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May 12, 2014

FDA Issues Proposal to Extend Authority Over Additional Tobacco Products

May 12, 2014

Dr. Erika TraplThe following piece was written by Dr. Erika Trapl, Associate Director of the Prevention Research Center for Healthy Neighborhoods, and Assistant Professor of Epidemiology & Biostatistics at CWRU. Dr. Trapl was invited to write this guest commentary based on her extensive research in with e-cigarettes and other tobacco products.

The Food and Drug Administration's (FDA) Center for Tobacco Products recently proposed a new rule to extend their regulatory authority to cover alternative tobacco products –including e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and dissolvables. For those involved in tobacco control, this announcement from the FDA is long overdue and is just the first step in beginning to exercise the regulatory actions needed to continue to reduce tobacco use in the U.S.

In 2009, the Family Smoking Prevention and Tobacco Control Act was enacted, creating the Center for Tobacco Policy (CTP) within the FDA. The CTP gave the FDA regulatory authority over the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco by1:

  • Requiring tobacco product manufacturers to register with FDA.
  • Establishing standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness.
  • Establishing limits on the sale and distribution of tobacco products.
  • Requiring premarket review for new and modified risk tobacco products to protect the public health.

However, the FDA's regulatory authority has been limited to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, which allowed tobacco companies to skirt regulations and entice a new generation of smokers by marketing alternative tobacco products. While FDA was able to ban flavored cigarettes in 2009, that ban did not extend to flavored cigars, cigarillos and little cigars or the shisha tobacco used in hookah pipes, products that are heavily marketed to youth and young adults.

Our local surveillance data in Cuyahoga County has revealed that high school youth are using other tobacco products at the higher rates than cigarettes. Specifically, in 2013, only 10.4% of high school youth reported smoking cigarettes in the past 30 days, compared to 10.6% reporting current hookah use and 16.9% reporting current cigar, little cigar, or cigarillo use2.

Recently, electronic cigarettes (e-cigarettes) have been receiving a significant amount of attention in the media. While not a tobacco product, these devices are designed to look like a cigarette and deliver nicotine through an inhaled aerosol. Only e-cigarettes marketed for therapeutic purposes are regulated by the FDA; the vast majority of products on the market are currently unregulated. Without regulation, e-cigarette manufacturers are not obligated to report the contents of the e-cigarette cartridges; the use of flavors is widespread and may make the product more appealing to youth. Similarly, there are no limitations placed on marketing or promotion practices, and tobacco control advocates have noted that e-cigarette companies are using strategies used by tobacco companies in the past to attract the youth market.

Proponents of e-cigarettes argue that these products are useful cessation aids, that the contents of e-cigarettes are significantly safer than smoking tobacco, and that these products are being marketed to current smokers. There are many more questions to be answered before knowing the full risk of these products. However, extending FDA regulatory authority to these products is the one of the surest ways to protect the public's health, especially youth.

The FDA's proposed new rule would close the loophole for alternative tobacco products by:

  • Requiring tobacco companies to register with the FDA and report product & ingredient listings.
  • Only allowing tobacco companies to market new tobacco products after completing an FDA review.
  • Only allowing tobacco companies to make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
  • Preventing tobacco companies from distributing free samples.

The proposed new rule is just a first step to make an impact on U.S. smoking rates. The FDA must next look to apply rules currently enacted for cigarettes to alternative tobacco products, including banning flavored products, the use and messaging of warning labels, and restricting marketing practices from targeting youth.

Tobacco use remains the leading cause of preventable death and disease, including cancer and cancer death, in the United States today3. By supporting the FDA's proposed new rule extending its regulatory authority over these alternative tobacco products, we can help to reduce the 440,000 deaths attributable to tobacco each year, including the nearly 40% of these deaths caused by cancer.



2Trapl ES, Frank JL, Yoder LD, Jewett-Tennant J, Borawski EA (Jan. 2014). Youth Data Brief: Youth Smoking in Cuyahoga County. Cleveland, OH: Prevention Research Center for Healthy Neighborhoods at Case Western Reserve University

3U.S. Department of Health and Human Services. The Health Consequences of Smoking–50 Years of Progress. A Report of the Surgeon General.Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014 [accessed 2014 May 6].