Pre-Package passed: Everything you need to know about OMMA packaging requirements
HB 3361 was signed into law by Governor Stitt yesterday, ushering the end of Oklahoma’s Deli-Style dispensary experience.
A bill that would require all cannabis flower to be distributed in pre-packaged form was signed into law yesterday. HB 3361 will go into effect in June of 2025, signaling the end of the deli-style dispensary experience Oklahoma medical marijuana patients have grown accustomed to.
Since we have already focused on the potential impacts of mandating pre-packaged cannabis products, this blog will focus on what’s next for businesses and important packaging requirements to keep in mind navigating this transitionary period.
HB 3361 mandates prepackaging marijuana flower for sales from licensed growers and processors to licensed dispensaries. There is nothing in HB 3361 that would require pre-packaging marijuana flower for transactions between a grower and processor or another grower.
Starting June 2025, marijuana flower must be prepackaged in package sizes weighing no less than half a gram and no more than three ounces.
The bill states, non-opaque materials may be used when packaging medical marijuana flower, provided all other packaging and labeling requirements are met and it’s placed in an opaque container before leaving a dispensary.
Many businesses who have primarily shipped bulk weight to dispensaries might be dealing with packaging compliance regulations for the very first time. Flashy brands may fly off shelves, but operators should be just as careful in establishing a compliance flow as they are a creative one when developing packaging. Below is a comprehensive guide to OMMA packaging requirements.
GENERAL OMMA PACKAGING REQUIREMENTS
These requirements shall apply to ALL medical marijuana and medical marijuana products being transferred or sold to a dispensary or b a dispensary:
Packaging Appeal: Labels, packages, and containers must not attract children. They should not include toys, cartoons, or similar child-targeting images. Packages should only show the producer's business name logo and an image of the product.
Mandatory Labels: Every package must have labels stating "Keep out of reach of children" and "For use by licensed medical marijuana patients only."
Child-Resistant Packaging: All products must be in child-resistant containers which may be clear for viewing the product. These should be placed in an exit package during sale or transfer to patients, their parents or legal guardians if the patient is a minor, or caregivers.
Pregnancy Warning: Labels must have a warning that women should not use the products during pregnancy due to the risk of birth defects.
Truthful Information: Labels must not contain deceptive, false, or misleading information. Claims of being organic are only allowed if certified under the National Organic Program. Also, products cannot be labeled "Pesticide-free" unless they are truly free from pesticides.
Avoiding Confusion: The packaging and labeling should not confuse or mislead patients into thinking the product is a trademarked or brand-name product not actually contained in the package.
Trademark Compliance: Packaging and labeling must not violate any federal trademark laws.
No Health Claims: Packages and labels must not claim that the products offer any health or physical benefits.
State-Specific Branding: The Oklahoma Medical Marijuana Authority logo or any other state's symbols should not appear on the packages or labels. Additionally, there should be no statements or symbols suggesting the product is from outside Oklahoma.
Label Clarity: Labels must clearly and accurately present the contents and potency of the product. Old labels must be fully removed before applying new ones, and overlaying labels is not allowed.
Accurate Information: All packaging and labeling must include up-to-date and correct details as registered with the Authority, like the licensee’s legal and trade name, and license number.
Accuracy of Content: The packaging must accurately reflect the cannabinoid and THC content within a margin of 15%. For example, if a label claims 100mg of THC, the actual content verified by the Certificate of Analysis (COA) must be between 85mg and 115mg.
LABEL REQUIREMENTS FOR SALES TO DISPENSARIES OR BY DISPENSARIES.
Basic Label Information: Labels must include the following basic information:
Seller Details: The name and license number of the grower, dispensary, or processor selling or transferring the product.
Product Name: The name of the medical marijuana or medical marijuana product.
Batch Number: The batch number to which the product belongs.
Net Weight: The net quantity or weight of the contents in the package.
Ingredients: A list of ingredients used in the product.
