Editor's note: This article initially stated this was an expansion of a previous recall. That was inaccurate. This is the first recall relating to this issue.
Peace Naturals, an Ontario-based licensed producer of medical cannabis, says they have recently issued a voluntary product recall from earlier this year for cannabis that tested positive for a disallowed product.
Health Canada announced early last month the results of a new inspection and testing program, which included results from seven different sites: RedeCan, 7Acres, Tweed, Tilray, Broken Coast, Hydropothecary and Peace Naturals. The first five passed testing, while two, Hydropothecary and Peace Naturals, did not. The testing was completed on May 1st and 4th by Health Canada’s Pest Management Regulatory Agency. Piperonyl butoxide (PBO) is an organic compound used as a component of pesticides and found in many insecticides approved for use by Health Canada.
A representative for Peace Naturals stated in May that the PBO came from a product approved for use by the Pest Management Regulatory Agency (PMRA), used by a former employee of the company to sanitize rooms after a harvest.
“Peace’s root cause analysis indicates that this was the result of cross-contamination from a sanitation protocol that is no longer practiced at Peace. The sanitation protocol has not been practiced since new management implemented an improved production methodology after taking control of Peace. The source of the PBO was a PMRA approved product that was used to sanitize empty rooms between harvests.”
“There is no evidence to suggest that PBO at these levels is likely to cause any adverse health effects when inhaled or ingested. However, out of an abundance of caution, Peace is in the process of assessing which lots have been impacted, notifying patients, and will voluntarily recall any products that have even potentially been implicated.”
According to Health Canada, “both leaf samples at Hydropothecary tested positive for myclobutanil at low level concentrations of between 0.012 and 0.023 parts per million (ppm), and one leaf sample from plants at Peace Naturals tested positive for piperonyl butoxide at a low level concentration of 0.78 ppm.” Piperonyl butoxide (PBO) is an organic compound used as a component of pesticides and found in many insecticides approved for use by Health Canada.
Eric Klein, head of Marketing & Communications of the Cronos Group, which owns Peace Naturals, offered Lift this comment:
“Patient safety is our number one concern and we have many employees that are also patients. As a result, we extended the recall beyond just the products that tested positive for trace levels of PBO and instead included any products that had been harvested in those same rooms (meaning only 50% of the total number of lots recalled tested positive for trace levels).
“We have already completed our recall protocol, contacting all impacted patients by email, phone or mail explaining the situation and offering a credit to our valued patients. The email was sent out in the morning and by the end of that same day we broke an all-time record for orders recorded in a single 24 hour period. This overwhelmingly supportive response is a testament to the support we have from our patients and the trust our clients have in our new GMP certified process, which replaced the old sanitation protocol that led to this issue. The credits will not have a significant impact on our financial results, but it was the right thing to do for our clients so that all patients (past and present) can continue to experience how Peace has improved. We now have third party lab results posted online for all products that are actively being sold.”
Health Canada announced their new testing program last February after products from two different licensed producers were found to have the presence of myclobutanil and/or bifenazate, both unapproved pesticides for cannabis in Canada. As of May 2, only 17 pesticides are approved for use on cannabis in Canada by the Pest Management Regulatory Agency (PMRA).
From an email sent to Peace Naturals' patients:
“These products are being recalled because Peace Naturals recently found low levels of piperonyl butoxide (PBO) in the recalled products. PBO is a synergist, an organic compound that, while having no pesticidal activity of its own, can enhance the effectiveness of certain pesticides. Currently the ACMPR authorizes the use of 17 approved pesticides for Cannabis cultivation, and Peace Naturals does not use unapproved pesticides on our products.
“Our root cause analysis indicates that the trace amounts of PBO were the result of cross-contamination from a sanitation process that is no longer practiced at Peace Naturals. The source of the PBO was a Pest Management Regulatory Agency-registered product that was used to sanitize empty rooms in between harvests. This sanitation process was amended, and the use of the product containing PBO was eliminated after new management took control of the company in 2016, implementing an improved production methodology.
“Peace Naturals is confident that all products currently available for sale are not impacted by the presence of PBO; lab certificates for these products have been posted on our website. This voluntary precautionary type III recall will not disrupt our ability to supply safe medicinal cannabis to our patients.”
The email states they have issued a credit to patients for recalled products.