4/24/2015 — 

WASHINGTON, DC – With alarming reports that youth e-cigarette use has tripled over the last year, ten U.S. Senators today called on the U.S. Department of Health and Human Services (HHS) to strengthen and finalize regulations for e-cigarettes, which are essentially operating without oversight until a rule proposed by the FDA a year ago is finalized.  In a letter to HHS Secretary Sylvia Burwell, U.S. Senators Jack Reed (D-RI), Sherrod Brown (D-OH), Richard Durbin (D-IL), Edward Markey (D-MA), Richard Blumenthal (D-CT), Barbara Boxer (D-CA), Charles Schumer (D-NY), Patty Murray (D-WA), Dianne Feinstein (D-CA), and Jeff Merkley (D-OR) voiced concern that the proposed rule does not go far enough to prohibit the marketing of e-cigarettes to minors, and urged that regulations be strengthened and swiftly implemented.

Six years ago, the FDA was granted the authority to regulate all tobacco products.  And over one year has passed since the FDA announced its intention to assert its authority over all tobacco products, including e-cigarettes.  However, the proposed regulations released by the agency have yet to be finalized, and as the delay drags on e-cigarette companies are employing the same tactics that Big Tobacco used to entice and addict previous generations of young people.

The senators expressed support for the proposed rule’s provisions to prohibit e-cigarette sales to minors, vending machine sales, and free samples.  The senators also applauded the proposed requirements that manufacturers list product ingredients; tobacco products containing nicotine carry an addiction warning label; and new or changed tobacco products to be approved by the FDA before going to market.  However, the senators cautioned that the proposed rule must be improved to address the marketing of these products to children, and must also address e-cigarette flavorings that appeal to minors.

“Until this rule is finalized, e-cigarettes will continue to operate completely unregulated, with an increasing number of children taking up this addictive habit every day,” the senators wrote.  “We are disappointed that FDA did not propose stronger rules to prevent companies from marketing e-cigarette products to children.  E-cigarette companies are taking a page out of the Big Tobacco playbook, using celebrity endorsements of their products, cartoons, and advertising in magazines with youth readership and at music festivals and sports events targeted at children.  It is well known that tobacco advertising influences consumer behavior, especially that of children, and we urge you to apply the same marketing regulations to e-cigarettes that already exist for traditional cigarettes.”

According to a 2014 study in the journal Pediatrics, exposure to e-cigarette marketing by children aged 12 to 17 increased by 256 percent between 2011 and 2013, exposing 24 million children to e-cigarette advertisements.  And it appears the marketing is working.  The Centers for Disease Control’s 2014 National Youth Tobacco Survey just released last week found that e-cigarette use among high school students tripled in the last year from 4.5 percent in 2013 to 13.4 percent in 2014.

“We urge you to work swiftly to finalize the proposed rule and improve it by barring e-cigarette marketing to minors, preventing the sale of candy flavored products, and eliminating online sales.  These changes, in addition to FDA’s existing proposal, will better align e-cigarette regulation to traditional cigarettes and ensure that our children are protected from these harmful nicotine products,” the senators concluded.

The full text of the letter is as follows:

April 24, 2015

 

The Honorable Sylvia Mathews Burwell

Secretary       

U.S. Department of Health and Human Services

200 Independence Avenue, S.W.

Washington, D.C. 20201

 

Dear Secretary Burwell:

We write today on the one year anniversary of the Food and Drug Administration’s (FDA) proposed e-cigarette and other tobacco products deeming rule to urge you to strengthen and finalize this rule without further delay. 

This proposed rule is an important first step to allow FDA to exercise its authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act of 2009.  We were pleased to see that the rule proposes prohibiting e-cigarette sales to minors, as well as prohibiting vending machine sales and free samples, to further prevent sales and use by minors.  In addition, the proposed rule requires manufacturers to list product ingredients, tobacco products containing nicotine to carry an addiction warning label, and new or changed tobacco products to be approved by FDA before going to market.  While we commend FDA on proposing these important steps, we believe the proposed rule must be improved to address the marketing of these products to children and e-cigarette flavorings and be finalized as soon as possible.  

