What is the FDA Vape Flavor Regulation and Why It Matters!

The media loves stirring up controversy, and at times, it can be quite tricky discerning the truth. The same line of thinking can be said about our government, and whether or not our government has the people's best interest at heart.

From the fear mongering you hear in the news, to the parents freaking about their kids, to the lawsuit the FDA is facing, you can only imagine the pressure on our government’s shoulders. The fact that ‘Juuling’ has become a verb among our youth is ridiculous and incredibly concerning.

We know it’s hard to believe, but this time, we genuinely believe that the government is trying to do the right thing. The anti-vaping advocates are voicing their concerns about the youth vaping and the FDA also understands that vaping can be beneficial in helping smokers quit cigarettes.

The anti-vaping constituents are screaming loud and clear to the FDA TO DO SOMETHING, and it’s working.

The FDA has recently released an Advanced Notice of Proposed Rulemaking (ANPRM) to collect comments, data, research results, and other information from interested parties to understand better how they should proceed in regulating vape juice flavors.

Simply put, the FDA is seeking information to understand how flavor plays a role in vaping and what actions the FDA should take to regulate flavors.

The FDA will close the public discussion after June 19, 2018. This is a window of opportunity for the vaping community to be heard, and to make a difference.

What we are asking from you in the vaping community is to take action. Don’t let the media drown out your truth because your voice matters too.

Before you do, let’s go over what events have led to this moment and what you can do to protect your freedom to vape as you please.

Why Does The FDA Care About Flavors?

The first thing you should know is that the FDA considers all e-cigarette products as a tobacco product. Under the Tobacco Control Act, the FDA has the authority to regulate all aspects of e-cigarette products and is formally classified as an Electronic Nicotine Delivery System (ENDS). Whether we agree or not is a discussion for a later time.

So, how did we end up here?

The argument presented to the FDA is summarized as the following:

1. E-juice flavors entice the youth to start vaping
2. Vaping at a young age increases the risk of youth smoking cigarettes in the future (Gateway Theory)

Therefore, the risks outweigh the benefits if more minors continue to vape.

This argument poses a problem to the FDA since e-cigarette flavors are also beneficial to adults as a means to quit smoking. The FDA wants to know if the potential health benefits of vaping outweigh the risks?

According to a study done by the University of Michigan, the public health benefits from vaping outweighs the risks of youths moving from e-cigarettes to cigarettes.

Regardless of the information out there, the FDA is being open-minded in their approach and wants to hold a public comment to better understand how they can proceed in regulating vape flavors.

Let’s go over a quick summary of the ANPRM and why the FDA is proposing to regulate vape flavors.

Key Points In The ANPRM Document

You can read the full ANPRM document here. We have broken down each section into bite-sized bits.

The Role of Flavors in Tobacco Products Use:

• Youth (under 18) and Young Adults (18-24) are at a time of heightened vulnerability and are at most risk to develop nicotine addiction.

• The primary population of concern for our government is the youth and young adults who have never smoked cigarettes before and are trying e-cigarettes.

• Certain flavors such as sweet flavors are appealing to children and youth.

• Fruit and candy flavor was used to attract the youth by tobacco companies according to the U. Surgeon General

The Appeal of Flavors Generally And In Tobacco Products Specifically:

• Flavors can trigger reward pathways in the brain to enhance the rewards of nicotine use. This applies to both youth and adults.

Tobacco Product Use Patterns By Youth:

• According to the National Youth Tobacco Survey (NYTS), e-cigarette use among teens has increased significantly between 2011 and 2015. Although there was a decrease in e-cigarette use among the youth in 2016, vaping is currently the most popular product for tobacco use.

• Results from the 2014 NYTS showed that 3.26 million youth had used flavored tobacco products, and 1.58 million of those have reported using flavored e-cigarettes.

• Youth and young adult smokers are more likely to smoke menthol compared to adult smokers. First time users who used menthol were at greater risk to continue smoking than those who did not.

Flavors and Perceptions Of Harm and Likelihood Of Tobacco product Use:

• Some findings showed that all age group perceives flavored tobacco products as less harmful than non-flavored products. Perceived harm influences the use of tobacco product in adolescents.

Flavors And Progression To Regular Use:

• Majority of youth (81%), young adults (86%), and adults (54%) had use flavored tobacco products when they used for the first time. It was also found that the youth who tried flavored products were 13% higher to continue to use compared to those who did not have flavor product. For adults, it was found to be 32% higher.

