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On Behalf of | Mar 3, 2017 | Wang IP Law Blog

Following the rampant and combative anti-smoking ads of the 90’s and early 2000’s was an era filled with young people vehemently against and disgusted by smoking cigarettes. It was this revulsion that propelled the e-cigarette and vaping industry, serving the droves of people addicted to nicotine and ashamed of smoking. The growth of this industry has been exceptional, with 8,500 vape shops opening in the U.S. and the sale of vape equipment and products climbing to $3.5 billion since 2008.

Cigarettes vs. Vaporizers

Vape products today are a drastic improvement from the old, single-use e-cigarette you could buy at a gas station. Due to major technological advancements and patents over the past few years, the vaping experience has greatly departed from traditional smoking. The major concern with smoking cigarettes is that by inhaling the smoke produced by burning tobacco, you are exposed to toxic compounds including carbon monoxide, heavy metals, and carcinogens, potentially leading to lung, throat, or stomach cancer. Vaporizers, however, administer nicotine by vaporizing a liquid, allowing it to be released into the air without burning, thereby lasting longer and without toxic byproducts. Without dismissing the fact that nicotine has negative effects on the body, e-liquid has been found to be 95% safer than cigarettes.


In 2016, the Food and Drug Administration (FDA) finalized a rule extending regulatory authority that covers tobacco products to include vaporizers, vape pens, hookah pens, electronic cigarettes, e-pipes, and all other electronic nicotine delivery systems (ENDS), even though most ENDS are not even tobacco-based. With the addition of California increasing the age to buy tobacco products to 21 in the same year, the vape industry abruptly took a huge blow.

Some of these regulations are agreeable, such as banning the sale of ENDS to minors, requiring identification, and prohibiting free samples. However, manufacturers are being forced to comply retroactively with rules set out in the Tobacco Control Act of 2009, despite important qualitative differences between ENDS and tobacco based products. ENDS manufacturers are required, in the span of two years, to get pre-approval from the FDA for each vape-related product in the market after February 15, 2007, an application and process that the FDA claims will take 5000 hours and cost $330,000.00 each. The ENDS industry is still in a nascent stage, built on very recent technology, so these regulations will impact almost every single vape product in the market. Smaller manufacturers and shops will potentially be eliminated by this costly process.

The newly proposed Deeming Authority Clarification Act of 2017 gives the vape industry an opportunity to prepare for these regulations by limiting the FDA’s ability to regulate tobacco products. It still allows the FDA to classify ENDS as tobacco products, but it would amend existing law to provide relief to vape manufacturers. This Act would change the nominated date for newly deemed tobacco products, ensure that licensing and advertising guidelines set for vaping products are practical, and create a separate tobacco product classification for ENDS, protecting them from the regulations in place for cigarettes. Most importantly, the proposed legislation would exempt ENDS created before 2017 from being subject to the pre-approval process.