May 29, 2014

Stanton A. Glantz, PhD

FDA inappropriately discounts health benefits of regulating ecigs and cigars by 70% because of lost pleasure of smoking

Anna Song, a professor of psychology, Paul Brown, a professor of economics, and I have submitted a public comment detailing why the FDA's decision to discount the health benefits of regulating ecigs, cigars, and other tobacco products by 70% is inconsistent with a large body of scientific evidence. 
The FDA's argument for doing so in the "Regulatory Impact Analysis" is also logically inconsistent with the scientific evidence that the FDA itself presents in the body of the deeming rule.
 
Our public comment is 22 pages long, so I am not including the whole thing in this blog post; you can read the whole comment here.
 
This is the introduction and summary of the comment:

 
Like the cost-benefit analysis that the FDA conducted for its graphic warning label regulation,1 the Preliminary Regulatory Impact Analysis (RIA) for the proposed rule deeming tobacco products to be subject to FDA jurisdiction,{Economics Staff, April 2014, p. 52} the FDA estimated the benefits due to reduced tobacco-induced illness and premature death, and then cut these estimated benefits of these warning labels by 70 percent[1] to account for the cost of lost "welfare" smokers incurred as a result of quitting (and lost welfare would-be smokers would never experience) because of the effects of changes proposed in the new rule. 
 
The RIA presents no empirical justification for this large discount, which, without explanation, was increased from the 50 percent discount in the warning label rule.  Indeed, as discussed in detail below, the RIA ignores extensive evidence, presented in the proposed rule itself,{Food and Drug Administration, 2014, p. 23146 and p. 23159} that the underlying economic concept of consumer surplus upon which this discount is based is not appropriate for analysis of behavior involving tobacco because tobacco use and the associated nicotine addiction almost always begin during adolescence (well before the age of reason) and that nicotine changes the way the brain processes information, and thus, rendering “rational” decision-making models inapplicable.
 
For these reasons, expanded below, the FDA should drop any such discount from the RIA for this rule and all subsequent rules related to the use of tobacco products.

 

[1] This 70 percent discount is presented differently in the RIA as the remaining 30% welfare gain ratio (rather than the corresponding 70 percent discount), on page 52 of the RIA.

 
The comment number is 1jy-8cdp-qb60.

Comments

Comment: 

<dl;
<dt;Dear Dr. Glatz,</dt;
<dt;&nbsp;</dt;
<dt;Why don't you highlight the research showing that tobaco addiction works through negative reinforcement ? People smoke to avoid withdrawal symptoms, which creates an allusion of pleasure ( see sources quoted in PMID:&nbsp;16463194).</dt;
</dl;

Comment: 

Carefully read the comment.&nbsp; That is one of the reasons that consumer surplus does not make sense when applied to tobacco use (nicotine addiction).

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