What are the Current Laws on Vaping?

While the health benefits or hazards of e-cigarettes, consequently vaping, are being debated each day, the vaping industry is witnessing upheavals in the form of new vaping laws. Before deep diving into the current vaping laws, let us read about the history of vaping policies so far.

The advent and acceptance of vaping in the U.S. have been anything but smooth sailing. The relation began in the 1990s when a major U.S. tobacco company requested permission from the Food and Drug Administration (FDA) to launch an e-cigarette. At that time, the FDA did not regulate tobacco products, but they did regulate drug delivery devices. The FDA denied their request, resulting in vanishing attempts to bring e-cigarettes into the U.S. market. However, three years after the first e-cigarettes were invented in China, by Hon Lik, the U.S. was finally introduced to e-cigarettes and vaping in 2006.

With the global introduction of vaping taking place around this time, innumerable studies are conducted, globally, to assess the extent of harmful effects of this smoking alternative. First, the World Health Organization proclaimed that it does not consider e-cigarettes to be a legitimate aid for smoking cessation, then a study funded by Ruyan, Health New Zealand concluded that e-cigarettes contain below-harmful levels of carcinogens and toxicants. Such conflicting statements flooded the local news, creating confusion and more controversy.

The year 2009 brought with it a long-drawn judicial tug of war between FDA and an e-cigarette company, Smoking Everywhere. This case dictated the future vaping laws. It began with FDA notifying Smoking Everywhere that their shipment had been denied entry into the U.S. because e-cigarettes appear to be a combination of drug-device products, which require pre-approval.

FDA tested few cartridges of Smoking Everywhere and found trace amounts of tobacco-specific nitrosamines. These levels were comparable to those found in FDA-approved nicotine cessation products. The liquid in one of the cartridges was also found to contain a non-toxic concentration (approximately 1%) of diethylene glycol. However, the FDA issued press releases that discouraged the use of e-cigarettes, without making the aforementioned findings public.

In the same year, the Family Smoking Prevention and Tobacco Control Act was passed that conferred powers to the FDA to regulate the tobacco industry. This Act is critical in the implementation of the current vaping laws.

Referring to the 2009 Tobacco Control Act, FDA published the ‘Deeming Rule’ in mid-May 2016. This rule stated that all vaping devices and products would be regulated in the same way as combustible cigarettes and other nicotine products that contained nicotine. This rule was followed by the official announcement that e-cigarettes and vaping products would now be deemed as tobacco products.

As a result of this directive, all vaping products that had been introduced before February 15, 2007, were required to file a Pre-Market Tobacco Application (PMTA).

A Right to Vape Tour was launched to urge a change in the predicate date from 2/15/07 to 08/08/2016. This tour also urged recognition of the vaping industry as one that sells products that are at least 95% less harmful than combustible cigarettes, thereby hinting that the industry should not be treated more harshly than cigarettes ever were.

Due to the Covid-19 pandemic, the deadline for filing the PMTA was pushed to September 2020.

Once the PMTA is filed, it indicates that the specific flavor, concentration, device, etc. can stay on the U.S. market until FDA either approves or denies the application. The FDA can take a whole year to either approve or deny the applications. Product manufacturers will be sent letters that will state whether the product has been approved permission or denied.

Even with the change in predicate date, nearly 99% of vapor products are staring at the possibility of completely vanishing off the face of the Earth. In summation, the new vaping rules could force thousands of businesses to shut down and millions of consumers to lose access to low-risk products.

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