ALBANY — The New York State Cannabis Control Board has approved regulations presented by the Office of Cannabis Management establishing the State’s Cannabinoid Hemp Program. The regulations create new standards for processing, manufacturing, laboratory testing, and packaging designed to regulate cannabinoid hemp products (e.g., CBD products) in New York State. The new regulations will be effective immediately, but business will have a six-month window to comply with the new testing, and packaging and labeling requirements.
The regulations were previously issued for public comment by the Department of Health (DOH) but are being filed by the Office of Cannabis Management (OCM), which was given oversight of the Cannabinoid Hemp Program with the enactment of the Marijuana Regulation & Taxation Act (MRTA) in March. The regulations adopted as final by the Board reflect changes requested during the first comment period, but largely mirror the regulations as re-filed by the DOH in July. In addition, the Board has indicated further changes will be coming in the near future to account for additional public comments and harmonize certain regulations with the upcoming Adult-Use Cannabis Program.
With the adoption of the regulations, the OCM will be issuing final licenses to all businesses that have submitted the required application information and have been operating under provisional licenses or permits, with no additional fee or actions required by the licensees. Businesses interested in processing, manufacturing, or selling cannabinoid hemp products will be able to apply for a license on the Program’s Website. With regulations soon to be in effect, all businesses selling cannabinoid hemp products to consumers in New York State are required to obtain a license to do so.
“We are working as quickly as we can to build a new, safe industry that promotes public health and grows our economy, and with today’s approval of hemp regulations, we are taking another step forward in delivering on that promise for New Yorkers,” said Board Chair Tremaine Wright. “In just our first month of operating, we have already made it easier for patients to access medical cannabis. Governor Hochul and the Legislature moved quickly together to make appointments, and we will continue that momentum to implement the Cannabinoid Hemp Program and build an industry focused on health, safety, equity, and economic development.”
“The hemp regulations we approved today will provide new and expanded opportunities for New York’s farmers, processors, and retail businesses, including allowing the sale of hemp flower products and food and beverage products containing CBD” said Board Member Jen Metzger, who chaired the Agriculture Committee when she served in the State Senate and sponsored the original Cannabinoid Hemp Program Bill in 2019. “We are opening the doors for the hemp program to grow responsibly, establishing standards and requirements to assure safe, high-quality products for the New York market and beyond.”
“The Office of Cannabis Management is hard at work to build a new, safe cannabis industry in New York, and we are proud that in our first month we have already worked with our Board to finalize the rules for our hemp program and vastly expand access to our medical program so New Yorkers can get the relief they need,” said OCM Executive Director Chris Alexander. “The regulations approved by the Control Board today are just the start for the Cannabinoid Hemp Program, and we plan to soon propose for public and Board consideration further changes that will bring the program in-line with the regulatory structures in other states, ensuring New Yorkers have the highest level of protection while providing our businesses with the tools they need to compete.”
”We’ve been working for years to establish hemp as a new crop in NYS, one with multiple uses. While farmers are also growing hemp for it’s seed and fiber, cannabinoid hemp extracts require a unique set of safety standards. The regulations approved by OCM today position NYS as a national leader in consumer protection and industry excellence. I am proud to have sponsored the original Cannabinoid Hemp Program Bill in the State Assembly and thank the Governor and all involved for taking this long awaited step.” said Assemblymember Donna Lupardo.
Kaelan Castetter, Vice President of the NY Cannabis Growers and Processors Association said: “As an association dedicated to ensuring diverse and thriving cannabis industries here in New York, we are thrilled with the enactment of these regulations. They will allow for new market opportunities by allowing cannabinoid food & beverage products, strengthen demand for NY grown hemp, and will protect our processors from being undercut by imported products that do not meet the necessary quality standards set by these regulations. Our hope is that the FDA will look at these rules as a model for consumer safety that also prioritizes industry growth.”
The Cannabis Control Board’s adoption today of the original regulations issued by the DOH begins the process of formally bringing the program under the jurisdiction of the OCM, enabling the OCM to issue final licenses. The regulations already received public comment when they were promulgated by the DOH. Aside from changing the name of the regulator and providing for the six-month window for businesses to comply, the proposed rules are unchanged from those issued by the DOH previously. Key provisions are described below:
• Products must be manufactured using Good Manufacturing Practices (GMP) specific to the product form (e.g., food or dietary supplement) to ensure the products are produced in sanitary conditions
• Products must be tested by accredited laboratories (ISO/IEC 17025) prior to sale to the consumer for a full panel of analytes including cannabinoid profile, heavy metals, microbials, pesticides, mycotoxins, and residual solvents
Packaging and Labeling Standards
• Packaging and labeling of products must include the following information:
- Nutritional or supplement fact panel
- List of all ingredients in the product;
- Total cannabinoids per product/serving, stating the amount of CBD and THC, if applicable
- QR code or link to Certificate of Analysis
- Required Warnings for the consumer
- Mechanism to report an adverse event
- Expiration or best buy date
• The regulations permit cannabinoid hemp flower products to be sold. For hemp flower products to be sold, they must not be marketed or advertised for the purpose of smoking or be in the form of a pre-roll, cigar or joint.
• The regulations prohibit the sale of Delta-8 THC products. These products contain intoxicating qualities which are better left to be regulated in the future Adult-Use program. The Office does not regulate Delat-8 THC products available online or in stores today and strongly urges consumer caution when purchasing a product from an unknown source.
Under the MRTA, the Cannabinoid Hemp Program is designed to comprehensively regulate cannabinoid hemp products in New York State by providing clear rules for what is allowed and what is not allowed to help foster the development of a robust cannabinoid hemp industry. To do this, the program establishes consumer protection and quality control standards for the manufacturing, packaging, and labeling, and laboratory testing of cannabinoid products grounded in public health best practices. In implementing the program, the OCM educates and enforces against sub-standard products or disallowed forms of cannabinoid hemp products in the marketplace.
So far, the Cannabinoid Hemp Program has provisionally approved a total of 2,856 licenses. The following is a breakdown of the number of provisional licenses:
- 403 distributor provisional licenses;
- 35 manufacturer provisional licenses;
- 36 processor provisional licenses; and
- 2,384 retailer provisional licenses.
Additional items covered in today’s meeting include:
• The 60-day public comment period on regulations for the cultivation of home-grown medical cannabis by patients and caregivers is now open and can be found here.
• Municipal governments can now upload their opt-out information here, which they must do in order for the opt-out to be recognized by the state. The information can be uploaded here.
–NYS Office of Cannabis Management