experienced lawyers to assess the risks of exporting their products overseas.

For more on cannabis and international law, check out the following:

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Beyond the Crackdown: New York Classifies Hemp-CBD as a Dietary Supplement (Part Two)

Home of “dietary supplement” CBD.

This post is part two of two on how New York is regulating CBD.

On Monday, I wrote about the New York City Department of Health’s (“DOH”) recent crackdown on Hemp-CBD in food and how it was consistent with the New York State Department of Agriculture’s (“Department”) FAQs on hemp-derived CBD (“Hemp CBD”). In summary, the Department’s FAQs state that any Hemp-CBD product sold in New York state must be labeled and manufactured as a dietary supplement. Today’s post focuses on the Department’s Template CBD Processor Research Partner Agreement (“CBD Agreement”) which elaborates on the dietary supplement classification.

The CBD Agreement is a research contract between Hemp-CBD processors, referred to as “Research Partners” in the Agreement, and the Department. Its provisions would not bind other actors including Hemp-CBD sellers or Hemp-CBD processors legally operating in other states. However, the CBD Agreement does shed light on what the Department is going to require for Hemp-CBD.

Research Partners cannot process or sell Hemp-CBD as food. A Research Partner must also obtain written approval from the Department if it intends to sell or distribute Hemp-CBD dietary supplements in a form other than “pill, capsule, caplet, tablet, tinctures, droplets or elixir, chewable, or isolate form[.]”

The CBD Agreement expands on how Research Partners, or CBD processors in other states hoping to sell products in New York, can comply with FDA’s dietary supplement standards:

For the purposes of this Research Agreement, products and production methods used shall comply with FDA law, regulation and guidance concerning dietary supplements with respect to the standards for: personnel, facilities, production, process control systems, quality control measures, record retention, packaging, holding and distribution, supply chain management, recalls, returns, complaints and training associated with dietary supplements.

The dietary supplement standards are in addition to THC testing for CBD products. Hemp-CBD intended to be consumed or absorbed into the human body must also be tested under New York’s medical marijuana program for “cannabinoid profile, solvents, pesticides, heavy metals, bacteria and molds.”

The CBD requirements requires that Research Partners must also provide a serving size and applicable warning on the label. According to the CBD Agreement, CBD products shall also include the following information:

  • The list of all pharmacological active ingredients, including and not limited to THC, CBD, and other cannabinoid content over .05%;
  • The CBD product must set forth the servings per bottle/package, the amount of CBD in milligrams per serving and the total CBD content, in milligrams per package, and the maximum recommended daily amount;
  • The list of all solvents (pesticides) used in the cultivation/extraction process;
  • The manufacture date and source;
  • The batch number;
  • The product expiration date, and
  • The following warning, along with an appropriate warning to consult with a physician concerning the product use:

“This product is neither reviewed nor approved by the State of New York; and has not been analyzed by the FDA. There is limited information on the effects of using this product. Keep out of reach of children.”

The CBD agreement also covers reporting, approved extraction methods, and sourcing hemp. According to the CBD Agreement, the Department may eventually require registration from entities selling Hemp-CBD.

Recently, I wrote about the FDA’s stated position is that Hemp-CBD is not a dietary supplement. As such, the Department’s position is contrary to the FDA’s. The following language in the CBD Agreement requires Research Partners to acknowledge the FDA’s position:

The Research Partner represents that it has sought whatever legal or other advice it believes to be appropriate and is not relying upon the Department’s approval of its research proposal or any other statement or conduct by the Department in connection with the Research Partner’s evaluation of any legal or other risk to which the Research Partner may be exposed in undertaking the project, including, without limitation, the FDA’s position with respect to CBD and dietary supplements.

For CBD Processors in New York, the CBD Agreement must be carefully observed. For CBD Processors operating in other states who wish to sell products in New York, the Department’s position makes things a little more complicated. For example, the FDA has different standards for cosmetic products. CBD Processors may want to argue that they are selling a CBD cosmetic not a dietary supplement. However, if that CBD cosmetic is sold in New York, it must be labeled as a dietary supplement. This may mean that the CBD cosmetic distributor may need to avoid New York or adopt labeling and manufacturing requirements as if the product was a dietary supplement.

Though it may be hard to comply with the Department’s regulations, the FAQs and CBD Agreement at least provide guidance. If you want to sell Hemp-CBD in New York, it must be sold as a dietary supplement, at least for now.

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Legislation to Legalize Marijuana Passed by New Mexico Committee

Legislation that would legalize marijuana for everyone 21 and older has been passed by a key House committee in New Mexico.

The House Health and Human Services Committee passed House Bill 356 by a vote of 5 to 2, with all of the “Yes” votes coming from Democrats.

“Prohibition simply does not work, and the country is coming to the realization of that”, said Representative Antonio Maestas, one of the bill’s sponsors.

The measure would allow those 21 and older to possess and grow personal amounts of marijuana. They would be authorized to purchase the plant from a licensed retail outlet.

The proposal would establish a 19% tax on recreational marijuana sales. The tax revenue would be split between law enforcement, health and research programs, and city and county governments. The measure would also allow for the expungement of past charges that would become legal if it’s passed.

The proposal must now be passed by the full House of Represents and then Senate before it can be sent to Gov. Michelle Lujan Grisham for consideration. Govewrnor Grisham has said she would support a legalization law under certain conditions, such as having strong safeguards to prevent children from obtaining cannabis.

For the full text of House Bill 356, click here.

The post Legislation to Legalize Marijuana Passed by New Mexico Committee appeared first on TheJointBlog.

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