Electronic Cigarette Association

Response To The FDA

Video Response From ECA President, Matt Salmon:

Below is the FDA press release and the rebuttal by the Electronic Cigarette Association. We also encourage those interested to read Disingenuousness of the FDA’s Press Conference is Concerning; FDA and Anti-Smoking Groups are Committing Medical Malpractice on a Massive Scale by Michael Siegel, MD, MPH, Boston University School of Public Health.

FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

Because these products 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.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

The Electronic Cigarette Association Refutes FDA Statement

The Electronic Cigarette Association (ECA) said that the FDA’s laboratory analysis of electronic cigarettes released today is too narrow to reach any valid and reliable conclusions and ignores the continued efforts by its member companies to ensure that their products include health warnings and to only market its products as an alternative to long-time, adult smokers.

“I’m a little shocked that the FDA would release a study that is so narrow in its scope and target a specific industry when there are a number of nicotine products on the market today not in the FDA’s crosshairs. Are they saying that those products and cigarettes themselves are safer to use,” said Matt Salmon, former Arizona Congressman and president of the ECA. “Our member companies have taken a responsible approach by ensuring that those who use their
products are well-informed about their products and to ensure that their products are not marketed or accessible to children.”

The Electronic Cigarette Association (ECA) was created to help the industry and its participants establish and follow codes of conduct and best practices for the good of consumers, society and the industry. These practices outlined include:

• Agreeing to not make any cessation claims in all marketing materials.
• Agreeing to not make any health claims in all marketing materials.
• Agreeing to not sell the product to those younger than the legal smoking age.

“We understand the FDA concern about manufacturing standards, and have been a priority of ours in establishing best practices beyond the electronic cigarette companies themselves,”
said Salmon. “We have been reaching out and working with companies and manufacturers since our inception last March, and have already come a long way in setting the standards, as noted in our requirements to be an ECA member.”

NJOY is a recognized member of the ECA.

About The ECA

The ECA is an association of private sector companies engaged in electronic cigarette technologies. Its mission is to provide the tools and information necessary for policy-makers, opinion leaders, media, and private sector companies worldwide to make informed decisions about the management and use of electronic cigarette technologies. The association institutes and promotes industry-wide standards and a code of conduct, works to maintain sound professional practices, educates
the public and policy-makers on the industry’s activities and potential, and works to ensure the ethical use of electronic cigarette technologies.