Everyday FDA: Making Sense of the Proposed E-Cigarette Regulations

BY: KATHY STAATS

You know those “vape pens” you’ve heard about or seen around? Here, I will refer to them as e-cigarettes. Within the public health world and beyond, there has been extensive discussion around their safety, use, and advertising. Let me first make a disclaimer and say that I personally think that someday e-cigarettes may be an effective tool to help someone quit–if and only when scientifically-rigorous studies say so. When that day may be, I don’t know.

Before I dig into the regulations proposed by the FDA and what they would mean to the e-cigarette landscape, I’ll give a few reasons why e-cigarettes are an issue to public health professionals. According to the National Association of City and County Health Officials’ (NACCHO) Big Cities Coalition’s list:

  1. E-cigarettes pose a potential risk to public health.
  2. E-cigarettes are both appealing and very accessible to youth.
  3. E-cigarette advertising is increasing in volume and prominence.
  4. E-cigarette marketing uses unsubstantiated claims related to health and safety.
  5. E-cigarettes are not required to display any health warnings. (1)

The way these products are marketed makes it hard to tell if use of the product is actually “quitting” or is encouraging continued smoking, just with a different product. I also have to wonder about the target market for these products. I assume that many 50-year-old lifelong smokers are not going to be using any of the gummy bear or cotton candy-flavored cartridges that e-cigarette companies so frequently advertise. The Surgeon General cites that 90% of tobacco users begin using before the age of 18, which is a fact I’m sure is not lost on the manufacturers of these products. (2) In addition, we’ve seen a significant increase in calls to the Poison Center from children’s use of the product (3), which is something to ponder considering that the contents and material makeup of each company’s e-cigarette is unknown and currently unregulated.

This brings me to the regulations proposed by the FDA on e-cigarettes. In 2009, the FDA was granted federal authority to restrict the sale and distribution of tobacco products under the Tobacco Control Act. The tobacco products listed in this regulation were cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco. There were two additional purposes for this ruling: for the FDA to “deem” other tobacco products under the definitions of tobacco and to apply appropriate provisions to “deemed” tobacco products that protect the public’s health.

Many public health officials expressed frustration that products like cigars and e-cigarettes hadn’t fallen under FDA regulations earlier. E-cigarettes were designated to be deemed as a tobacco product because their main ingredient, nicotine, is derived from tobacco.
There are many important differences between the recently suggested regulations for e-cigarettes and cigars and the regulations imposed on tobacco products in 2009. The sale of these products will at last be restricted to only those over 18 years old like any other tobacco product and will require an ID for purchase.

However, there is no indication that the FDA will limit flavors in e-cigarettes or any sort of marketing around the product as ruled for the previous tobacco products. This will be apparently be a focus for the future, after they research whether the current marketing or flavors are proven to cause increased use in youth. Mitch Zeller, the director for the FDA’s Center for Tobacco Products called these regulations “foundational.” An open comment period will be available until July 9, 2014 for individuals, companies, or groups to provide feedback on the regulations.

Any public health work is a series of compromises and competing interests and I appreciate a first step being made by regulatory authorities. That being said, are these suggested regulations on age of sale enough to address the broad scope of issues with e-cigarettes? If flavors in other tobacco products have been proven to increase youth use, how are these vapor products any different? What sort of and how much research would be needed to prove this? And, as mentioned earlier, why is there not a provision that initiates FDA research to study the potential development of a type of vapor product that could help people quit using any tobacco product? Is it because there is pressure by the vapor/tobacco industries not to create a proven cessation product at all?

Only strong advocacy from tobacco prevention/public health community members, smart decisions from lawmakers, and valid research will be able to answer these questions the right way.

Sources cited:
1. http://bit.ly/1jHNfVW
2. http://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/exec-summary.pdf
3. http://www.cnn.com/2014/04/03/health/ecigs-nicotine-poisoning/index.html?hpt=hp_t3

Other sources utilized:
http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-0001
http://www.nytimes.com/2014/04/24/health/fda-will-propose-new-regulations-for-e-cigarettes.html?_r=1

Advertisements

Leave a Comment

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s