E-Cigarettes: FDA To Regulate All Tobacco Products, Including Electronic Cigarettes

The U.S. FDA made a long-anticipated announcement Thursday regarding e-cigarette regulation. In a nutshell, the FDA will now regulate all tobacco products sold in the United States, including cigarettes and smokeless tobacco, which the FDA already regulated, as well as e-cigarettes, cigars, pipe tobacco, and hookah tobacco, reports CNN. In the past several years, the e-cigarette (otherwise referred to as “vaping”) industry has boomed to the point that it currently rakes in roughly $3 billion annually.

Now, the FDA will be able to regulate the sale of e-cigarettes, including implementing a federal law forbidding the sale of e-cigarette products to minors, as well as regulate the ingredients used in e-cigarette products.

“This action is a milestone in consumer protection — going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products.”

The FDA’s battle to take control over e-cigarettes began back in 2009 and an investigation that indicated detectable levels of toxic chemicals, including carcinogens, in e-cigarette samples. However, in 2010 a court ruled against the FDA, stating that the FDA hadn’t proven evidence of harm from e-cigarettes.

As Vox reports, the secretary of the U.S. Department of Health and Human Services, Sylvia Burwell, said that the FDA has “more to do to protect Americans from the tobacco and nicotine, especially our youth.” Burwell, who oversees the FDA, went on to say that despite a drop in cigarette smoking among youth, teen use of e-cigarettes has “taken a drastic leap.”

The FDA gained sweeping regulatory authority over the tobacco industry in 2009 with the Family Smoking Prevention and Tobacco Control Act. However, that piece of legislation didn’t cover some nicotine products, such as cigars and the increasingly popular e-cigarettes. By April 2011, the FDA was working to close the gap in its authority because of mounting health concerns surrounding e-cigarettes as well as reports of increased e-cigarette use among minors. In April 2014, the FDA proposed a draft rule to redefine e-cigarettes as tobacco products, and that rule (all 499 pages of which are available here) was just finalized, expanding the parameters of the Family Smoking Prevention and Tobacco Control Act and thereby granting the FDA regulatory authority over all tobacco products in the U.S.

The FDA’s sweeping new e-cigarette regulations will go into effect in 90 days, and they cover a lot of ground. The new rules, more than two years in the making, will do the following.

• Ban the sale of e-cigarettes (as well as cigars, hookah, and pipe tobacco) to minors. This rule will apply both online and in person. Some states have already passed legislation to prevent minors from buying e-cigarettes within their borders, but now the restrictions will be federal.
• Require age to be verified with a photo ID before purchasing e-cigarettes.
• Force manufacturers of e-cigarette (and other previously unregulated) products that came on the market after February 15, 2007, to seek FDA approval in order to keep selling their products. This will include disclosing safety problems, product designs, and ingredients to the FDA. Manufacturers will have one to two years to comply depending on the “regulatory pathway forward.”
• Require companies selling e-cigarettes and other previously unregulated tobacco products to add warnings to their product labels. These warnings must include the negative health effects of nicotine and the potential for addiction.
• Ban the sale of all tobacco products in vending machines (machines in “adult-only” venues will be exempt).
• Prohibit the dispensation of free e-cigarette (and other tobacco product) samples.

While some are applauding the FDA’s sweeping new e-cigarette authority, not everyone is happy. Some of those who called for more regulations of the e-cigarette industry say that the FDA should have done more, citing candy e-cigarette flavors that many believe are being marketed directly to kids. Others think that the FDA is allowing e-cigarette manufacturers too much time to get FDA approval for their products. The FDA is allowing manufacturers to continue selling their products during the FDA approval process, which could take years. Some estimate that it could be three years, maybe a little more, before all potentially-dangerous e-cigarette products are taken off of the market.

Some doctors even think that the new regulations send the wrong message to smokers using e-cigarettes to quit smoking the real thing.

“Regulators need to watch out for intended consequences of overzealous regulation, such as stifling such developments or making e-cigarettes more expensive and less attractive to smokers; and also avoid conveying a message that e-cigarettes are regulated as strictly [as] or even more strictly than cigarettes because they are as bad.”

E-cigarette manufacturers have a different set of complaints about the FDA’s new authority. Collectively, they’ve said for years that such stringent FDA regulations could wipe them out. It has been anticipated that by 2017, e-cigarette sales could surpass the sales of conventional cigarettes in the U.S. Prior to today’s FDA announcement, these products haven’t been subject to any FDA approval processes at all. Many manufacturers have been fighting the new regulations on the grounds that they could “kill the industry,” which was expected to reach $10 billion annually by 2017.

According to some reports, these concerns were the reason behind the FDA’s staggered compliance dates and lengthy approval timelines.

Unfortunately for the e-cigarette industry, the increasing popularity of e-cigarette products is precisely why the FDA had to step in. According to a 2015 CDC report, e-cigarette use among middle and high school children tripled between 2013 and 2014, with about 13 percent of students now using e-cigarette products. Those are numbers that leave both parents and the FDA concerned about the safety of e-cigarettes as well as their accessibility to minors.

[Image Courtesy Of Dan Kitwood/Getty Images]