When the FDA extended the deadline to submit PMTAs for vapor products to 2022, that was a victory for vaping rights. Although a small one. All of the deeming regulations remain in tact. Yes, e-cig companies can now continue to stay in business but they still face expensive, enormous hurdles to bring you any new products. Unless something changes in the costs of FDA red tape, the threat to independent e-cig companies remains.
The only true victory for vaping rights will come when the deeming regulations themselves are changed. When the FDA first announced what the e-cig deeming regulations would be, Nicopure labs immediately jumped into the fight. Nicopure launched a lawsuit challenging the FDAs authority over vapor products. Well that lawsuit came before the courts in July. The Right 2 Be Smoke Free lawsuit was folded into the Nicopure suit and both were heard and adjudicated in a DC Federal Court.
In a 93 page decision, Judge Amy Berman Jackson ruled against Nicopure and the Right 2 Be Smoke Free coalition. What does this decision mean? This court decision essentially upholds the FDAs total authority to regulate electronic cigarette products as they see fit. Nicopure may appeal. Several similar cases are pending and the vaping community is hopeful that there is a court somewhere that will bring a different decision. For now, they are watching and weighing options.
Nicopure Keeping Its Eye On The Ball
By no means is Nicopure giving up they fight. The company released a statement indicating that while they welcome the news of the FDA extension for PMTA applications, they are not taking their eye off the ball. The extension is just that, an extension. It is not a change in law or policy. The oppressive regulations remain in place. The crux of the Nicopure statement was that now is not a time to rest and they are not going to stop fighting.
How could that fight unfold? There are a few things happening all of which could challenge the FDAs authority over vapor technology. There are bills before Congress that propose to change the grandfather date for new products entering the market. That would be great but would not address the barriers to get new products to market now. There is legislation passed by Congressional committee that would block the FDA from regulating vapor products altogether. An act by Congress is one possibility to change the regulation of electronic cigarettes.
Will it be a court case that changes the FDA deeming regulations? Or will it be an act of Congress? We do not know. The fight for vaping rights is being fought on several fronts. Nicopure and Halo Cigs are watching and will be continuing to develop a strategy. A strategy to maximize the best use of their resources to fight FDA overreach.