Guidance

Michigan Growers and Processors: New Guidance on Water Usage Requirements

The Michigan Department of Environmental Quality Water Resources Division issued guidance to inform growers and processors about state and local water use regulations. Growers and processors that use more than 100,000 gallons per day of groundwater or surface water must use the Water Withdrawal Assessment tool to determine what other state or local regulatory approvals or actions are necessary. The guidance outlines reporting, land use and water use requirements under the water use regulations. Cultivators or processors should consider the following items:

  • Is local municipality approval required to use land for cultivation / processing purposes or water usage?

  • Are land improvements required to prevent toxic runoff due to the land’s proximity to streams, rivers, lakes, wetlands, floodplains, or a regulated wetland on the property?

  • Do you need to report annual water usage to the either Michigan Department of Agriculture and Rural Development (MDARD) (for farms) or DEQ (all other withdrawals including municipal water supplies)?

  • Do you need other permits or approvals to make planned alterations to the property?

Massachusetts Regulator Issues Guidance on Tinctures: Not Edibles

The Massachusetts Cannabis Control Commission has issued guidance regarding tinctures. The Commission believes that tinctures are concentrates but not edibles. The Commission distinguished the method of ingesting tinctures, by dropper or measuring spoon, as compared to an edible that is consumed by eating or drinking. The Commission also indicated that edibles generally “appear and taste like commonly prepared foods.” The distinction between an edible and a tincture provided in the guidance is not as clear as it appears. For example, how would a cannabis-infused olive oil be treated under this guidance? Olive oil seems to fit in both categories as it is a cannabis-infused oil that can be ingested using a dropper or measuring spoon. Would the olive oil be considered an edible if it is used on pasta?

The classification of concentrate versus edible matters due to the compliance requirements associated with each product. For example, edibles are subject to dosing limitations. Reclassifying products into tinctures would allow firms to avoid this restriction. Based on strategic goals, firms should consider this guidance when developing new products.

Michigan: Guidance on New Licensee To-Dos During 30 Day Honeymoon Period

Michigan issued an advisory bulletin reminding new licensees of their obligations with regards to marijuana products that are in the current inventory at the time of receiving a license. New licensees may face sanctions or fines if they fail, within 30 days, to (1) enter the inventory into the state’s seed-to-sale tracking system; (2) growers and processors must test marijuana product prior to transfer to a retail dispensary, and (3) retail establishments must obtain a written acknowledgement from patients or caregivers’s prior to selling untested marijuana product. Following the 30 honeymoon period, licensees must destroy all remaining marijuana that does not comply with regulations (i.e., entered into tracking system, tested, etc.)

POSSESSING CBD OIL IN OHIO IS ILLEGAL

Only medical marijuana dispensaries can sell CBD oil in Ohio.  Under Ohio law, CBD oil falls under the definition of marijuana, and is subject to the same regulations.  Medical marijuana dispensaries will need to comply with the known  source requirements, understand the active ingredients, and ensure that the product is tested.  Testing can only be performed by laboratories that are licensed by the Ohio Department of Commerce.  

Ohio announced the approval of 56 medical dispensaries in June.  However, the medical dispensaries must show the state that they can operate before receiving a certificate to engage in business.  Until that time, possession of CBD oil or marijuana is illegal.,

MA GUIDANCE: CREATING AN EQUITABLE INDUSTRY

The Massachusetts Cannabis Control Commission published Guidance on Equitable Cannabis Policies   for Municipalities, which contains recommendations on how municipalities can create an equitable marijuana industry.  The guidance is intended to help municipalities develop cannabis policies that are aligned with the Social Equity program, and promote an equitable and meaningful participation of persons dispproportionately affected by the enforcement of previous cannabis laws.  State law also provides the Commission with the authority to take remedial measures against a municipality if there is evidence of discrimination or barriers to entry in the regulated cannabis industry.

Massachusetts' recommendations for creating an equitable cannabis industry include:

  • Allow various types of businesses:  Communities should consider allowing different types of license types that meet the strategic goals for the community.  For example, micro businesses and craft cooperatives promote small businesses.

  • Consider whether caps are necessary:  Offering limited cannabis business licenses in commercial parts of town prevents opportunities for small businesses.  

  • Zoning:  Communities should consider carefully whether to expand the 500 feet buffer around schools.

  • Host community agreements:  Clearly identify the licenses, permits and the process for operating a marijuana business.

  • Selection process:  Institute an objective, transparent selection process that prioritizes review for state-designated economic empowerment applicants. Municipalities should consider instituting preferences for state- designated Social Equity Program participants, or applications from companies owned by marginalized groups. A municipality should evaluate all applicant's diversity plan and understand how the impact will have a positive impact on communities that have been disproportionately harmed by the enforcement of previous cannabis laws.

CANADA ISSUES ADVERTISING WARNING

Canada posted an informational bulletin for licensed producers discussing the restrictions on cannabis advertisements and the corresponding penalty for non-compliance.  Canada's Food and Drug Act (FDA) prohibits advertisements for food or drugs as a treatment or cure for certain diseases published by the government.  In addition, labeling and advertisements must not produce a false impression as to the product's character, value, quantity, composition, merit or safety.  

Licensed producers should seek guidance from local counsel to ensure that advertisements and labeling comply with the FDA as penalties can range from $250,000 to $5,000,000, or to a term of imprisonment ranging from six months to two years, or to both.