Youth and Young Adult Flavor Preferences:

• In one particular study, the most common reasons to use e-cigarettes among the youth are curiosity (54.4%), appealing flavors (43.8%), and friends influence (31.6%)

• In a study of 1567 young adults (18-34), the most common flavors used were the following: fruit (66.9%), candy (35.1%), and caramel/vanilla/chocolate/cream (33.3%).

• Sweet-flavored e-cigarettes have greater appeal among the youth than non-sweet flavor and tobacco flavored e-cigarettes.

Adults’ Use of Flavors in Tobacco Products:

• 63.2% of e-cigarette adult users use flavored e-juice. Among tobacco product users (polyusers), 68.9% use at least one flavored product.

• Sweetness in flavors has a greater impact than coolness on liking tobacco products.

Flavors May Contain Or Form Toxic Compounds:

• Diacetyl and acetyl propionyl have been detected in e-cigarette vapors with specific flavors. Both of which are highly irritating volatile organic compounds.

• Adverse respiratory health outcomes have been linked to these compounds.

The Potential Role of Flavors in Facilitating Transition From Cigarettes to Tobacco Products That May Pose Less Risk:

• FDA is aware of the potential benefits from e-cigarettes as means to quit smoking cigarettes

• In an online survey, flavor variety was noted as a critical factor in reducing or quitting smoking. Additionally, limiting the available flavors would make quitting cigarettes difficult and less likely

In summary, the ANPRM makes a case to support why the FDA should regulate flavors. The role flavors play in vaping is an important one to both the youth and adults, and the FDA understands both sides of the story.

What Is The FDA Up To And What They Are Planning To Do

The FDA is ramping up its efforts to please constituents, and recently, the FDA working in concert with the FTC have issued 17 warnings to vaping companies practicing deceptive marketing.

From someone working in the industry, it’s hard to disagree with the FDA’s action taken on certain vaping companies. It is imperative for vaping companies to practice responsible marketing to avoid any misconception of companies marketing to children.

According to the ANPRM, the FDA has been proposing these regulatory actions: 

• Tobacco Product Standards: regulating the manufacturing, marketing, and sale of tobacco products.

• Restrictions On Sales And Distribution Of Tobacco Products With Flavors

With the Family Smoking Prevention and Tobacco Control Act, the FDA’s authority is far-reaching and all-encompassing. If the FDA wants to ban flavors entirely, the FDA can do so. However, the public comment open until June 19th is there for a reason so FDA can take account of all sides of the story.

What You Can Do To Make A Difference!!

Let’s go over how to submit an effective comment on the ANPRM. You can also read here for tips on submitting an effective comment.

• Read the ANPRM document or the summarized version above so you can clearly identify the issue and constructively make a comment.

• There is no minimum or max length to your comment. However, remember to be concise and support your claims.

• Every comment counts but one well-supported comment can be influential as hundreds of comment.

• Use sound reasoning, scientific evidence, expert opinions, and/or how the proposed regulations will impact you

• If you disagree with the proposed regulations, suggest an alternative solution to solve the issue at hand.

• Be respectful and courteous.

What kind of information will be helpful in influencing the FDA's decision?

• Discuss how e-cigarettes helped you quit smoking and how flavor played a role in your smoking cessation. How has your quality of life improved?

• Be specific about what flavor you used to help you quit smoking (tobacco, menthol, fruit, candy, custards, etc.)

• Define specific age groups as youth (under 18), young adults (18-24), and adults (25 and older)

• You can also comment on how flavors play a role in different age groups even if it doesn't relate to tobacco products. Arguing against the fact that flavor entices the youth to vape as well as the gateway theory that comes with it

• What actions should the FDA take on regulating flavors? What are the solutions? Justify your reasoning. If possible, try to base your arguments with data, evidence, or expert opinions. You can read our vaping vs smoking article if you would like to use credible studies to support your argument.

• Changes in labeling or packaging with flavors? Educational campaigns for the youth? Holding vape shops and vaping companies accountable?

• What are the health and economic impacts? Remember, the FDA is trying to assess how to better the public health through a benefit-risk framework.

The fact that the youth is getting hooked on nicotine is sad and unfortunate. In America, we never like to find the root cause of the issue, and instead, we like to find a scapegoat to fix our problems temporarily. When in fact, no responsible vaping company intentionally tries to target our children with flavors.

It’s saddening and extremely irresponsible for anti-vaping advocates to tout that vaping companies are marketing to children when flavors are one of the main reasons people can quit smoking cigarettes.

The vaping industry represents the freedom of choice, a choice to choose a different alternative, and a commitment to make nicotine products as safe as possible. Like many of us in the vaping community, we know how vaping has helped improve our quality of life, and this is our chance to make a difference.