US Senate Committee on Health, Education, Labor, & Pensions

Harkin, Senate Democrats Call On FTC and FDA To Protect Consumers From False Advertising Claims By E-Cigarette Makers

Citing New Health Studies, Senators Urge the Agencies to Crack Down on Unsubstantiated or False Claims by Manufacturers that E-cigarettes Help People Quit Smoking

Monday, April 07, 2014

WASHINGTON, D.C.— U.S. Senators Tom Harkin (D-IA), Barbara Boxer (D-CA), Richard Blumenthal (D-CT), Dick Durbin (D-IL), Edward J. Markey (D-MA), and Sherrod Brown (D-OH) wrote to the heads of the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) today, urging the agencies to take enforcement action against e-cigarette manufacturers who make unsubstantiated or false claims in their advertising, including unproven assertions that their products help smokers of conventional cigarettes quit.

In today’s letters, the senators highlighted recent studies demonstrating that claims by e-cigarette manufacturers that their products help people quit smoking are not substantiated by current science. “We urge you to review this evidence and begin to take actions against companies that are making unsubstantiated and potentially false therapeutic claims about products that have not been approved by FDA as safe and effective,” the senators wrote.

In their letter to FTC Chairwoman Edith Ramirez, the senators called on the agency to use its existing authority to investigate manufacturers who are making these false or unsubstantiated claims in their advertising. “The FTC has not stepped in to protect consumers from the health risks posed by nicotine and other chemicals contained in electronic cigarettes,” the Senators wrote. “We believe that you can and should act immediately to crack down on these false and deceptive claims by e-cigarette manufacturers.”

Today’s letters to the FTC and FDA follow up on a letter the Senators sent to FTC Chairwoman Edith Ramirez in December, urging the FTC to investigate the marketing practices of e-cigarette manufacturers and to pursue enforcement action against companies that make false or misleading health claims in their advertising.

The senators have repeatedly called upon the Office of Management and Budget to expeditiously complete its review of a proposed rule from the FDA which would expand the FDA’s regulatory authority over tobacco products. Last month, in response to reports of a dramatic increase in accidental nicotine poisonings among children, Senator Harkin joined six senators in once again calling on the Food and Drug Administration to move quickly to regulate the rapidly evolving market of e-cigarettes and other nicotine products.

“We recognize that the FDA has been working to regulate these products, and that a proposed ‘deeming’ regulation that could clarify that FDA has authority to regulate electronic cigarettes as tobacco products has been pending at the Office of Management and Budget for more than six months,” the senators noted today. “However, the FDA’s Center for Drug Evaluation and Research does not need this regulation or any new authority in order to investigate companies making unsubstantiated and potentially false therapeutic claims.”

In February, Senator Harkin joined Senators Boxer, Durbin, Blumenthal, Markey and Brown to introduce the Protecting Children from Electronic Cigarette Advertising Act to prohibit the marketing of e-cigarettes to children and teens. The bill has been endorsed by the American Public Health Association, the American Academy of Pediatrics, the American Heart Association, the American Lung Association, the American Cancer Society Cancer Action Network and Campaign for Tobacco-Free Kids.

The full text of the letters follow:

April 7, 2014

The Honorable Edith Ramirez

Chairwoman

Federal Trade Commission

600 Pennsylvania Avenue, NW

Washington, DC 20580

Dear Chairwoman Ramirez:

As we wrote to you on December 18, 2013, electronic cigarette or “e-cigarette” companies have often made unsubstantiated health and therapeutic claims. For example, NEwhere electronic cigarettes advertised on its website using a graphic with the text "Quit Smoking with Electronic Cigarettes." Unsubstantiated claims that e-cigarettes help people to quit smoking are false and deceptive advertising and the Federal Trade Commission (FTC) currently has the authority to investigate and take punitive actions against these companies.

You responded on January 24, 2014 that the Food and Drug Administration (FDA) announced in 2011 its intention to propose regulations pursuant to the Family Smoking Prevention and Tobacco Control Act and that “FTC and FDA staff have long worked together… and I would fully expect that tradition to continue here.” The regulations announced by FDA have been pending at the Office of Management and Budget (OMB) for more than six months. Even when released by OMB, they will still be in proposed form and will ultimately need to be finalized in order to have any real impact. In the meantime, the electronic cigarette industry remains unregulated and Americans’ health remains at risk.

Your mission “to prevent business practices that are anticompetitive or deceptive or unfair to consumers” is clear and does not depend on additional FDA action. The FTC has not stepped in to protect consumers from the health risks posed by nicotine and other chemicals contained in electronic cigarettes. We believe that you can and should act immediately to crack down on these false and deceptive claims by e-cigarette manufacturers.

