Whenever a new, groundbreaking product enters the U.S. marketplace, government regulation is sure to follow. This has never been more apparent than with the American vaping industry, which is currently fighting newly announced FDA deeming regulations that threaten to wipe out nearly 99 percent of the industry.
Even though advocacy groups like the American Vaping Association (AVA) and the Smoke Free Alternatives Trade Association (SFATA) are working hard to win the War on Vaping, the average vaper is often completely unaware of the dire circumstances surrounding their way of life. E-cigs and vape mods were designed to be a safer, healthier alternative to smoking. The e-liquid contained inside is a simple mixture of propylene glycol, vegetable oil, a bit of flavoring, and a whole lot of water. Small amounts of nicotine may or may not be added to the e-liquid, but nicotine, in itself, is not harmful. After all, eggplants, tomatoes, and potatoes even carry small amounts of nicotine.
It’s smoked tobacco that is the real killer. And as vaping has grown in popularity over the past decade, sales of conventional cigarettes are at an all-time low. Big Tobacco is losing money, and the cigarette companies are fighting back.
The FDA takes charge.
Big Tobacco has very deep pockets and wields a tremendous amount of political influence of Capitol Hill. These companies spend billions of dollars on the re-election campaigns of political officials from all areas of the country. It is this pay-for-play mentality that has led to the FDA entering the War on Vaping.
(Related Article: BIG PHARMA AND THE FDA DEEMING REGULATIONS: A HISTORY OF CORRUPTION)
Even though e-liquid is 100% tobacco-free, the FDA still wanted to regulate the industry out of existence to benefit Big Tobacco. But the FDA did not have the legal authority to regulate the vaping industry until an obscure law was passed in 2009. The Tobacco Control Act somehow managed to reclassify e-cigarettes and vaping technology as “tobacco products” even though they contain no tobacco. All e-cigs released to market after the predicate date of February 15, 2007…almost ten years ago…would now be forced to submit a Pre-Market Tobacco Application (PMTA). This is the same application that the FDA requires Big Tobacco to file for their conventional cigarettes and other products.
What is the PMTA?
The PMTA process is expensive and time-consuming. The estimated costs range from $300,000 per product to over $1 million. And according to the FDA, the approval process might take up to 1,700 hours to process. Furthermore, filing a PMTA does not guarantee approval. In fact, only one application has been approved in the past six years.
(Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS)
The PMTA process must be completed, according to the Tobacco Control Act of 2009, for every e-cig, vape mod, piece and part of a vaping device. This also includes the e-liquids inside. For every new flavor of e-liquid placed on the market for sale, a million-dollar PMTA must be submitted and approved. Mom and Pop vape shops cannot afford this massive fee, which leads us to the core of the problem.
“The (FDA’s) economic analysis of the rule predicts that the cost of such approvals will be so high that approximately 99 percent of products on the market will not even be put through the application process,” states a spokesperson for the AVA.
The FDA deeming regulations were first announced on May 5, 2016, and within days, several retailers filed lawsuits. The most significant is the case surrounding Nicopure Labs, an e-liquid manufacturer whose legal proceedings just began last week. Judge Amy Berman Jackson heard opening arguments from both the plaintiffs and the defendants, but the final ruling might take several months. All eyes are on this historic lawsuit. Whatever happens in the case of Nicopure Labs v. FDA will set a legal precedent for future rulings.
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- Tags: Big Tobacco, FDA Deeming Regulations, Nicopure Labs, PMTA, Tobacco Control Act of 2009