On Friday February 4, 2022, the Pennsylvania Department of Health sent an email to all PA medical marijuana patients issuing a mandatory recall for certain vape products. This recall comes on the back of a months-long DOH statewide review of all marijuana vapes that contain added ingredients. The Department stated that after finishing their review they determined that certain vaporized medical marijuana products containing added ingredients have not been approved for inhalation by the United States Food and Drug Administration (FDA).
The over 500 different products being recalled are from both growers and clinical registrants in the program. The DOH has stated they expect the affected products to stop being produced by growers and stop being sold to patients at dispensaries. Here is the number of vape products grower/processors had recalled:
188 Moxie Purepenn distillate and other cartridges
76 Grassroots products under its Select Brand
60 INSA products
48 Holistic Farms products under its Strane Brand
40 PennHealth Group distillate cartridges
38 Jushi products under its The Lab brand
22 AYR Wellness flavored cartridges
18 Ilera cartridges
16 Franklin Labs products under its Modern Flower Brand
6 GTI products under its &Shine brand
4 Ethos products under its MuV brand
3 Cresco BHO cartridges
Agri-Kind liquid sugar cartridges
gLeaf distillate cartridges
Farmaceutical Rx burst cartridges
Evaluation of Additives in Marijuana Vape Products
It is common practice in medicinal and legal markets across the country for growers to use additives in vape products. Vape products that utilize distillate as the oil in the cartridge often reintroduce botanical or synthetic terpenes to mimic the terpene profile of the strain used to make the distillate.
The Department of Health does not specifically indicate which MMJ products contained which additives. Also, the PA DOH did not specifically state whether it prohibited any product that contained an additive or if there are products that contain additives that are still determined to be safe for inhalation by patients. As vape products are really the only products that have ingredients added in the postproduction process, this should not affect any other product category in PA. In this list the Department breaks down each additive by whether it is on the FDA excipient list, considered food safe by the FDA, and if it has been approved for inhalation by the FDA.
The FDA excipient list displays any inactive ingredient that is a component of an FDA approved pharmaceutical and has been intentionally added to the drug. Excipients are not a part of the active substance but have been evaluated for safety by the FDA and approved to be included in the drug. Excipients typically serve one or more of the following purposes for a drug:
Aid in the processing of the drug delivery system during its manufacture
Protect, support, or enhance stability, bioavailability, or patient acceptability
Assist in product identification, and enhance any attribute of the overall safety
Assist in the effectiveness and/or delivery of the drug in use
Assist in maintaining the integrity of the drug product during storage
For the purposes of medical marijuana vape cartridges it appears the Department considers all the additives as excipients, with cannabinoids and naturally occurring terpenes as the active ingredients. Because of the construction of vape products and the limitations on marijuana extracts that can be used in cartridges, there is a case that some of the additives can serve the purposes listed above.
The next evaluation is whether the additive is considered food safe by the FDA. Many of the additives are artificial terpenes or artificial flavoring agents, so there are additives on the list that are the same additives used in certain food products. It is important to note that an FDA designation as safe for consumption through food does not equate to safe for inhalation. These effect the body differently and must be held to a different scientific standard for approval.
The last designation used by the Department is whether the additive has been approved for inhalation by the FDA. While several of the additives listed above were contained on the approved excipient list, and considered food safe, there are no additives that are approved for inhalation by the FDA.
PA Grower Response
The Pennsylvania Cannabis Coalition, a trade organization comprised of PA medical marijuana permit holders issued a press release in response to the Department’s decision that said the following:
“The Pennsylvania Cannabis Coalition strongly disagrees with the ill-advised action by the Pennsylvania Department of Health, Office of Medical Marijuana to ban all additives in vaporized medical marijuana products. This action affects the second largest category of products on the market. The Department has previously approved these products which hundreds of thousands of patients have been safely and effectively using to treat their serious medical conditions since 2018. During that time the Department has not once publicly reported any adverse events related to these products. The Department of Health has unnecessarily caused panic amongst patients. The decision issued via email is a gross misinterpretation of statute and is not based on any scientific standard. This action will not only deprive patients of their medicine but will create an artificial supply issue in the regulated market. It will cause irreparable damage to Pennsylvania’s thriving medical marijuana market while putting patients’ health and safety at risk by driving them back into the illicit market. We encourage the Department to stay its order and to meet with medical and industry experts to develop product standards that provide safe, effective medicine to the Commonwealth’s half a million medical marijuana patients.”
The coalition counts several of the affected growers as members, including Cresco, Curaleaf, gLeaf, Ilera, Jushi, Holistic Industries, PennHealth Group, and PurePenn.
Curaleaf issued a statement saying that:
"We strongly disagree that these products should be recalled, and we stand behind the quality of all our products. Curaleaf is complying with the Pennsylvania D.O.H. on this matter and has implemented mandatory recall procedures with respect to Grassroots disposable pen and Select Fresh cartridge products."
They make note that many of the “recalled” products on the DOH recall list are products that were approved by the D.O.H but Curaleaf has not yet marketed. Curaleaf is licensed as a clinical registrant and owns Grassroots.