WHAT IS THE FDA VAPE FLAVOR REGULATION AND WHY IT MATTERS!

It can sometimes be difficult to discern the truth. This same thought process can be applied to our government and whether it has our best interests at heart.

You can imagine the amount of pressure our government is under. From the fear-mongering in the media to parents who are worried about their children to the FDA’s lawsuit, you cannot even begin to imagine. It is absurd and extremely concerning that the term’ Juuling’ among youths has become a verb.

It’s hard to imagine, but we truly believe this time that the government wants to do the right things. Anti-vaping activists are concerned about youth vaping, and the FDA understands how vaping can help smokers quit.

The anti-vaping constituents are shouting loudly and clearly at the FDA to DO SOMETHING, and they’re working.

The FDA recently published an Advance Notice of Proposed Rulemaking (ANPRM) to collect comments, data, and research results from interested parties in order to understand better how they should proceed with regulating vape liquid flavors.

The FDA wants to know how flavors are used in vaping and what steps it should take to regulate them.

After June 19, 2018, the FDA will end public discussions. The vaping community has a chance to be heard and make a change.

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.

Let’s take a moment to review the events that led up to this point and discuss what you can do to protect your right to vape at will.

Why is the FDA concerned about flavors?

 

First, you should be aware that all electronic cigarettes are considered tobacco products by the FDA. According to the Tobacco Control Act, the FDA is authorized to regulate all aspects of e-cigarettes. It’s also classified as an Electronic Nicotine Delivery System. We can discuss whether we agree later.

How did we get here?

This is the argument that was presented to the FDA:

  1. Vaping is a popular trend among youths, and e-juice flavors are a great way to get them started.
  2. The Gateway Theory suggests that vaping increases the likelihood of youths smoking cigarettes later in life (Gateway Theory).

The risks are greater than the benefits if minors continue vaping.

The FDA is unable to accept this argument because e-cigarettes are beneficial for adults to help them quit smoking. The FDA is interested in knowing if vaping’s potential health benefits outweigh its risks.

According to a recent study by the University of Michigan, the benefits of vaping to public health outweigh the risks of youths switching from e-cigarettes to tobacco cigarettes.

The FDA wants to hear from the public to understand the best way to regulate vape flavors.

We’ll go through a summary of the ANPRM and the reasons why the FDA wants to regulate flavors in vapes.

KEY POINTS OF THE ANPRM DOCUMENT

 

The full ANPRM can be found here. Each section has been broken into bite-sized pieces.

The Role of Flavors in Tobacco Product Use:

  • The risk of nicotine addiction is highest for youth (under 18 years old) and young adults (18-24 years old).
  • Our government’s primary concern is with the youth and young adults who have never tried e-cigarettes before.
  • Children and youth are attracted to certain flavors, such as sweet flavors.
  • According to the U.S. Surgeon General, tobacco companies used fruit and candy flavors to attract youth. According to the U.S. Surgeon General, tobacco companies used fruit and candy flavors to attract youth.

The appeal of flavors in tobacco products and, more generally:

  • Flavors trigger reward pathways in your brain, which can enhance the benefits of nicotine. Both youth and adults can benefit from this.

TOBACCO PRODUCT USAGE PATTERNS OF YOUTH:

  • According to the National Youth Tobacco Survey, e-cigarette usage among teens increased between 2011 and 2015 according to NYTS. Vaping has become the most popular tobacco product among youth despite a decline in e-cigarette use in 2016.
  • The 2014 NYTS revealed that 3,26 million youths had used flavored tobacco, and 1,58 million of them reported using flavored electronic cigarettes.
  • Smokers younger than 25 are more likely than smokers older than 25 to use menthol. First-time users of menthol are more likely to smoke than non-users.

The taste influences the perception of harm and the likelihood of using tobacco products.

  • The findings revealed that all age groups perceive flavored tobacco products to be less harmful than non-flavored ones. Perceived harm affects the use of tobacco products by adolescents.

FLAVORS and PROGRESSions to Regular Use:

  • Most youth (81%), young adults (86%), and adults (54%) had used flavored tobacco products for the first use. The youth who used flavored tobacco products were also 13% more likely to continue using them than those who didn’t. Adults were found to have a 32% greater likelihood of using the product.

You can choose between a variety of flavors for young adults and children.

  • According to a study, among youth, the main reasons for using e-cigarettes 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%).
  • Youth prefer e-cigarettes with sweet flavors over those without.

ADULT USE OF FLAVORS in TOBACCO PRODUCTS

  • 63.2% of adult e-cigarette users use flavored liquid. Among polymers (those who use more than one tobacco product), 68.9% of them use at least a flavored product.
  • The sweetness of flavors is more important than the coolness to influence tobacco product liking.

FLAVORS MAY CONTAIN TOXIC COMPOUNDS OR FORM THEM:

  • In e-cigarettes, vapors of specific flavors have been found to contain acetylpropionyl and diacetyl. Both are highly irritating volatile compounds.
  • These compounds have been associated with adverse respiratory health outcomes.

THE POTENTIAL ROLE OF FLAVORS IN FACILITATING THE TRANSITION FROM CIGARETTES TO TOBACCO PRODUCTS THAT MAY POSE LESS RISK:

  • FDA has recognized the benefits of e-cigarettes for quitting smoking
  • Online survey results revealed that flavor variety is a key factor in quitting or reducing smoking. Limiting the flavors available would also make it more difficult to quit smoking.

The ANPRM summarizes the reasons why the FDA should be regulating flavors. Both adults and youth are concerned about the role that flavors play in e-cigarettes, and the FDA is aware of this.

What is the FDA up to, and what are they planning to do?

 

Recently, the FDA, working with the FTC, issued 17 warnings against vaping companies that engage in deceptive marketing.

 

It’s difficult to disagree with the FDA’s actions taken against certain vaping businesses as someone who works in the industry. Vaping companies must practice responsible marketing in order to avoid the misconception that they are marketing to children.

The FDA has proposed these regulatory actions in the ANPRM:

  • Tobacco Product Standards: Regulates the manufacture, marketing, and sale of tobacco products.
  • Restriction on the sale and distribution of tobacco products with flavors

The FDA has a wide range of authority with the Family Smoking Prevention and Tobacco Control Act. The FDA has the right to ban all flavors. The FDA is allowing public comments until June 19 so that it can consider all perspectives.

What you can do to make a difference!!

 

Here’s how to make an effective comment about the ANPRM. Tips on how to submit an effective comment are available here.

  • You can identify the problem and make constructive comments by reading the document ANPRM or the summary version shown above.
  • Your comment can be as long or short as you like. Remember to keep your comments concise and back up any claims you make.
  • Each comment is important, but a well-supported comment that has a lot of support can have as much influence as hundreds.
  • Consider using scientific evidence, expert opinion, or your reasoning to determine the impact of proposed regulations.
  • You can suggest an alternative to the proposed regulation if you don’t agree with it.
  • Respect and courtesy are essential.

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

  • Talk about how you were able to quit smoking using e-cigarettes and what role flavor played in this. What has been the improvement in your quality of living?
  • Tell us what flavors you used to quit smoking.
  • Define specific age categories as youth (under 18, young adults (18-24), adults (25 years and older).
  • Comment on the role flavors play in different age groups, even if they don’t have anything to do with tobacco products. Arguments against flavoring entice youth to vape and the gateway theory that goes with it.
  • What should the FDA do to regulate flavors? What are the possible solutions? Justify your reasoning. Try to support your arguments using data, expert opinion, or evidence. If you want to use credible studies as a basis for your idea, read our Vaping vs Smoking article.
  • Changes to the packaging or labeling of flavors? Education campaigns for youth? Are vape shops and vaping manufacturers held accountable?
  • What are the economic and health impacts? Remember that the FDA is attempting to improve public health by using a benefit-risk model.

Unfortunately, youth are becoming addicted to nicotine. We Americans are not interested in finding the real cause of a problem but rather prefer to blame someone else to fix it temporarily. No responsible vaping company tries to intentionally target our children by using flavors.

It is sad and irresponsible of anti-vaping activists to claim that vaping companies market to children when flavor is one of the most important reasons for people to quit smoking cigarettes.

The vaping industry represents freedom of choice. It is a way to try a new alternative and to be as safe as you can. We, the vaping community, know that vaping has improved our lives, and now is our opportunity to help others.

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