Cannabinoid Hemp vs. Marijuana

There are over 100 cannabinoids found in the cannabis plant (Cannabis sativa), among which cannabidiol (CBD) and tetrahydrocannabinol (THC) are the most commonly found natural compounds.

Cannabinoid Hemp (< 0.3% THC, dry basis)

• Touted for wellness benefits; does not produce a feeling of being high.
• Examples of cannabinoid hemp products include: tinctures, oils, topicals, pills, capsules, and food or beverages that contain cannabinoids and are intended for human consumption.

Marijuana (> 0.3% THC, dry basis)

• Psychoactive drug; gives a feeling of being high (i.e. altered time and sensory perception caused by delta-9-THC).
• Marijuana is categorized in two different ways.
  • Adult/recreational use marijuana, which includes cannabis flower and concentrated cannabis such as oils, tinctures, edibles, vapes, etc.
  • Medical cannabis or medical use marijuana for qualifying health conditions, which includes vape cartridges/pens, capsules, tablets, oils, oral sprays or powders.

New York State Cannabis Licensing and Regulatory Agencies

Oversight for both cannabinoid hemp and marijuana is under the Office of Cannabis Management (OCM) and the Cannabis Control Board.

Laws & Regulations

• The Marijuana Regulation and Taxation Act (MRTA) established the cannabis law (Chapter 7-A), which authorizes a person to apply for a license to process, manufacture and sell cannabinoid hemp products in New York State (Article 5 Cannabinoid Hemp and Hemp Extract).
• On November 3, 2021, the Cannabis Control Board under the Office of Cannabis Management (OCM), approved regulations for New York State’s Cannabinoid Hemp Program. These regulations provide standards for industry to produce cannabinoid products with consistency and quality and include requirements for manufacturing, laboratory testing, packaging and labeling.
  • The OCM provided a 6-month period (November 2021 – April 2022) for licensees to meet certain regulatory requirements.
  • Visit this page from the OCM to view the Cannabinoid Hemp Regulation.

Additional Requirements for Processing Cannabinoid Hemp Products

Processors who manufacture cannabinoid hemp food or dietary supplements must adhere to more stringent requirements than those who process food or dietary supplements not produced from cannabinoid hemp. Some of the more stringent requirements include obtaining a qualified third-party good manufacturing practice (GMP) audit of the processing facility, applying for a cannabinoid hemp processor license, and having a testing laboratory perform specific analytical analyses of cannabinoid hemp products. These added requirements also increase the costs associated with manufacturing cannabinoid hemp products compared to other food and beverages or dietary supplements.

Good Manufacturing Practice (GMP) Audit of Your Processing Facility

GMPs are quality control systems to ensure product quality and consistency, which is required to meet federal regulations established by FDA. Cannabinoid hemp processors should meet the requirements for one of the following GMP regulations as appropriate for the type of product being manufactured:

1. 21 CFR part 117, subpart B (for food and beverage products); or
2. 21 CFR part 111 (for dietary supplements).

In addition to meeting the requirements outlined in the GMP regulations, you will need to have an accredited, third-party certification body conduct a GMP audit of your processing facility. The New York State Office of Cannabis Management (OCM) has published a Cannabinoid Hemp Processor GMP Audit Guidance and a list of approved third-party GMP auditors on their website.

Cannabinoid Hemp Processor Licenses

Who

Any person who processes cannabinoid hemp or hemp extract used for human consumption in New York State must obtain a cannabinoid hemp processor license.

• The Cannabis Law § 92: Cannabinoid hemp processor license.
  • Persons processing cannabinoid hemp or hemp extract used for human consumption, whether in intermediate or final form, shall be required to obtain a cannabinoid hemp processor license from the board.

Types

There are two types of licenses for cannabinoid hemp processors, either for "extracting and manufacturing" or "manufacturing only.”

How

Apply on the Office of Cannabis Management’s website.

Fees

There are application and licensing fees that apply.

• For an “extracting and manufacturing” license, it costs a total of $4,500 ($1,000 application fee + $3,500 license fee).
• For a “manufacturing only” license, it costs a total of $1,500 ($500 application fee + $1,000 license fee).

Analytical Tests on Cannabinoid Hemp Products

You will need to contract an ISO/IEC 17025 accredited third-party laboratory to perform one or more analytical tests (e.g., cannabinoids, heavy metals, microbial impurities, mycotoxins, residual pesticides, residual solvents and processing chemicals, and terpenoids) on your cannabinoid hemp products. The testing laboratory must be approved to test medical marijuana or meet the minimum requirements outlined in the Cannabinoid Hemp Regulation. Laboratories approved to test medical marijuana must be located in New York State, licensed by the department’s Bureau of Narcotic Enforcement and approved for the analysis of medical marijuana.

Online Courses and Training Opportunities

According to the part 114 cannabinoid hemp regulation, cannabinoid hemp processors must comply with the federal regulations for food labeling (21 CFR 101), preventive controls for human food (21 CFR 117), and/or current GMP for dietary supplements (21 CFR 111) that apply to the type of product being produced.

• § 114.8 Cannabinoid hemp product requirements. (a) All cannabinoid hemp products distributed or offered for retail sale in New York State shall: (1) be manufactured in accordance with Parts 101, 111 or 117 of Title 21 of the Code of Federal Regulations, as appropriate for the type of product being manufactured and as otherwise determined appropriate by the office in guidance or future regulation.

For processors that utilize cannabinoid hemp or hemp extract in their food, beverage or dietary supplement production, the following Cornell courses and training opportunities are offered to meet the state and federal regulations:

1. Online Good Manufacturing Practices Part 117 course (for human food and beverages).
2. Online Good Manufacturing Practices Part 111 course (for dietary supplements) coming in 2023!
3. Supplemental GMPs course on Processing Cannabinoid Hemp Products in New York State coming in 2023!
   • This short course (6 hours) is being designed to review the newly adopted regulatory requirements in New York State for manufacturing cannabinoid hemp products under Part 114 Cannabinoid Hemp Regulation. This course should help cannabinoid hemp processors understand and comply with federal and state regulatory requirements. The online course will be available in 2023. Participants will receive a Certificate of Course Completion issued by the IFS@CU upon successfully completing the course.

Resources

• Office of Cannabis Management (OCM)
• Office of Cannabis Management (OCM) Cannabinoid Hemp Program
• The Cannabis Law
• Cannabinoid Hemp Regulation

Assistance from Cornell University

Cornell Hemp Extension Team

• Extension team members can assist producers with growing hemp in NYS and hemp agronomy.

Cornell Hemp Program (School of Integrative Plant Science)

• Hosts annual Hemp Research Field Day.
• Provides resources for growing hemp.
• Hosts FAQ web page addressing questions about hemp, how to grow it, the difference between THC and CBD, and more.
• Upcoming events can also be found on their website.

Cornell Food Venture Center (CFVC) and Pilot Plant

• Offers assistance for hemp-based products that need to comply with current regulations, product development as well as process validation for product safety and stability.

Institute for Food Safety at Cornell University (IFS@CU)

• Offers Good Manufacturing Practices Part 117 online training for human food and beverages.