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Smoke-Free Alternatives Trade Association (SFATA) issued the following announcement on Oct. 4.
On October 2, 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 Pediatrics 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.
About SFATA: SFATA is the premier and largest vapor and e-cig trade association. The association represents the interests of the entire supply chain, including manufacturers, online retailers, brick and mortar vapor store, distributors, importers, and wholesalers. For more information about SFATA, visit https://www.sfata.org and follow SFATA on Facebook, Twitter, Instagram.