Until this rule is finalized, e-cigarettes will continue to operate completely unregulated, with an increasing number of children taking up this addictive habit every day.  In fact, the CDC’s 2014 National Youth Tobacco Survey  just released last week found that e-cigarette use among high school students tripled in the last year from 4.5 percent in 2013 to 13.4 percent in 2014, and the University of Michigan’s annual Monitoring the Future survey  shows that more teenagers reported using e-cigarettes than traditional tobacco products in 2014.  This demonstrates the need for FDA to regulate these products to ensure that the positive strides we have made in reducing smoking rates are not reversed.   

First, we are disappointed that FDA did not propose stronger rules to prevent companies from marketing e-cigarette products to children.  E-cigarette companies are taking a page out of the Big Tobacco playbook, using celebrity endorsements of their products, cartoons, and advertising in magazines with youth readership and at music festivals and sports events targeted at children.  According to a 2014 study in the journal Pediatrics , exposure to e-cigarette marketing by children aged 12 to17 increased by 256 percent between 2011 and 2013, exposing 24 million children to e-cigarette advertisements.  In this context, it is unsurprising that youth use of e-cigarettes has skyrocketed during the same timeframe.  It is well known that tobacco advertising influences consumer behavior, especially that of children, and we urge you to apply the same marketing regulations to e-cigarettes that already exist for traditional cigarettes. 

Second, we are concerned that the proposed rule does not address the use of flavorings, like candy, soft drink, and fruit flavors, in e-cigarettes.  FDA itself acknowledged in the proposed rule that children are the most likely to use flavored tobacco products.  The Family Smoking Prevention and Tobacco Control Act prohibits these kinds of flavorings from being used in traditional cigarettes and we believe the same scrutiny should be applied to e-cigarettes and refill liquids so that children are not attracted to these products.  Therefore, we urge you to similarly ban candy, soft drink, and fruit-flavored e-cigarettes and refill liquids that appeal to children.

Additionally, we believe FDA must explicitly ban online sales of e-cigarettes due to the ease with which minors are able to purchase these products, undermining any bans on purchases by minors.  In fact, a study published this year by the University of North Carolina Lineberger Comprehensive Cancer Center  found that only 5 out of 98 attempts by teens to purchase e-cigarettes online were blocked by age verification requirements.  We urge you to ban online sales outright to better ensure that children do not have easy access to these products.

Lastly, we are encouraged that FDA’s proposed rule requires pre-market approval for products that were not on the market as of February 15, 2007, as set forth in the Family Smoking Prevention and Tobacco Control Act of 2009.  As a result, nearly every e-cigarette product on the market will be subject to review by FDA, as intended by the law.  We understand that e-cigarette manufacturers are lobbying to change the grandfather date for products subject to FDA regulations, so as to exempt more of their products.  We support FDA’s position that this grandfather date is unchangeable and urge you to finalize the rule with this policy to better protect more consumers, including children. 

Last year, FDA took an important initial step by proposing to regulate e-cigarettes, but more must be done to strengthen this rule and ensure that the same practices used by Big Tobacco for years to promote smoking are not used by e-cigarette companies to create a new generation of smokers.  We urge you to work swiftly to finalize the proposed rule and improve it by barring e-cigarette marketing to minors, preventing the sale of candy flavored products, and eliminating online sales.  These changes, in addition to FDA’s existing proposal, will better align e-cigarette regulation to traditional cigarettes and ensure that our children are protected from these harmful nicotine products.  We look forward to continuing to work closely with FDA and HHS on this and other issues essential to protecting the public health. 

Sincerely,

 

Jack Reed                                                                   

U.S. Senator

 

Sherrod Brown           

U.S. Senator                                    

 

Richard J. Durbin                                         

U.S. Senator

 

Edward J. Markey

U.S. Senator                                    

 

Richard Blumenthal                                       

U.S. Senator

 

Barbara Boxer

U.S. Senator                                    

 

Charles E. Schumer                                                    

U.S. Senator

                      

Patty Murray

U.S. Senator

 

Dianne Feinstein

U.S. Senator

 

Jeff Merkley

U.S. Senator

 -end-