FDA Electronic Cigarette Regulations
August 8, 2016
Today, several components of Food and Drug Administration (FDA) regulations on electronic cigarettes finally took effect, more than 2 years after the regulations were proposed. Read full statement.
Electronic Cigarettes are NOT a safe alternative!
Electronic or e-cigarettes are devices designed to mimic cigarettes. The metal tubes are designed to look like real cigarettes and contain a cartridge filled with a nicotine-laced liquid that is vaporized by a battery-powered heating element. The nicotine vapor is inhaled by smokers when they draw on the device, as they would a regular cigarette. Most e-cigarettes claim to contain nicotine, and some claim to also sell nicotine-free cartridges. They come in a variety of flavors, nicotine levels, and varieties, all claiming to be a less dangerous alternative to smoking cigarettes, and are flooding the market.
Read our 4-page document Electronic Smoking Devices (ESDs) and Smokefree Laws.
This graphic shows the progress made in keeping electronic smoking devices out of smokefree environments.
See the FDA press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm
Our partners at the Tobacco Control Legal Consortium (TCLC) have developed several resources on FDA authority to regulate other tobacco products that provide helpful background to understand the FDAs deeming proposal:
Sign up for TCLC's FDA Action Alert emails to get the latest information about what the FDA is up to and how you can engage.
While the FDA has now released deeming regulations on e-cigarette product development and warning labels, it is important to know that cities and states can, and should, adopt laws that regulate:
The ANR Foundation's U.S. State and Local Laws Regulating Use of Electronic Cigarettes list provides more information on existing laws regulating these products.
Source: Tobacco Fact Sheet: Electronic Cigarettes, Legacy, June 2013 (revised May 2014).
Science on Secondhand Vapor
The base of science on the constituents of e-cig "vapor" and the health effects of e-cig use and exposure is growing. In October 2013, California's Tobacco Related Disease Research Program (TRDRP) convened a panel of researchers to present scientific findings on electronic cigarettes. Visit the TRDRP site to review several presentations on a variety of aspects including "Electronic Cigarette Liquids And Vapors: Is It Harmless Water Vapor?" and "Electronic Cigarettes: How Will They Impact Human Health?"
UCSF Professor Stanton A. Glantz has an informative blog post on the "9 chemicals identified so far in e-cig vapor that are on the California Prop 65 list of carcinogens and reproductive toxins."
Manufacturers are not required to disclose the ingredients in e-cigarette liquid, nor the substances present in the vapor inhaled and exhaled by the user. This information is critical, not only to evaluate the health risks for the users, but also to determine the risks for the people around them. At present, health research is underway into multiple facets of e-cigarette use and safety.
Health concerns exist about the safety of the e-cigarette to nonsmokers. A
study published in February 2010 found that nicotine causes the formation of
carcinogens when it reacts with nitrous acid - a common component of indoor
air. Most e-cigarettes contain nicotine, which is exhaled by the user in a vapor
cloud. Nicotine is a sticky substance that remains on surfaces for days and
weeks, so the hazardous carcinogens continue to be created over time, which
are then inhaled, absorbed or ingested. A study
published in 2012 in the journal Indoor Air looked at the contents of
e-cigarette vapor and found that exhaling the vapor releases measurable amounts
of carcinogens and toxins into the air, including nicotine, formaldehyde, and
acetaldehyde. The authors concluded that e-cigarettes are a new source of chemical
and aerosol exposure and their potential health impact is a concern that should
be investigated further.
In July 2009, the U.S. Food and Drug Administration (FDA) released results of its analysis of certain electronic cigarettes, which was the first known analysis of these new products. The analysis found that the e-cigarette cartridges contain carcinogens, including nitrosamines, and toxic chemicals such as diethylene glycol. The FDA commissioner of food and drugs stated, "The FDA is concerned about the safety of these products and how they are marketed to the public." There is also concern that since e-cigarettes "have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user," nor is any information known about the risks of inhaling secondhand vapor. To read more from the FDA, see their press release and electronic cigarettes information page.
Americans for Nonsmokers' Rights is concerned that e-cigarettes are being marketed as something that smokers can use in workplaces and public places where the smoking of tobacco products is prohibited. Absent any proof that e-cigarettes are harmless to people exposed to the vapors they emit, their use in workplaces and public places would be a great disservice to public health. We believe that public health officials should make it clear that e-cigarettes are not an acceptable substitute for tobacco products in places that the law requires to be smokefree.
False Claims and Misleading Advertising
E-cigarettes are widely promoted as a way for people to quit smoking, but they have not been submitted to the FDA for evaluation or approval, and there is no scientific evidence that e-cigarettes are an effective cessation tool. All cessation devices must be FDA approved in order to be advertised and marketed for this purpose, and there is great risk of the public being deceived by false and potentially dangerous advertising claims.
E-cigarette manufacturers and proponents are actively promoting the products with unsubstantiated claims through paid press releases and advertorials, and via online social media such as Facebook, Twitter, and YouTube. Most egregious are direct advertisements with false and misleading claims, including that e-cigarettes are effective smoking cessation devices, that e-cigarette use is permissible in all indoor environments including venues that are smokefree by local or state law, and targeting pregnant women claiming that e-cigarettes are safer and healthier than other tobacco products.
Also troubling, e-cigarettes come in a wide variety of flavors, including chocolate and strawberry, that are likely to hook kids and other first-time users into trying the product.
E-cigarettes are currently an unregulated product, which leaves a great deal of unknowns not only about the health risks, but also about product manufacturing and safety. The FDA is investigating how it can regulate e-cigarettes to ensure that only safe and effective products are allowed on the market. The FDA aims to regulate them as tobacco products, after a U.S. Court of Appeals decided that the FDA cannot regulate e-cigarettes as a drug delivery device, which is how nicotine replacement products are regulated. The FDA believes that it is necessary to regulate these products, which have not yet been proven to be safe and which are proliferating around the country.
There are several hundred brands of e-cigarettes on the market, and test results vary greatly between brands and even among models from the same brand. Researchers have found inconsistent labeling of nicotine content on e-cigarette cartridges, such that cartridges labeled as not having nicotine did in fact contain nicotine, and vice versa, as well as other signs of poor quality control, including leaky cartridges and defective parts.
In September 2010, the FDA sent warning letters to five electronic cigarette retailers, informing the retailers that some of their practices are in violation of the Federal Food, Drug, and Cosmetic Act, such as unsubstantiated claims that e-cigarettes can help people quit smoking. Additionally, the FDA has informed the Electronic Cigarette Association, a trade group, that the FDA plans to regulate e-cigarettes and associated products.
A 2010 study shows strong public support for regulation of electronic cigarettes. According to a study conducted by the C.S. Mott Children's Hospital at the University of Michigan Department of Pediatrics and Communicable Disease, and the University of Michigan Child Health Evaluation and Research (CHEAR) Unit, 85% of adults favor prohibiting the sale of e-cigarettes to minors, 82% support FDA regulation of e-cigarettes, and 69% support prohibiting the use of e-cigarettes in indoor places and workplaces.
The current lack of available research on e-cigarettes and the potential health
risks posed by the use of these products, both to the user and to the people
around them, is of grave concern. The burden of proof rests on the manufacturers
of e-cigarettes to demonstrate that their products are safe. At this time, Americans
for Nonsmokers' Rights recommends that e-cigarettes not be used in areas where
people will be exposed to the vapors they emit.