How the FDA’s 2018 Roadmap May Impact Vaping

Earlier this month, the FDA released its plan for the year ahead in a document entitled Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap (link). It specifically addresses vaping and already has some in the industry running scared.

Let’s look at what it actually says.

FDA Roadmap 2018: Healthy Innovation, Safer Families

Roadmap Overview

The FDA roadmap is divided into four “strategic policy areas” – yes, that’s the way bureaucrats write. And to show just how well educated they are, the four points are numbered I through IV using Roman numerals:

Working in collaboration with the leadership of FDA’s Centers, we identified the following four priority areas that will be the focus of additional policy activity in 2018:

I. Reduce the burden of addiction crises that are threatening American families

II. Leverage innovation and competition to improve health care, broaden access, and advance public health goals

III. Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease

IV. Strengthen FDA’s scientific workforce and its tools for efficient risk management

I. Reduce the Burden of Addiction Crises

Opiod Addiction

The FDA wants to make it clear that there is more than one addiction crisis in the US, the opiod epidemic being the one that gets the most press and is probably having the most immediate impact on people in our nation. To bring it home, the report notes that “Ninety-one Americans die every day from an opiod overdose.” Opiods are highly addictive and have been inappropriately (over-)prescribed in the past, keeping people on them too long and increasing their odds of becoming addicted.

From 2000 to 2015, the FDA reports that more than a half-million people died from drug overdoses, which averages over 30,000 people per year.  To address this, the FDA wants to reduce the use of opiods and thereby reduce the rate of addiction. And we are talking a very strong addiction, where withdrawal symptoms can be far, far worse than the pain the medication was prescribed for in the first place.

Nicotine Addiction

Here’s where smoking and vaping come into the picture. The FDA specifically calls out “nicotine in combustible cigarettes” as the problem. In 2014, the Surgeon General reported that 480,000 people in the US die prematurely every year because of tobacco use – to put things in perspective, almost that many have died from opiod addiction over 15 years. Yet we tend not to see smoking as a crisis, because smoking and its related other diseases have been with us for so long.

The FDA states that tobacco regulation is one of its biggest opportunities to save lives. (The FDA had no authority to regulate tobacco until the Family Smoking Prevention and Tobacco Control Act was passed in 2009. I don’t know what “family smoking” is but suspect the word family was added to make it easier to sell to legislators and the public.) I don’t think anyone would dispute that reducing tobacco use will save lives.

However, the FDA has some odd ideas on how to address smoking. Rather than ban cigarettes outright or raise taxes on tobacco to make them less accessible, the FDA wants to regulate nicotine in all products that include it. Step one is to push for reducing nicotine content in cigarettes to “non-addictive” levels – a vague term that has not yet been quantified by research (something they should cover in Section IV of the roadmap).

Nicotine is a naturally occurring ingredient in tobacco, and one initial estimate is that reducing nicotine content from the current 10-15 mg per cigarette to 0.5 mg per would make cigarettes non-addictive.

One problem with that proposal is that smokers adjust their level of cigarette use to achieve the level of nicotine they are used to. Smokers switching to reduced-nicotine cigarettes tend to smoke more cigarettes, and thus expose themselves to more of the carcinogens and toxins in burning tobacco, to achieve their desired nicotine kick. If the level of nicotine in cigarettes is suddenly dropped by 90% or more, smokers may well choose to smoke more – a lot more (but probably not ten times more!) to get the nicotine their body craves, doing much more harm to their bodies.

The most likely outcome is that they will look for another source of nicotine, perhaps using nicotine gum or a nicotine patch while smoking “non-addictive” cigarettes. Or they may supplement (or hopefully replace) smoking with vaping.

Perhaps a wiser course would be to slowly reduce the amount of nicotine in cigarettes so smokers don’t suddenly feel the need to smoke a lot more of them to get the nicotine level they desire.  Maybe set a maximum of 10 mg per cigarette this year and reduce it by 1-2 mg per year until they reach that non-addictive level.

