Health

Risk Perception and FDA Regulation of Nicotine, Vaping, and Smoking

advertisement

Are we properly contextualizing the risks in public health, policy formulation, and regulation?

Kevin Ann

The news outlets are sounding the alarm with terrifying headlines about lung collapse and deaths caused by nicotine-infused vaping and a raging youth epidemic involving vaping in general and JUUL-ing in particular.

When for-profit media machines compete, they’re incentivized to incite fear and rile up the masses to get attention in exchange for greater advertisement dollars. When this is combined with incomplete public understanding and muddled morality, we can forget about balanced and nuanced perspectives involving facts and reason.

  • What are the risks of vaping?
  • How do they compare with the risks of smoking?
  • Where does nicotine fit in?
  • What segment of the population is most vulnerable?
  • How should we prioritize government action for public health?
  • What about broader issues like government power and the proper role of government in America?

I will attempt to consider these questions without the alarmism of the news headlines or the posturing and rancor of Social Media.

advertisement

Why Compare?

Vaping has been touted as a safer alternative to tobacco smoking, either as an outright ongoing replacement for tobacco smoking or as an offramp to help those addicted to nicotine in cigarettes quit smoking.

Thus, it’s important to assess the risks of each and in context relative to each other for optimal public health policy, in particular how it may involve FDA regulations.

Nicotine

The core substance connecting vaping and smoking is nicotine, which is extremely addictive.

Recently tobacco companies have begun reframing the role of nicotine by explicitly advertising and spinning that nicotine itself is not a dangerous substance. Although this is true, it is not the whole truth and is misleading and irrelevant.

Nicotine by itself is not necessarily harmful, but it is extremely addictive and makes it very difficult or impossible for people to quit smoking. It’s the inhalation of smoke that contains additional carcinogenic chemicals in cigarettes that’s harmful. The same can be said in the vaping context where nicotine is not the harmful ingredient, but the continued and extreme vaping and interaction of the vaping and the lungs is the harmful process.

Deaths and Illnesses from Vaping

What is the scale of death and illnesses that are attributable to vaping? The Centers for Disease Control webpage Outbreak of Lung Disease Associated with E-Cigarette Use, or Vaping shows that:

  • Deaths: Less than 10
    “Six deaths have been confirmed in California, Illinois, Indiana, Kansas, Minnesota, and Oregon.”
  • Illnesses: Few hundred cases
    “September 11, 2019 at 5pm, 380 cases of lung illness associated with the use of e-cigarette products.”

These numbers lack precision and greater context since vaping has existed for many years and we didn’t have this amount of media, government, and popular scrutiny before. It’s hard to say definitively if there have been fewer or greater deaths previously that can be attributable to vaping. But given the media sensationalism, it is more likely that there weren’t a significantly larger number of deaths since we haven’t heard of a large number of mysterious lung illnesses or deaths, whether related to vaping or not.

For the sake of a first-order comparison with deaths from smoking, let’s round up from the actual six confirmed deaths to say:

  • 10 deaths that can be definitely from vaping and that it is over a timeframe of one month

This comparison with smoking neglects many things, such as the ethics and morality of treating human life as cold arithmetic, ignoring the severity and length of suffering, the burden on families and loved ones, or the secondary effects of second-hand smoke or mist from vaping. It will just focus on deaths since these are the most severe, tangible, and quantifiable indicators.

Deaths From Smoking

The CDC Factsheet on smoking says that:

  • More than 480,000 deaths annually are attributed to smoking

For the sake of comparison with vaping, let’s round up from 480,000 to 520,000 annually for easy estimation. This is less than 10%, compared with rounding up from 6 deaths to 10 death (66%) in the vaping case giving vaping an extra boost in danger and mortality.

  • This means there are 10,000 deaths attributable to smoking per week, or about 40,000 deaths per month.
  • Compare the 40,000 deaths from smoking to an estimated 10 deaths from vaping during that month period, and it comes out to a factor of 4,000 to 1.
  • This could be construed that 4,000 people die from smoking for every one person who dies from vaping.
  • Thus vaping has lead to 1/4000th or 0.025% of as many deaths as tobacco smoking.

Thus, the real public threat is still smoking by 3 to 4 orders of magnitude.

Caveats with Back-of-Envelope Analysis and Other Issues

There are some caveats to this simple back-of-envelope comparison, for example, it could very well be that we’re vastly underestimating the danger of vaping due to unknown factors or incomplete data collection and reporting.

So for the sake of exploration, let’s assume that we’re vastly wrong or incomplete in our assessment.

  • Let’s say we only see 1% of all deaths attributable to vaping, and that vaping is in reality 100x as dangerous.
  • Thus, there are 100x as many deaths at 1,000 per month instead of only 10 per month.
  • In this case, smoking still causes 40x as many deaths, which is between one to two orders of magnitude more dangerous.

