Cancer Groups Urge FDA to Regulate Vape Pens

Cancer Groups Urge FDA Action on E-Cigarettes

A joint policy statement issued by two prominent national cancer organizations urges the FDA to get involved in the regulation of electronic cigarettes and similar products, and recommends additional research to determine the long-term effects of these products on the human body and whether they help people to stop smoking tobacco.

According to the U.S. Surgeon General, nearly 484,000 deaths in the United States each year are related to using tobacco products. Smoking and other tobacco use is the largest preventable cause of death and disability in developed countries, is responsible for nearly 30% of all cancer deaths, and increases cancer risk for 18 types of cancer. Electronic cigarettes, or e-cigarettes, are battery-operated electronic nicotine deliver systems (ENDS) marketed as smoking cessation products and a healthier alternative to regular tobacco smoking but there are no medical studies on the long-term effects of these products on the human body, or whether they help smokers quit smoking.

The American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR) recently issued a joint statement expressing concern over ENDS manufacturers’ claims of health benefits and smoking cessation, advising policymakers that no solid evidence exists to support either the alleged benefits or negatives of using e-cigarettes and ENDS, urging further research on ENDS products, and asking the FDA to step in and regulate these products like regular combustible cigarettes and tobacco cessation products. “We call for additional research to determine with certainty the potential negative public health consequences of these products, particularly in youth,” explained Dr. Carlos L. Arteaga, MD, AACR President. Added Roy S. Herbst, MD, PhD, Chair of the AACR/ASCO Joint Committee, “Further research and regulation are needed to determine if e-cigarettes can help people stop smoking combustible cigarettes.”

Although the cancer groups who authored the joint statement acknowledge the importance of helping people to stop using tobacco, they are concerned whether the use of e-cigarettes and ENDS is the way to achieve this goal or are whether these products are simply creating other health problems. Even if the product helps with smoking cessation, is there a greater likelihood of nicotine addiction or other health problems from ingesting the vapor? Is there any danger to bystanders breathing in secondhand nicotine vapor? How does it affect pregnant women and their unborn children? Safety tests need to be done now because of the rapidly growing use of e-cigarettes and ENDS, especially since they’re heavily marketed to youth and young adults.

FDA must get involved now

Currently, the FDA has no authority to regulate e-cigarettes and other electronic nicotine delivery systems. In fact, unlike combustible tobacco cigarettes, there is no regulatory authority in place to evaluate alleged beneficial health claims or negative effects, nor any regulations related to the manufacturer, sale, distribution, marketing or advertising of these products, and as such, there are no boundaries on what manufacturers can or cannot claim.

Cancer groups are particularly concerned because these products are heavily marketed to youth who may be attracted to the product because of the sexy product designs and names, and the colorful vapor lights, and fear youths using e-cigarettes and ENDS may end up addicted to the nicotine, thereby increasing the odds they may eventually start smoking tobacco.

E-cigarettes and ENDS products are also injuring younger children. There are no regulations requiring childproof packaging to prevent accidental ingestion of the nicotine liquid that are easily accessible to children attracted to the colorful nicotine tubes. A toddler in Florida recently died due to accidental ingestion of the nicotine liquid and doctors nationwide report a surge in calls to poison control centers and trips to emergency rooms by children poisoned from accidental ingestion of the liquid nicotine.

If other nicotine cessation devices such as nicotine gum and the nicotine patch need FDA approval and oversight, why not ENDS and e-cigarettes?

ASCO/AACR Joint Policy Recommendations

The joint policy statement recommends:

  • FDA regulate e-cigarettes and ENDS products just as it does combustible cigarettes;
  • Require e-cigarette and ENDS manufacturers to register with the FDA, and supply a list of all their products, all ingredients in their products and identify the percentage of nicotine in each product;
  • Demand that e-cigarette and ENDS products contain health warnings and safety labeling;
  • Prohibit e-cigarette and ENDS manufacturers from marketing, advertising and selling their products to youth;
  • Restrict Internet and mail-order sales of e-cigarettes and ENDS products requiring proof of age before purchase;
  • Require childproof caps on all nicotine liquid containers;
  • Prohibit e-cigarette and ENDS use where regular combustible tobacco products are prohibited according to federal, state and local laws;
  • Tax e-cigarettes and ENDS products to pay for research on the long-term health effects of using the products;
  • Require e-cigarette and ENDS manufacturers to turn over and provide data on the health effects of their products;
  • Enact state and local laws to protect the public health, and to restrict access to e-cigarettes and ENDS products by youth.

Oncologists are also advised to encourage their patients to stop smoking by means other than e-cigarettes and ENDS until these studies are completed.