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FDA Poised To Regulate E-Liquids for E-Cigs

Within the next few months, the U.S. Food and Drug Administration (FDA) is expected to decide whether it will regulate liquid nicotine as a tobacco product.

As of August 2015, the FDA regulates traditional cigarettes, loose tobacco and smokeless tobacco, such as snuff. If the current proposal is finalized, the FDA also will regulate liquid nicotine, which is used in e-cigarettes and vaporizers. The proposal also includes new regulations for cigars, pipe tobacco and other tobacco gels and dissolvables. 

According to the FDA website, if the “Tobacco Products Deemed To Be Subject to the Food, Drug & Cosmetic Act (Deeming)” rule becomes final, the “FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to reduce tobacco-related disease and death.”

Since e-cigs were first available about 15 years ago they have sparked controversy. Proponents point out the devices are much safer because users are not inhaling the thousands of chemicals in traditional tobacco cigarettes. Instead, they are inhaling a smokeless vapor that provides them with the nicotine they enjoy. Supporters also point out that the devices don’t put others at risk and aren’t a smelly nuisance because they do not give off a cloud of thick, slowing-dissipating smoke. In some cases, users of e-cigs aren’t using nicotine – a stimulant known to be addictive, like caffeine – but are instead simply enjoying a flavored vapor. Flavors include coffee, various fruits, chocolate and vanilla, among many others.

Opponents of e-cigarettes have raised concern about the vapor given off and argue users are still inhaling chemicals and getting unsafe tobacco byproducts. They also have expressed concerns that e-cigs are appealing to youth and can lead to eventual use of traditional cigarettes. FDA officials say the reason for the regulations is because tobacco is still killing too many people.

“Despite decades of efforts to reduce tobacco use, it continues to be the leading cause of preventable disease and death in the United States,” the FDA states on their website. “To address this public health problem, FDA proposes extending its authority to cover additional products that meet the definition of a tobacco product.”

So what does this mean for consumers? Those against the proposed regulations say they will mean less choice for e-cigarette users and higher costs. By way of example, they point to how traditional cigarettes are regulated these days. Currently, you can find dozens of cigarette brands at the local smoke shop and grocery store. But if you look closely, you will see that most of those smokes are made by one of three, big tobacco companies. These big companies can afford the costs of FDA regulations, which require that companies do testing, provide details about ingredients, share reports about health effects, etc. 

When it comes to e-cigs, the market is filled with dozens of brands and eager start-ups, giving customers more choices when it comes to styles, flavors and price, among other things. Opponents of the new regulations say its associated costs will sink these smaller companies. As a result, the big tobacco companies – which have more resources to cover the expenses of dealing with federal regulations and red tape – will control the market. If the regulations are put in place, companies would have two years to comply.

Gregory Conley, president of the American Vaping Association, says one of the biggest issues with the proposed regulations is that they would require more than 99 percent of those making e-cig liquids to halt sales and production. This is because the FDA has proposed retroactively applying ‘’premarket tobacco review requirements”that force new tobacco products to go through a lengthy and typically multimillion dollar review before hitting the store shelves. The vaping association – which is a nonprofit organization that advocates for small- and medium-sized businesses in the vaping and electronic cigarette industry – says that’s not fair to companies or consumers. Conley said many former smokers are healthier today due to switching to e-cigarettes.

“This would be a disaster not only for thousands of small businesses, but also public health,” Conley said. “It is unconscionable to effectively ban the sale of tens of thousands of vapor products while leaving combustible cigarettes freely available.”