The Dauphin County Courthouse in Harrisburg, Pa. Credit: Wikipedia

Two months have passed since the Pennsylvania Department of Health issued a recall on over 600 medical cannabis vape cartridges and operators remain in the dark on the future for recalled product that remains in secure storage.

Seeking answers, a group of cultivators, manufacturers, and dispensaries formed PA Medical Marijuana Access and Patient Safety (PAMMAPS) to file litigation and to recoup losses resulting from the DOH recall.

[Read the PAMMAPS complaint.]

“I will frame it this way,” said Judith Cassel, an attorney from HMS Legal representing the PAMMAPS group. “One of our witnesses, Dr. Sue Sisley, has said that these specific types of products are sold in all legalized marijuana states and have been so for over 10 years.

“So that means that tens of millions of people have used these kinds of products without incident. That is the largest clinical trial in the world. There is no pharmaceutical company that can boast such results.”

Cassel estimates $18 million in sales losses resulting from the recall.

“It’s significant,” she continued. “It is not a small deal. It’s a very significant loss that would result from this recall.”

The good news is the product has not been destroyed. The Department of Health has allowed secure storage of potentially affected products, pending the outcome of the preliminary injunction filed.

The DOH has issued no follow up comment since issuing the recall, and declined to comment to Grown In on matters involved in litigation.

“Join the club,” laughed Oliver Summers, a cannabis advocate and a director of compliance for Superior Herbal Health in Los Angeles, California, who has over 20 years of experience managing cultivation operations and dispensaries. “I wish you could see my shocked face.”

Cassel, on behalf of PAMAPPS, contacted the DOH prior to the Feb. 14 recall and asked for clarity on what prompted the decision.

“[These products] had been preapproved for years,” said Cassel. “We had reached out before the recall and continue to try and be open if they want to discuss options.

“The litigation we filed in February was a preliminary injunction for a withdrawal of the recall and for products to be placed back on shelves and the appropriate hands so patients can partake in the right medicine they feel they need for their condition.

“The hearing was scheduled for Feb. 24 and then again a week later and the DOH did not put on any witnesses. They did not defend their position. We have since filed briefs and it’s in the hands of the judge at this time.”

Agri-Kind, another company listed on the DOH withdrawal from market list, is a Pennsylvania cultivator that has products served at various dispensaries throughout the state. They were also recently awarded a conditional license in New Jersey to begin operating in preparation for adult use legalization.

According to their website, Agri-kind uses only 100 percent cannabis extract, which extends to the terpenes in its vape products. There is a drop-down banner for consumers to garner as much information from the DOH recall as possible, but unfortunately only states what other operators have said previously – they are currently investigating why their products were included and are working to rectify the situation.

“It was a huge shock and a huge hit,” said Agri-Kind founder and CEO Jon Cohn. “Most of the others were because they used after-market terpenes, botanicals derived from plants. We never did that and never would use additives of any sort.”

Agri-Kind chose not to be a part of the PAMAPPS suit, but filed their own. The decision to file separately is based on the belief that they shouldn’t be grouped in with other operators who may not use completely natural terpenes. Cohn says Agri-Kind found itself on the DOH’s recall list due to a filtering process that uses bentonite clay, a product commonly used in alcohol filtering and even by fitness enthusiasts for health and wellness.

“Vodka and gin are filtered by it,” said Cohn. “Almost everyone in the world does this. They got back to us and said if we could prove it they would rescind our recall. We went to three labs and proved there was none in the end product. … we actually showed it was cleaner than flower.”

There is no immediate timeline for a judge’s ruling on either suit. 

“We are still at a point where if something tests positive on cherries, they say you can still sell these,” said Summers. “But if that same positive comes on cannabis, it will be destroyed and you can’t sell it. There’s a crazy double standard.

“So when it comes down to stringent rules, obviously, I’d like to see them loosened up. I think most of them are asinine.”