Senators Again Urge FDA to Provide Stronger Warnings on E-Cigarettes

U.S. Senators Barbara Boxer (D-Cal.), Dick Durbin (D-Ill.), Richard Blumenthal (D-Conn.), Jack Reed (D-R.I.), Sherrod Brown (D-Ohio), and Edward Markey (D-Mass.) have again written the FDA Commissioner Margaret Hamburg asking the agency to (1) move quickly to finalize its proposed deeming regulations that would expand the FDA’s regulatory authority over e-cigarettes (see E-cigarette regulations would ban sales to minors, require health warnings, April 25, 2014), and (2) further strengthen the health warnings on e-cigarettes. On August 6, 2014, they previously asked the FDA to move quickly to finalize its proposed rule on e-cigarettes, and to include provisions that would limit youth access to the addictive products (see Congressional plea to FDA: regulate e-cigarette sales to minors now, August 6, 2014).

The FDA’s proposed label warning for e-cigarettes currently reads “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” With regard to this proposed warning, the Senators’ state “We support requiring a label on nicotine’s addictive properties, but we ask the FDA pursue requirements for more extensive warnings that address health risks that e-cigarettes pose.”

New York Times Article

In their letter, the Senators cite a recent New York Times article which indicates that in the absence of FDA standards, e-cigarette manufacturers are concocting their own health warnings that lack conformity and do not comprehensively list all of the health threats of e-cigarettes. According to the New York Times article, tobacco companies are attempting to position themselves as “protectors of consumer well-being” by providing very strong health warnings on their e-cigarettes, going much further than the warnings they provide on traditional cigarettes.

For example, the Times article quotes a warning provided by the manufacturer of Camel cigarettes, Reynolds American, which warns that their e-cigarette product is not intended for persons “who have an unstable heart condition, high blood pressure, or diabetes; or persons who are at risk for heart disease or are taking medicine for depression or asthma.”

Apparently another manufacturer has gone even farther. According to the article, the warning label on MarkTen e-cigarettes goes on for over 100 words and warns that children, people with heart disease, high blood pressure or diabetes should not use the product. It also warns that nicotine can cause dizziness, nausea, stomach pains, and may worsen asthma.

World Health Organization (WHO)

The Times article also cites a WHO report that concludes because “e-cigarettes and similar devices are frequently marketed by manufacturers as aids to quit smoking, or as healthier alternatives to tobacco, [they] require global regulation in the interest of public health.” According to the WHO report, e-cigarette regulations are needed to: (1) impede e-cigarette promotion to non-smokers and young people; (2) minimize potential health risks to e-cigarette users and nonusers; (3) prohibit unproven health claims about e-cigarettes; and (4) protect existing tobacco control efforts from commercial and other vested interests of the tobacco industry.

While the WHO calls for additional research on multiple areas of e-cigarette use, it believes that regulations are required now for advertising and indoor use. The report calls for an appropriate government body to restrict e-cigarette advertising, promotion and sponsorship, to ensure that it does not target youth and non-smokers or people who do not currently use nicotine. In addition, the report recommends that legal steps be taken to end the use of e-cigarettes indoors in public and work places. The report cites evidence suggesting that exhaled e-cigarette aerosol increases the background air level of some toxicants, nicotine and particles.

Response Requested

In their letter to Commissioner Hamburg, the Senators’ request that she respond with details about the actions the FDA is taking to require e-cigarette manufacturers to truly disclose the risks their products pose to consumers.