Smoke-Free Alternatives Trade Association and Coalition of Vapor Businesses and State Associations have been granted motion to intervene in American Association of Paediatrics v FDA lawsuit.
The appeal was granted following the recent release of the Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) report that highlighted most of the people (77%) in the American lung injury outbreak reported using THC-containing products, or both THC-containing products and nicotine-containing products.
Finally, the CDC is acknowledging what we have known for two months — illicit THC cartridges are the primary cause of lung illnesses.
— American Vaping Assn (@AVABoard) September 27, 2019
Paul W. Grimm, Judge of the United States District Court, District of Maryland issued his decision via Letter Order in the American Association of Paediatrics v the FDA.
What the judge wrote
“I will grant the Vapor Associations’ Motion to intervene exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum.
“Here, the businesses represented by the Vapor Associations manufacture and sell the e-cigarette products at issue in this case. Therefore, they are subject to the FDA’s PMTA requirements and they will be directly affected by the filing deadlines, which could impact sales that otherwise would be possible without the Remedy Order’s accelerated deadline, if the businesses and manufacturers are not able to meet the deadline and obtain approval for their sales.
“Thus, I am persuaded that the Vapor Associations have shown that they have standing and a protectable interest that justifies their intervention for the limited purpose of appealing my final rulings, as the Remedy Order affects the FDA regulations that control the businesses’ activities and ability to profit in the vapor industry.
“Further, they claim that the accelerated deadlines in the Remedy Order would be devastating to their industry, and the Government is moving toward enforcement rather than protecting their interests. The Vapor Associations have demonstrated that they should be permitted to intervene as of right. See id.; Fed. R. Civ. P. 24(a)(2). Their Motion to Intervene is granted exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum Opinion and Order and the Remedy Order and for no other purpose.”
What it means
While he did not grant the Vapor Associations’ Motion to Stay the 10-month deadline decision, the Associations are now parties to the litigation, can appeal the entire case – and move to stay the PMTA deadline – with the Fourth Circuit Court of Appeals.
Calls for better regulation
The move follows calls from industry bodies for better regulation of medical cannabis devices.
Americans for Safe Access (ASA) and the National Cannabis Industry recently wrote a letter to the heads of the US Food & Drug Administration (FDA), the Centers for Disease Control and Prevention, and the US Department of Health and Human Services, calling for the safe regulation of vapourisation products and cartridges.
They have urged the FDA to use its regulatory authority to issue guidance that encourages consumers to only buy vapourisation products in legal, licensed stores and not on the illicit market.