In a new video for Cheddar, Allison Margolin explains some common misconceptions about hemp legalization and the 2018 Farm Bill:
The House Committee on Agriculture is in the process of finalizing the 2018 Farm Bill, which is expected to go into effect later this month. It’s likely that the bill’s provisions will include the legalization of hemp, in the form of the removal of the plant from the government’s list of Schedule I Controlled Substances. Not only will this mean that hemp can be grown much more widely, it will also affect the production of hemp derivatives, including hemp-derived CBD. However, the legality of CBD products remains more complicated than this news may suggest.
As discussed in a prior blog post, the legal status of CBD can be very confusing to consumers, businesses, and lawmakers alike. As a substance that is derived from the cannabis plant, but is not cannabis’ main active ingredient, CBD currently occupies an unclear middle ground – particularly in California, where the state has imposed additional rules affecting how the various types of CBD may be legally used.
The legalization of hemp, though a step forward in the overall process of cannabis legalization, doesn’t do much to resolve the confusion surrounding CBD products. Even after hemp is legalized, CBD will be considered a drug and therefore subject to regulation by the FDA. Though the FDA has approved certain cannabis-derived CBD medications, CBD’s status as a drug makes it illegal to use as an ingredient in any kind of food or food additive.
Topicals, oils, and other non-edible forms of hemp-derived CBD, on the other hand, may not necessarily be banned once hemp is legalized. However, the FDA has yet to make a statement regarding this possibility – though they have sent unambiguous legal warnings to CBD businesses that make unsubstantiated or false claims about their products, indicating that they plan to regulate all CBD products to some degree, they’re less clear about the future legal status of hemp-derived CBD and non-edible hemp derivatives in general.
In California, the law on CBD edibles will remain paradoxical even after hemp is legalized. While CBD products with THC levels of 0.3% or more will be treated as cannabis edibles and therefore legal, CBD products with lower THC levels – or no THC at all – will be considered food products and therefore banned, regardless of whether they’re derived from cannabis or hemp. However, hemp-based non-edible CBD products are not currently regulated by any state agency, meaning their legal status remains unclear. For the sake of the state’s cannabis consumers and businesses, hopefully California will respond to the new Farm Bill by clarifying the legal status of these products.
Steps toward the legalization of cannabis in New York and New Jersey have been in the news recently. But how close are these states to having fully licensed legal cannabis supply chains? Here's a brief overview of the two states' marijuana laws and where they stand in regard to cannabis licensing.
NY State Licensing Overview
Currently, there are ten (10) “Registered Organizations” responsible for manufacturing and distributing medical marijuana in New York State. Pursuant to the Compassionate Care Act (CCA), which established New York’s comprehensive medical marijuana program in July 2014, each Registered Organization is authorized to have up to four (4) dispensing facilities.
New York’s State Department of Health (NYSDOH) began accepting applications for registrations for a Registered Organization on April 27, 2015, with a deadline for receipt of applications on June 5, 2015. Of the original 43 applicants, five (5) Registered Organizations were approved July 31, 2015; another five (5) were registered by NYSDOH on August 1, 2017. The NYSDOH has yet to announce opening another application window for additional prospective Registered Organizations.
While New York’s Medical Marijuana Program is currently closed to would-be applicants looking to manufacture and dispense medical marijuana under the CCA, a spokesperson for Gov. Andrew Cuomo recently stated that the administration expects to introduce a comprehensive proposal for legalizing and regulating recreational adult-use marijuana in 2019. Therefore, cannabis businesses interested in becoming licensed in New York State should be looking down the road to determine next steps in preparation for licensure.
NJ State Licensing Overview
Currently, there are six (6) “Alternative Treatment Centers” (ATCs) responsible for manufacturing and distributing medical marijuana in New Jersey, pursuant to the Compassionate Use Medical Marijuana Act, which established the state's medical marijuana program in 2011. In August 2018, the New Jersey Department of Health (NJDOH) accepted 146 applications in response to its request to add up to six (6) additional ATCs. Despite a November 1st target date, NJDOH has yet to announce the successful applicants, stating that additional time is needed to complete a full review of the applications submitted. The NJDOH is not currently accepting applications to open additional ATCs. But on November 26th, the state Senate and Assembly budget committees passed Senate Act S2426, which, once passed by the full Senate and Assembly and signed into law by Gov. Phil Murphy, would require the NJDOH to issue licenses for 34 new dispensaries and six new cultivation facilities within 90 days.
