FDA Head To Use Science To Determine Vaping Regulations

Article from ChurnMag.com
FDA Head To Use Science To Determine Vaping Regulations - ChurnMag

As Democrats cling to the idea that they are the “party of science,” paving the way for a conversation on climate change and the environmental hazards of oil pipelines crisscrossing the country, there is one area of the field they have yet to accept: the public health advantages of vaping.

The confirmation of Dr. Scott Gottlieb as the Food and Drug Administration is discussed, at length, in a blog post published on the Competitive Enterprise Institute’s website. The focus on the discussion remains in the Democrat Party’s unwillingness to entertain the idea that vaping can be an advantage for smokers who are trying to find a smoking cessation method that helps them quit the habit for good.

Gottlieb testified before the House Appropriations Committee late last week, with the focus of the hearing seeming to revolve around vaping and the “deeming” rule that categorizes the products right along tobacco products. Committee members trotted out a line of questioning aimed at clarifying Gottlieb’s stance on vaping, how the new Commissioner intends to keep kids and young adults from beginning a smoking habit; his commitment to the deeming rule, which was enacted by former President Barack Obama’s administration, was also called into question.

The last of these questions remain the most important because the rule that categorizes vape products as tobacco products works to regulate the former far more stringently than the latter.

The deeming rule acts as a provision for products that want to enter the market after the predicate date of February 15, 2007, the date which the FDA uses as a market for which products must go through a review process. This was a requirement of the 2009 Tobacco Control Act for all tobacco products. Because most tobacco products were on the market well before the predicate date, companies were not required to undergo an extensive review process.

In the case of vaping, businesses who want to sell vape products must undergo a Pre-Market Tobacco Application process, which in and of itself can costs, on average, around $200,000 per product. The review process displaces an unfair advantage on the tobacco companies because vape companies didn’t exist in America until late 2009 after the predicate date was set.

The result is that the nearly every vape business currently in operation must go through the PMTA process, which can take years as well as hundreds of thousands of dollars in application and legal fees, all with the knowledge that there is no guarantee that the agency will approve any of the application.

To add to the onerous application process is the common knowledge that the FDA has very few resources to handle the influx of vape applications that are expected to flood the agency prior to the August 2018 deadline. The agency, which has yet to be fully stuffed, is in no position to undertake the PMTA process that will be needed, especially as each application must be declined or approved in 180 days; the applications are for individual products at each nicotine flavor and each flavor.

It is also important to understand that the PMTAs were specifically designed to address tobacco products, including public health concerns, the effects of second-hand smoke, carcinogens, and more. The applications are not meant for vape products, which differ from tobacco products in a multitude of ways, including the absence of smoke and most carcinogens. The application process also does not address the idea that vaping could be seen as a smoking cessation method; because vaping can utilize nicotine within its delivery system, as well as mimics the same behaviors smokers are already used to, it is thought that it could be a strong contender for the most effective method for quitting smoking.

However, the FDA has final approval over the vape products that stay on the market; the agency could very well decide not to approve any products for the market, thus eradicating vaping from existence in America.

If the FDA continues with the PMTAs, it will fly directly in the face of science. Nearly all of the research and studies done on vaping shows that the products are less dangerous than traditional tobacco products; a study done in England showed that vaping is 95 percent safer than smoking. This is an issue that many Democrats, particularly in Congress, would like to forget.

Nita Lowey, a Democrat from New York, is a ranking member on the House Appropriations Committee, declared at the hearing that vaping is addictive and a “gateway for teenagers to use tobacco,” a statement that has been disproven again and again by studies.

Sitting next to Representative Sanford Bishop, a Democrat from Georgia, and the man whose bipartisan bill she killed with aplomb less than six months ago, Lowey had an exchange with Gottlieb that many in the vape community will find interesting.

Lowey began the exchange by demanding that the FDA Commissioner stand with science and, according to transcripts, commit to “fully implementing the deeming rule, including through the courts, if need be.”

The Commissioner, who politely declined to address the insinuation that Big Tobacco was supporting the vape community’s efforts to readjust the deeming rule, instead deciding to focus on the question at hand. He responded that science was, and is, the measure of government at the agency and he will make decisions on tobacco harm reduction and cessation methods based on science, with the express design that they would be “maximally achieving the public health goals set by Congress.”

Gottlieb also stated that he would not “preside over a period of time when teenage smoking went back up in this country. As a cancer-survivor [sic] and a physician that’s not going to be my legacy.”

Lowey, seemingly disappointed in Gottlieb’s answer, continued with her line of questioning by asking him: “as a father, would you be comfortable with your children having such easy access to e-cigarettes and other flavored tobacco products?”

This is a stunning emotional manipulation delivered by a ranking member of the House Appropriations Committee in a public hearing, one that begs the question of its appropriateness when discussing policy. As the article points out, Gottlieb could have replied with a question of his own, asking her if she would be concerned about her children having easier access to caffeine, which is known to be a central nervous system stimulant as well as a vessel for carcinogens, and which shares the same withdrawal symptoms as nicotine withdrawal does.

Instead, Gottlieb’s answer was diplomatic. He stated simply that: “As a father, I’m not comfortable with any child being started on a nicotine product.”

The exchange ended there, but for those in the vaping community, the debate is just heating up: will Gottlieb be a reasonable and logical FDA Commissioner? Will he allow science the platform to determine whether or not vaping is safe for consumption? Will he examine the evidence based on its merit, make a decision using objective data, and craft policy that could positively or negatively impact American citizens?

This publication will continue to update readers on any changes to FDA policy as it is released.