June 29, 2017

Dear Congressman Sanford Bishop and Tom Cole:

On behalf of more than 3.2 million Americans for Prosperity activists in all 50 states, I write in strong support
of your bill H.R. 1136 the FDA Deeming Authority and Clarification Act of 2017. This bill would change the
predicate date on the FDAs deeming rule and grant relief from unnecessary and expensive regulations that will
crush small businesses.

The FDAs deeming rules, which expand the FDAs authority to regulate everything from cigars to e-cigarettes,
are not only overly burdensome and costly but are also hopelessly outdated. This rule sets the predicate date
at February 15, 2007 meaning that all products not on the market on this date would have to undergo a
premarket review process as if they were new products. This arbitrary cutoff date is misguided and makes little
sense given that these products are currently on the market with few problems. Additionally, by the FDAs own
admission this process will take 5000 hours and costs a minimum of $330,000 to complete per product for e-
cigarette products.

This backward looking predicate date will, by FDAs own estimate, essentially ban 98.5 percent of e-cigarettes
on the market. Similarly this deeming rule would be excessively burdensome for the hand premium industry.
Although the FDA had considered exempting the premium cigar market, the FDA ultimately decided to not
grant an exception and as a result, the final rule will be destructive for an industry that is primarily comprised of
small local businesses. The deeming rule will force a cigar maker to go through the arduous and expensive
premarket review process every time it changes blend change even though they pose no additional risks to
consumers.

Like many other government regulations, they favor entrenched interests at the expense of small businesses.
With such expensive costs to get a new product approved, only large companies with millions of dollars will be
able to bring new products to market. Meanwhile their smaller competition will be crushed by this regulation
and thousands of small businesses will close.

Congress has made it a priority this session to peel back many of the harmful regulations passed during the
Obama administration and Congress should make reforming the predicate date a similar priority. AFP urges you
to support the FDA Deeming Authority Clarification Act of 2017 as well as any other legislation or amendment
which would grant relief from the predicate date. We appreciate your consideration, and we look forward to
working with you.

Sincerely,

Brent Gardner, Vice President of Government Affairs

Americans for Prosperity
Americans for Prosperity (AFP) exists to recruit, educate, and mobilize citizens in support of the policies and goals of a free society at the local, state, and
federal level, helping every American live their dream especially the least fortunate. AFP has more than 3.2 million activists across the nation, a local infrastructure
that includes 36 state chapters, and has received financial support from more than 100,000 Americans in all 50 states. For more information, visit
www.AmericansForProsperity.org.
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