US is to regulate all tobacco products, including e-cigarettes and hookah tobacco

BMJ 2016; 353 doi: (Published 06 May 2016) Cite this as: BMJ 2016;353:i2594
  1. Michael McCarthy
  1. Seattle

The US Food and Drug Administration (FDA) is extending its authority to regulate all tobacco products, including electronic cigarettes, cigars, hookah tobacco, and pipe tobacco, the agency announced on 4 May.

In a news conference the health and human services secretary, Sylvia Burwell, said that the new regulations were needed to “catch up” with changes in the marketplace.1 She said, “We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction.”

The prevalence of e-cigarette use among high school students in the United States has risen sharply in recent years, from 1.5% in 2011 to 16% in 2015, while hookah use rose from 4.1% to 7.2%.2 Although some states have adopted regulations limiting access to e-cigarettes, there had been no federal laws prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18 until the FDA’s announcement.

Under the new rules, laid out in a 499 page document, sale of e-cigarettes, hookah tobacco, or cigars to people under age 18 will be prohibited and retailers will have to ask for photo identification to verify purchasers’ age. Distribution of free samples will also be prohibited, as will the sale of tobacco products in vending machines outside adult only facilities.

The FDA will also require manufacturers of all products covered by the new regulations to receive marketing authorization, unless the product was on the market as at 15 February 2007. The FDA’s review will include evaluation of ingredients, product design, health risks, and the products’ potential appeal to young people and non-users. Manufacturers of approved products will also be required to place health warnings on product packaging and in advertisements.

The new rules were welcomed by such organizations as the American Academy of Pediatrics and the American Public Health Association but drew criticism from congressional lawmakers sponsoring legislation that would limit the FDA’s authority to regulate e-cigarettes and cigars.

“The rule is a welcomed starting point,” said the American Academy of Pediatrics in a statement, “but it is only a framework upon which to build meaningful regulation to end the tobacco epidemic in the United States once and for all.”

But Representative Tom Cole, a Republican from Oklahoma who introduced an amendment to an appropriations bill that would make it substantially easier for e-cigarettes to pass FDA review, said that, although he agreed that tobacco products should not be marketed to children, the FDA’s plan to regulate all tobacco products was “just another example of the Obama administration’s regulatory overreach and nanny state mentality.”


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