Advertising Prohibitions on Cannabis - Information Bulletin
www.canada.ca/en/health-canada/services/drugs-medication/cannabis/licensed-producers/advertising-prohibitions-cannabis-information-bulletin.html


CANADA ISSUES IMPORT / EXPORT BULLETIN

Canada issued an informational bulletin on the import and export of marijuana by licensed producers.  The bulletin indicates that licensed producers may import or export marijuana in very limited circumstances such as importing starting materials or exporting a unique strain for research purposes.  Licensed producers will not be able to export cannabis to foreign markets where recreational use is legal.

Licensed producers that are seeking to import or export marijuana must file an application.  When determining whether to grant the application, the Canadian government will consider several factors including Canada's obligations under international treaties; whether it is consistent with applicable regulations; whether the receiving country has issued an import permit; and the risks to public safety.

Import and Export of Marijuana by Licensed Producers - Information Bulletin
www.canada.ca/en/health-canada/services/drugs-medication/cannabis/licensed-producers/policies-directives-guidance-information-bulletins/import-export-cannabis-licensed-producers-information-bulletin.html

ONTARIO CANNABIS STORE PICKS SUPPLIERS

The Ontario Cannabis Store (OCS) has announced that it will be ready to open its online store doors on October 17 for home delivery.  OCS entered into supply agreements with 26 licensed producers to provide cannabis products including the following companies.

  • 7ACRES/The Supreme Cannabis Company

  • AgMedica Bioscience Inc.

  • Aphria Inc.

  • Aurora Cannabis Enterprises Inc.

  • Beleave Kannabis Corp.

  • Broken Coast Cannabis Ltd.

  • CannTrust Inc.

  • Canopy Growth Corporation

  • Emblem Cannabis Corporation

  • HEXO Operations Inc.

  • Hiku Brands Company Ltd.

  • Maricann Inc.

  • MedReleaf Corp.

  • Natural MedCo Ltd.

  • Northern Green Canada Inc.

MICHIGAN GUIDANCE ON PERMISSIBLE EDIBLES

Michigan published guidance outlining examples of edibles that are and are not permissible under the MMFLA.  The bulletin also indicates that only a processor may produce edibles that do not require refrigeration for safety.  The department also requires processors to retain proof that shelf stable, perishable food products have been treated by heat and/or dried to to destroy foodborne microorganisms that can cause illness or spoil food.

 The list of permissible non-refrigerated edible examples include:

• Breads, cookies, muffins and cakes
• Cooked fruit pies, including pie crusts made with butter, lard or shortening
• Fruit jams and jellies (as defined in 21 CFR part 150) in glass jars that can be stored at
room temperature (except vegetable and other non-fruit-based jams/jellies)
• Confections and sweets (made without alcohol)
• Dry herbs, herb mixtures, dip and soup mixes
• Popcorn, granola, coated/uncoated nuts, dehydrated vegetables and fruits
• Chocolate covered pretzels, marshmallows, graham crackers and cereal bars
• Dried pasta made with or without eggs
• Roasted coffee beans or ground roasted coffee
• Vinegars and flavored vinegars

The list of edible examples requiring proof of additional processing to be shelf stable include:

• Salad dressings
• Sauces and condiments, including barbeque sauce, hot sauce, ketchup and mustard
• All beverages, including fruit/vegetable juices, Kombucha tea and apple cider
• Canned pickled products like corn relish, pickles and sauerkraut
• Canned fruits and vegetables like salsa and canned peaches

The list of non-permissible edibles examples include:

 • Hummus
• Garlic in oil mixtures
• Ice and ice products including ice cream
• Pies/cakes that require refrigeration (banana cream, pumpkin, lemon meringue, custard)
• Cheesecake and cakes with glaze and/or frosting that requires refrigeration
• Vegetable jams/jellies such as hot pepper jelly
• Milk and dairy products like butter, cheese and yogurt
• Canned fruit or vegetable butters like pumpkin and apple butter
• Focaccia style breads with fresh vegetables and/or cheeses
• Meat and meat products like fresh and dried meats (jerky)
• Fish and fish products like smoked fish
• Cut melons
• Caramel apples
• Cut tomatoes and chopped/shredded leafy greens
• Products made from fresh cut tomatoes, cut melons and cut leafy greens
• Products made with cooked vegetable products that are not canned

MICHIGAN'S GUIDANCE FOR TESTING FACILITIES

Michigan published guidance for Licensed Safety Compliance Facilities (SCF).  The guidance sets forth the regulatory requirements for testing medical marijuana for safety and potency including moisture content and water content, chemical residue, heavy medals, residual solvents, and microbial and mycotoxin screening by using required safety tests and limits.

The guidance indicates that SCF's must ensure that the following items are in place in order to meet the regulator's expectations for medical marijuana testing:

  • Be in good standing with a third party accrediting party (ISO 17025)

  • Internal operating procedures that minimize imprecision and bias and lists chronological steps that ensure a consistent and repeatable method including 

    • Sampling procedures to ensure the proper collection, clear labeling, proper preservation, careful transportation and storage of samples by trained personnel for laboratory analyses. 

    • Collection procedures that cover sampling methodology, equipment and supplies, records and documentation, testing process, and demonstration of capability

    • Initial documented training of staff

    • Audits of field activities


Michigan's revised Safety Compliance Facility Information (August 17, 2018)
www.michigan.gov/documents/lara/08.17.18.FINAL.TESTING.GUIDE_630799_7.pdf