Trump’s FDA may finally end Obama’s war on vaping – By Paul Blair (washingtonexaminer.com) / Aug 6 2018
(Gabby Jones/Bloomberg)
For more than a year, the Food and Drug Administration has hung the start-up vapor industry out to dry with anticipation for a more sane and rational approach to the regulation of electronic cigarettes. Last week, the FDA finally announced steps geared towards making it easier to bring new products to market, soliciting input from the public and signaling that Obama-era prohibition may not be the intended outcome of the agency. This largely positive announcement takes a significant step in the right direction toward regulatory certainty that could unquestionably improve public health.
Context is important. This summer marks the one-year anniversary of the FDA’s “Comprehensive Plan for Tobacco and Nicotine Regulation” and the nine-year anniversary of the passage of the Family Smoking Prevention and Tobacco Control Act. In his 2017 Plan, FDA Commissioner Scott Gottlieb acknowledged that when it comes to nicotine use, there is a continuum of risk for consumers. He signaled that despite the Obama administration’s 2016 Deeming Rule – which defined vapor products as tobacco and subjected them to retroactive pre-approval processes designed to end in failure – the outcome didn’t have to be so guaranteed.
Since last year, however, there hasn’t been any clarity, transparency, or efficiency in the approval process for products. the only efforts surrounding e-cigarettes have included a veiled threat of banning flavored ones and several statements about concerns over youth use. This has done nothing to calm the fears of thousands of American businesses facing a 2022 deadline to get approval from the FDA to keep life-saving products on the market.
That may be changing. The first step of the announced plan is the most important, providing clarity to companies about how to actually bring or keep a product on the market. It sounds silly, but this information is currently close to non-existent, perhaps by design. The FDA announced that they “will lay out a transparent, modern, and science-based framework for manufacturing practices and the development of tobacco product applications that meet the legal requirements.”
For context, the new applications required of manufacturers of tobacco and now vapor products were created in 2009 with the Tobacco Control Act. It was the intent of Congress for the FDA to approve new products that could help smokers move away from cigarettes. No new cigarette can be brought to market; only products that can improve public health by giving consumers access to less harmful alternatives. Companies seeking the approval to market or advertise these products, however, have essentially been shooting blindly into the air since 2009, hoping the agency would at some point provide future clarity on how exactly to obtain approval.
Phillip Morris International, for example, submitted applications last year seeking permission to bring a product known as IQOS to market in the United States. Sold in dozens of countries around the world, this “heat-not-burn” technology provides smokers an option of using a small heated piece of tobacco without nearly any of the health risks of cigarettes. It’s truly an e-cigarette by every definition, as it uses a battery to heat tobacco instead of fire, delivering nicotine without tar.
Statutorily and as a matter of present law, the FDA had 180 days to approve or reject the application. That deadline passed in February and the agency hasn’t announced a decision. This inaction flies in the face of a vote by an independent FDA advisory committee agreeing with a marketing claim that the products represent a reduced risk of exposure to dangerous chemicals when compared to cigarettes. Inaction in the face of clear scientific evidence generally suggests a motive unrelated to public health.
But this announcement isn’t really about Phillip Morris; it’s about thousands of small businesses and the countless products already on the market. Pre-approval applications are required of every product, regardless of whether a company has one employee or ten thousand. That’s why the announcement that the FDA is working towards “increased flexibility and efficiencies within the application review process” is important. Only a select few tobacco companies can afford the millions of dollars required to subject products to a process that currently lacks transparency or efficiency.
The agency also acknowledges “an opportunity may exist to allow for faster and cheaper development of products that will benefit public health.” This opportunity cannot be realized without immediate reforms to the processes by which a manufacturer may bring a product to market and, perhaps more importantly, truthfully advertise it to consumers. If scientific evidence suggests that a particular e-cigarette is less harmful than cigarettes generally, consumers don’t only deserve access to those products and that information, but improved public health outcomes demand it.
The FDA is at a true turning point. Will the agency succumb to the fear-mongering and demagoguery vocalized by a shrinking minority of prohibitionists and their allies in the press? Or will they allow for market innovations to finally solve the smoking crisis? Only time will tell.
https://www.washingtonexaminer.com/opinion/trumps-fda-may-finally-end-obamas-war-on-vaping
