11. The FDA scientific analysis in the draft regulations is biased, naive, inaccurate, arbitrary, and capricious
Arguably the most glaring evidence that FDA is not fulfilling or even pursuing its obligations to
the public is the presentation of the scientific evidence about e-cigarettes in the proposed
regulation and related documents and statements. It is FDA’s job to evaluate the research in an
unbiased manner. But in its presentation of the scientific information, FDA has not adopted the
role of judge, but has inappropriately assumed the role of prosecutor. Evidence is cherry picked
from areas full of legitimate controversy in order to imply greater support for particular
conclusions than an honest review would. Indeed, FDA has even violated the ethical obligations
of a prosecutor, not just emphasizing what it thinks might justify the proposed regulations and
downplaying exculpatory evidence, but actually fabricating claims that tend to support the rules
and hiding evidence that does not.
It is not just the overt bias that is troubling. Evaluation and analysis of the science is required.
FDA is asserting that it has sufficient expertise to regulate businesses and millions of consumers 35
in this sector. Yet it presents scientific evidence in the naive manner of a child writing his first
research paper, treating any assertion that is written down as if it must be correct. CDER would
not regulate based on such naivety, and it is similarly inappropriate for CTP to do so. The
scientific analysis by FDA in and surrounding the proposed regulation falls far short of what is
required for good public policy and what is demanded by White House and OMB directives. It
falls even further short of the standards of evidence demanded by FDA itself of manufacturers of
tobacco products and other goods it regulates.
