FDA allows use of unapproved e-cigs for scientific research

Some unapproved vaporizers can from now on be used for scientific research as long as they were already on the market by the 8th of August 2016, the date when the FDA’s deeming rule came into play, confirmed the agency.

Diane Caruana

October 28, 2016

The U.S. Food and Drug Administration’s announcement included that these unapproved devices can only be used for research as long as they meet compliance deadlines, which in layman’s terms means that the same regulations apply for vaping products whether they are being sold or used for research.

Just this week the FDA announced that it will start accepting health related documentation submissions for devices released on the market between the 23rd of June 2009 and the 31st of December of the same year. Therefore in relation to using unapproved vaping products for research, the agency insisted that as long as the 8th of August cut-off date is observed, and the approval applications for these same devices are submitted on time, no legal action would be take against these products up until the 8th of August 2018.

About the applications

These costly applications will force smaller companies out of business, and lead to increases in prices, which in turn will force many smokers or ex-smokers who are using these e-cigs as smoking cessation tools, to purchase them on the black market.

e-cigarette companies can choose between two applications for approval of their products, the Substantial Equivalent (SE), and the PreMarket Tobacco Product Application (PMTA), the exact cut-off dates for receipt of applications will vary however most manufacturers are expected to go for the second option which happens to have a later deadline.

If the FDA finds a product unsuitable for use, it can take it off the market a year after its application has been submitted, whilst any products for which applications are not submitted on time will immediately be considered illegal. On the other hand products introduced to the market after the 8th of August will have to go through one of the approval processes before they can be sold or used for research.

The real cost of these application submissions

Many e-cigarette companies are expected to struggle as the costs of these applications required by the FDA are high, therefore to avoid this expense many companies will most certainly just discard certain products. This will force smaller companies out of business, and any companies that survive to increase their prices, which in turn will lead to many smokers or ex-smokers who are using this devices as smoking cessation tools, to purchase products on the black market where they are completely unregulated and possibly unsafe.

Therefore, while everyone from health experts to e-cigarette companies themselves, agree that some sort of regulation is necessary as to avoid the sale of products unfit for use, over-regulating them is proving to be detrimental, and will sadly only contribute towards the current public health crises caused by smoking.