April 16, 2013

Senators Call on FDA to Restrict the Sale, Distribution, and Marketing of E-Cigarettes

New nicotine delivery devices on the market are unregulated and available for purchase by children and young adults

[WASHINGTON, D.C.] - Calling e-cigarettes a possible pathway to traditional cigarettes and other tobacco products, five U.S. Senators today called on the Food and Drug Administration (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.  Though the number of U.S. adults who have tried e-cigarettes has doubled since 2010 and limited research has raised consumer safety concerns, the nicotine delivery devices are currently not required to be evaluated or approved by the FDA.

 

Today’s letter was signed by the following: U.S. Senators Dick Durbin (D-IL), U.S. Senator Frank Lautenberg (D-NJ), U.S. Senator Richard Blumenthal (D-CT), U.S. Senator Sherrod Brown (D-OH) and U.S. Senator Jack Reed (D-RI). 

 

“Unlike traditional tobacco products, e-cigarettes can be legally sold to children and are not subject to age verification laws,” the Senators wrote.  “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.  Smoking costs the United States about $193 billion each year in health care expenses and lost productivity.

 

Text of today’s letter is below.

 

April 16, 2013

 

The Honorable Margaret Hamburg

Commissioner

U.S.  Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

 

Dear Commissioner Hamburg:

 

We write to urge the Food and Drug Administration (FDA) to issue “deeming regulations” asserting the agency’s regulatory authority over tobacco products, such as cigars, pipe tobacco, electronic cigarettes, and 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 the emergence of novel nicotine products for which FDA has yet to assert regulatory authority, such as electronic cigarettes, which raise concerns regarding safety and marketing to children.

 

As you know, 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 Centers for Disease Control and Prevention (CDC), e-cigarette use is growing rapidly.  Since 2010, the number of U.S. adults who have tried e-cigarettes has doubled.  In 2011, approximately 21 percent of adults who smoked traditional cigarettes had used electronic cigarettes – a 10 percent increase from 2010.

 

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, e-cigarettes are currently not required to be submitted to the FDA for evaluation or approval.  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 tobacco products, e-cigarettes can be legally sold to children and are not subject to age verification laws.  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 FDA to issue deeming regulations asserting the agency’s regulatory authority over e-cigarettes and other tobacco products.  Once FDA regulates these products, we urge the Agency to aggressively enforce the authority given by Congress under the Family Smoking and Tobacco Control Act, including restricting the sale, distribution, and marketing of e-cigarettes and other nicotine products to children and adolescents.
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