Product Recalls and Being Proactive

Written by Jenny Germano

The days of untested products flooding the regulated market is slowly making its way into the past. However even if product has been tested in a licensed laboratory and passes, product can still be compromised due to a variety of circumstances. Initiating a Recall or even being caught up in a Product Recall, like an inventory hold can cost your business time, money, loss of inventory, and potential damage to your brand.

There are a variety of reasons a Harvest Batch or Production Batch Recall could be initiated, here are a few examples: (These examples are Recalls in Colorado)

• Total yeast and mold contaminated harvest batches
• Lead contaminated harvest batches
• Mislabeled production batches
• Unsafe levels of microbial contamination
• Unsafe pesticide residues
• Unsafe levels of heavy metals
• Banned additives

Tested and passed product can become compromised in many ways. Here are just a few examples:

• During transport B2B – due to unsafe conditions and mishandling of product such as sanitation and temperature issues.
• Harvest Batch sample increment originally passed and was sold, then ground up to create pre-rolls and in the final form (pre-rolls) fails testing due to contamination from improper handling, storage and/or the pre-roll wrapper was contaminated with a banned ingredient.
• Regulators coming in and doing “Random Testing” on products sold in Dispensaries, or bulk Harvest Batch storage at a Cultivation and/or Manufacturer.
• Department of Agriculture coming in for a compliance inspection and taking swabs from the walls in grow rooms and trimming shears, samples from plants and determining banned pesticides residues were found.
• Poor storage conditions – Harvest Batch originally passes, however forms mold due to poor storage conditions and then sold, repurposed into a new final form at a manufacturers or store and then fails.

In Colorado, Product Recalls have dropped drastically compared to 2017 and earlier years – due to better clarifying regulations, testing program reform, and more education such as State issued compliance tips for owners and employees. As of January 1, 2021 operators in Colorado must have a Recall Plan in place.

In the newer emerging marketplaces like Michigan, Missouri and Illinois recall plans are addressed right out of the gate in the application process and commencement inspections for conditional licenses.

Being proactive can help you be better prepared if your business must initiate a recall and/or if your Dispensary’s inventory gets tied up in a recall.

Recently Colorado’s Science and Policy workgroup, QMS Subcommittee released some helpful guidance on building a Recall Plan. It is a wonderful tool if you are creating a recall plan in-house for your business.

Additionally, they produced CAPA plan guidance (Corrective Action and Preventive Action) which goes hand in hand with developing a recall plan.

If you are a Dispensary, you might be saying “What do I need a Recall Plan for?” At a minimum, a Dispensary should have a SOP in place for how to handle a product recall at the retail store level. Products on the shelf at a Dispensary can potentially get caught up in a Recall and the inventory could then have a hold placed on it, in the State Inventory Tracking System.

What are some important areas a Dispensary should include in their recall plan? Here are a few examples to consider for a Retail Location:

• The Person responsible at the Retail Location for handling Recalled Product.
• The implementation of the Recall notice and communicating the next steps.
• The specific steps and actions needed to remove recalled product from the shelves and keep it separated from non-recalled inventory.
• Evaluation of a Complaint or Condition (if applicable) see guidance document link.
• Communicating with Regulators and State Tracking System (Metrc) on what to do with product once it is quarantined – does it go back to the originating license or destroyed on camera, on site at the retail location.

Another way to be proactive is to implement preventative health and sanitation standards when handling raw and unpackaged product in the licensed facility. Ensuring all employees are properly trained on current SOPS and utilizing cleaning sanitizers correctly for surfaces where raw product come in contact with, wearing gloves, engaging in proper handwashing procedures, and adhering to sample preparation or collection requirements.

Some of the examples listed, may not apply in the State you are currently operating in, for example some States the license holder is responsible for sample increment preparation and collection, where in other States the laboratory or transporter collect and prepare the sample increments. It is up to the operator and management to fully understand the scope of the regulatory requirements concerning their license.

Some cultivation and manufacturing operators are doing their own research to be proactive by testing the wrappers for pre-rolls and rolling papers to ensure there are no banned additives/ingredients in the wrapping materials for inhaled products that would cause the pre-rolls in final form to fail a laboratory test.

When considering any packaging, it is important to understand if there is anything in the package coming in direct contact with the raw product that could cause it to fail a testing requirement while in its final form.

Operating under the Cannabis regulatory microscope requires at a minimum due diligence with public safety at the top of list when producing any product going to market for public consumption. It is just good business and a healthy practice.

ICS Consulting specializes in Compliance based services, such as Third-Party State Regulatory Audits, State and Local License Application Support, Technical Writing, Standard Operating Procedures Development, Compliance Operations Training, Employee Retention Solutions, and Employee Onboarding. For more information on how ICS Consulting Service can help your Cannabis Business, book a free 30-minute consult and we'll help you map out your next steps to be successful in the Regulated Cannabis Industry.