CDC, FDA and Harry Reid on Vaping

January 29, 2016

Thank you for contacting me about the regulation of tobacco products by the Food and Drug Administration (FDA).  I appreciate hearing from you regarding this important issue.

Electronic cigarettes, also known as e-cigarettes, are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. According to the Centers for Disease Control and Prevention, e-cigarette use among middle school and high school students tripled in just one year. In 2014, almost 48 percent of adults who currently smoke have tried an e-cigarette, up from 21 percent just three years prior.

As you may know, the FDA regulates both the safety and the effectiveness of human drugs, biologics (e.g., vaccines, blood, and blood components), medical devices, and animal drugs. As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing whether e-cigarettes are safe, what chemicals are in e-cigarettes, how much nicotine or other potentially harmful chemicals are being inhaled during use, or if there are any benefits associated with using these products.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). This legislation gave the FDA the authority to reduce youth smoking, prevent the sale of tobacco to minors, help current smokers quit, and reduce the toxicity of tobacco products. This legislation also gave the FDA the legal authority necessary to regulate several tobacco products, including cigarettes, smokeless tobacco, and cigars.  In addition, the Family Smoking Prevention and Tobacco Control Act includes a provision that requires new tobacco products to be approved by the FDA before they go to market.  Under the law, a tobacco product is considered new if it is first introduced on the market after February 15, 2007.  On April 24, 2014, the FDA issued a proposed rule to extend their authority to cover additional tobacco products, including electronic cigarettes.  This proposed rule also lists the date at which a tobacco product is considered new as February 15, 2007.  You can learn more by visiting the FDA’s website at http://www.fda.gov/TobaccoProducts/Labeling/ucm388395.htm.

On December 18, 2015, President Obama signed the Consolidated Appropriations Act, 2016 (P.L. 114-113) into law.  This bill, which funds the federal government through fiscal year 2016, does not include a policy rider on electronic cigarettes.  I have noted your support for the FDA Deeming Authority Clarification Act (H.R. 2058). As you know, Representative Tom Cole (R-OK-4) introduced H.R. 2058 on April 28, 2015, to address the FDA’s authority to regulate e-cigarettes.  This legislation is currently pending in the House of Representatives and has not been introduced in the Senate.  Please be assured that I will keep your thoughts in mind should H.R. 2058 reach the full Senate for consideration.

Again, thank you for taking the time to share your thoughts with me. I look forward to hearing from you in the near future.

My best wishes to you.

Sincerely,

United States Senator

HR:kmt