The first premarket tobacco application (PMTA) from the independent vapor industry may come from Cosmic Fog Vapors. The company announced Thursday that it has sent a briefing document to the FDA — “for the purpose of submitting Premarket Tobacco Applications (PMTAs) for their range of E-Liquid products.”
Cosmic Fog is located in Costa Mesa, CA. The company was founded in 2013, and is one of the oldest and largest premium e-liquid manufacturers in the country. They also sell their products in 60 countries around the world, including in all 28 European Union member states.
The company’s press release says Cosmic Fog’s compliance team will meet with the FDA on June 13 to discuss its “PMTA strategy, including product analysis, behavioral studies, non-clinical and clinical studies such as actual use, pharmacokinetic and pharmacodynamic studies.”
The company will complete its studies by June 2018, according to an e-mail from company spokesperson Christine Lawrie. She says they intend to file the application with the FDA in September 2018, though it could be postponed if the deadline is changed by the agency. The FDA has delayed some deadlines already.
According to the press release, “The Cosmic Fog regulatory team includes strategic advisors with decades of experience in navigating regulated industries such as the medical device, tobacco and pharmaceutical industries.”
The requirements for approval of a PMTA are unknown, but the FDA’s deeming regulations do list some of the tests and studies they will require. Many vaping advocates believe the specific requirements are deliberately situated beyond the ability of small companies to meet, and are designed to prevent the independent industry from pursuing approval.
The bottom line is that a company submitting a vapor product for marketing approval must prove that the product will be beneficial for the overall public health. That means that the manufacturer must analyze how its presence in the marketplace will affect smokers and vapers, but also non-smokers. They must explain how it will affect youth uptake of vapor (and cigarettes), and prove that when weighing all costs and benefits that the product will be a net positive for public health.
“The FDA has no idea what it is doing,” wrote Dr. Michael Siegel soon after the rule was announced. “And what it is doing is completely losing its perspective.” But things have changed since Siegel wrote those words.
Many in the vapor industry are pinning their hopes on new FDA Commissioner Scott Gottlieb. As recently as last year, he served on the board of a vape shop franchising company. More importantly, he has indicated a belief in harm reduction — reducing use of high-risk products (like cigarettes) by making attractive, low-risk ones (like e-cigs) widely available.
There are two paths to remaining on the market after November 8, 2018. Vape manufacturers who want to stay in business have to decide whether to fight or comply. People call the PMTA process a “million dollar lottery” because while preparing the application may cost a fortune, there is no guarantee of approval.
Since even the largest independent companies don’t have millions to gamble, most will be unlikely to attempt the PMTA path. For them, putting money into advocacy strategies is the only option. But Cosmic Fog says it intends to pursue both possibilities.
“Today is a bittersweet day,” CEO Robert Crossley said in the press release. “Since the announcement of the Deeming Rule last May, we have worked tirelessly on advocating for a fair and fact based regulatory system for the vapor product category. Today, we take the responsibility of finding those facts and delivering them to the FDA ourselves. Although we will continue to support advocacy based efforts,” he continued, “we have a responsibility to our customers to ensure our products are available and on their shelves no matter what may happen in the future.”
Cosmic Fog has been known as a financial supporter of vaping advocacy causes. The company was a founding member of the Right to be Smoke-Free Coalition, which led a lawsuit against the FDA last year. (The suit was later consolidated with the Nicopure Labs suit, and is still pending. The ruling could come any day.)
That won’t change, according to Christine Lawrie. “We will continue to support advocacy at the same level as we have in the past,” the company spokesperson said in an e-mail to Vaping360. “The purpose of that statement was to let the industry know that although we have started down this regulatory pathway, we have not given up the fight.”
That’s good, because while everyone in the vaping world is wishing luck to Cosmic Fog, very few other e-liquid companies can afford to play the compliance game. Most are counting on a legislative or administrative answer. But if no one takes the chance and puts their money behind a PMTA strategy, as Cosmic Fog is about to do, we’ll never know if the possibility of FDA approval exists.