Health Dialog Connections

Chronic Condition Prevention: What the New FDA Tobacco Rule Could Mean for Public Health

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The U.S. Food and Drug Administration aims to reduce the use of tobacco, which remains the leading cause of preventable chronic conditions and death in the United States. The latest FDA rule, which will take effect August 8th this year, extends regulations to include all tobacco products, including e-cigarettes (also called electronic cigarettes or electronic nicotine delivery systems (ENDS)), dissolvables, hookah tobacco, cigars, pipe tobacco, and any novel or future tobacco products. New steps will protect public health by evaluating the ingredients of these tobacco products, block distribution of products that do not meet public health standards, help consumers understand the risks of their use, and protect youth.

Provisions and requirements for all manufacturers, importers and/or retailers of these newly regulated tobacco products, include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

Restriction of youth access to tobacco products

In addition, the new regulations will prohibit the sale of all regulated tobacco products to anyone under 18 and sale of tobacco products in vending machines (unless in an adult-only facility). The CDC has projected 5.6 million Americans under the age of 18 will die prematurely from a smoking-related chronic condition, so it is not surprising that the response to this ban has been mostly positive. These new restrictions are seen as a solid step towards dampening the popularity of e-cigarettes among youth. The use of e-cigarettes has risen dramatically among middle school and high school students making them the most commonly used tobacco product by youth in 2015.

E-cigarettes: a potential smoking cessation aid?

A major concern is that the new regulations could stunt use of e-cigarettes as an effective smoking cessation aid. New expenses for manufactures may lead to a rise costs for consumers and may have former smokers returning to more harmful, traditional tobacco products. Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, stated, “[the] final rule pulls the rug out from the 9 million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year, and costs the U.S. more than $300 billion in annual healthcare expenses.” However, some argue this may be an opportunity for e-cigarette manufactures to invest in research about the potential benefits, such as chronic condition prevention.

Support for individuals trying to kick tobacco:

Products approved by the FDA as smoking cessation aids include: nicotine gum, nicotine skin patches, nicotine lozenges, nicotine oral inhaled products, nicotine nasal spray, and some non-nicotine medications. Health Dialog’s tobacco cessation program combines predictive analytics, coaching, and education materials to help reduce the use of tobacco products in a population. We educate individuals on the risk factors and impact of tobacco use, identify triggers and other barriers to change, help to develop a personalized quit plan, and provide ongoing support and guidance.



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