Regulatory Focus™ > News Articles > Up in Smoke: Canadian Regulators Find Pot too Potent

Up in Smoke: Canadian Regulators Find Pot too Potent

Posted 13 February 2015 | By Michael Mezher 

Up in Smoke: Canadian Regulators Find Pot too Potent

A licensed medical marijuana producer in Canada has issued a recall for its pot-based product, saying some batches of it are too strong.

According to an information update on the Health Canada website, third party tests of samples of its "Nice N'EZ" product were found to exceed the product’s labeled strength for delta-9-tetahydrocannabinol, marijuana's active ingredient.


Medical marijuana (spelled ‘marihuana’ in some official documents) has been regulated in Canada since May 1999, when an interim guidance document was issued to “assist individuals who want to apply for an exemption [from the Controlled Drugs and Substances Act (CDSA)] for medical purposes.” In June 1999, Health Canada issued its Research Plan for Marijuana for Medical Purposes, which detailed provisions for studying marijuana for medical purposes.

In 2001, the Marihuana Medical Access Regulations (MMAR) was enacted, which established parameters for the possession, production and study of marijuana for medical purposes. Under MMAR, individuals were able to obtain marijuana by applying for a license to either produce their own marijuana, choose another individual to grow the product for them or purchase directly from Health Canada.

While many patients and advocates valued the ability for individuals to grow marijuana, critics of MMAR found the program was “open to abuse.” Also, because MMAR only allowed for individual licensing to produce marijuana, Health Canada was inundated with applications for these licenses.

In 2011, Health Canada held a public consultation to review MMAR, taking into consideration the views of licensed individuals, law enforcement, government bodies and other concerned stakeholders. The consultation yielded a number of proposed changes to MMAR, namely restricting personal production of marijuana in favor of commercially licensed production. Groups supporting MMAR suggested stricter controls on home producers rather than abolishing home production altogether.

Following the consultation, the Marihuana for Medical Purposes Regulations (MMPR), was enacted with the goal of treating marijuana more like other regulated drugs. As such, individuals may no longer produce marijuana for personal use. Under MMPR, medical marijuana is subject to strict regulations for licensing, manufacturing, labeling, quality and distribution. To enforce these requirements, Health Canada regularly inspects licensed producers, of which there are 23 listed on the Health Canada website.

The Recall

Health Canada reports that during a routine inspection, two lots of Peace Naturals’ medical marijuana tested to have delta-9-tetrahydrocannibinol (THC) content more than 4% higher than the labeled range of 9.05 +/- 2%.

Neither Health Canada nor Peace Naturals have received any reports of adverse effects related to the lots in question. Health Canada also said that “the level of THC in this product does not appear to have been high enough to trigger an increased risk to the health and safety of clients,” but cautioned that high levels of THC “may be associated with increased risks of experiencing certain adverse effects.”

Peace Naturals is voluntarily recalling these lots and has asked patients to stop using the affected product immediately.

Strict Enforcement

Health Canada is taking a stringent approach to regulating medical marijuana. In the months since MMPR came into effect there have been several recalls of medical marijuana for manufacturing and quality issues.

Commercial medical marijuana growers are trying to comply with the requirements under MMPR. However, as a newly regulated industry, many are finding it difficult to develop best practices for producing marijuana to Health Canada’s standards. In an interview with CBC News last April, Peace Naturals’ CEO Mark Gobuty said Health Canada “isn’t intimate with cannabis” and doesn’t provide instructions on how to meet their requirements, so producers have had to learn good practices on their own.

The recall is one of several announced by Health Canada since 2014.


Health Canada Announcement


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.