August 13, 2015

Udall Leads Coalition Pressing FDA to Tackle Toxics in E-Cigarettes

As e-cigarette popularity soars, clear standards are needed to protect public health

WASHINGTON - U.S. Senators Tom Udall (D-N.M.), Richard Blumenthal (D-Conn.), Barbara Boxer (D-Calif.), Sherrod Brown (D-Ohio), Dick Durbin (D-Ill.), Amy Klobuchar (D-Minn.), Jack Reed (D-R.I.) and Brian Schatz (D-Hawaii) called for clear product standards and good manufacturing processes to combat the health risks of toxic substances in e-cigarettes as the U.S. Food and Drug Administration finalizes its first regulations of the aerosol-producing products. The number of e-cigarette users — especially among young people — has soared in recent years, but little is known about the long-term health risks for users and the risks of breathing in second-hand aerosol.

"Because e-cigarettes are not yet regulated by FDA, e-cigarette manufacturers have been able to introduce these products to the market without having to test them for potentially harmful substances, adhere to good manufacturing processes or meet other standards to minimize risk," the senators wrote in a letter to Acting FDA Commissioner Stephen Ostroff.

More than 466 different brands of e-cigarettes in thousands of flavors have entered the market without any testing. Carcinogens and other toxins have been found in the aerosol produced by e-cigarettes, and poor manufacturing can cause problems like battery leaks and explosions.

"Studies have shown that the level of toxic substances can vary significantly among different e-cigarette products as a result of the content of the e-liquid and the design features of the e-cigarette. For example, the type of solvent used and the voltage of the battery appear to affect the levels of formaldehyde and acetaldehyde that are generated," the letter continues.

"Clearly, research and oversight are lacking for e-cigarettes, including a better understanding of the long-term health risks of using them and the risks to non-users of breathing in second-hand aerosol emitted from them."

The vast majority of e-cigarettes sold in the United States are produced in China, and a New York Times investigation exposed low safety standards among some Chinese manufacturers.

The full text of the letter is available HERE and below:

Dr. Stephen Ostroff
Acting Commissioner
U.S. Food and Drug Administration
10901 New Hampshire Avenue
Silver Spring, MD 20993

Dear Acting Commissioner Ostroff:

As you work to complete a final rule asserting FDA's jurisdiction over e-cigarettes, we urge you to include product standards and appropriate manufacturing processes to eliminate or sharply reduce toxic substances that have been found in e-cigarettes.

In recent years, the number of people using e-cigarettes has soared, including among young people. The Centers for Disease Control and Prevention recently released their annual survey of youth tobacco use, which estimates that e-cigarette use by high school and middle school students tripled from 2013 to 2014. This growth has occurred in an unregulated marketplace. Manufacturers have introduced a wide variety of e-cigarettes. As of January 2014, an estimated 466 different brands of e-cigarettes were on the market, available in more than 7,000 unique flavors. Because e-cigarettes are not yet regulated by FDA, e-cigarette manufacturers have been able to introduce these products to the market without having to test them for potentially harmful substances, adhere to good manufacturing processes or meet other standards to minimize risk.

Through published studies and presentations at the 2014 FDA workshop on e-cigarettes, we know that carcinogens and other toxins, including formaldehyde, acetaldehyde, acrolein, volatile organic compounds, tobacco-specific nitrosamines, and metals like nickel and lead have been found in the aerosol generated by e-cigarettes. Studies have shown that the level of toxic substances can vary significantly among different e-cigarette products as a result of the content of the e-liquid and the design features of the e-cigarette. For example, the type of solvent used and the voltage of the battery appear to affect the levels of formaldehyde and acetaldehyde that are generated.

Poor manufacturing can also create potential health risks. The majority of e-cigarettes sold in the United States are imported, primarily from China. A New York Times investigation found little oversight and quality control standards among some Chinese e-cigarette manufacturers. Metals and other compounds used to construct e-cigarettes can leach into the e-liquid and into the aerosol that is inhaled, and batteries can leak, overheat or explode. Clearly, research and oversight are lacking for e-cigarettes, including a better understanding of the long-term health risks of using them and the risks to non-users of breathing in second-hand aerosol emitted from them.

Millions of Americans have used e-cigarettes, and the e-cigarette market continues to grow. We urge you to include product standards and good manufacturing processes to help minimize the health risks of toxins in e-cigarettes in the final rule that will assert FDA's jurisdiction over e-cigarettes. Thank you in advance for your timely response and attention to this important matter.