The FDA Admits It Is Over-Reaching


The FDA Admits It Is Over-Reaching

The FDA Admits It Is Over-Reaching

I have to say this first: I have not had the time to read through the complete proposal sent forward by the FDA.  I do advocate that everyone who is going to comment on this situation should actually read the actual proposal.  And, bear in mind, it is still a proposal.  It is not law, it is not legislation.  It is a proposal to extend the FDA’s power to allow them to regulate another class of products that are on the market.  It is, on this basis, that I believe the FDA is over-reaching.  And, even the FDA admits it is over-reaching.

The FDA Is Over-Reaching

So, how is it that I believe the FDA is over-reaching?  Well, if you read Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements [PDF] (yes, that is the complete, formal title of the proposal) you will find a few statements regarding electronic cigarettes:

Recent years have seen the introduction of new nicotine-containing products, such as electronic hookahs, “vape sticks,” and electronic cigarette liquids with fruit and candy flavorings that are not currently covered under FDA’s regulatory authorities. (Section I B, Page 11)

And most tellingly:

Because tobacco products contain nicotine—an addictive substance (Ref. 2 [HHS, 1988])—their regulation is consistent with policy recommendations derived from economic models of addiction (examples include Gruber and Köszegi [Ref. 4, 2001]; Bernheim and Rangel [Ref. 6, 2004]; and Gul and Pesendorfer [Ref. 8, 2007]). (Section I B, Page 10)

That last quote is, in essence, the single biggest over-reach in the document.  It is, in fact, a logical fallacy — a form of bad logic.

Bad Logic and Fallacies

The reasoning the FDA is using in this report, plain and simply false.  And, I will show in a moment that even the people behind the report from the FDA recognize that they have bad logic in this proposal.

But, quickly, let’s explain what a logical fallacy is.  Quite simply put, it’s a series of statements that imply a relationship, however when the two statements are related to each other, the conclusion is false.  Take the following example:

  • Water evaporates;
  • Humans contain water:
  • Therefore humans evaporate

Clearly, that isn’t true.  We don’t actually evaporate just because we contain a high percentage of water in our bodies.  This is the kind of bad logic that I quoted above, the logic works something like this:

  • Tobacco contains nicotine,
  • e-Cigarettes contain nicotine:
  • Therefore e-Cigarettes are Tobacco.

Now, that is an egregious error in this proposal.  There are lots of other plants that contain nicotine, such as chocolate.  Does this mean chocolate is tobacco, and therefore should be regulated under this proposal? (You know, the more I think about it, maybe chocolate should be regulated given how many people are addicted to it. )  I doubt anyone at the FDA would ever take that statement seriously, in fact I would hope they would laugh at that suggestion.  However, based on the bad logic they have presented that is exactly what they are proposing, if their false logic goes unchallenged.

The FDA Admits It Is Over-Reaching

There is an interesting footnote to Table 16 that is quite telling:

If there is no valid predicate tobacco product for e-cigarettes, the number of products or UPCs on the market under the proposed rule would depend on the number of marketing authorizations obtained through premarket tobacco applications. (Sect II B2, Table 16, Page 26)

They are admitting here, in somewhat obscure language, is that they don’t really know (or think) that it is a valid argument to classify e-Cigarettes as a Tobacco Product.  The fancy wording “no valid predicate” means that there has not been a product brought to market like e-Cigarettes before.

What Next?

This is, in my opinion, the greatest argument that we have against this FDA proposal.  It is based on bad logic, and even the FDA knows that it is not a valid argument.

Logical fallacies are easy to explain. They are easy to message.  Politicians, the press, and the general public will understand this argument.  We make jokes using logical fallacies all the time, and people get it. (Think recently about a Saturday Night Live skit that centered on e-Crack Pipes…that was obviously based on a fallacy, and a lot of people thought it was funny.)

We need to make a concerted campaign around the lack of logical arguments for this classification of e-Cigarettes and Vaping/  We need to make it clear that the classification of e-Cigarettes and Vaping in this group of products is based on bad and false logic.

16 thoughts on “The FDA Admits It Is Over-Reaching

  1. I haven’t been able to find any information about chocolate containing nicotine. Though it is in tomatoes, potatoes, eggplants, and cauliflower. Just curious about where you found that information. The article in general though I agree with entirely.