We only focus on deaths here to keep the comparison of risks relatively clean, but there are other important issues not considered but may warrant more research and attention such, as the nuances of:

  • Vaping that includes THC vs. nicotine
  • Brands of vaping products, most especially the dominant market leader JUUL
  • Flavors of vaping, both tobacco and non-tobacco flavors like creme, mango, and cucumber
  • Different ages, most especially youth under 18 versus adults
  • Pre-existing conditions such as Asthma, COPD, or allergies
Photo by Rubén Bagüés on Unsplash

FDA Regulation of Vaping For Adults

So if we consider the relative risks of smoking and vaping by itself, it is clear that vaping still remains a much safer alternative to smoking, either ongoing as a replacement for smoking or as an offramp from smoking.

Thus, any consideration of banning vaping should also consider the unintended negative consequences of banning a viable alternative to regular tobacco smoking or as a smoking cessation aid.

It would be somewhat analogous to banning seatbelts if there were cases of people who were strangled to death or otherwise injured by seatbelts, and ignoring the larger impact of seatbelts in safety for vehicle crashes. Not a perfect analogy, but captures the essence.

Youth Use

Now, there are still dangers that vaping can still provide an onramp to tobacco smoking to youths who otherwise wouldn’t have done so. Furthermore, there’s the draw of vaping infused flavors other than tobacco such as mango, cream, or watermelon.

However, these cases should be dealt with simply by enforcing current regulation that prohibits youth to buy tobacco products in the first place. It is not a policy or product problem, but rather one concerning inadequate enforcement.

Although it is not illegal to market an advertise to youth on the internet, there can be pressure from organized advocacy groups to stop marketing and advertising to the youth.

Nicotine And Product Addictiveness

Another danger exists in the extreme addictiveness and concentration of nicotine in vaping products that may surpass even traditional cigarettes because it exists in a more convenient and slick high-tech product that may deliver nicotine with greater efficiency.

For example, a JUUL pod that’s used with a sleek JUUL vaporizer that looks like a USB stick delivers as much nicotine as a pack of cigarettes and supports approximately 200 puffs of 3 seconds each. Inhaling a puff is much more convenient and requires less work than lighting up a cigarette. Furthermore, many smaller doses or much larger doses of nicotine can be achieved much more easily.

So even though the relative risks of deaths in vaping may be much less than smoking as in our comparison, that is only a preliminary first-order consideration since it doesn’t consider the usage characteristics or quality of life issues.

Low Nicotine FDA Mandate

The FDA is considering an outright Low Nicotine Mandate for all tobacco smoking products to bring the limit on the amount of nicotine in a cigarette to below 0.4 mg per gram of tobacco, which is considered to be the non-addictive level, a claim that enjoys plenty of scientific evidence, for example:

For comparison, a typical cigarette contains between 10–15 mg per gram of tobacco.

A Reasonable Regulation Plan

Perhaps a good plan going forward is to keep vaping regulations as they are without any special executive orders or outright bans that are driven by news-driven hysteria. This may mean one or all of the following:

  • No vaping products for youth as the law already states, with greater enforcement of existing law.
  • Continue on the path towards the Low Nicotine FDA Mandate in traditional tobacco smoking products along with existing vaping as a safer alternative to tobacco available to adults.

Checks and Balances Among Branches of Government

As of this time in mid-September 2019, Michigan and New York have led the charge in banning the sale of flavored vaping products, with an intention to raise the age limit from 18 to 21. Other states like Massachusetts and California are have also introduced similar bills to halt sales of flavored vaping products.

In fact, Governor Cuomo of New York has issued an Emergency Executive Order to ban the sale of flavored vaping products. This is problematic with respect to government power.

While legislation goes through the normal channels of government, the use of Executive Orders by the Executive Branch at either the State or Federal erodes the checks and balances built into the American Republic since it effectively bypasses the Legislative Branch in the law-making process, as well as established regulatory agencies like the FDA with specific rules and processes in formulating regulations.

Role of Government

Furthermore, America was founded based on the premise that the people are best-suited to make decisions for themselves and the proper role of government is minimal and not necessarily to protect them from every danger they pose to themselves. This is within reason of course as many counterexamples can be given.

Why must government act so forcefully here? Why not simply provide people with the choice by taking the addictive nicotine component out of cigarettes or vaping products? Why do we need outright bans?

There may be a bit of safety with more government action in the short-term, but it is purchased at the price of overall erosion of liberties long-term as the government is more empowered to determine what risks we may assume or ourselves.

Finally, government action is incommensurate with the risks. If vaping were so dangerous to warrant such intervention, wouldn’t tobacco smoking be much more dangerous? If so, why hasn’t anything been done with tobacco smoking? At the very least, legislate in a standard way with respect to risks and harm, not based on alarmism and emotion.

Nicotine Takes Away Individual Choice

The crucial issue here is nicotine and addiction.

Because nicotine takes away the crucial freedom of choice through the illness of addiction, the usual conceptions of rational thinking and free choice are diminished or rendered irrelevant. So let’s try to see the true cause of the problem as nicotine and addiction and not its symptoms in terms of cigarettes and vaping products.

Otherwise, there will be broader consequences for this social engineering and erosion of our system of government, which may be more dangerous long-term than the consequences of nicotine, vaping, and smoking.

Tags
Show More

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button

Adblock Detected

Please consider supporting us by disabling your ad blocker