A recall issued by the Pennsylvania Department of Health earlier this month of 670 items, including cannabis liquid vape cartridges and liquid distillate dart pods, included specific details on the items recalled. But the regulators’ recall reasons have not been as detailed.
Multiple phone calls and messages left with DOH by Grown In over the last week went unanswered, a recurring theme with the department, according to experienced industry advocates.
“I wish I had some clear answers,” said Chris Lindsey, Director of Government Relations for the Marijuana Policy Project. “We seem to have some regulators that have decided to create some regulation out of thin air.
“It was a pretty big surprise to a lot of folks here that there is a ban based on regulations that don’t exist.”
Meredith Buettner, executive director of the Pennsylvania Cannabis Coalition, a consumer advocacy group, claims that although Pennsylvania is considered to have one of the strictest testing regimes in the country, the recall process has been unclear with little in the way of transparency from the DOH.
“From what we are aware of and what has been publicly reported, there are no adverse effects from these products,” Buettner said last week. “We have asked for clarity and for meetings and information to help better understand and we have been denied all of that.”
Buettner believes the Department is reevaluating products against an FDA standard for inhalation, and considering that cannabis is still federally illegal, they’re using an unfair measurement.
“They are applying a [federa] standard and from my evaluations they don’t have the authority to to apply this kind of standard. Safety is the highest priority for our operators. If there are products unsafe for patients, we certainly support there being repercussions, but I haven’t seen anything from the DOH that indicates to me that these products are unsafe.”
Since the recall operators and advocates have been trying to answer: While various vape carts for unregulated vaping products containing nicotine, CBD, or Delta-8 continue to stay on shelves, why are regulated medical cannabis products being taken off the shelves at state licensed facilities being recalled?
“This has a lot of negative impact for medical patients,” said Lindsey. “It begs the question, what is going on?
“The information that I have is that the decision was based on certain ingredients that have not been approved by the FDA. The problem is, because cannabis is illegal to the federal government, there are no ingredients that have been approved.
“It’s a nonsense rule and no other jurisdictions have taken this action. There hasn’t been a problem with these devices anywhere else,” Lindsey continued.
The DOH released a document on Feb. 2 detailing known additives in products that were part of the recall. Earlier, in November 2021, the Department reached out to suppliers to ask for a list of non-cannabis ingredients included, with a warning that anything not on the FDA-approved list would likely become a part of the withdrawal.
Curaleaf, one of 15 companies impacted by the recall notice, appeared 94 times.
“This was an unexpected, and we feel, unjustified change in regulation regarding products that have previously been tested and approved for sale,” read a Curaleaf corporate statement. The company operates 101 dispensaries in 23 states. “The Pennsylvania DOH has never indicated whether any specific concerns underlie the recall.”
Robert Rudnitsky, executive director of PhillyNORML, the Philadelphia chapter of the National Organization for the Reform of Marijuana Laws, was not as surprised to hear the news of a recall, especially regarding vape products.
“When laws are changed, sometimes the i’s are not dotted and the t’s aren’t crossed,” Rudnitsky said. “We are four years into the game and still learning. I can deal with a recall of pens because it’s regulation. It is necessary.”
Curaleaf says it is complying with the Department on the matter, claims that many of the products on the DOH recall list had not yet been marketed, and released its own recall notice for patients.