Additionally, the most recent version of the New Jersey Cannabis Regulatory and Expungement Aid Modernization Act (the NJ Act) was released last week and also passed by the state Senate and Assembly budget committees yesterday, November 26th. The next step for New Jersey is a vote by the full Senate and Assembly slated for mid-December. Until then, negotiations between Gov. Phil Murphy and NJ’s legislature will continue, mostly with regard to the tax rate and how much power the proposed Cannabis Regulatory Commission will exercise over the industry.
Because New York is at the inception of legalizing recreational marijuana, regulations and licensing requirements for adult-use cannabis businesses have not yet been implemented. That being said, a review of the NYSDOH Medical Marijuana Program Application for Registration as a Registered Organization (https://www.health.ny.gov/forms/doh-5138.pdf) is likely a good place to start for prospective medical and recreational cannabis businesses alike.
New Jersey is closer than New York to recreational legalization, and could have a bill passed before 2019. It is important for anyone looking to establish a medical cannabis business in New Jersey to keep an eye on the passage of S2426, which would mandate NJDOH’s licensure of 34 new dispensaries and 6 cultivation facilities within ninety (90) days. However, it remains unclear whether the NJDOH would open another application window, or choose from the 146 applications submitted in August 2018. In the meantime, it would behoove any prospective cannabis business licensee to take a look at both the NJ Act (S2703), as well as the ATC permit request application materials (https://www.nj.gov/health/medicalmarijuana/alt-treatment-centers/applications.shtml). Because the NJ Act gives local governments the power to enact their own cannabis regulations and ordinances – prospective licensees will first need to make sure their cannabis business will be permitted by their local jurisdiction.
While we recognize that any future recreational adult-use business license applications will differ from the above-mentioned applications for Registered Organizations and ATCs, much of the information requested will most certainly be the same. As is standard throughout jurisdictions that have legalized the use of both medical and recreational marijuana, any cannabis business seeking licensure will need to make full disclosures of entity, ownership and financial information, as well as identify and describe proposed facility locations, buildings and equipment. Additionally, those seeking licensure will need to provide licensing authorities with an extensive operating plan with detailed descriptions of policies and procedures related to its operations including but not limited to: processes, devices, security, quality assurance, recalls, staffing and record keeping.
To get a head start as the regulatory frameworks for cannabis businesses in New York and New Jersey continue to develop, anyone looking to establish a cannabis business in either state should be taking steps to create a tentative operating plan, focusing on those aspects and information that can be reasonably assumed as required for any future licensing application.
For more information on cannabis licensing in New York, New Jersey, and any other state, contact our cannabis attorneys at email@example.com.
What is white labeling, and how might the proposed white labeling ban affect commercial cannabis deal structures?
Both established and nascent players in the cannabis industry have turned to white labeling – rebranding an existing product under a different producer's name – as a means to carve out their niche. For instance, some manufacturers in the process of obtaining proper local and state licenses have entered into contractual arrangements whereby they source product from licensed cultivators or manufacturers before branding and distributing the product as their own. Other deals see established brands, traditionally unassociated with cannabis, staking their industry claim by offering their intellectual property (branding) and promotional efforts in joint ventures with licensed manufacturers looking to find brand awareness for their product.
Despite the fact that white labeling is standard operating procedure in product manufacturing at large, the current version of the California Bureau of Cannabis Control’s proposed regulations have been interpreted by industry stakeholders who are disturbed at what is being called an outright ban on intellectual property licensing. While §5032 seems to be taking aim at arrangements whereby non-licensees are purchasing, packaging and selling cannabis without a license, the language has been interpreted to reach as far as to ban licensees from entering into trademark licensing agreements with brand owners. Such interpretation could even prohibit a parent company from holding its licensed cannabis manufacturing operations in one entity and its unlicensed brand in another – suggesting the need for license options to facilitate trademark licensing in the cannabis space:
If §5032 is promulgated as currently drafted, the strictest interpretation would force parties currently engaged in white labeling to re-structure their deals or get proper licensing. Established brands may need to sell rather than license trademarks – effectively forcing or keeping brand owners out of the cannabis industry and companies holding their brands in separate entities may need to obtain additional licenses – an expensive and time consuming endeavor.
