The day vapers and e-cigarette manufacturers have been anticipating for years has come: The FDA’s Deeming Regulations were officially announced on May 10, 2016. This date marks the first time the US Food and Drug Administration can successfully regulate the vape industry. The FDA Deeming Regulations ruling bans the sale of e-cigarettes and vape pens to minors and now categorizes vapor products under “tobacco products.” The new e-cig laws don’t go into full effect until August 8, 2016. In the meantime, let’s take a look back at where it all began with the passing of the Family Smoking Prevention and Tobacco Control Act of 2009.
Family Smoking Prevention and Tobacco Control Act
The FSPTCA, or the Tobacco Control Act for short, clarified the FDA’s authority over products “made or derived from tobacco.” When President Barack Obama signed the Tobacco Control Act into law on June 22, 2009, it provided the FDA with an avenue to impose restrictions on e-cigs. After a 2010 court ruling determined that e-cigarettes cannot be regulated as drugs, but regulated as “tobacco products” instead, the FDA notified stakeholders of its intention to do just that.
When you hear or see the term “deeming regulations,” this is what people are talking about: The federal government gave the FDA power to “deem” e-cigs and other products not explicitly addressed in the FSPTCA as “tobacco products,” therefore subjecting them to the same rules that apply to traditional tobacco.
How the Tobacco Control Act Effects Electronic Cigarettes
Among other things, the new deeming rules require electronic cigarettes and vapor products to follow the same restrictions as tobacco products.
Here’s a look at a few changes coming soon:
- Vapor products must carry the same health warnings found on boxes of cigarettes.
- Selling e-cig products to customers under age 18 is now a criminal offense in all 50 states.
- E-liquid manufacturers must clearly disclose their ingredients on the packaging.
- E-cig components and accessories like batteries, coils, and tanks may soon be subject to new regulations.
Most notably, the new deeming regulations mandate pre-market approval for all vapor products manufactured after a designated grandfather date of February 2007. Obtaining pre-market approval requires paying hefty fees to the FDA, in addition to self-funding specific safety testing protocols. While this process is obviously meant to protect consumers, most e-cig companies do not have the same resources as big tobacco companies, so they can’t afford to meet the FDA’s burdensome requirements to keep their products on the market, as the co-owner of Alchemy E-lixirs stated, “If it comes, it comes. We’ll test the waters and probably be out of business, and our 17 employees would have no jobs. Every one of us has a share in this thing.” While Tige Mercer, the owner of Vape Atlanta, stated, “Worst-case scenario for me, I fire all my employees, go back to one shop and work myself.”
White Cloud has extensively covered the potential damage that this specific provision could cause to the vape industry, and organizations like CASAA are still advocating for an amendment that would extend the grandfather period for e-cigs to when the new regulations officially became law. While e-cig manufacturers prepare for the worst, there is still time for vapers to urge their congressional representatives to support logical implementation and enforcement of new policies, including showing support for HR 2058, pending legislation that would change the current February 2007 grandfather date to a more logical date that could save the vaping industry.
Should E-cigs Be Considered Tobacco Products?
Electronic cigarettes were originally designed to look like tobacco cigarettes to simulate the act of smoking, but without tobacco and combustion. Research has suggested e-cigs are 95 percent safer than traditional cigarettes, as noted by a thorough evidence-based review by Public Health England released in August of 2015.
On April 28, 2016, the UK’s Royal College of Physicians backed up this review by releasing a report titled “Nicotine without smoke: Tobacco harm reduction” which encourages doctors to recommend e-cigs to help smokers quit smoking. Nonetheless, health officials in the U.S. and many other countries have opted not to follow suit. Instead of acknowledging the potential of e-cigs as tobacco cessation tools, the FDA insists on categorizing them as tobacco products.
Why? Because the nicotine in e-liquids is extracted from tobacco plants. While some e-liquids contain nicotine that is synthesized in a laboratory and many other e-liquids do not contain any nicotine at all, they are somehow deemed tobacco products by the FDA. Studies show that e-cig vapor is very different than tobacco smoke. Unlike secondhand smoke, studies continue to suggest e-cig vapor has little to no effect on indoor air quality and poses no health risks to bystanders, while other studies have shown that directly inhaling e-cig vapor may even be as harmless as breathing ambient air.
While some health officials have raised concerns that vaping could act as a gateway to smoking, no credible research supports this fear. In fact, the inverse relationship between rising vaping rates and declining smoking rates seems to indicate the opposite: E-cigs aren’t encouraging people to start smoking, but may actually be helping people quit.
The FDA claims that the Tobacco Control Act and the new deeming regulations were intended to combat the smoking epidemic and encourage a tobacco-free society. However, making it harder to purchase potentially safer alternatives to smoking only helps the tobacco industry maintain its stronghold on nicotine addicts.
So, What Are We Doing About The Deeming Regs?
White Cloud has always supported sensible e-cigarette regulations based on rigorous medical research. We believe that the vape industry should adhere to basic safety standards and that e-cigs should only be sold to adults. We also know that e-cigs have tremendous potential for tobacco harm reduction and smoking cessation. No matter what the future holds for vapers, White Cloud will keep our customers informed while we continue to deliver the highest quality vape products on the market.
For more information on the FDA’s Deeming Regulations, check out our “E-Cigs DeMISTified webinar series featuring key leaders in vaping advocacy and tobacco harm reduction.