Thursday, November 12, 2015

First PMTA Approvals by FDA Demonstrate Why Treating E-Cigarettes Like Tobacco Products Makes No Sense and Will Decimate the Industry

This Tuesday, the FDA announced that for the first time, it had approved a set of new tobacco products for delivery into inter-state commerce under the PMTA (pre-market tobacco products application) pathway. This is the same pathway that the FDA will require all electronic cigarette products to follow. Unlike e-cigarettes, all smokeless tobacco products and cigarettes that were on the market as of 2007 were exempted from the requirement to file a PMTA. Thus, virtually the entire combustible cigarette market was grandfathered in and need not obtain any approval to continue marketing of these deadly products.

This week's PMTA approvals relate to a series of eight snus products produced by Swedish Match. With the FDA's approval, these products may now be marketed in the U.S.

The Rest of the Story

What the FDA did not readily reveal is that the Swedish Match application was incredibly complex, rigorous, burdensome, comprehensive, and extensive, weighing in at a total of more than 100,000 pages!

The FDA's decision summary is itself 67 pages long. The application had to be reviewed by the following disciplines:
  • Behavioral Pharmacology
  • Chemistry
  • Clinical Pharmacology
  • Engineering
  • Environmental Science
  • Epidemiology
  • Medical
  • Microbiology
  • Social Science
  • Statistics
  • Toxicology
In contrast, here are the disciplines that needed to review applications for the following much more toxic products to remain on the market:

  • Bupkes
  • Bupkes
  • Bupkes
  • Bupkes
Virginia Slims
  • Bupkes
  • Bupkes

The importance of this story is two-fold:

First, it demonstrates that successfully submitting a PMTA is a resource-intensive, complex, burdensome, and highly expensive project that can only be completed successfully by, if anyone, the absolutely largest e-cigarette companies (including the tobacco companies and the largest of the independent e-cigarette companies). This is simply not something that a vape shop owner, the owner of a small e-cigarette business, or the owner of a small e-liquid business is going to have the capability or resources to carry out. This backs up my point made yesterday that the FDA deeming regulations amount to a de facto prohibition of all or most electronic cigarettes currently on the market.

Second, it demonstrates the absurdity of the FDA's regulatory approach. While the most toxic consumer products on the market - combustible cigarettes - have to do absolutely nothing to stay on the market, much safer products such as snus and tobacco-free electronic cigarettes have to file burdensome and prohibitively expensive applications with little technical possibility of being approved under the guidance proposed by the agency.

This is an insane way to craft a regulatory strategy for the range of nicotine-containing products on the market. In fact, it is the exact opposite of the proper approach. The most toxic products - combustible cigarettes - are being given a free ride. The safest products on the market - electronic cigarettes - are being forced to complete complex, burdensome, expensive, and unruly applications for which in most cases it is technically impossible to make the demonstrations that are required by the deeming regulations.

No comments: