Brown and Seven Other Senators Press FDA to Take Action on E-Cigarettes

WASHINGTON – U.S. Senator Sherrod Brown (D-OH) joined seven of his colleagues in calling on the Food and Drug Administration to set clear product and manufacturing standards to combat the health risks of toxic substances in e-cigarettes. 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. The letter was also signed by Tom Udall (D-N.M.), Richard Blumenthal (D-Conn.), Barbara Boxer (D-Calif.), Dick Durbin (D-Ill.), Amy Klobuchar (D-Minn.), Jack Reed (D-R.I.), and Brian Schatz (D-Hawaii).

“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. 

According the Centers for Disease Control and Prevention (CDC), e-cigarette use among high school students increased from 4.5 percent in 2013 to 13.4 percent in 2014,, and from 1.1 percent in 2013 to 3.9 percent in 2014 among middle school students.

Brown has criticized the Obama Administration for its failure to finalize tobacco deeming regulations that would give the agency the same regulatory authority it has over cigarettes to other unregulated tobacco products, such as e-cigarettes and hookah. In the year that the FDA has failed to finalize regulations, e-cigarette use among both high school and middle school students has tripled. The FDA’s proposed rule was released more than one year ago – on April 25, 2014 – but has not yet been finalized. In March, Brown sent a letter to Secretary Burwell urging her to finalize these rules. Brown has also introduced legislation to close loopholes in the tax code that allow the tobacco industry to avoid paying taxes on their products. The Tobacco Tax Equity Act would simplify and equalize taxes on all tobacco products, including existing products that currently fall into loopholes as well as new products like e-cigarettes.

The full text of the most recent letter is available  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.

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