Regulatory Symbol: The Oklahoma Uniform Symbol as specified by the Authority.
THC Potency: THC potency as indicated on the Certificate of Analysis (COA) for that batch.
Terpenoid Content: Total terpenoid content in the format prescribed by the Authority.
Safety Statement: A statement confirming that the product has been tested for contaminants.
Additional Requirements for Edibles: Labels on edible medical marijuana products must also comply with specific additional standards detailed in the Oklahoma Administrative Code (OAC) 442:10-5-8.
RFID Tags: If used, RFID (Radio Frequency Identification) tags must be placed in a way that does not cover or obscure any of the required information on the labels or packaging.
LABEL REQUIREMENTS FOR SALES BETWEEN GROWERS AND/OR PROCESSORS
Seller Information: Labels must include the name and license number of the grower or processor who is selling or transferring the medical marijuana or medical marijuana products.
Batch Identification: The batch number of the medical marijuana or medical marijuana product must be included.
Harvest or Production Date: The date when the marijuana was harvested or the product was produced should be clearly stated.
Testing Statement: The label must have a statement indicating whether the medical marijuana or medical marijuana products have passed quality testing. If the product failed testing, the label should state that it is being transferred to another processor for remediation purposes.
LABEL AND PACKAGING REQUIREMENTS FOR EDIBLES
Federal Incorporation: The federal regulations from 21 CFR Part 101, as of August 22, 2018, are incorporated into these rules where applicable and as long as they do not conflict with Oklahoma state laws 63 O.S. § 420 et seq. and 63 O.S. § 427.1 et seq.
Principal Display Panel Requirements:
Business Information: Name and address of the business.
Product Name: Name of the food product.
Net Content: Net quantity or weight of the contents.
Ingredients: Complete list of ingredients.
Allergen Information: Information regarding food allergens.
Nutrition: Nutrition labeling, if required under 21 CFR § 101.9.
Additional Cannabis-Specific Information:
Cannabis Ingredients: List all cannabis-related ingredients.
Batch Number: Indicate the batch number of the cannabis used.
Marijuana Strain: Optionally, the strain of the marijuana can be included.
THC Dosage: Amount of THC in milligrams per unit.
Lot Code: Include the lot code for traceability.
Compliance with FDA Guidelines:
Claims: Any nutrient content, health, or other claims must adhere to the FDA Food Labeling Guide.
Safety Information:
Emergency Contact: Include the statement, "For accidental ingestion call 1-800-222-1222."
Visibility of Oklahoma Uniform Symbol:
Placement and Size: This symbol must be clearly visible, printed in color, and at least one-half inch by one-half inch in size on all packages and individually-packaged product units.
Pregnancy and Breastfeeding Warning:
Warning Label: Packages must include the warning, "Women should not use marijuana or medical marijuana products during pregnancy because of the risk of birth defects or while breastfeeding."
Reference this link to 21 CFR Part 101 CFR - Code of Federal Regulations Title 21 (fda.gov).
As the cannabis industry in Oklahoma adapts to the impending changes brought by HB 3361, it becomes increasingly crucial for businesses to ensure their operations align with the new legal landscape. Compliance is not merely a regulatory requirement but a foundation for maintaining a reputable, trustworthy brand in a competitive market. Understanding and implementing these packaging regulations will be paramount to avoid costly legal complications and to preserve the integrity of your products in the eyes of consumers and regulators alike.
At Gies Law Firm, we recognize the complexities this transition may pose for your business. Our team of experienced cannabis law attorneys is dedicated to guiding you through the nuances of these regulations, ensuring your business not only meets the new compliance standards but thrives under them. Don't let regulatory changes disrupt your operation or market presence. Reach out to us for a comprehensive compliance consultation, and secure your business's future in Oklahoma's evolving cannabis landscape. Contact us at 405.281.0276 or book your appointment directly here to navigate these changes with confidence and legal expertise.
