Petition Calls on FDA Commissioner to Finalize a Rule to Help Protect Public HealthFriday, March 13th 2015 - Washington, D.C. - U.S. Senator Barbara Boxer (D-CA) today sent a letter to Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg along with a petition signed by more than 5,000 Californians urging the agency to finalize a rule to regulate e-cigarettes and protect public health.
"On behalf of the thousands of constituents who have signed their names to this petition, I urge the FDA to finalize this regulation immediately," Senator Boxer wrote.
In the letter, Senator Boxer highlighted some of the comments from Californians who signed the petition - including Susan from Long Beach, who wrote, "I am a 7th grade health teacher and it is clear that students think 'vaping' is okay and a healthy alternative to smoking. Shops selling e-cigarettes have popped up in all the stores around their neighborhoods advertising their products. A clear message needs to be sent that e-cigarettes are not for children under the age of 18."
The rule would bring e-cigarettes under the purview of the FDA and would also ban sales to children under 18, require disclosure of product ingredients, and prohibit manufacturers from claiming their products are less harmful than traditional cigarettes without scientific evidence supporting their claims.
Currently, e-cigarettes are not subject to federal laws and regulations that apply to traditional cigarettes, including a ban on marketing to youth. Senator Boxer is a leader in the fight to protect children from e-cigarettes and the author of the Protecting Children from Electronic Cigarette Advertising Act, legislation to prohibit the marketing of e-cigarettes to children and teens.
According to the journal Pediatrics, the number of children aged 12 to 17 years exposed to e-cigarette marketing increased by 256% between 2011 and 2013. This increased exposure has coincided with a dramatic rise in the use of e-cigarettes by youth and an increased risk of addiction to tobacco products, with the Centers for Disease Control and Prevention reporting that e-cigarette use among high school students tripled during the same period. In 2014, for the first time, the government-sponsored Monitoring the Future national survey found that significantly more teens reported recent use of e-cigarettes than traditional cigarettes.
In the letter, the Senator also highlighted a new study released this week that revealed that secondhand exposure to the e-cigarette aerosol may expose bystanders to potentially dangerous ultrafine particles containing nicotine, glycerin, glycols, artificial flavorings and preservatives.
The full text of Senator Boxer's letter to the FDA is below:
The Honorable Margaret Hamburg
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Hamburg:
I write to thank you for your 6 years of public service at the Food and Drug Administration (FDA). Before you leave at the end of this month, on behalf of the 5,113 of my constituents who signed the attached petition, I urge the FDA to finalize the proposed deeming regulations that would give the Agency regulatory authority over e-cigarettes.
Yesterday, a new research brief from RTI International looked at secondhand exposures to e-cigarettes and found that "a non-user may be exposed to aerosol particles smaller than 1000 nanometers, similar in size to tobacco smoke and diesel engine smoke." In addition, the researchers found that the aerosol produced by the products can contain nicotine, glycerin, glycols, artificial flavorings, and preservatives.
These potential dangers are why the FDA needs to finalize this deeming rule immediately. As you know, the rule would require disclosure of ingredients, but it would also ban sales to children under 18 and prohibit manufacturers from claiming their products are less harmful than traditional cigarettes without scientific support.
Many of my constituents who signed the petition I am forwarding today share these concerns about the potential dangers of e-cigarettes.
Bob from Cathedral City wrote, "We need to know what health and/or safety dangers are associated with e-cigarettes."
Susan from Long Beach wrote, "I am a 7th grade health teacher and it is clear that students think "vaping" is okay and a healthy alternative to smoking. Shops selling e-cigarettes have popped up in all the stores around their neighborhoods advertising their products. A clear message needs to be sent that e-cigarettes are not for children under the age of 18."
Judith from Fairfield wrote, "I teach high school, and too many students are using e-cigarettes, thinking they are safer than regular cigarettes. In the meantime, they are getting addicted to nicotine, and putting them at risk for a lifetime of impacts to their health."
On behalf of the thousands of constituents who have signed their names to this petition, I urge the FDA to finalize this regulation immediately. I thank you for commitment to public health.
United States Senator
CC: Mitch Zeller, Director, Center for Tobacco Products