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FDA proposes e-cigarette regulations that appear to take middle ground

May 1, 2014
by Shannon Brys, Associate Editor
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After last week’s announcement from the Food and Drug Administration (FDA) of proposed new rules to regulate electronic cigarettes, cigars, and other tobacco products that had not yet been under its authority, various organizations and individuals have come forward with reactions reflecting both support and opposition.

American Medical Association (APA) President Ardis Dee Hoven, MD, issued a statement to show support for the FDA’s proposed rules. She pointed out that the AMA has always supported anti-tobacco efforts to improve public health and has been advocating regulations of this nature in order to deter the sale of tobacco to minors.

“The AMA also strongly encourages further study of the factors that contribute to the widespread use of these tobacco products and appeal among minors and others, so we can continue to drive down use of these products to prevent the negative health effects of nicotine,” Hoven said. “Improving the health of the nation is a top priority for the AMA and we will continue to advocate for policies that help reduce the burden of preventable diseases like cardiovascular disease and type 2 diabetes, which can both be linked to smoking.”

The FDA’s proposal took some of the key provisions of the 2009 Family Smoking Prevention and Tobacco Control Act and applied them to e-cigarettes and other newly regulated tobacco products, and also added some modified regulations. For example, the provisions would include:

  • Vending machine sales to be restricted to adult-only locations.
  • A requirement for a minimum age of purchase: no one under the age of 18 can purchase these products and retailers would be required to verify age for all over-the-counter sales. This would also provide for federal enforcement and penalties against any retailers who allow minors to purchase the products.
  • The prohibition of free samples.
  • A requirement for health and addiction warnings for product packages and advertisements.
  • Pre-market review requirements; this would prohibit the introduction of new or modified products without prior FDA review and scientific evidence demonstrating that allowing a product is “appropriate for the protection of public health” or found to be substantially equivalent to a product that already exists.
  • An authorization for the FDA to set standards that govern the content of tobacco products.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, believes these proposed regulations are good news, but recognizes that the FDA still has challenges to come. The main challenge, once the rule is finalized, would be for the FDA to effectively enforce the provisions, he says.

One thing that is missing from the proposed rule is a ban for flavoring in cigars and e-cigarettes that may appeal to young people, Myers explained. “The FDA must now move quickly to develop additional regulations addressing these important issues. These additional regulations should restrict marketing that appeals to kids, prohibit flavors that are attractive to kids and also require packaging for e-cigarettes that addresses the recent surge in nicotine poisoning cases related to e-cigarettes,” he said.

Although e-cigarette producers and distributors claim that they don’t market to adolescents, Myers said they are using the same themes that tobacco companies used in the marketing of regular cigarettes to young people. He also cited some statistics about youth and e-cigarette use:

  • The Centers for Disease Control and Prevention (CDC) found tyouth e-cigarette use more than doubled from 2011 to 2012.
  • The percentage of high school students who reported ever using e-cigarettes increased from 4.7% to 10% in that same time frame.
  • The CDC estimated that 1.78 million youth in the United States had tried e-cigarettes as of 2012.

A ban on advertising and Internet sales were two other areas left untouched by the recently proposed regulations. To makers of the e-cigarettes, this news has come as a relief, as they believe this will allow more investment and even more varieties.

Stanton Glantz, head of the Center for Tobacco Control Research and Education at the University of California, San Francisco, told The Wall Street Journal that these latest moves were a “big win for Big Tobacco” and believes that e-cigarettes should be regulated just as regular cigarettes are.

During a conference call with reporters, Mitch Zeller, director of the FDA’s Center for Tobacco Products, responded to critics of the regulations by explaining that the approach is based on “walk before you run.” Research will continue on the impacts of e-cigarettes, and if necessary, the FDA will move at a later point to toughen the restrictions.

The regulations are open for public comment for 75 days. At that point, the FDA then has the opportunity to make final changes; it could end up taking a year or longer for the rules to take effect. If e-cigarette companies and affected industries choose to lobby against and/or sue to block the regulations, there could be much more of a delay.