DENVER - The International Association for the Study of Lung Cancer (IASLC) applauds the U.S. FDA's decision to extend its regulation of tobacco products to e-cigarettes, cigars, hookah tobacco, and pipe tobacco, among other products. This action by the FDA puts these products more in alignment with the Family Smoking Prevention and Tobacco Control Act and is a vast step forward for public health.
Essential parts of the new, 499-page rule include:
- Banning the sale, either in person or online, of e-cigarette, hookah, pipe tobacco, and cigar products to anyone under 18 in the U.S.
- Requiring age verification by photo ID for purchase of the newly regulated products.
- Requiring manufacturers of products produced after Feb. 15, 2007 to register and submit their products for FDA approval, disclosing the ingredients, safety and emissions data, and manufacturing process.
- Requiring companies to put health warning labels on e-cigarettes and other tobacco products, including warnings about the possibility of addiction and the health effects of nicotine.
- Prohibiting sales of tobacco products in vending machines, aside from adult-only facilities.
- Banning free samples of e-cigarettes and other tobacco products.
The new rule policy came about after Congress authorized the FDA to regulate additional tobacco products in 2009 with the Family Smoking Prevention and Tobacco Control Act.
"Giving FDA authority over all tobacco products is a good thing," said Dr. Kenneth Michael Cummings, Professor, Hollings Cancer Center, Medical University of South Carolina, and member of IASLC's Tobacco Control and Smoking Cessation Committee. "It clears up a loophole in the original law that excluded products like cigars."
An e-cigarette is a handheld electronic device that vaporizes a flavored liquid that includes nicotine. The user then inhales that vapor, which is why it is sometimes called "vaping." In 2015, a Reuters/Ipsos poll calculated that about 10 percent of U.S. adults now vape and a large chunk of those are 18 to 24 years old. According to a 2015 survey by the FDA and the Centers for Disease Control and Prevention (CDC), e-cigarette use among U.S. high school students skyrocketed from 1.5 percent in 2011 to 16 percent in 2015, an increase of more than 900 percent. An additional study by the FDA and the National Institutes of Health (NIH) shows that many younger tobacco users point to appealing flavors, such as candy and fruit, as the reason they use.
"E-cigarettes are relatively new. They may come with some risk and need to be regulated. We need to be careful and cautious or else we are putting our children in unnecessary danger and putting them on a track toward potentially debilitating medical conditions," said Fred R. Hirsch, MD, PhD, Professor of Medicine and Pathology at the University of Colorado Cancer Center and School of Medicine and CEO of IASLC.
The safety of e-cigarettes is an ongoing debate. A 2015 study found that e-cigarettes are about 95 percent less harmful than tobacco products, but many others dispute those results. Manufacturers claim e-cigarettes can help people quit smoking tobacco, but many public health groups say the product is still dangerous. Many also agree that the product is simply too new to have in-depth data on the dangers.
"The FDA now has the authority to regulate the manufacturing elements of the products, such as ingredients, the introduction of new products, and more. The devil is in the details of how the FDA will do this, but presumably it will base actions on a continuum-of-risk basis, addressing the most dangerous products and practices first," Dr. Cummings said.
Each year, lung cancer is responsible for more deaths worldwide than prostate, breast and colon cancer combined, and more than 80 percent of lung cancer cases stem from the use of tobacco products. Limiting tobacco use, especially smoking products, is the best way to move the needle in decreasing lung cancer cases. While there is no proof that e-cigarettes can cause lung cancer, many experts believe they can be harmful.
"This is another important step in stopping lung cancer before it starts. We are all working hard to save lives and it is a welcome sight to see the FDA adding its efforts toward this universal goal," Dr. Hirsch said.
Read the FDA's news release about the change: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm.
Read the full 499-page rule from the FDA: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf.
About the IASLC
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer. Founded in 1974, the association's membership includes more than 5,000 lung cancer specialists in over 100 countries. Visit http://www.iaslc.org for more information.