(This story was updated Tuesday to include a comment from a state official that patient safety is the reason for the directive).
In an unprecedented move, Pennsylvania medical marijuana regulators are ordering every licensed grower/processor to resubmit vaporized cannabis products that contain additives for another approval – a move that experts fear could cause serious product disruptions and financial losses.
The directive includes any product that is used in an inhalation process, such as shatter. Devices used to vaporize substances for inhalation include inhalers, vape pens and portable vaporizers.
The product reapprovals, detailing each ingredient, must be submitted to state regulators by Nov. 30, according to a recent email from Sunny Podolak, the state health department’s chief compliance officer.
The email warns that disciplinary action – including possible license suspension or revocation – could occur if a licensed grower/processor doesn’t comply with the request and continues to sell vaporized products after that date.
In explaining the move, a department spokesman said “patient safety is of utmost importance.”
But Pennsylvania cannabis attorney Judith Cassel characterized the request as “onerous and arbitrary.”
“This could mean millions of dollars of inhalation products, previously approved, could now be required to be destroyed,” Cassel told MJBizDaily in a telephone interview.
Such products account for the second-largest category of MMJ sales in Pennsylvania, she said.
The state’s medical marijuana market is estimated to be approaching $1 billion a year in dispensary sales.
Based on the state’s directive, Cassel said, it’s her understanding that each product that could be inhaled must be reapproved through a resubmission by Nov. 30.
“Each additive must be broken down as to each ingredient contained within the additive, with growers having to do their own analysis as to whether the FDA (U.S. Food and Drug Administration) has approved the ingredient,” she said.
She characterized that as a “monumental exercise.”
If state regulators ultimately decide to deny the resubmissions, “it is going to impact not only the grower/processors, but dispensaries might have to pull product from their shelves, which will impact medicine availability for patients,” Cassel added.
Cassel said she represents about a dozen clients that could be impacted.
‘A blow to the program’
Jackie Parker, a lobbyist for growers, processors and testing laboratories, expressed similar concerns.
“It’s just really a blow to the program,” Parker said. “It seemed to come out of nowhere. … It seems preposterous.”
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Pennsylvania, she noted, has a “great (MMJ) program with over 600,000 registered participants, and now you want to interrupt that by arbitrarily saying that we want to reapprove products that already have been approved.”
The directive comes at a time when Pennsylvania’s MMJ market is booming and, by most accounts, is considered well-run with common-sense regulations.
It comes a full two years after a vaping crisis led regulators in such states as Massachusetts to crack down on, or more closely monitor, certain vaporized products.
The 2021 MJBizFactbook projects that MMJ sales in Pennsylvania will reach $775 million to $925 million this year. The number of patients enrolled in the program totaled more than 630,000 as of August.
The email by the Pennsylvania regulator doesn’t explain the rationale for the vaporized product review, nor why the deadline is so tight for submitting the information.
Mark O’Neill, press secretary for the Pennsylvania Department of Health, told MJBizDaily on Tuesday that the state’s Medical Marijuana Office “instituted a statewide review of vaporized medical marijuana products on November 16, 2021, to ensure that permittees are not using additives that are not safe for inhalation.”
“Patient safety is of utmost importance to the Medical Marijuana Office and those they serve,” O’Neill wrote in an email.
“Because this is a patient safety issue, all permittees have been directed to resubmit for approval all vaporized products containing added ingredients by November 30, 2021.”
Severe penalties threatened
Podolak’s email warns of dire consequences should businesses not comply with the request or produce any vaporized MMJ products that contain ingredients not approved by the FDA for inhalation.
“Failure to comply with any part of this communication may result in the department suspending the sale of your entire line of vaporized products,” his email states.
The email also said operators could get their license revoked or suspended.
The request requires every grower/processor to submit a separate form for each product and list the amount of each ingredient used in that product.
Each ingredient in a terpene blend, for example, must be identified.
Cassel and Parker both indicated that growers/processors are considering next steps including possible legal or legislative action.
Jeff Smith can be reached at firstname.lastname@example.org.