One of the pillars of the state regulated adult use cannabis market is the safety of the products for the public. Consumers can expect to purchase safe products with reliable dosages from legal dispensaries. Cannabis products have strict testing requirements to ensure the product is as advertised on the package, has the concentration of THC or other cannabinoids advertised and is free from contaminants and unauthorized ingredients.
The acceptable tolerance for THC and CBD concentration is 25% from the mean concentration of total THC and CBD in milligrams per single serving for that submitted lot unless the products have a specified total THC and CBD concentration less than two (2) milligrams per single serving. In the latter case, the acceptable tolerance is within 0.5 milligrams per serving of the mean concentration.
Producers of cannabis retail products must implement a unique lot-identifier system and maintain detailed records regarding production of the product and sample testing by certified labs. They are also required to retain representative sample(s) stored on-site at the licensee’s facilities to allow for testing in the future. The lot-identifier can be used to access a complete history of production, manufacturing, testing, holding, distribution, or recall of a lot of adult-use cannabis product.
One of the tests that must be performed is homogeneity testing. Homogeneity refers to the even distribution of the active ingredients throughout the cannabis product. Each dose should have a uniform amount of effective cannabinoid or THC. If not uniformly dispersed, some portions could have more than the dosing listed on the package and some could potentially have no active ingredients at all. Producers must submit samples from ready-to-consume final product that is in its final packaging. The sample must be in final packaging but the entire lot need not be in final packaging at the time of sample collection. Product awaiting testing and packaging must be segregated in a designated area for storage and must be clearly labeled as to include but not limited to product name, product type, total quantity, lot/batch number, date of production, and date of expiration. Once the licensee receives passing compliance testing results from the permitted laboratory, the licensee must package the entire lot prior to releasing any portion of it for retail sale.
When products submitted for testing are new offerings from a licensee, laboratories must test five (5) samples of cannabis product for homogeneity, regardless of batch or lot size. Once initial
homogeneity testing is completed on three (3) consecutive lot/batches and the results demonstrate the product is homogeneous, all subsequent lots/batches may forego homogeneity unless there is a significant change to the standard operating procedures affecting the manufacturing of a previously produced cannabis product (e.g., batch/lot size or volume, mixing or handling methods, change in ingredients, change in equipment) or any other instance that may significantly affect homogeneity.
The OCM’s guidance document on lab testing requirements can be downloaded here: https://cannabis.ny.gov/system/files/documents/2024/06/ocm-laboratory-testing-guidance-for-au-licensees-and-ros-6-12-24-revision.pdf
Understanding the complex procedures for record keeping, laboratory testing and sample storage can be challenging. In this highly regulated industry, missteps can have expensive and sometimes irreversible consequences on the business and its principals. The entire business investment could be lost or the principal could become ineligible for further licenses in New York (and potentially other states as well). It is important to have an experienced team of consultants to guide your operations.
If you’d like legal guidance, please contact our office. We would be honored to help.
Tracy Jong is a Senior attorney at Evans Fox LLP with 30 years of experience focusing her practice in business law, intellectual property and licensing for alcohol and cannabis. Tracy Jong is a member of the New York Bar and is a registered attorney at the United States Patent and Trademark Office. She can be reached at [email protected].
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The content has been prepared for informational purposes only; it should not be construed as legal advice, does not create or constitute an attorney-client relationship, and readers should not act upon it without seeking professional counsel.