We want to make sure you have seen recent studies demonstrating that electronic cigarette use is not associated with helping people quit smoking, as many e-cigarette companies claim. Enclosed is an article outlining a recent small sample study published in JAMA Internal Medicine out of the University of California, San Francisco which concluded that e-cigarette use is not correlated with smoking cessation. This adds to growing evidence that e-cigarettes may not be effective cessation devices, including a longitudinal, international study published in the American Journal of Preventive Medicine which found that although 85% of smokers who used e–cigarettes reported using them to quit, e-cigarette users did not quit more frequently than others. Yet another study published in Nicotine and Tobacco Research examined quitline callers in the United States found that e-cigarette users were less likely to have quit at 7 months than nonusers.

We urge you to review this evidence and begin to take actions against companies that are making unsubstantiated and potentially false therapeutic claims about products that have not been approved by FDA as safe and effective. Not only has the research noted above failed to find an association between e-cigarette use and smoking cessation, but these products can also be hazardous through means other than intentional use. Last week, the Centers for Disease Control and Prevention (CDC) released new data that shows calls to poison centers involving e-cigarettes rose from 1 per month in September 2010 to 215 per month in February 2014. The CDC also found that roughly 50 percent of all poison calls regarding e-cigarette exposures were about a child under the age of 6. Without proper oversight of e-cigarette companies and their marketing practices, the progress we have made in this country over the past few decades to reduce nicotine addiction could stall if not reverse. Please respond with the current activities that the FTC is undertaking to ensure that consumers are getting evidence-based information.

Sincerely,

Barbara Boxer
United States Senator

Richard Blumenthal
United States Senator

Richard J. Durbin
United States Senator

Tom Harkin
United States Senator

Edward J. Markey
United States Senator

Sherrod Brown

United States Senator

 

April 7, 2014

The Honorable Margaret Hamburg

Commissioner

U.S.  Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Hamburg:

We write urging the Food and Drug Administration (FDA) to investigate e-cigarette companies that are making unsubstantiated and potentially false therapeutic claims about products that have not been approved by your agency.  Manufacturers of electronic cigarettes (“e-cigarettes”), battery-operated devices designed to deliver nicotine, flavor, and other chemicals, have often made unsubstantiated health and therapeutic claims. For example, NEwhere electronic cigarettes advertised on its website using a graphic with the text “Quit Smoking with Electronic Cigarettes.”

At the same time, growing evidence suggests that electronic cigarette use is not associated with many of the companies’ therapeutic claims that these products can help people quit smoking. We urge the FDA to review the evidence related to these therapeutic claims. Enclosed is an article outlining a recent small sample study published in JAMA Internal Medicine out of the University of California, San Francisco which concluded that e-cigarette use is not correlated with smoking cessation. This adds to evidence that e-cigarettes may not be effective cessation devices, including a longitudinal, international study published in the American Journal of Preventive Medicine which found that although 85% of smokers who used e–cigarettes reported using them to quit, e-cigarette users did not quit more frequently than others. Yet another study published in Nicotine and Tobacco Research examined quitline callers in the United States found that e-cigarette users were less likely to have quit at 7 months than nonusers.

We recognize that the FDA has been working to regulate these products, and that a proposed “deeming” regulation that could clarify that FDA has authority to regulate electronic cigarettes as tobacco products has been pending at the Office of Management and Budget for more than six months. However, the FDA’s Center for Drug Evaluation and Research does not need this regulation or any new authority in order to investigate companies making unsubstantiated and potentially false therapeutic claims.

Not only has the research noted above failed to find an association between e-cigarette use and smoking cessation, but these products can also be hazardous through means other than intentional use. Last week, the Centers for Disease Control and Prevention (CDC) released new data that shows calls to poison centers involving e-cigarettes rose from 1 per month in September 2010 to 215 per month in February 2014. The CDC also found that roughly 50 percent of all poison calls regarding e-cigarette exposures were about a child under the age of 6. Without proper oversight of e-cigarette companies and their marketing practices, the progress we have made in this country over the past few decades to reduce nicotine addiction could stall if not reverse. Please respond with the current activities that the FDA is undertaking to ensure that consumers are getting evidence-based information.

Sincerely,

Barbara Boxer
United States Senator

Richard Blumenthal
United States Senator

Richard J. Durbin
United States Senator

Tom Harkin
United States Senator

Edward J. Markey
United States Senator

Sherrod Brown 
United States Senator

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