Last updated on December 13th, 2021
An Important Milestone in the History of E-Cigarettes
On July 22nd 2014 Federal Judge Richard J. Leon ruled in favor of tobacco harm reduction by starting a process that would de-legitimatizing conflicted big Pharma funding of anti-ecig groups.
Ruling in favor of the Plaintiff, Lorillard inc. against the FDA, judge Leon called the appointment of Tobacco Products Scientific Advisory Committee (TPSAC) members Neal Benowitz, Jack Henningfield and Jonathan Samet “arbitrary, capricious, an abuse of discretion, and otherwise not in compliance with the law” because they had conflicts of interest.
This ruling comes at a time when the FDA is reviewing scientific evidence regarding e-cigarette safety and effectiveness prior to making final regulatory rules.
While current e-cigarette news reports feature political interest groups frolicking in a frenzy of e-cig bashing and destructive regulations, it's refreshing to see judicial rulings that see through the anti-ecigarette manipulations.
Judge Leon has Ruled in Favor of E-Cigarettes Before
In April of 2010, the FDA was granted the authority to regulate tobacco products. In an act of bravado, and under pressure from anti-smoking lobbyists, the agency decided to flex it's newly acquired muscle and withheld shipments from two electronic cigarette companies, NJoy and Smoking Everywhere.
Why Were the Products Seized?
The shipment of e-cigarettes was seized because the FDA had previously conducted its own non-controlled “safety” tests. They claimed the products tested contained detectable levels of toxic cancer-causing chemicals.
These test results were widely publicized in an attempt to scare consumers away from purchasing e-cigarettes and to fuel the continued sale and use of tobacco products. The tests were later shown to be unscientific, because the FDA published its findings without showing the numbers. Any unhealthful chemicals found, were in fact, microscopic.
The Judge Leon went on to say,
“Electronic cigarettes are substantially likely to succeed on their merits and are likely to suffer irreparable harm if the FDA continues to exert its authority over them. This case appears to be yet another example of the FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA.”
When the ruling was passed in 2010 it was a triumph for the electronic cigarette industry. Reports exposed the unscrupulous methods used to test the products, yet the FDA's test results have been regularly cited by those bent on banning and discrediting e-cigs.
Impending FDA Regulations
To date, the FDA has yet to regulate e-cigarettes.
In the meantime, the most dependable electronic cigarette companies choose to be self-regulated. In preparation for upcoming government regulations, several companies such as VaporFi now practice the highest safety and quality control methods.
While the world waits, (and hopes) for scientifically based regulation, this potentially life saving product remains under attack. Those who stand to profit from crippling regulations and bans continue to flood the media with antiquated, ludicrous claims that e-cigarettes contain dangerous chemicals.
In the face of imminent regulations we should remember that in 1996, the FDA approved over-the-counter sale of several nicotine delivery systems – one brand of nicotine gum,(Nicorette) and two brands of nicotine patch (Nicotrol and Nicoderm).
Congress did not intend tobacco products delivering nicotine for recreational use to be classified as a drug. If they did, all nicotine products would be either banned or sold by prescription. In the light of recent EU rulings classifying electronic cigarettes as tobacco products, it's unlikely the FDA will classify e-cigarettes as medicines. Whether they will dilute the product's effectiveness by only permitting ultra low nicotine levels in e-liquids, restricted flavors of e-liquids, or tank-style vaporizers, remains to be seen.
One thing is known. The FDA is courted by many powerful self interest groups. Parties who realize that the popularity of this highly effective consumer product threatens to upstage 10 years of anti-smoking campaigns. They also threaten the pharmaceutical giants who fear that an inexpensive cigarette look-alike product will greatly reduce the need for smoking cessation drugs, and dare I say anti-cancer drugs and treatments. In addition, national health agencies will face overwhelming challenges with fewer people dying from tobacco related illness.
The battle to publicly acknowledge the merits of e-cigarettes continues. Sales continue to rise as more smokers learn that this “smoking alternative” is very effective.
In the past year, advocates of e-cigarettes have seen greater support from medical professionals who realize the powerful link between e-cigarettes and tobacco harm reduction. Sadly, most regulators choose to ignore this fact. Hopefully, the FDA will see beyond political and financial self interests and will act with judicious wisdom as did the Honorable Richard J. Leon years ago and again in 2014.
[…] it’s old news and the public has a short memory, the FDA is still smarting from being struck down by a Federal judge in 2010 when they were sued by several e-cigarette companies for stepping outside of their […]