    • The reason why is because theyou don’t have to disclose it. Because when products are approved by FDA it’s not necessarily means you have to disclose all ingredients. This is a facts proven base on FDA regulations. Why do you think there will be a change on disclosing ingredients on leveling by next year because somebody/ someone had push for it. You can always go to FDA sire for this information.


      • Yzell,

        I’m not certain I understand how the labelling of juices relates to the argument the FDA are presenting for the classification of e-Cigarettes as tobacco products. In fact, although I haven’t gone through the proposal closely enough to be certain of this, it would seem that they are proposing that the ingredients be listed even if e-Cigarettes are classified as a tobacco product.


  2. Unfortunatly right and wrong will not figure in whether these proposals go through.
    the largest legal team will dictate it,and you can bet your bottom dollar the fda (with big tobacco and pharmas backing) will have a sizeable one.


    • Actually, in this case since we are talking about the FDA and Congress, it’s not really so much about lawyers as it is about money. But there is still place for popular opinion – no politician will want to pass new legislation that causes them to lose power (aka their job, which is the source of power and money).

      That’s the underlying truth of all of this. But our in for fighting this is through the proposal itself. So, we still have a chance to take this on by poisoning the well, so to speak.


  3. Unfortunately you’re incorrect in believing the FDA is using a logical fallacy in deeming e-cigs. The FDA is calling e-cigs a tobacco product not because they contain nicotine but because they contain nicotine DERIVED from the tobacco plant. If you look up the definition of TOBACCO PRODUCT you will see it’s a pretty broad definition. The real fallacy is in that definition it would be more like calling a piece of paper a tree because it has tree pulp in it. Is the FDA over reaching yes but its not as big a reach as most would think. The definition of TOBACCO PRODUCT is what needs to be changed.


    • No, I am not incorrect in my reading of the proposal as it is submitted. One of the things I have learned over time is to not add things that are not stated with the scope of a document. This is the way trial lawyers proceed when trying a case, they do not add anything to a line of logic or a line of questioning. They only make statements for everything that they know an answer to. The same needs to be done when examining this proposal. It needs to be treated on the same level as a legal document, therefore adding context for things that aren’t presented within the document is a dangerous thing to do.

      This is why I’ve stated in a couple of places I couldn’t talk about the portion of the document that refers to nicotine as an addictive substance. Those sections reference other documents that I do not have immediate access to. Until I have access to those documents, and can put the references within the context of the proposal I won’t speculate.

      I don’t disagree with your larger point. The idea that e-Cigarettes would be classified as tobacco products based on the idea that they have a single common ingredient in common is quite ridiculous. The idea that cigars can somehow side-step the classification of a tobacco product is even more ridiculous. Yes, we need to examine the classification of e-Cigarettes as tobacco products as part of this battle. However, that doesn’t nullify the logical fallacy at play within the document, and that needs to be dealt with.


  4. Also chocolate, eggplant and tomatoes produce their own nicotine and it’s not derived from any part of the tobacco plant and that’s why those things, while yes containing nicotine, are not considered tobacco products.


    • Everyone seems to get hung up on the fact that I pointed to chocolate. 🙂 My only point there was to use it as an example, not to make it some substantial part of the argument. The main argument still stands even if you leave that part out, and just use the first fallacy I present about the human body and water.


  5. First off thanks for the info. How can we have the vapor community understand the power in larger numbers will get Congress to take a second look at passing something ridiculous.


    • This is where we need to work with groups like CASAA, local vaping groups, etc. to organize, put together petitions, get stories into the press, contact representatives, submit feedback to the FDA etc.

      There’s a lot of things we can do, I will be writing about them soon.


  6. Consumer Advocates For Safer Alternatives Association (
    First Call to Action for FDA Proposed Regulations – Consumer Request for an Extension of Comment Period

    “On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations. This is the first of several Calls to Action anticipated in CASAA’s Action Plan. (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)

    FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate.

    The First Call to Action is for CONSUMERS to request a 105-day extension of the comment period, requesting a total of 180 days to make comments. We understand that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

    We have prepared a suggested letter–which we encourage you to edit to accurately reflect your views and circumstances–along with instructions on how to request the extension. (Please note that submitting this request will not prevent you from later offering a substantive comment, and should not affect your subsequent comment in any way.)”


    • Hi Lisa,

      Thanks for the update. CASAA hadn’t posted that last time I looked. I am glad they have finally come out swinging with a call to action that we can all follow!


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