Published on April 26th, 2017 | by Jimmy Hafrey
The United States House of Representatives is gearing up for an introduction to a piece of legislation that would see the so-called “deeming rule” on vaping disappear and give hope to the growing industry that is weakened by it.
Fox Business is reporting today that Hunter’s Bill, which is named after the Republican House Representative Duncan Hunter of California, would reverse the deeming rule, allowing the industry to thrive. The rule, which was enacted in August of last year by the Obama Administration, deems that vape products are tobacco products and should be subjected to the same regulations of traditional cigarettes.
Enlightened readers will know that vape products are different than cigarettes in a variety of ways, including the fact that while cigarettes are burned in order to create smoke, vape liquids are heated to create vapor.
More importantly, vape e-liquids do not contain tobacco; in fact, the only thing that vape products and cigarettes have in common is nicotine, which in the past has been naturally derived from tobacco. This is no longer the case, as many companies have formulated synthetic nicotine, which is created in a lab, meaning that more and more vape liquids do not contain natural nicotine, making the fact that the products are classified as tobacco moot.
But the debate around whether or not vaping should be classified as a tobacco habit is still brewing, and Congress is getting ready to wade into the fray.
Hunter’s bill would strike down the FDA’s deeming rule, but it would also do something else that is just as important: it would remove the requirement for all new vape products to be reviewed and authorized by the FDA before hitting shelves.
Not all vape products would be exempt from this rule; a new predicate date would be issued, and vape products on the market before that date would be grandfathered in. New products that have not yet launched would require an application and a review.
But the current need to have a PMTA done and reviewed before August 8, 2018, is a monumental task, especially for businesses that have dozens of products at different nicotine levels; the application process is thought to cost small business around $250,000 per product per nicotine level in legal and application fees.
The bill, which is accompanied in the House by the Cole-Bishop amendment, has a good shot of getting passed; both the House and the Senate, as well as the White House, are currently controlled by Republicans, who are generally in favor of rolling back regulations as well as vaping as a smoking cessation method.
The Cole-Bishop amendment, however, is not a full bill and is expected to be attached to Trump’s budget; the budget has not yet been voted on. This amendment would exempt all vape devices from the PMTA process by setting a new predicate date; the one that the FDA is currently using is February 15, 2007, which was well before the vape industry found its footing in America.
But, as Hunter’s team points out, the Cole-Bishop doesn’t go far enough to help the vape industry. The amendment does not touch on the fact that vaping is not tobacco and therefore should not be held to the same standards.
“Cole-Bishop is like gaining the inch, and Hunter’s legislation the yard,” said Joe Kasper, Hunter’s chief of staff, when asked to compare the two pieces of legislation.
The bill is also good news for the FDA, even if it doesn’t know it yet.
The agency, which is not yet fully staffed by the Trump Administration, doesn’t have the staff or the resources to effectively deal with the PMTAs that they will be receiving. Because each individual product at every level of nicotine needs to be reviewed, the agency is looking at an influx of thousands of products that, by law, must be processed within 180 days of the receipt of the application.
The FDA also has another problem: Big Tobacco.
Tobacco companies are coming out in force to support Hunter’s bill and the Bishop-Cole amendment, standing right next to small vape businesses in their bid to get the FDA regulations rolled back or overturned in favor of regulations that fit the industry. These companies see the logic in incorporating vaping into their already tested business model and have already begun investing into vape technology and buying vape companies to improve on the technology.
Speaking to the press on this very subject was David Sutton, a spokesman for Altria. He said that:
“We believe that regulation should promote innovation of potentially less risky tobacco products.”
Hunter’s bill addresses this as well. The legislation would incorporate the concept of harm reduction, in whatever form that may take, into the FDA’s mission by requiring the agency to support safer methods of nicotine delivery. This would include vaping, which has already seen massive success in the UK and Europe as a smoking cessation method. And because harm reduction should already be at the core of the FDA’s mission, the bill would simply bring that to the forefront so that public health can benefit.
While the vaping industry is excited about the idea of having regulations rolled back, opponents are not so thrilled. The common misconception that children would use vape products as a gateway to smoking traditional cigarettes has long been heralded as fact by vape critics, even though it’s been proven false in studies both here at home and abroad.
The fear may have good intentions, such as wanting to keep children from trying something that could harm them, but the fact remains that most high school students and young people who try vaping don’t use liquids that contain nicotine. Even more important is that as vaping raises its profile in America, the number of young people interested in smoking decreases because they are seeing how destructive smoking can be.
“While we’re always going to have some concerns about kids accessing either cigarettes or vaping pens, that should not motivate the federal government to go in the complete opposite direction and say nobody can have them,” Kasper said when asked about children and vaping.
Hunter’s bill is being introduced in the House this week, and it is expected that it will first go to committee before being debated on the floor. This publication will continue to update readers on its progress.