The problem is tobacco and its multitude of unregulated ingredients, some of them carcinogens or toxins. Smoking tobacco causes 480,000 deaths per year, and that is likely to remain the case for many more years, whether cigarettes have a lot of nicotine or a non-addictive level of it. Reducing the level of nicotine may make it less likely that new smokers will become addicted, but it won’t make cigarettes any safer. But by targeting nicotine instead of tobacco, the FDA looks like it is doing something beneficial to smokers.

Beneficial to Big Tobacco, perhaps, but not to those who already smoke and continue to do so.

The FDA considers this part of its “comprehensive approach to the regulation of nicotine.” They claim their plan could prevent 8 million premature deaths over the course of the 21st Century – about 100,000 per year – and keep “tens of millions” from becoming addicted to cigarettes.

Helping Smokers Quit

For vapers, the best pair of sentences in the entire roadmap is found on page 3:

Nicotine, while not an entirely benign substance, is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year. It is the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death – not the nicotine.

As part of its “comprehensive approach” to reducing tobacco addiction, the FDA wants to take a fresh look at products that can deliver enough nicotine to help smokers quit. They see a two-fold way to address the nicotine craving that has so long held smokers under its sway:

  1. Medicinal Nicotine Products, such as nicotine patches and gum
  2. Vaping (a.k.a. “electronic nicotine delivery systems” – ENDS in bureaucracy speak)

It’s interesting how the FDA separates these two points in its roadmap. Some vaping sites (example) have read “new medicinal nicotine products and electronic nicotine delivery systems” to mean that vaping would now be considered medicinal, which would imply much higher levels of regulation. I do not read it that way. Go to page 3 and read it for yourself and try to understand exactly what the FDA is saying. Bureacracy speak sometimes deliberately makes things seem vague because of plans to reinterpret them in the future.

Regardless, the next paragraph makes it clear that the FDA wants to “to put nicotine at the center of [its] regulatory efforts.” It started with regulating nicotine gum and patches, is now being extended to the level of nicotine in tobacco products, and aims squarely at electronic nicotine deliverly systems (a.k.a. vaping).

At the same time, the FDA does not want to kill off vaping. The roadmap states,

“In a properly regulated market, these products would be available for adults who want to enjoy satisfying levels of nicotine through routes that may not pose all of the same risks as combusting tobacco.”

And, of course, keeping products containing nicotine away from “kids” – by which I assume the FDA means minors or those not old enough to smoke legally in their state of residence, which is a minimum of 18 years old by federal law, and which many states have raised to 21.

II. Strengthening FDA’s Gold Standard

We’re going to pass over section two, which promotes increasing generic drug competition and thereby keep prices down.

III. Empower Consumers to Make Better and More Informed Decisions About Their Health

The primary focus of this section is on diet, nutrition, and health. Surprisingly, there is no mention of tobacco or nicotine at all in this section.

IV. Strengthen FDA’s Scientific Workforce and Its Tools for Risk Management

This should always be at the center of the FDA’s mission, to do good science related to food and drugs (the F and D in FDA) to the benefit of our general health and wellbeing.

The FDA has grown beyond its original mandate, so there’s more than just food and drugs that they deal with. Tobacco has been on the list since 2009, and cosmetics are also coming under its sway under the label “consumer products”. I have to wonder, shouldn’t tobacco, nicotine, and cosmetics fall under the oversight of the Consumer Product Safety Commission, a different federal agency meant to cover areas not included under food and drugs?

Looking at the Details

If you’re reading the report, don’t skip the big table at the end entitled Key Initiatives, Goals, and Actions. Our federal government sneaks in something not mentioned earlier in the report: e-cigarettes are considered “tobacco products” even when they contain no tobacco.

