Smokefree DC is a citizen-based group whose goal is to promote smokefree environments in Washington, DC.

Comments to FDA on e-cigarette rule

Below are the comments Smokefree DC has submitted to the U.S. Food and Drug Administration regarding the proposed rule to regulate e-cigarettes and other tobacco products:

Amid the debate over the regulation of e-cigarettes, one key question looms: How dangerous to nonsmokers is the aerosol that emanates from e-cigarettes?

Initial research shows that it might be quite harmful. It is therefore vital that the FDA require e-cigarette manufacturers to test the aerosol that comes out of their e-cigarettes and report the chemicals it contains.

Here’s what we know so far:

  • In 2009, the FDA released a warning about e-cigarettes, saying that a laboratory analysis had found that they contain carcinogens and toxic chemicals, including diethylene glycol, which is found in antifreeze. The agency said that it “is concerned about the safety of these products.”
  • Renowned secondhand smoke researcher Stan Glantz determined that e-cigarette aerosol contains a host of chemicals that in California are required to carry a warning because they can cause cancer or reproductive problems. The chemicals include acetaldehyde, benzene, cadmium, formaldehyde, isoprene, lead, nickel, nicotine, nitrosonornicotine and toluene.
  • A 2012 study published in the journal Indoor Air concluded that: “The consumption of e-cigarettes marks a new source for chemical and aerosol exposure in the indoor environment. To evaluate the impact of e-cigarettes on indoor air quality and to estimate the possible effect of passive vaping, information about the chemical characteristics of the released vapor is needed.”
  • Aerosol from e-cigarettes contains fine particles. “It is unclear whether the ultrafine particles delivered by e-cigarettes have health effects and toxicity similar to ambient fine particles generated by conventional cigarette smoke or secondhand smoke,” according to a scientific review of e-cigarettes published this year in the journal Circulation.

The tobacco industry touts e-cigarettes as safer than cigarettes. Given the industry’s long record of making false claims, and knowing that the little research we have indicates that nonsmokers may be exposed to dangerous chemicals and particulate matter when an e-cigarette is fired up nearby, the FDA should require full disclosure of the chemicals in the aerosol.

Specifically:

-       E-cigarette manufacturers should be required to report to the FDA a complete list of the aerosol chemicals, the concentrations in which they appear and their potential dangers;

-       E-cigarette manufacturers should be required to post the same information on their websites;

-       E-cigarette manufacturers should be required to include in or on their packages the same information about the chemicals in the aerosol and their potential dangers; and

-       The FDA should make publicly available on its website a complete listing of the chemicals found in the aerosol of each make and brand of e-cigarette, the concentrations in which they appear and their potential dangers.

The FDA should take the information into account when developing product rules. In addition, making this information widely available will be informative to the public and policymakers nationwide.

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