The cannabis industry is heavily regulated. Now more than ever, it is of utmost importance to follow the state-wise laws of packaging and labeling of Cannabis and its derived products, be it oil, tinctures, concentrate, creams or even dried strains, etc.
The laws of packaging and labeling determine the fate of the product when it is sitting in the grocery store among so many similar products waiting for their potential buyers. The laws of packaging and labeling enable a buyer to quickly identify the product, get essential information available on the label, and decide whether it should be added to the cart or not. The more the laws are innovative, the more convenience and information is provided to the potential buyer. As a result, this makes the shopping experience more stress-free.
The booming cannabis industry has taken full advantage of the policies of packing and labeling of Cannabis products. These laws focus on conveying essential information to the customer by printing it on the label of each derived Cannabis product.
Every state has its autonomous Cannabis laws and regulations, from harvesting to selling Cannabis-based products and even transporting the Cannabis products across the state lines. With that said, an important factor cannot be missed, i.e., the knowledge of the universal Cannabis packaging and labeling laws.
Yes, it’s true! The slightest negligence or non-compliance to Cannabis packaging Laws and labeling requirements can land the seller into great trouble. And in this particular case, trouble means license cancellation, a hefty fine, or even jail.
Are the cannabis products in my state following all the packaging regulations?
Unfortunately, Cannabis is still illegal federally. So unless you live in a state where Cannabis programs are legal, growing Cannabis and selling the derived products could mean jail. This interprets that Cannabis selling is still a critical matter because it contains psychoactive components, and this is why each state has made its own laws regarding Cannabis products.
Although there are some universal regulations related to Cannabis and its derived products that each state follows, we will shed some light on both the unique and common state-wise Cannabis packaging and labeling laws. However, the main purpose of this article is to educate people about New York’s Cannabis Packaging and Labeling Laws and Requirements.
New York Cannabis packaging Laws and labeling requirements.
As per New York’s Cannabis packaging Laws and labeling requirements, the approved medical marijuana products shall be limited to the following forms and routes of administration:
- Liquid or oil preparations for metered oromucosal or sublingual administration or administration per tube
- Metered liquid or oil preparations for vaporization;
capsules for oral administration; or - Any additional form and route of administration approved by the commissioner. Smoking is not an approved route of administration
- Approved medical marijuana products may not be incorporated into edible food products by the registered organization unless approved by the commissioner.
As per law New York’s Cannabis packaging Laws and labeling requirements, the registered organization shall package the final form of the approved medical Marijuana product at the manufacturing site. The original seal shall not be broken except for quality testing at an approved laboratory, for adverse event investigations, by the department or by the certified patient or designated caregiver.
The registered organization shall package the approved medical Marijuana product in a way that it is child-resistant, tamper-proof/tamper-evident, light-resistant, and in a resealable package that minimizes oxygen exposure.
The registered organization shall identify each lot of approved medical marijuana products with a unique lot identifier.
In addition, each approved medical Marijuana product shall be affixed with a product label. Medical Marijuana product labels shall be approved by the department prior to use.
Each product label shall be applied at the manufacturing facility, be easily readable, firmly affixed, and include:
- Name, address, and registration number of the registered organization;
- Medical Marijuana product form and brand designation;
- Single-dose THC and CBD content for the product set forth in milligrams (mg);
- Medical Marijuana product lot unique identifier (lot number or bar code);
- Quantity included in the package;
- Date packaged;
- Date of expiration of the product;
- Proper storage conditions;
- Language stating:
(i) “Medical Marijuana products must be kept in the original container in which they were dispensed and removed from the original container only when ready for use by the certified patient”;
(ii) “Keep secured at all times”;
(iii) “May not be resold or transferred to another person”;
(iv) “This product might impair the ability to drive”;
(v) “KEEP THIS PRODUCT AWAY FROM CHILDREN (unless medical Marijuana product is being given to the child under a practitioner’s care”); and
(vi) “This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the certifying practitioner, and in the case of breastfeeding mothers, including the infant’s pediatrician.”
For each lot of medical Marijuana product produced, the registered organization shall submit a predetermined number of final medical Marijuana products (e.g., sealed vials or capsules; with the number of samples submitted, based on statistical analysis, determined to be representative of the lot) to an independent laboratory/laboratories approved by the department.
The laboratory verifying the cannabinoid content shall be approved for the analysis of medical Marijuana products by the department in accordance with section five hundred two of the public health law and subpart 55-2 of this title.
Such laboratory, or approved laboratories cumulatively, shall certify the medical Marijuana product lot as passing all contaminant testing and verify that the content is consistent with the brand prior to the medical Marijuana product being released from the manufacturer to any dispensing facility.
(1) Any lot not meeting the minimum standards or specifications for safety shall be rejected and destroyed by the registered organization in accordance with the registered organization’s approved operating plan.
(2) Any lot not meeting the minimum standards or specifications for brand consistency shall be rejected and destroyed by the registered organization in accordance with the registered organization’s approved operating plan.
(3) The registered organization shall keep and maintain records documenting submission of medical Marijuana products to approved laboratories as required herein and the results of the laboratory testing. The registered organization shall provide the department with such records upon request.
The registered organization shall demonstrate the stability of each approved medical Marijuana product produced (each brand in each form) by testing at an approved laboratory in accordance with section 1004.14 of this title:
(1) The stability and expiration date of the final distributed medical Marijuana product shall be validated and shall be stable for a minimum of 60 days under the specified storage conditions (light, temperature, and humidity) when opened;
(2) Shelf-life of unopened medical Marijuana products (e.g., packages or vials) shall be validated by ongoing stability testing according to a schedule determined by the department, and expiration date for unopened products shall be determined through the stability testing;
(3) Specifications regarding storage conditions must address storage at the manufacturing facility once the package is sealed, during transport, at the dispensing facility, in the patient’s home, and for samples retained for future testing.
Lastly, New York’s Cannabis packaging Laws and labeling requirements state that no synthetic Marijuana additives shall be used in the production of any medical Marijuana product.