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Nicopure makes history; files first lawsuit over FDA e-cig regulations

Posted by Matt Rowland on

One of the leading e-liquid manufacturers in the United States is taking the Food and Drug Administration (FDA) to court over recent sweeping e-cig regulations that many believe will eradicate an entire industry.  Tampa-based Nicopure Labs filed the historical lawsuit on May 9 in Federal District Court in Washington, DC.   The basis of the lawsuit stems from the agency’s new classification of all e-cigs as tobacco products. 

According to the lawsuit, Nicopure believes that the FDA e-cig regulations violate the Administrative Procedure Act of 1946 along with the First Amendment to the U.S. Constitution.  But the FDA is countering that electronic cigarettes now fall under the same federal oversight as Big Tobacco due to the recently passed 2009 Family Smoking Prevention and Control Act. 

FDA e-cig regulations and the PMTA process

Through a years-long media campaign that targets e-cigs as a gateway to teenage smoking, the FDA seems to be gaining overwhelming public support for the anti-vaping regulations.  But many in the vaping community believe that the real issue is not “teen smoking” but rather good, old-fashioned greed.

(Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS)

The controversy over the e-cig regulations involves several factors, perhaps the most important of which is the new requirement for all e-liquid manufacturers to undergo a Pre-Market Tobacco Applications process (PMTA).  This is the same approval process used by Big Tobacco products, such as tobacco cigarettes, pipe tobacco, and chewing tobacco. 

The PMTA process alone may very well eliminate 99% of the current e-cig products on the market today.  It will be a very time-consuming process that could cost upwards of $1 million dollars per product, money that the typical manufacturer of a $10 bottle of e-juice simply can’t pay. 

(Related Article: FDA E-CIG REGULATIONS: USING 911 SCARE TACTICS TO KILL AMERICANS FOR PROFIT)

Even if the FDA were to reduce the cost of the PMTA process substantially, the resulting bureaucratic red tape will stifle innovation to a near standstill.  The vaping industry has been around for decades, but the most significant technological advancements have only taken place in the past four years.

Nicopure releases statement

As a result, many in the vaping industry believe that this recent surge in e-cig popularity is attracting a greedy FDA who wants only to benefit from a billion-dollar PMTA process by targeting an essentially newborn industry without reason.

“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness…The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”
- Patricia Kovacevic, General Counsel and Chief Compliance Officer for Nicopure Labs

 

(Related Article: ARE THE NEW FDA E-CIG REGULATIONS A WINDFALL FOR BIG TOBACCO AT THE EXPENSE OF PUBLIC HEALTH?)

The Nicopure lawsuit is important.  It will be interesting to see if other manufacturers of electronic cigarettes and e-liquids will follow suit.  If the past few years are any indication, vape tech companies are already showing great strength and determination to drive its industry towards the highest possible levels of quality and innovation. 

For the most part, manufacturers already have the best interests of public health in mind.  The FDA e-cig regulations and the associated PMTA process are not only unnecessary, they will set back industry progress for decades while leading millions of vapers back to cancer-causing tobacco cigarettes in the meantime.  Strangely, many of the new smokers will come from today’s generation of teenagers, the very people that the FDA is allegedly trying to protect.

Or is this what the FDA secretly wants?  Does the FDA favor the deep pockets of Big Tobacco over the meager earnings of a fledgling e-cig industry?  Perhaps the Nicopure lawsuit will shed some light.

 (Related Article:  FDA VAPING REGULATION - E-CIG PROHIBITION (What You can do to fight the FDA e-cig regulations)


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  • Hello this is Christina tsatsis from specialty vapors. I am just a little vaoe shop but we are willing to do whatever we can to spread the word and inform the public. What is to happen to all the little vape shops all around the country that are helping people on a one on one level. Let me know anything that shops like mine can do o make a difference.
    Thank you
    Christina Tsatsis

    Christina tsatsis on

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