Open Letter: Mold regulations must be reviewed

A copy of this letter was sent to Lyndall Fraker, Director of Missouri DHSS Section for Medical Marijuana Regulation, on Monday, October 26th. 

In light of the recent report of mold on one of the first batches of cannabis available to patients and the subsequent investigation by the Missouri Department of Health and Senior Services  (DHSS) concluding that the batch was safe for human consumption, I believe we have an opportunity for a collaborative effort to review the sufficiency of our existing standards. I know that many patients, myself included, were quite alarmed to find out that mold is not tested for in products. As a layperson, I’ll admit that I don’t have a complete scientific understanding of this issue, but do understand that a number of states (Colorado, Nevada, and California) and Canada test for mold, some in addition to mycotoxin screening and some in lieu of the same. I question the characterization of our testing standards as some of the most stringent in the nation for this reason. Given the abysmal standards in many other states, I believe a statement like this, even if true, would need to stand within that context.

As someone with a long and storied cannabis history, I understand the difficulty that comes with cultivating a product that is sufficiently free of mold to pass visual inspections and laboratory testing. That said, here in Missouri, we’ve moved this plant into a legal status as a medicine. So although I take the point made by DHSS that isolated incidents of mold will occur on natural products and recognize that mold plays an essential role in certain biological processes (including, but not limited to, its role in creating foods that we consume), I don’t think the comparison is fair. We would not, for instance, say that it is normal or acceptable to find mold on a person’s prescription medication like Lisinopril or Atorvastatin. Obviously, cannabis is a botanical medicine and, as such, presents some unique challenges because of that.

It is to that end that I would suggest a working group composed of members of the patient community in Missouri, members of industry, and representatives from DHSS. This group should be facilitated by a patient without any financial interest in the industry. I’d suggest that this group be advised by a neutral third-party technical advisor with an advanced understanding of the role of mold and mycotoxins in human health. The goal for a group like this would be to review our existing standards and make recommendations regarding how they might be enhanced while still maintaining patient access. Although I am very concerned about the safety of the medicine we consume, I do recognize that you can overtest a product like this (increasing cost to patients and thereby decreasing access). The result of overtesting might be that patients turn to the black market for their medicine, where no formal quality assurance standards exist. I don’t speak for all patients here, but part of the reason I obtained a medical card, coming out of the black market to obtain my medicine, is that I believe cannabis provided through our regulated market will be of a higher quality in the long term. 

Although mycotoxin testing is a reasonable way to look at mold content indirectly, I think we need to explore this issue more as a community. In particular, I’d be interested in exploring the requirement of a total yeast and mold count (TYMC). I believe this kind of testing would provide patients with a more complete picture of the potential for harm when ingesting a product like this, especially given my understanding that mycotoxins (as a secondary metabolite of fungus) can be produced by mold long after a product has been tested, such as when it is sitting on a dispensary shelf. Additionally, because we have patients in the state with autoimmune conditions, and because we know that the combustion and inhalation of mold itself may exacerbate those conditions, I believe this test is worth considering. This type of collaborative effort, wherein patients, industry, and regulators come together to advance a common good, could serve to highlight Missouri’s program in a much more positive light than it has been to date, while also serving as a model that other states could look to as they consider their own testing requirements. 

   

Finally, I’d call on DHSS to take two specific actions related to this most recent issue:

1. Given the patient community’s current state of trust in DHSS decision-making (primarily as a result of concerns over application scoring), DHSS should release the lab tests that were conducted on the affected batch and commit to complete transparency in any future investigations related to patient safety. 
2. DHSS should commit publicly to the annual review of their testing requirements, publishing the findings of such a review in their annual report to the governor or as a standalone report. 

I’m happy that we are finally at the point where legal sales are happening, but I have to admit my disappointment at the state of access to quality medicine currently. I am not alone in this disappointment and know that many patients are concerned about the quality of the product that they will receive. I believe a working group, as described above, is a reasonable way to bring the various viewpoints on this issue together, advancing the shared interest we all have in providing quality medicine to Missouri’s patient population. 

Here’s to a Missouri future of high quality, affordable, and accessible medication,

Chase Cookson, DBA