Oncology Groups Praise FDA Decision to Regulate E-Cigarettes
The FDA is getting praise from oncology groups for its landmark decision to regulate electronic cigarettes, cigars, hookah tobacco, pipe tobacco and other electronic nicotine delivery systems.
For the first time, the FDA will review these items, including e-cigarettes and the ingredients in them, which had been unregulated since they hit the market about a decade ago.
“We commend the FDA for taking this important step and will be happy to provide appropriate guidance and feedback as the agency works to understand the true public health benefits and risks of these products,” said Julie M. Vose, president of the American Society of Clinical Oncology.
The new FDA rules ban all sales to anyone under the age of 18, the distribution of free samples and the sale of tobacco products covered under the federal act in vending machines, unless in an adult-only facility. All of the rules go into effect in August.
In addition, in order to gain marketing clearance, manufacturers of all newly regulated products will now have to prove the products meet the applicable public health standard set forth by the FDA’s new ruling, with the exception of products on the market before Feb. 15, 2007. In reviewing these products, the FDA will evaluate ingredients, product design, health risks and level of appeal to youth and non-users. All labels and advertisements will be required to have public health warnings on them.
While many of the changes will be seen this summer, the FDA has staggered timelines for manufacturers, who will be able to continue selling their products for up to two years while they submit new tobacco product applications for items they already sell. The FDA will then have an additional year to review those applications.
E-cigarette proponents have argued that this process will be too onerous for mom-and-pop companies that sell these products. Under the regulations, e-cigarette companies will have to register each product and its ingredients with the FDA, a process that will cost $334,000 per product, the agency has told CURE.
Bill Godshall, executive director of Smokefree Pennsylvania, guesses that the expense of registration will push several thousand e-cigarette companies out of business — all except the country’s three largest tobacco companies, which have greater financial resources.
The decision to regulate was based, in part, on concerns about younger people using these products.
According to a survey by the FDA and the Centers for Disease Control and Prevention, e-cigarette use skyrocketed from 1.5 percent in 2011 to 16 percent in 2015. Hookah use has also risen, and high school boys are smoking cigars at the same frequency at which they smoke cigarettes.
Electronic cigarettes may also act as a gateway to conventional smoking. Researchers from the National Institutes of Health conducted a survey from 2013 to 2014 and found that, during the first six months, 30.7 percent of those who had used e-cigarettes but no combustible tobacco products started using cigarettes, cigars or hookahs, compared with only 8.1 percent of those who had never used e-cigarettes.
The statistics are a concern for health care professionals because, while the lasting effects of cigarette smoking are well-known, no one is sure what the effects are for e-cigarettes, cigars, hookah tobacco or pipe tobacco.
Until more research is conducted about the safety of products like e-cigarettes and their value as a tobacco-cessation technique, the best way to quit using tobacco is to use FDA-approved tools, said Roy S. Herbst, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center.