Other types of arrangements may or may not meet regulatory requirements. For instance, would it be OK for a cannabis brand to operate as an unlicensed subsidiary of a licensed manufacturer? What if the unlicensed cannabis brand acquires an ownership interest in the licensed manufacturer, but remains unlicensed itself? At the moment, the answers to these questions are unclear.
Until the industry is provided with some official guidance from the BCC or the regulations are tested, many licensees and non-licensees operating in cannabis will need to examine and possibly modify their business relationships or look into licensing options in attempt to stay compliant.
Fun fact: Wine industry folks who purchase bulk wine before bottling/branding/selling it as their own combine two licenses (17/20) to achieve ABC compliance. A type 17 is a beer/wine wholesaler license and a type 20 is an off-premise beer/wine retailer license.
For more information on cannabis business and licensing, reach out to our California cannabis attorneys at firstname.lastname@example.org.
- Disconnecting DWP utility services to unlicensed businesses
- Issuing citations to certain employees working in unlicensed businesses
- -Sending cease and desist letters to businesses and landlords
- Requiring all licensed retailers to display an emblem so the public knows whether a given business is licensed
- Sending letters to creditors and contractors of unlicensed businesses
- Bringing civil and criminal cases against unlicensed businesses
2. Opportunity to Appeal Rejected Dispensary Permits
Applicants who applied in Phase 1 and were found to be ineligible based on failure to qualify as an Existing Medical Marijuana Dispensary were given a chance to appeal the written findings of the DCR. These parties were given an opportunity to present their points, with back-and-forth discussion on the points of the appeal with members of the commission.
Each Applicant appealing was allowed either have a single person present the appeal or to have multiple witnesses – each side was allowed to submit any documents up until a week before hearing, and given 10 minutes to present arguments and evidence. The DCR was then allowed to present its case and findings for 10 minutes. The hearing officer could grant either side more time if appropriate, and the applicant was allowed 5 minutes at the end of the session to address DCR’s comments, followed by discussion and questions.
The main issues in the appeal were whether the Applicant had a 2017 L050 BTRC or, if no 2017 BTRC, if the Applicant had a L050 2015 or 2016 BTRC and met all the pre-ICO requirements, including registering for the ICO in 2007. One applicant was rejected who met all the requirements other than registering for the ICO in 2007 (the City reviewed records of office of city clerk regarding who was on the ICO registry), even though the business had BTRCs from 2007 to 2015 and had been paying taxes all along.
One applicant claimed another applicant mis-used the applicant’s ICO filing, applying under it for priority registration even though he was not an officer or director of the ICO registered entity. However, it turned out the ICO registered entity had registered as a sole proprietor “doing business as” a name similar to the current applicant, and the current applicant corporation was just using a similar same name as the 2007 entity but had a different legal name and different tax history and was a separate legal entity.
There were disputes during the appeals involving BTRCs issued with different account numbers or different entities, BTRCs that had been erroneously issued for addresses outside LA and then closed out, and BTRCs issued to related entities that had failed to follow merger process with the city. As a rule, only the same business entity that meets the eligibility requirements is eligible for priority processing.
Parties found ineligible for priority processing were encouraged to re-apply in Phase 3 general licensing, anticipated to open in 2019. Going forward, the DCR will prioritize annual licensing for Phase 1 and 2 applicants first, then registration for social equity applicants, and then Phase 3 will open.
For more information on the cannabis licensing and social equity process in Los Angeles, keep checking this blog or reach out to our cannabis attorneys at email@example.com.
Twilight is approaching in the state of commercial cannabis in California. Pursuant to the Medicinal and Adult-Use Cannabis Regulations and Safety Act (MAUCRSA), Business and Professions Code Section 26050.1, each of the state licensing authorities regulating commercial cannabis are subject to a Sunset Clause that prohibits the issuance or extension of temporary state licenses starting January 1, 2019.
