Following a months-long review of vape products sold by Pennsylvania’s licensed cannabis operators, the state’s Department of Health (DOH) has issued a sprawling mandatory recall.
The list includes hundreds of vape products from PurePenn, PennAlt Organics, Pennsylvania Medical Solutions, MLH Explorations, Insa, Ilera Healthcare, Holistic Farms, Hanging Gardens, GTI Pennsylvania, Goodblend Pennsylvania, Franklin Labs, Curaleaf PA, Cresco Yeltrah, CannTech PA, Agri-Kind, and AES Compassionate Care—some of the largest multistate operators in the region, needless to say.
“After finishing this review, the Department has determined that certain vaporized medical marijuana products containing some added ingredients have not been approved for inhalation by the United States Food and Drug Administration (FDA),” according to the Feb. 4 memo. “Although some of these added ingredients may be considered safe in other non-inhaled products, patient safety is the top priority of the Medical Marijuana Program. Therefore, the Department has issued a mandatory recall for all affected vaporized products.”
The review in question was first announced to the public on Dec. 1. The DOH targeted vape products “state-wide” to gather information on whether “added ingredients” were present in those products—some of which were being sold on dispensary shelves. Back on Nov. 16, the DOH had sent a message to all licensed cannabis business owners, asking for them to submit all vape products containing added ingredients for review (even those that had already passed state testing).
No rationale was provided for the review, although communication from the DOH referenced additive regulations in other states—presumably referring to regulations that may allow certain additives outside of Pennsylvania.
In a follow-up message to business owners, sent from Sunny D. Podolak, Assistant Director and Chief Compliance Officer with the DOH’s Office of Medical Marijuana, on Dec. 13, the phrase “additives” was qualified as “artificial terpenes or flavorings.”
Little information followed, confusing business owners and patients alike.
The Feb. 4 recall, however, did not elaborate on which ingredients were triggering the review or, indeed, triggering the mandatory recall.
[Editor's note: Feb. 7 update: The department has published a list of "known additives contained in one or more products on the withdraw list," which is itself a staggering list that includes many additives, and particularly terpenes, not approved by the FDA for inhalation.]
"If you have previously used these recalled products, please consult with the medical professional at the dispensary to help identify which alternative products may be appropriate for you," the Department of Health said in an email sent to all medical marijuana patients statewide. "We are committed to your continued access to safe and effective medical marijuana products."
So, what's a Pennsylvania cannabis business operator to do?
"First of all, obviously, digest the information that the Commonwealth is providing, which is to say the products that are affected by this recall," said Michael Sampson, partner at Leech Tishman in Pennsylvania and co-leader of the firm's Cannabis Group. "Obviously it's a long list, and make sure that you carefully review the list and carefully identify any products that you handle that are impacted. It's going to be imperative to watch the fallout and the commentary that comes after this, if we'll get more detail from the government as to what additives were the focus of this. That may also give some indication if there could potentially be any further, similar recall in the future. That may impact businesses as they look at what products they want to produce or stock or sell. As far as immediate actions, Pennsylvania regulations certainly speak to mandatory recalls and the steps that grower-processors need to take in the event of a mandatory recall, which includes following the recall plan that should be in place already."
Insa provided the following statement to Cannabis Business Times:
"Insa is working quickly to comply with a recall issued by the the Pennsylvania Department of Health for all vaporizer medical marijuana products containing botanically derived terpenes. We are working hard on the launch of a new vape line that will include Cannabis Derived Terpenes and Live Resin that we expect to be approved in the near future and are looking forward to sharing that with our consumers and retail partners."