December 20, 2013

Senators Urge Swift Review of FDA Rule to Regulare the Manufacturing, Sale, and Marketing of E-Cigarettes

Proposed rule could also help combat flavored cigars and other tobacco products that target kids and young adults

[WASHINGTON, D.C.] – As tobacco products like electronic cigarettes and flavored cigars continue to grow in popularity and increase nicotine addiction and tobacco use among young people, U.S. Senators Dick Durbin (D-IL), Sherrod Brown (D-OH), Barbara Boxer (D-CA), and Ed Markey (D-MA) today called on the Office of Management and Budget (OMB) to promptly complete its review of a proposed rule from the U.S. Food and Drug Administration (FDA), which would expand the FDA’s regulatory authority over tobacco products.

 

The Senators drew particular attention to the growing popularity of electronic cigarettes – or “e-cigs” – which have more than doubled in use among high school students since the 2011-2012 school year. A report published by the Centers for Disease Control and Prevention earlier this year found that in addition to releasing candy and fruit flavored vapors that appeal to youth, many release nicotine, which could increase the likelihood that youth start using conventional cigarettes.  

 

“The FDA has made commendable efforts to enhance the regulation of cigarettes and smokeless tobacco products. However, we have seen the emergence of nicotine products for which FDA has yet to assert regulatory authority, such as electronic cigarettes and cigars with candy-like flavors, which raise concerns regarding safety and marketing to children,” the Senators wrote.

 

“Unlike traditional cigarettes, e-cigarettes are not subject to federal age verification laws. Further, e-cigarettes marketed to appeal to kids in candy and fruit flavors, like bubblegum and strawberry, are readily available to youth in shopping malls and online. These products risk addicting children to nicotine, which could be a pathway to cigarettes and other tobacco products.”

 

In April, Durbin and U.S. Senators Frank Lautenberg (D-NJ), Richard Blumenthal (D-CT), Sherrod Brown (D-OH), and Jack Reed (D-RI) called on the FDA to issue “deeming regulations” asserting regulatory authority over tobacco products, such as electronic cigarettes, and to restrict the sale, distribution and marketing of e-cigarettes and other nicotine products to children and young adults. A copy of that letter is available here.

 

Tobacco use is the number one cause of death in the United States. Every year, tobacco use kills 443,000 Americans – accounting for one in five deaths. The U.S. Surgeon General, the CDC, and the National Cancer Institute have concluded that smokeless tobacco causes cancer, heart disease, stroke, and lung diseases. Smoking costs the United States about $193 billion each year in health care expenses and lost productivity.

 

[Text of today’s letter is below]

 

December 20, 2013

 

The Honorable Sylvia Mathew Burwell

Director

Office of Management and Budget

725 17th Street NW

Washington, DC 20503

 

Dear Director Burwell:

 

We write to urge the Office of Management and Budget (OMB) to expeditiously review the proposed rule from the U.S. Food and Drug Administration (FDA), which would expand FDA’s regulatory authority over tobacco products. Although the draft proposed rule is not public, it is expected to expand FDA’s regulatory authority to all tobacco products, including cigars, pipe tobacco, electronic cigarettes, and certain dissolvable tobacco products.

 

As a result of the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has made commendable efforts to enhance the regulation of cigarettes and smokeless tobacco products. However, we have seen increased use of nicotine products for which FDA has yet to assert regulatory authority, such as electronic cigarettes and cigars with candy-like flavors, which raise concerns regarding safety and marketing to children.

 

Flavored cigars sold in flavors that appeal to kids like chocolate, cherry, and grape are increasing nicotine addiction and tobacco use among young people. Cigars contain the same toxic and cancer-causing chemicals found in cigarettes, and public health experts have warned that cigars are not a safe alternative to cigarettes. According to the National Cancer Institute, cigar smoking is linked to cancer of the lung, mouth, throat, and esophagus. The Centers for Disease Control and Prevention (CDC) estimates that over 13 million Americans smoke cigars, including 12.6 percent of high school students, making cigar smoking the second most common form of tobacco use among youth.

 

Electronic cigarettes, also called e-cigarettes, are battery-operated devices that simulate traditional tobacco cigarettes. E-cigarettes contain cartridges filled with flavors, chemicals, and the highly addictive substance nicotine, which are vaporized and inhaled by the user. According to the CDC, e-cigarette use is growing rapidly. Between 2010 and 2011, the number of U.S. adults who have tried e-cigarettes doubled. Further, a CDC study released in September 2013 found that in just one year, from 2011 to 2012, the percentage of high school students who have ever used e-cigarettes more than doubled from 4.7% to 10%.

 

In spite of the growing popularity of e-cigarettes and limited research on their long-term health effects and risk for increasing use of traditional cigarettes, information about e-cigarettes is currently not required to be submitted to the FDA for evaluation. In 2009, FDA conducted a limited analysis of a sample of e-cigarettes. The analysis found significant quality control issues such as the presence of carcinogens and toxic chemicals, variation in the dose of nicotine in each inhalation, and the presence of nicotine in products claiming to be nicotine-free. The study raises concerns regarding the safety of these products, the levels of nicotine and other potentially harmful chemicals, and the marketing of e-cigarettes to children and teens.

 

Unlike traditional cigarettes, e-cigarettes are not subject to federal age verification laws. Further, e-cigarettes marketed to appeal to kids in candy and fruit flavors, like bubblegum and strawberry, are readily available to youth in shopping malls and online. These products risk addicting children to nicotine, which could be a pathway to cigarettes and other tobacco products.

 

Tobacco use is the number one cause of death in the United States. Every year, tobacco use kills 443,000 Americans – accounting for one in five deaths. The U.S. Surgeon General, the CDC, and the National Cancer Institute have concluded that smokeless tobacco causes cancer, heart disease, stroke, and lung diseases. Today, smoking costs the country about $193 billion each year in health care expenses and lost productivity.

 

We call on the OMB to promptly complete its review of the proposed rule, a critical step toward FDA expanding regulatory authority over other tobacco products. 

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