The long-awaited proposed regulation of e-cigarettes by the U.S. Food and Drug Administration (FDA) is out. It’s a mixed bag.
On the plus side, the agency proposes requiring e-cigarette manufacturers to register with the government and provide information about what’s in their products. They wouldn’t be able to sell e-cigarettes to anyone under 18 or dole out free samples. And e-cigarette makers would no longer be able to make claims about their products being less harmful without providing scientific evidence to the FDA.
But the rule is lacking in a number of significant respects. It doesn’t ban the candy flavorings that are in e-cigarette liquid, which are widely considered designed to lure children and teens into nicotine addiction. The rule also does nothing to address marketing of e-cigarettes. And it would give manufacturers of certain tobacco products two years from the issuance of the final rule – which is still at least a year away – to comply. That’s at least three years right there. That is way too long.
What’s more, the agency is considering exempting from regulation “premium” cigars – pricey cigars that are hand-rolled in tobacco leaves. That strikes those of us in the tobacco control world as crazy.
Regarding e-cigarettes, the FDA says:
We do not currently have sufficient data about e-cigarettes and similar products to determine what effects they have on the public health. … There is no evidence to date that e-cigarettes are effective cessation devices.
Regarding what we at Smokefree DC are particularly focused on — the health effects of the aerosol that emanates from e-cigarettes — the agency also says that there is evidence that the chemicals are harmful, but it needs more information:
Some studies have revealed the existence of toxicants in both the e-cigarette liquid and the exhaled aerosol of some e-cigarettes. For example, FDA previously noted the presence in a certain e-cigarette cartridge of contaminants such as diethylene glycol (DEG)—a chemical that has caused poisonings in other consumer products such as acetaminophen and cough syrup and which FDA has stated “is toxic to humans” (Ref. 100, Ref. 101 citing Refs. 102, 103, and 104). While the presence of DEG in any product is of great concern, we note that it was found in only 1 of 18 cartridges studied and it was not found at all in another 16 studies (Ref. 41).
Further, one study found that toxic chemicals such as formaldehyde and acetaldehyde were detected in the cartridges as well as the aerosol from certain e-cigarette nicotine solutions (Ref. 47). Acrolein, which can cause irritation to the nasal cavity and damage to the lining of the lungs and may contribute to cardiovascular disease in cigarette smokers, was also found in the aerosol (id.). While the level of carcinogenic formaldehyde from the e-cigarette aerosol was somewhat comparable to the amount received from cigarette smoking, the overall levels of the toxicants tested in this study were 9 to 450 times lower than those in cigarette smoke (id.). In another study, a total of 22 chemical elements, some of which can cause adverse health effects in the respiratory and nervous systems, were identified in e-cigarette aerosol (Ref. 105). Among those elements were lead, nickel, and chromium, which are included on the Agency’s harmful and potentially harmful constituents list (id., citing 77 FR 20034, April 3, 2012). Research published in 2013 reported that under near real-use conditions, e-cigarettes increased indoor air levels of polycyclic aromatic hydrocarbons, 1,2-propanediol, 1,2,3-propanetriol, glycerine, nicotine, fine particles, ultrafine particles, particle number concentrations, and aluminum. (Refs. 106 and 107).
The fact that something harmful might be coming out of e-cigarettes means that they should be included in smokefree laws as a precaution. Many cities have done this, but the D.C. Council has been waiting to see what the FDA will do. The Council shouldn’t wait any longer. The final FDA rule is at least a year away. The regulatory process is a lengthy one, and this is just the beginning.
The deadline to submit comments to the FDA is May 27. Information about how to submit comments is here.
Smokefree DC will continue to analyze the rule. Stay tuned for more.