Will The FDA Ruin E-Cigarette Business and Condemn Millions?
There has been a lot of talk about the e-Cigarette market in recent months. A threat by the FDA to completely ban the sale of electronic cigarettes had many nervous, but it looks as if that will not be happening, at least not immediately.
A new message, publicly released, by the Food and Drug Administration suggests that the authorities are willing to, at very least, consider the merit behind the flavored vapor. However, if that good faith is to extend beyond a few months’ time, those same powers will have to recognize the potential benefits offered by e-liquid flavors, rather than obsessing about a list of theorized side effects.
The underlying message sent by the FDA is that e-cigarettes are now to be treated as Tobacco products and, as such, will be regulated by the organization. The trouble, of course, is that e-cigarettes do not contain any tobacco. There is a thin line drawn, as the nicotine contained in the e-liquids is an extract of the tobacco leaf. Thereby, the FDA argues that they can in fact be considered tobacco products.
THE GOOD NEWS
There is some good news to be derived from this public announcement. It does mean that, for now, that e-cigarettes will remain on the shelves, serving those trying to get away from the toxic properties of traditional cigarettes without giving up nicotine right away. The FDA hasn’t banned tobacco cigarettes, known to be life threatening, so there is certainly some hope for e-liquids.
THE BAD NEWS
With the good comes the bad; very few of the e-cigarettes on the market today will fall under the grandfathering clause that has protected the leading traditional cigarette manufacturers.
“Tobacco products that were commercially marketed (other than for test marketing) in the United States as of February 15, 2007, are not “new tobacco products” subject to the premarket requirements, and FDA refers to these products as ‘grandfathered.’” – Department of Health and Human Services
Without the protection of the grandfather clause, e-cigarette manufacturers will have to jump through many, very costly hoops, in order to keep their products accessible to the general public. Can e-cigs fall under the grandfather clause? Those that were sold prior to the cut-off date definitely can. Others will have to prove that their product is essentially the same as those early-comers.
There are a few months allocated for those who want to apply to be accepted under the grandfathering clause, by proving that there products are substantially similar to those that were launched prior to the cut-off date. Some believe that the FDA will be highly accepting of these pleas, because, although there have been improvements in the technology, the liquid and applications have remained fundamentally the same.
That, however, is not the general consensus. The majority of the products sold were launched after February, 2007 and many feel that a large percentage of those will not qualify under the similarity clause. Since 2009, the FDA has received thousands of applications for ‘substantial equivalence’ from tobacco manufacturers. Fewer than one percent have been accepted.
Therefore, they will be considered new products and there will be a huge expense assessed if the manufacturers hope to continue sales. The market will likely be deprived of a large number of those currently available products. Those using vapers to stay away from cigarettes may find that their preferred tools are no longer found on the shelves.
HOLDING OUT HOPE
There is still hope that this hit to the e-cigarette business will not be so severe. Within the published document from the FDA, there are several requests from the organization for further information on the potential benefits of e-liquids.
“The FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE [substantial equivalence] pathway.” — Forbes
This is a sign that the FDA hasn’t completely given up on the potential benefits of e-cigarettes. However, there is reason for concern among those that support the lifesaving advantages of vapers over cigarettes.
FDA CITES TOO LITTLE EVIDENCE
Though the FDA does make mention of the fact that e-cigarettes could be a tool for those hoping to kick a bad habit, the agency is not willing to go far enough to formally recognize those advantages.
“we do not currently have sufficient data about e-cigarettes and similar products to determine what effects they have on the public health.” — Forbes
There is too little evidence one way or the other, is the claim made by the FDA.
Forty-four articles are included in this analysis. E-cigarette aerosols may contain propylene glycol, glycerol, flavorings, other chemicals and, usually, nicotine. Aerosolized propylene glycol and glycerol produce mouth and throat irritation and dry cough. No data on the effects of flavoring inhalation were identiﬁed. Data on short-term health effects are limited and there are no adequate data on long-term effects. –Open Access
THE DANGER IN HESITATING
Supporters of e-cigarettes claim that the FDA is putting millions of people in harm’s way by hesitating to recognize the benefits. By pointing the message in the research article cited above, it will likely deter people from making the switch from cigarettes to vapers. The aerosol put off by e-cigarettes is undeniably preferable to the toxins and carcinogens found in tobacco smoke.
Yet, e-cigarette manufacturers will not be able to make these claims. The classification as tobacco products will place e-cigarettes under many different legal stipulations. The manufacturers will not be able to claim any health advantage over other tobacco products. Therefore, even factual statements that e-liquids do not produce smoke or that they do not produce tar will be forbidden. Furthermore, the FDA is likely to reign in on any perceived ‘marketing’ moves made by manufacturers.
“The FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being marketed with characterizing flavors, and that these flavors can be especially attractive to youth.
The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. FDA also notes the increase in e-cigarette use by youth and the availability of fruit and candy-flavored e-cigarette liquid.” – Department of Health and Human Services
It could take a year or longer for the proposed rule to be finalized, after which the manufacturers will have two years to apply for product approval. Until decisions are made, e-liquids will remain available to the public. There is still time left for research to undeniably prove the advantages of e-cigarettes, but not as much time as many would prefer.
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