The FDA Takes First Steps to Address Flavored Tobacco Products and e-Cigarettes

Today, the FDA issued an advanced notice of proposed rulemaking in the Federal Register to solicit information on the role that flavors play in tobacco products.  Specifically, the FDA is seeking information on the how these flavored products attract children and whether and how they could play a role in smoking cessation for adults.  The FDA’s Center for Tobacco Products (CTP), which oversees the implementation of the Family Smoking Prevention and Tobacco Control Act (2009), is contemplating the establishment of standards for tobacco product flavors, as well as restrictions on the sale and distribution of these products.  The deadline for public comments is June 19, 2018.

According to Scott Gottlieb, M.D., FDA Commissioner, the basis for proposed rulemaking is twofold.  First, Dr. Gottlieb wants to make it more difficult for children to become addicted to nicotine.  As, issued in a press release yesterday, “The thought of any child starting down a path of a lifelong addiction to tobacco, which could ultimately lead to their death, is unacceptable. We need to take every effort to prevent kids from getting hooked on nicotine.”  He cites some disturbing statistics about the seductive effects of flavored tobacco products on children.  Every single day in the United States, 2,300 children under 18 will smoke their first cigarette, and nearly 1,900 children will smoke their first cigar.  Children consistently report flavoring as a leading factor in their reasons for trying tobacco products in the first place.  As ninety percent of adult smokers have already begun using tobacco products before age 18, regulations focused on preventing youth access to tobacco products would be a welcome step in addressing the public health harms of tobacco use.  According to analysis from the Center for Tobacco Control Research and Education out of the University of California San Francisco and the Department of Pediatrics at Stanford University, secret tobacco industry documents have shown that tobacco companies know that flavored smokeless tobacco products have been associated with young and inexperienced tobacco use and that flavors replicating candy increase appeal to children by creating an illusion of mildness, while masking the harsh tobacco taste.  Astonishingly, there are over 7,700 flavors used in tobacco products as of 2014.

The second factor Dr. Gottlieb cites in soliciting public comment on regulations for flavored tobacco products is related to harm reduction in adult smokers.  Acknowledging that combustible tobacco products are universally regarded as harmful, Dr. Gottlieb shares anecdotal evidence about how flavored cigarettes could help smokers switch to e-cigarettes and enjoy the benefits of potentially less harmful tobacco products.  He also emphasizes that the FDA is committed to public health, as evidenced by issuing an advanced notice of proposed rulemaking on March 15, 2018 in which the FDA would consider lowering nicotine levels in combustible tobacco products to minimally or non-addictive levels.


The Centers for Disease Control (CDC) also acknowledges that e-cigarettes do, in fact, have the potential to reduce harm for smokers currently using combustible tobacco products.  However, the CDC cautions us not to draw a false equivalency between “harm reduction” and being a “safe product.”  The CDC cites the known adverse health effects of nicotine, which include being highly addictive, being toxic to fetuses, potential harms to adolescent brain development, and dangers to pregnant women and developing babies. The aerosols used to deliver nicotine in e-cigarettes are also associated with known health risks, which include tiny particles that reach deep into lungs, heavy metals like lead, volatile organic compounds, and other cancer-causing agents.

Currently, the FDA does not recognize e-cigarettes as an effective smoking cessation aid.  Furthermore, the U.S. Preventive Services Task Force (USPTF) has concluded that there is insufficient evidence to recommend e-cigarettes as an effective smoking cessation aid and recommends that clinicians continue utilizing existing smoking cessation strategies, such as nicotine gum, nicotine patches, and pharmaceuticals, such as Chantix.  In its official statement, “the USPSTF concludes that the current evidence is insufficient to recommend electronic nicotine delivery systems (ENDS) for tobacco cessation in adults, including pregnant women. The USPSTF recommends that clinicians direct patients who smoke tobacco to other cessation interventions with established effectiveness and safety.”


Dr. Gottlieb’s intentions are admirable.  The proliferation of flavored tobacco products and e-cigarettes poses risks to children.  However, the potential expansion of this market may not be the ideal solution to the public health threat posed by tobacco products.  E-cigarettes are not safe.  They are merely less harmful than combustible tobacco products.  The regulation of flavored tobacco products is worth revisiting at the conclusion of the notice and comment period in 90 days.

-Andrew Hennessy-Strahs

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