|E-cigarette designs have changed and improved dramatically|
since the introduction of the original "cigarette look alikes."
Photo Credit: youtubecommercial on ECF
In an April 25, 2011 letter to stakeholders, the FDA described its intention to regulate electronic cigarettes (e-cigarettes) “and other tobacco products.” The FDA plans to impose Section 905(j) of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) on e-cigarettes. Specifically, the FDA will consider any product that was not being marketed before February of 2007 a “new tobacco product and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action.”
Translation: The FDA failed to ban e-cigarettes by regulating them as drug-delivery devices, so the Agency has found a way to ban all but the most primitive early models of e-cigarettes by applying a section of the law that is inappropriate for this type of product. Section 905(j) was intended to stop the proliferation of new brands of combusted cigarettes.
Unlike tobacco cigarettes, e-cigarettes are high tech devices. Compare the features and performance of the computers or cell phones being sold five years ago to today’s products. Technology develops at a very rapid pace. The batteries in the 2007 models of e-cigarettes went dead after a couple of hours. Cartridges were poorly constructed and often leaked nicotine-laced liquid onto the user’s skin and even into the user’s mouth. Vapor production was sluggish, and as the liquid levels in the cartridge went down, users needed to inhale more and more strongly to produce vapor.
Researchers at the University of California, Riverside, documented these product deficiencies. [Trtchounian A, Williams M, Talbot P. Conventional and electronic cigarettes (e-cigarettes) have different smoking characteristics. Nicotine Tob Res. 2010 Sep;12(9):905-12. Epub 2010 Jul 19. http://www.ncbi.nlm.nih.gov/pubmed/20644
Today’s products are a vast improvement on the original models. Larger and more powerful batteries last all day, and even several days for some users. Modern designs that don’t contain the fibrous filling used in the original products eliminate the need to increase puff intensity as the liquid is used up. Clever inventors have figured out ways to eliminate the leakage that plagued the original products.
More importantly, today’s products are more effective than their predecessors. Many people tried to use the early models of e-cigarettes as a replacement for smoking and were unable to do so, mostly due to inadequate vapor production and inefficient delivery of nicotine.
In order for a product that was not on the market prior to February 2007 to be approved for sale, it must prove that it is “substantially equivalent” to a “grandfathered” product that was being sold. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.” http://www.fda.gov/downloads/TobaccoProd
“Substantial Equivalence,” according to the Guidance document, means that the new product has the same characteristics as the predicate tobacco product, or has different characteristics and the report submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates the product does not raise different questions of public health.
The FDA defines Characteristics as “the materials, ingredients, design, composition, heating source, or other features of a tobacco product.” So the definition of characteristics is extremely broad, the required proof may be time-consuming and expensive to gather, and the criteria for approval is highly subjective.
How long will it take before there is a government stamp of approval on modern, effective e-cigarette models? Many long-time smokers don’t have any time to waste. The damage has already started and will continue until they find a way to stop inhaling smoke.