There are some things in life and happenings in our world that are simply ironic. The latest satiric event is when the FDA released its ecigarette proposal to treat electronic cigarettes as tobacco products even though they are not really tobacco.
Proposed Regulations
According to Jacob Sullum, it initially appears that the FDA’s proposed rule is lighter and more accommodating that its attempt in 2009 to ban ecigs because they are unregulated drug device combination devices. This attempt was blocked by the court.
This time, however, the FDA wants ecigarettes to be categorized as tobacco products although they contain no tobacco. The only trace of tobacco in ecigs is the nicotine added to the eliquids that the devices turn to vapor. Nicotine is commonly sourced from tobacco so it is supposed that ecigs should be classified as tobacco.
If the same logic would be used, NRTs like patches, gums and lozenges should also be treated as tobacco. As tobacco, ecigs have much better chances to stay in the market since the FDA seems not interested in banning the far more dangerous conventional cigarettes.
FDA Authority
The federal agency’s authority over tobacco was given to it by the 2009 Family Smoking Prevention and Tobacco Control Act that also grandfathered familiar cigarette brands.
The FDA said that ecigs are also included under its oversight as long as the products were on the market as of February 15th of 2007. The grandfather clause does not really cover much since ecigs are relatively young.
Surviving The Test
Ecig companies that did not exist in early 2007 could get FDA permission to continue selling their products be just demonstrating that products are considerably equivalent to the early ecig models. They need to meet the test in order to be permitted.
Chip Paul, who founded Palm Beach Vapors in Oklahoma, was asked by Sullum regarding this. Paul replied optimistically that he thinks that everybody will be able to argue and that they are only improving the technology present in 2007. From disposable models, there are now refillable tanks; but the technology essentially stays the same. He added that the products today are not substantially different from the products in 2007. He concluded that everybody in the business these days would be able to satisfy and pass the test.
Meanwhile, Oliver Kershaw who founded E-Cigarette Forum and now its CEO is less optimistic than Paul. He said that most products today would not qualify. Companies would need to submit them as new products with huge incurred costs.
The process is not just costly, but also lengthy. Unnecessary barriers will be created and many products that vapers are satisfyingly using now will be removed from the market. Kershaw is especially concerned about smaller companies offering refillable equipment without cartridges and appear different from conventional cigarette. These companies would not have the resources needed for dealing with the demands of FDA.
The federal agency has immense backlogs to deal with. Since 2009, the FDA has received over 3,000 substantial applications, but Kershaw said that only 20-30 have been approved as of now.
Founder and also president of Blu Cigs is Jason Healy who agrees that most of the products these days will not qualify as substantially equivalent. Yet, he sees flexibility from the Federal agency. He quoted some statements and regarded them as indications that the agency wants to look for a way to allow ecigarettes to remain in the market.
In order to win FDA approval that an ecig is a new tobacco product, an ecigarette company must persuade the agency that permitting such products in the market would be appropriate in protecting public health. This is certainly easier said than done.