What does this mean for you?
As a reminder, California has a dual-licensing system regulating commercial cannabis in the state. To operate legally, you must have both a local license issued by the local jurisdiction where your business is established, and a state license issued by one of the three state licensing agencies, the Bureau of Cannabis Control (BCC), California Department of Public Health (DPH), and California Department of Food and Agriculture (CDFA). Pursuant to MAUCRSA, the state temporary license enable business to operate while the state processes the annual license application. If you have already received a state temporary license and it expires prior to this date, you must submit an application for an annual license in order to receive the extension.
Each agency has set their own requirements dependent on the license type applied for and may be subject to compliance with ancillary agencies at the state level. Look through the application materials thoroughly, and consider consulting with an attorney to ensure you are in compliance with the necessary documentation.
To apply for a state temporary license, at a minimum you will need:
Evidence of Legal Right to Occupy
Should the state deem any part of your application incomplete, they will notify the primary contact with an opportunity to rectify any insufficiencies. This will inevitably delay the review of your application until all deficiencies are rectified. We would like to reassure our readers this is a normal part of the licensing process and is common practice to go back and forth with the state to ensure your application is in line with the regulations.
DO NOT DELAY
We advise sticking to the state’s December 1 recommended deadline to submit your application for a temporary license. The review period can take up to several weeks so make sure to submit the application timely to ensure there is sufficient time to receive the license. You may still apply for an annual license after the new year, but are subject to the state’s review period until they issue the annual license. The review period of the annual application can take up to several months. If you do not hold a valid local and state license you are prohibited from conducting commercial cannabis operations in the state.
This can have an significant repercussions for businesses to take into consideration. For example, if you are paying rent on the property and cannot operate can cause significant financial strains. We recommend consulting with an attorney in preparation of the annual license.
California Department of Public Health - Regulates Cannabis Manufacturing
California Department of Food and Agriculture - Regulates Cannabis Cultivation
Bureau of Cannabis Control - Regulates Cannabis Retail, Delivery, Distrbution, Testing, Microbusiness
Cannabidiol (CBD for short) is a naturally-occurring element of the cannabis plant that has recently exploded in popularity and availability. Like tetrahydrocannabinol (THC), CBD is believed to have therapeutic and medical benefits, but unlike THC, CBD has no intoxicating effects. Across the country, people can now find CBD products everywhere. But are they safe and legal?
Many products advertised as CBD are imported from other countries or produced in unregulated, unlicensed operations, with no verification that they are free from toxic compounds or that they even contain CBD. Even if the products contain “pure” CBD, knowledgeable experts contend that CBDs have little or no benefits when they are stripped from THC and other cannabinoids and compounds naturally occurring in the marijuana plant. CBDs appear to exhibit their medical and healing properties only when they are left combined with the other cannabinoids like THC, as they are found in nature.
CBD Production and Sales Remain a Federal Crime Without FDA Approval and a Doctor's Prescription
The law on CBD products is confusing, due to conflicts among local, state, federal, and international laws. Under the Supremacy Clause to the US Constitution, federal law controls to the extent it conflicts with state or local law. State law also controls to the extent it conflicts with city or county laws. Federal law in this area is moving, but it is not clear in what direction. Some predict the federal government will relinquish all regulation of CBDs and cannabis generally to the states, and keep a hands-off approach. Others expect the federal government to strictly regulate CBDs and cannabis as they do with prescription drugs through the FDA, leaving the states with little control. This approach was foreshadowed by the DEA’s recent memo announcing that drugs including CBD with THC content below 0.1% will be taken off of Schedule 1 of the controlled substances schedules, and moved to Schedule 5, which allows CBD products to be sold through traditional pharmacies with a doctor’s prescription so long as the particular product is first approved by the FDA. The order also disallows any importing or exporting of CBD products without a permit.
Under federal law, CBD with THC content above 0.1% remains classified as a Schedule 1 controlled substance, subject to severe criminal sanctions. The Rohrbacher-Farr amendment creates a limited exception, preventing the DOJ from prosecuting anyone in strict compliance with state medical marijuana laws (adult-use or recreational uses of CBD products may still be prosecuted).
