FDA: A gloomy future for the US vaping business

Beginning of May, the FDA released its new deeming rule for tobacco products that also concern e-cigarettes. Within two years, 99% of the current vaping products might disappear from the market. A deeper insight into the process with Patricia Kovacevic, General Counsel and Chief Compliance Officer for the e-liquid company Nicopure Labs LLC.

Simon Rosselat

July 19, 2016

What is your position regarding the future regulation of the FDA?

Patricia Kovacevic: First, a little reminder. In 2009, the US Congress passed the Family Smoking Prevention and Tobacco Control Act, giving the FDA the status of primary regulator of tobacco products. This law applies to tobacco and its derivatives, with the exception of medicines, as well as components and accessories of tobacco products. It results from a struggle of decades to counter the bad practices of the tobacco industry, but it has clearly not been thought with vaping products.

Today, the new regulations issued by the FDA includes products of vape, cigars, shisha and products containing nicotine in the Tobacco Control Act. In fact, this regulation does not take into account the reduced risks of certain products compared to those of smoking, such as vaping.

“One mod, sold alone, becomes a tobacco product. It’s absurd!” -P. Kovacevic, Nicopure Labs LLC.

The FDA also seeks to regulate products that are not derived from tobacco, such as hardware, batteries and drip tips. So, one mod sold alone becomes a tobacco product. It’s absurd! Moreover, the regulation does not take into account the real concerns, as some undesirable ingredients in e-liquid. It does not advocate good manufacturing practices or other types of product standards.

“We believe that the FDA has violated the Constitution and the Administrative Procedure Act by adopting this regulation.” -P. Kovacevic, Nicopure Labs LLC.

Nicopure Labs is not opposed to the principle of regulation. It is important for consumers and businesses to benefit from regulations based on scientific studies. They help to provide consumers with reliable products in which customers can trust. We are very disappointed that the FDA has considered or the impact on public health or the comments made by the vape industry during the consultations that led to the adoption of this regulation. Worse, we believe that the FDA has violated the Constitution and the Administrative Procedure Act by adopting this regulation.

How will the vape industry be impacted?

P.K.: In the short term, it freezes completely innovation because, from 8 August 2016, no product may be modified without FDA approval. Moreover, the price of the procedure is prohibitive. In addition, the FDA has no experience in examining this type of product. For their part, the vape shops will no longer manufacture their e-liquids. Manufacturers will no longer offer samples, and will no longer give statements such as “No diacetyl”, for example, on the packaging.

A second more devastating impact happens in two years when all importers and domestic manufacturers will have to file an extremely expensive folder for each product with the FDA. This folder will include clinical studies and other very expensive analyzes as prerequisites for maintaining products on the market. The resources, the expertise and the cost of implementing such a process, with little clear guidance from the FDA, are estimated at several million. Only large companies are able to bear such costs.

“FDA behaves as if it wanted to see these products off the market.” -P. Kovacevic, Nicopure Labs LLC.

In addition, we do not even know if, in the end, the FDA will approve these application procedures, even if they are well documented. So, even if we had the funds to comply within two years, we have anyway no assurance that the FDA will not remove all or most products in the market. FDA behaves as if it wanted to see these products off the market.

What is the worst case scenario?

P.K.: The worst for America, it would be that the current vapers be forced to return to smoking or they should defy the law and buy dangerous and unsafe products on the black market because the industry was wiped out by a disproportionate regulation, which is not based on scientific studies. There are precedents in the United States with the alcohol prohibition in the 1920s or with conventional cigarettes, the black market explodes when the legal industry declines.

How will this impact the vaper’s behavior?

P.K.: It would be naive to think that would somehow choose to move to medicinal nicotine replacement therapies if they can not buy vaping products. For some people, these substitutes just do not work. And fundamentally, people want the freedom to keep vaping. Public health and small business will be most affected if the direction taken is not reversed. Nicopure Labs is committed to change the course of things in two ways. First, we filed an appeal in federal court challenging the regulation, since its official publication. The case is ongoing. Second, through our participation on the board of the Vapor Technology Association (VTA), we can ensure that work with legislators has increased this year to develop a regulatory sense.

What do you expect the appeal lodged before the Washington federal court?

P.K.: We have confidence in our legal team and we are confident of our arguments, but we are only at the beginning of the case. We hope a rapid judgment as possible in the course of the year 2017. Of course, it may be longer because calls are possible thereafter. For now, nothing is.