Cancer Groups Applaud FDA's Tobacco Product Overhaul

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 (ENDS).

Lisa Schulmeister, MN, RN, ACNS-BC, FAAN

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 (ENDS).

For the first time, the FDA will review the devices 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, MD, MBA, FASCO, president of the American Society of Clinical Oncology.

Notable among the changes is the FDA’s effort to try and stem the alarming rate at which teenagers are using these tobacco products.

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.

These are all crucial moves as e-cigarette use among high school students has had an over 900% increase in 4 years. According to a survey by the FDA and the Centers for Disease Control and Prevention, e-cigarette use skyrocketed from 1.5% in 2011 to 16% in 2015. Hookah use has also risen, and high school boys are smoking cigars at a similar rate to cigarettes.

E-Cigarettes a “Gateway” to Smoking

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 during the first 6 months, 30.7% of those who had used e-cigarettes started using combustible tobacco products, such as cigarettes, cigars, and hookahs, compared with only 8.1% of those who had never used e-cigarettes.

The statistics are a concern for healthcare 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, and pipe tobacco.

“Tobacco is the leading cause of preventable death in the United States, and it is associated with 18 different types of cancers,” says Margaret Foti, PhD, MD (hc), chief executive officer of the American Association for Cancer Research (AACR). “Therefore, this action by the FDA is vitally important, especially if we are to protect our nation’s youth from becoming addicted to nicotine.”

In addition, 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, excluding products on the market before Feb. 15, 2007. This includes ingredients, product design, and health risks, as well as the appeal to youth and non-users. All labels and advertisements will also 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 2 years while they submit a new tobacco product application for items they already sell. The FDA will then have an additional year to review that application.

“Although there has been some pushback about the new rules, regulating e-cigarettes in the same way that tobacco is regulated makes sense,” noted Oncology Nursing News editor-in-chief Lisa Schulmeister, MN, RN, ACNS-BC, FAAN.

Clinicians Should Expect Questions About FDA Tobacco Product Rules

And, as these changes roll out, healthcare professionals such as doctors and nurses may start getting questions from patients.

The best way to serve patients who smoke, are trying to quit, and use tobacco products, is to encourage them to support their efforts to learn more about FDA-approved smoking cessation tools.

“We simply do not know enough about the long-term consequences of e-cigarette use, nor do we know whether they are truly effective as a long-term smoking cessation aid,” said Roy S. Herbst, MD, PhD, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center.

“Therefore, in addition to the FDA taking this critical step to regulate these products, it’s going to be extremely important to support research on the health consequences of these products, as well as investigate the potential benefits of e-cigarettes as a cessation tool for those people already addicted to nicotine.”