The FDA Admits It Is Over-Reaching

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.

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The FDA Admits It Is Over-Reaching by SndChaser is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

May 6th, 2014 by