Expect Questions About the New Rule on E-Cigarettes

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As cigarette smoking among those under age 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.

—HHS Secretary Sylvia Burwell

“There are a lot of myths around new and emerging tobacco products, including e-cigarettes, and unfortunately, the biggest misconception is that these products are fairly or entirely harmless and risk-free,” Alexander V. Prokhorov, MD, PhD, said in an interview with The ASCO Post about a new federal rule on tobacco products.1 The rule extends the oversight of the U.S. Food and Drug Administration (FDA) to all tobacco products, including electronic cigarettes (e-cigarettes), cigars, hookah tobacco, and pipe tobacco, and should help dispel these myths by restricting the sale and distribution of these and other tobacco products and requiring warning labels.

“We need to seriously pay attention to and educate our public about e-cigarettes, especially young people, who look for something interesting, new, unusual, and exotic,” Dr. Prokhorov said. E-cigarettes can fill the bill because they come in a variety of shapes and designs, with many different e-juices and flavors to choose from.

“Young people see these products and they try them and then unfortunately get hooked and sometimes cannot get rid of this addiction. That is why our mission is to inform them as much as we can,” Dr. Prokhorov added. He is Director of the Youth and Family Cancer Prevention Program and of the Tobacco Outreach Program and Distinguished Professor, Department of Behavioral Science, at the University of Texas, MD Anderson Cancer Center, Houston. “In general, the recommendation is to stay away from anything that contains nicotine and can get you hooked for life.”

Provisions Aimed at Restricting Access

“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 age 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,” said Health and Human Services Secretary Sylvia Burwell in announcing the new rule.2

Among the provisions aimed at restricting youth access listed by the FDA are:

  • Not allowing products to be sold to persons under the age of 18 (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the sale of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

These provisions go into effect on August 8.

Requirements for Manufacturers

The rule also “requires manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of February 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design, and health risks, as well as their appeal to youth and non-users,” according to the FDA.

Specific requirements listed by the FDA for manufacturers, importers, and retailers of newly regulated products include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients as well as harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified-risk tobacco products (including those described as ‘light,’ ‘low,’ or ‘mild’) unless authorized by the FDA.

Manufacturers can continue selling products for up to 2 years while they submit a new tobacco product application and another year while the FDA reviews it. ■

Disclosure: Dr. Prokhorov reported no potential conflicts of interest.


1. Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products: A Rule by the Food and Drug Administration, May 10, 2016.

2. FDA takes significant steps to protect Americans from dangers of tobacco use through new regulation. FDA press release, May 5, 2016.

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