Don’t you love how bureaucrats can redefine things in completely illogical ways to expand their domain and secure their jobs! While some e-juice is tobacco flavored, most is not. And if you read the points related to nicotine carefully, you will see the following:

  • “protect kids from tobacco products”
  • “Consider through rulemaking a nicotine standard for combustible cigarettes and a framework for addressing flavors in tobacco products to reduce initiation, addiction, and morbidity and mortality associated with smoking” (emphasis added)
  • “Develop tobacco product standards, including standards for the regulation of kid appealing flavors, to reduce youth initiation and use of tobacco products like electronic cigarettes” (emphasis added)
  • “Continue youth-focused tobacco education efforts to reduce youth initiation; expanding FDA’s public service programs aimed at reducing youth use of tobacco, including ENDS” (emphasis added)
  • “Establish a working group with FTC to enforce against manufacturers that advertise kid appealing e-liquid flavors and step up efforts to target marketing of nicotine products to kids.”

It’s all about the kids. Protect them from “tobacco products” – which have been officially redefined to include e-cigarettes. Tobacco-free e-cigarettes and e-juice.

And to add insult to injury, the FDA wants to work with the FTC (Federal Trade Commission, the organization that banned cigarette ads on TV all those years ago) to prevent advertising of “kid appealing e-liquid flavors” and prevent the marketing of nicotine-containing products to kids.

It’s all about the kids, despite the fact that every website selling vaping product requires you to click on a button indicating whether you are of legal age to purchase their product or not. Yes, anyone can lie about that, but that’s on the person clicking the “I am old enough” button, not the company that runs the website.

There is no marketing of vaping to “kids”. The phrase “kid appealing” is broad enough to let an aircraft carrier through. Does the FDA regulate “kid appealing” cereal flavors and candy flavors and soda flavors? Does something being labelled “kid appealing” imply that adults don’t enjoy a bowl of Cap’n Crunch or Fruit Loops? Or that we don’t grab a Dum-Dum every time we’re in the bank making a deposit? And let’s not forget the “kids meals” almost every fast food chain offers, which adults sometimes buy just to get the toy or because it’s a good value?

Why should the government have the authority to tell adults what flavors we can’t enjoy because kids might like them? It’s insane, but in our “it’s all about protecting the kids” culture, we are too often asked to surrender our rights as adults to “protect” them.

But this is ridiculous!

Less Harmful Alternatives

  • “Establish an appropriate regulatory framework for new product innovations that could serve as less harmful alternatives to combustible tobacco, for adults who want to get access to satisfying levels of nicotine. Create a framework to properly evaluate their safety and potential benefits”
  • “Develop a more efficient approach to the regulation of provisional applications and how sponsors establish substantial equivalence for new and currently marketed tobacco products”

The FDA considers e-cigarettes a less harmful alternative to cigarettes, and under its mandate, it has the obligation to evaluate e-cigarettes and e-juice for their safety. (Potential benefits? There’s another vague, undefined phrase for you. But giving up or at least cutting back on combustible tobacco use definitely qualifies as a benefit.)

Best of all for the vaping industry, the FDA want to develop a more efficient approach to handling “provisional applications” for new vaping product, especially e-juice. The currently proposed system is ridiculously expensive and will destroy most of the smaller companies making e-liquid – or give Big Tobacco, which has deep enough pockets and would be able to acquire them for next to nothing when the FDA deadline approaches in 2022, a way to expand into a market others have created.

The sensible thing for the FDA to do would be to test each of the main components found in e-liquid, declare the danger level (if any) for each of them, test the basic components when combined, and separately move on to flavoring, the biggest variable. If each of the ingredients passes muster, they should be willing to approve the product without testing each and every flavor and nicotine level of finished product from each and every e-juice maker in the US and e-liquid imported from around the world.

That will give the FDA more time to focus on other, more important issues than a product that Public Health England promotes as 95% safer than smoking cigarettes and which a recent report supported by the FDA finds beneficial to public health.

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Keywords: #fdaroadmap #vaping #ecigarette #tobaccoproducts

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