Stop Work Orders
A Stop Work Order requires a licensee to immediately halt certain activities. Depending on the violation, the order may be full or partial.
Full Stop Work Order
If a Full Stop Work Order is issued, the licensee must immediately stop all business operations and licensed activities. This includes cultivating, processing, distributing, delivering, testing or selling cannabis. Exceptions may be noted in the order.
Example: A licensee is found in possession of illicit cannabis.
Partial Stop Work Order
If a Partial Stop Work Order is issued, the licensee must immediately stop only the specific activities listed in the order.
Example: On-site consumption occurring at a licensed premises without authorization.
Quarantine Order
A Quarantine Order pauses certain products from moving through the supply chain until the Office completes an investigation and confirms that safety, quality, and regulatory standards are met.
- Quarantine Orders may apply to a specific product, lot, or batch, or to multiple products and licensees.
- When a Quarantine Order is issued, licensees must submit a Corrective Action Plan response to the Office within 24 hours of the order being issued. In some cases, a quarantine may lead to a consumer-level recall.
Common Reasons for Quarantines
- Missing required fields on final product label
- Use of unauthorized ingredients
- Products in disallowed forms or without required Office approval
- Use of unapproved solvent during production
- Packaging or labeling attractive to individuals under 21
- Lack of documentation proving the product was grown, processed, and/or manufactured in New York State (Traceability)
Common Labeling Errors
The most common labeling errors that result in cannabis products being quarantined are:
- Product not fully enclosed in packaging
- Packaging is not both child-resistant and tamper-evident
- Product or packaging is attractive to individuals under 21
- Missing the universal symbol and required warnings
- Missing nutritional information and potency (strength) details
Licensee Responsibilities
Processors:
- Receive the Quarantine Order if they produced and packaged the product.
- Submit preliminary Corrective Action Plan within 24 hours to the Office.
- Provide the Office with a list of number of units produced and sold for the quarantined product(s).
- Notify all Distributor & Retail licensees in possession of the quarantined product(s).
- Work collaboratively with the Office on resolution.
Distributors:
- Must stop distributing the quarantined product immediately.
- Work with the processor after the Office has approved the Corrective Action Plan.
- May be required to retrieve quarantined products from retail locations.
Retailers:
- Must immediately quarantine all products on-site and cease sales.
- Store products separately, securely, and clearly labeled as “Quarantined”
- Update status in point-of-sale system to “quarantine.”
- Work with distributor to remove quarantined product(s) from retail location.
- Will receive a Quarantine Order directly if selling expired and/or quarantined products.
Recalls
What is a recall?
A recall means a potentially defective or unsafe product must be returned to the manufacturer for remediation or destruction and cannot be sold to the public.
How is a recall different than a quarantine?
A recall happens at the consumer level and includes an Office-issued public notice and press release.
What do recalls and quarantines have in common?
Both recalls and quarantines can be initiated by either the Office or a licensee, but licensees must notify the Office within 24 hours. They may also be issued as a precaution and always require timely action from all affected licensees, including both supply-side and retail businesses that have the product on site.
What are potential causes for a recall to be issued?
- A recall is generally issued when testing, complaints, or inspections confirm a strong likelihood that a product is contaminated (biological, chemical, or physical) or is otherwise adulterated or misbranded.
- Other causes for a recall include packaging defects, missing safety features, inaccurate or missing labeling, and products of unknown sourcing or origin.
Overview of General Cannabis Product Recall Flow
- Step 1: Determine the scope of the affected product.
- Step 2: Conduct a risk assessment.
- Step 3: Decide on the recall classification with guidance from the Office.
- Step 4: Perform effectiveness checks to ensure recalled products are removed from distribution and properly disposed of.
- Step 5: Perform effectiveness checks to ensure recalled products are removed from distribution and properly disposed of.
- Step 6: Send recall notifications to all affected sources.
- Step 7: Submit weekly status reports to the Office.
- Step 8: The Office decides when the recall can be terminated.
Licensee Responsibility
Notification & Public Warnings
Public notification is critical during a recall. The recalling licensee must prepare a Recall Notification Letter and send it to all businesses that may have received the recalled product.
The Recall Notification Letter should include, but not limited to the following:
- The statement: “Urgent Cannabis Product Recall”
- Recalling licensee’s name, address, and phone number
- Name of product(s) being recalled
- Packaging type and container size
- Manufacturer/distributor of the product
- Lot number(s) and expiration date(s) affected
- Reason for the recall
- Instructions for disposition of the recalled product (i.e., product return process, on-site destruction, or re-labeling instructions)
- Requested response to confirm effectiveness check
Effectiveness Checks & Status Reports
Processors must conduct effectiveness checks to confirm recalled products are removed from the distribution chain and that instructions for product disposition are followed. These checks are typically included in recall notifications and should be documented in the best way available.
- If effectiveness checks show the recall isn’t working as intended, then additional steps—such as reissuing the notice in another manner—must be taken.
- All licensees affected by a cannabis product recall must compile data from their effectiveness checks and submit a weekly status report to the Office until the recall is officially terminated. Reports should be sent to [email protected].
How Licensees Can Prevent a Recall
Licensees can reduce the risk of recalls by prioritizing safety, compliance, and preparation at every stage of operations—and by remembering that standards may change as best practices evolve.
Know the Standards
- Stay up to date on product safety standards, Good Manufacturing Practices (GMPs), and cannabis regulations.
- Establish a compliance team to ensure laws and standards are met.
- Train employees so that product safety is treated as a top priority.
Scrutinize Suppliers
- Carefully vet and monitor all suppliers.
- Inspect all third-party materials and ingredients before using them in products.
- Require suppliers to meet quality standards, pass independent audits and lab testing for ingredients.
Strengthen Quality Control
- Conduct quality checks at multiple stages of production.
- Have quality control programs reviewed by an independent third party.
- Build a workplace culture where employees feel comfortable raising safety concerns.
Be Prepared
- Develop a recall plan in case of complaints or claims.
- Keep detailed records that allow for full product traceability throughout the supply chain.
- Perform mock recalls to test recall process.
- Work with an independent insurance agent to confirm adequate coverage is in place to help recover from a product recall.