On Wednesday in the United States, policymakers will face an important decision in the fight against smoking and the protection of public health. Effectively, The Food and Drug Administration (FDA) is poised to pass rules that could cripple the e-cigarette industry and hamper the availability of a safer alternative to cigarettes. These decision makers may well to be the last line of defense against this misguided action by the FDA.
HOW DID WE GET HERE?
It all started in 2009 when Congress gave power to the FDA to regulate cigarettes and some other tobacco products. Yet At the time, Congress did not include e-cigarettes in FDA regulations, but gave it the possibility of extending its powers to include e-cigarettes. It was necessary to wait the month April 2014 for the FDA to drop the curtain and make a proposal to regulate the vape. Nowadays, la FDA appears to be in the process of finalizing this proposal, imposing the same rules on e-cigarettes as tobacco.
IS THIS REALLY THE LATEST JUDGMENT FOR E-CIGARETTE IN THE US?
With the rules that have to be adopted, you have to understand certain points. If a tobacco product (or e-cigarette) was not on the market before February 15, 2007, so the rules “offer” 2 possibilities . Let lThe manufacturer can demonstrate that his new product is substantially equivalent to something already existing on the market before the 15 February 2007. Otherwise, the manufacturer will have to go through a costly and difficult process, that of submit a marketing review request which requires a large amount of scientific data.
Unfortunately, applying these rules to e-cigarettes would devastate the small companies which represent a large part of the innovation in the industry. The main problem is that there was almost no electronic cigarette on the market before the February 15 2007. We can now conclude that almost no product will have acquired rights and almost none of them will be able to find an equivalent on the market before February 2007. In most cases, the only way there is to leave a product on the market is to drop off a marketing review request.
AN IMPROVEMENT PROCESS!
Good and well be! Let's start with a go-to-market process since that seems to be the only solution. Obviously, it will not be so simple since it is up to the manufacturers to demonstrate that their products are safe and secure. But two elements of the process are particularly disturbing.
First, applicants must present research results with the impact of their product on the population as a whole. It will include a probability test taking into account former smokers as well as a comparison with drugs already approved by the FDA.. But it is not finished ! Applicants will also be required to demonstrate that their new product is of benefit to public health by showing that it has negligible impact on non-smokers especially young people who might be tempted to use it.
Finally, let's move to the financial side! To carry out the necessary investigations will be extremely heavy. The FDA estimates that it will cost around $300 000 to prepare and file an application. For some outside observers the real cost could be 2 Millions of dollars. Even Big Tobacco is afraid of it! Indeed, the process is so arduous that cigarette companies have only filed a handful of market review applications for their new products since 2009.
So yes, if the FDA applies its rules to e-cigarettes in the United States on Wednesday, it could well be the hour of the doomsday for vaping ...
Source : forbes.com