Without Commercial Cannabis License, CBDs Are Banned in California Food Products
In California, the Department of Public Health recently issued a memo confirming that CBD products are not allowed in any food products in the state (unless the products are regulated as commercial cannabis edibles, which by definition contain THC levels of at least 0.3%). Thus, under state law, CBDs are allowed to be sold and ingested as long as they include THC, and are banned in food if they come from industrial hemp with little or no THC. The reason CBD products with no THC are banned by state law is that California incorporates federal law regarding food additives, dietary use products, food labeling, and good manufacturing practices for food. Currently, the United States Food and Drug Administration (FDA) has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.
This is regardless of the source of the CBD – i.e., whether the CBD is derived from cannabis or industrial hemp. CBD used as a topical or smokeable product could arguably be allowed under either federal or state law as it may not be considered to be a food that is ingested.
Los Angeles Allows CBD Businesses Without a Cannabis License to Register for Business Tax Certificate to Engage in Commercial Activities
The City of Los Angeles recently issued a form for businesses seeking a Business Tax Registration Certificate to engage in commercial activities related to industrial hemp and/or CBD derived from industrial hemp in the City of Los Angeles. This form allows your business to pay local taxes, but it does not protect you from criminal prosecution under state or federal law. It likely also signals that enforcement of state CBD laws is not a high priority of the Los Angeles Police Department.
International Treaties Ban All Cannabis Extracts Including CBDs
In addition to local, state, and federal law, international treaties place obstacles to the sale of CBD products. The United Nations has had a series of International Drug Control Conventions (treaties of which the US and Canada are part), and while CBD is not specifically listed in the schedules of the Conventions, "extracts" of cannabis are apparently included within Schedule 1, meaning they are prohibited.
Given the controls required by the UN Conventions, the US would be unable to keep its obligations under the treaties if CBD products were de-controlled under federal law. The Federal Controlled Substances Act, moreover, indicates that scheduling decisions will be made in accordance with treaty obligations. For example, under section201(d)(I) of the CSA, if control of a substance is required under an international treaty or convention in effect on October 27, 1970, the Attorney General is required to impose controls on the substance by placing it under the schedule he deems most appropriate to carry out such obligations.
The World Health Organization Expert Committee on Drug Dependence is scheduled to review the UN’s classification of CBD, THC, and cannabis in general at its November 2018 meeting, which could lead to a change in the international treaty.
The result of all these different layers of law leave many confused. We expect that the laws will adapt over time to allow for open sales of CBD products, whether or not they also contain THC. For now, however, the law is full of problems for CBD products and cannabis in general, and we applaud those working to reform the laws for these products that are all around us.
Guest post by Donna Thompson, customlabels.net
Medical marijuana has been legalized in more than half of the states in the U.S. It is used for easing the symptoms of pain, nausea and vomiting, glaucoma, post-traumatic stress disorder (PTSD), and epilepsy. Although the number of people that advocate legalization of marijuana for medical purposes is on the rise, not all states in the U.S. have said “yes” to the legalization.
That’s why there is no federal law, and there are variations in medical marijuana laws in different states.
While some states allow the use of medical marijuana extract only, in other states it is allowed to use the whole plant.
When it comes to ways of obtaining medical marijuana, in some states dispensaries are the only place where you can buy it, but in others, like Michigan, you are also allowed to cultivate the plant in your own home.
Also, lists of medical conditions that qualify for medical marijuana treatment differ from state to state. That means that if you get a medical marijuana card in one state, you can buy a medical marijuana product in some other state only if that state lists your condition as one that can be treated with medical cannabis.
The absence of federal laws affects both consumers and producers of medical marijuana.
Besides all of these differences, states that legalized marijuana usage for medical purposes have different requirements for labeling and packaging medical marijuana products. Thus, when medical marijuana producers want to put their product on the market, they must comply with state specific regulations. For example, when it comes to packaging, products need to be tamper-proof and child-proof. As for labeling, the following infographic shows what common labels for medical marijuana products look like in the states that have legalized marijuana: