Pennsylvania’s sudden move to recall marijuana vapes raised questions. Were these products harmful all along?

For years, the Pennsylvania Department of Health allowed the state’s medical marijuana companies to sell hundreds of medicines that the agency now considers potentially unsafe.

Something changed in November when regulators started a process that led last month to a massive Marijuana/DOH%20-%20Withdraw%20of%20Products%20Containing%20Additives%20Not%20Approved%20for%20Inhalation%20by%20the%20FDA.pdf" target="_blank">recall and ban of 670 types of cannabis concentrates for vaping — $12 million worth — that they had previously approved for sale in Pennsylvania’s roughly 150 marijuana dispensaries.

The move blindsided patients and an industry dominated by companies hyper-focused on broader legalization of marijuana. And regulators declined to explain the action beyond saying the medicines contained “added ingredients that have not been approved for inhalation” by the FDA.

The episode, believed to be the first medical marijuana recall in Pennsylvania, raises questions about why the state allowed the products to be sold, in some cases since the program began in 2018, and exposes that the state is stonewalling the public by refusing to fully explain its decision, according to industry experts and patients.

The program had more than 380,000 patients in November. Since early 2018, patients have spent $2.4 billion on medical marijuana.

The lack of information about adverse events concerns Deborah Miran, a former medical marijuana regulator in Maryland and an analytical chemist who spent decades filing drug applications to the FDA.

“This level of recall only really happens when you have an imminent risk,” said Miran, now a director at the Cannabis Advisory Group, a nonprofit policy group.

Vaping involves an electronic device that heats a liquid form of cannabis to create a vapor or aerosol that the patient breaths in.

Miran and other experts say the additives the state objects to are natural chemicals called terpenes taken from other plants and fruits, and are used to restore flavors and aromas that the extraction process destroys.

The state allows terpenes from cannabis to be added back to enhance the flavor of the concentrate, creating such flavors as cherry lemonade from Terrapin, which says it only uses terpenes from cannabis in Pennsylvania. Terpenes are also believed to be beneficial for physical and mental health.

» READ MORE: Why medical marijuana in Pennsylvania is some of the most costly in the U.S.

An industry group formed to fight the ban, Medical Marijuana Access & Patient Safety Inc., called the health department’s reasoning “nonsensical,” given that the federal government considers cannabis an illegal substance with no accepted medical use. A lawsuit filed by the industry group, which represents the biggest cannabis companies in the state, is pending in Commonwealth Court.

Luke Schultz, a patient advocate on Pennsylvania’s Medical Marijuana Advisory Board, was among those puzzled by the department’s Nov. 16 notice to patients that it had “instituted a statewide review of vaporized products containing added ingredients such as externally sourced flavorings or terpenes.”

In a Dec. 2 email Schultz asked John Collins, the director of the state’s Office of Medical Marijuana: “Hasn’t this type of product review been ongoing since the program’s inception? Were there adverse effects associated with Pa. vaporization products or their ingredients that prompted this?”

Schultz said he received no response.

State Rep. Kathy Rapp, a Republican from Northwestern Pennsylvania who chairs the House Health Committee, said she asked her executive director to request more details on the recall, which does not appear to have created a shortage. The agency told him “that there was some contamination in a product at one of the sites in regards to vaping of medical marijuana,” Rapp said. “We did not get any information as to what facility or what the contamination was or anything like that.”

The health department did not answer questions from The Inquirer, citing the pending litigation.

State regulators such as Pennsylvania’s Acting Secretary of Health Keara Klinepeter are in an awkward position with cannabis.

Klinepeter told lawmakers on March 9 that state law requires her to operate a “pharmaceutical-grade” medical marijuana program for 23 health conditions. To do that, the health department borrows as much as it can from the FDA, which sets U.S. standards for safety and effectiveness in medicines.

However, “the FDA has not approved the cannabis plant for any medical use,” according to the U.S. Department of Health and Human Services, leaving the the medical marijuana industry in a regulatory gray zone.

That lack of clarity “allows people to exploit weaknesses in the regulations,” said Jahan Marcu, a consultant and medical marijuana advocate who received a doctorate in pharmacology from Temple University. In Pennsylvania, “the law was designed for extracted products from the plant, not stuff with foreign agents added to it to make it taste like cherry cola.”

Marcu praised the health department’s recall. “There need to be guardrails for consumers” because there’s been an explosion of new products. Cannabis companies missed an opportunity to work with regulators to set standards and show their products are safe, Marcu said.

» READ MORE: Legalizing weed in Pennsylvania faces complicated demands

Matt Darin, Curaleaf’s U.S. president, said his company and others were surprised by the agency’s action on vapes. Curaleaf, which has a partnership with the University of Pennsylvania’s Perelman School of Medicine, operates five dispensaries in Southeastern Pennsylvania.

“We and the other licensed grower-processors in the state have disclosed that information for years now to the Department of Health, so a new interpretation was made recently that really changed the viewpoint on some of these ingredients,” Darin said.

He said the products Pennsylvania recalled are widely used throughout the country.

Some patients, such as Brian “Box” Brown of Philadelphia, don’t trust vapes.

“There’s been very little clarity on what is actually in them. For me as a patient, if I were to get one, I would want one that is all cannabis oil,” said Brown, an illustrator and writer with a comic strip called “Legalization Nation.”

“I don’t care if it tastes like watermelon or anything like that,” Brown said.

Others complained about how the health department communicates.

Nicolas Koslasky, a medical marijuana patient in Belle Vernon, Pa., about 45 minutes southeast of Pittsburgh, said the agency’s list of recalled products was confusing because companies were listed under their licensed names. “I still haven’t figured out who’s who on that list,” Koslasky said.

Still others wanted a better explanation of the recall, said Schultz, the patient advocate on the medical marijuana advisory board.

“It was upsetting and concerning to a lot of patients because these products have been on the market and have been used for a number of years by the patient community,” Schultz said this month. The department “didn’t really give a clear answer as to why all of a sudden those same products that were on the market are now no good or suspect.”