INTRODUCING THE FDA DEEMING AUTHORITY CLARIFICATION ACT OF 2015; Congressional Record Vol. 161, No. 62
(Extensions of Remarks - April 28, 2015)

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[Extensions of Remarks]
[Page E596]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


    INTRODUCING THE FDA DEEMING AUTHORITY CLARIFICATION ACT OF 2015

                                  _____
                                 

                             HON. TOM COLE

                              of oklahoma

                    in the house of representatives

                        Tuesday, April 28, 2015

  Mr. COLE. Mr. Speaker, today I rise to introduce legislation, the FDA 
Deeming Authority Clarification Act of 2015, to make a technical change 
to the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The 
Family Smoking Prevention and Tobacco Control Act provides the 
framework for the Food and Drug Administration (FDA) to regulate 
tobacco products and products with nicotine derived from tobacco.
  Under the FSPTCA, the FDA was provided immediate regulatory authority 
over cigarettes, smokeless tobacco, and roll-your-own tobacco. Further, 
the FSPTCA allows FDA to regulate other tobacco products through a 
regulatory process.
  The issue that my legislation seeks to remedy relates to a specific 
date--the predicate/grandfather date of February 15, 2007. The FSPTCA 
specifies that any cigarette, smokeless tobacco or roll-your-own 
tobacco product that was in the market before February 15, 2007 is 
grandfathered and can stay on the market without manufacturers 
submitting applications to FDA approval, but FDA is still able to 
regulate these products.
  Manufacturers making changes to grandfathered tobacco products or 
introducing new tobacco products after this date are required to file 
an application with the FDA.
  Further, a manufacturer is able to file a more abbreviated 
substantial equivalence application if the manufacturer can demonstrate 
that the modified or new tobacco product is substantially equivalent to 
a tobacco product that was on the market before this grandfather date. 
For this reason, this date is doubly important because it serves as 
both the grandfather date and the predicate date.
  The FSPTCA further lays out that any products that came to market 
between February 15, 2007 and the date of enactment (June 22, 2009), or 
during the following 21 months (before March 22, 2011) were permitted 
to stay on the market, but the manufacturer was required to file a 
substantial equivalence (SE) for those products before the end of this 
transition period.
  Finally, no product may be brought to market after this transition 
period without authorization from FDA.
  Questions may be raised as to why the so-called predicate/grandfather 
date of February 15, 2007 was picked in the Act. If you look at the 
legislative history, February 15, 2007 was the date the Act was 
introduced in the 110th Congress. There was no other specific reason 
for the date chosen in the Act. Moreover, the 2007 date reflects the 
predicate/grandfather date for those immediately regulated products--
not for products that FDA could choose to regulate at a later time.
  On April 25, 2014, FDA released its proposed deeming regulation, 
which would grant authority for the agency to regulate cigars, vapor 
products and other products with nicotine derived from tobacco.
  However, in the proposed rule, the agency stated it would maintain 
the February 15, 2007 as the predicate/grandfather date for newly 
deemed products even though the FDA has the regulatory discretion to 
choose a different date. Notably, the FDA provided for a two-year 
transition period, similar to the 21-month transition period contained 
in the Act.
  The FDA claims that it lacks the legal authority to change the 
February 15, 2007 date even though it has used regulatory authority to 
make a number of decisions that were not spelled out in the initial 
Act. The agency should apply that same authority to altering the 
predicate/grandfather date for newly deemed tobacco products, while 
maintaining this important transition period.
  Should the agency choose not to alter the date, the February 15, 2007 
predicate/grandfather date will make it costly and create significant 
barriers for the industry and the FDA to bring innovative new products 
that may significantly reduce the harms associated with tobacco to 
market, and could force the withdrawal of many products that have come 
to market since February 2007.
  The end result will be that newly deemed tobacco products would be 
treated much more harshly than immediately regulated products. 
Specifically, the ``look back'' period for cigarettes, smokeless 
tobacco and roll-your-own tobacco products was two years (June 2009 to 
February 2007) while the period for newly deemed products would be 
eight years (June 2015 to February 2007) if FDA meets its June 2015 
target to publish a final deeming rule, and perhaps longer if FDA does 
not publish its final rule in time.
  It makes no sense that immediately regulated products--which Congress 
decided were most in need of FDA regulation--get such an advantage over 
later regulated products.
  In addition, applying the February 2007 predicate/grandfather date to 
newly deemed products or failure to provide for a transition period 
will immediately and dramatically add to FDA's enormous backlog of SE 
applications, which stands at thousands to date.
  Even though the FDA already has this authority, the legislation I 
introduce today will underscore that FDA should choose a new 
grandfather/predicate date each time the agency deems new tobacco 
products. Specifically, the bill would make the grandfather/predicate 
date for newly deemed tobacco products the effective date of the final 
rule and mimic the 21-month transition period provided for cigarettes, 
smokeless tobacco and roll-your-own tobacco.
  Accordingly, on the crucial issue of path to market, later regulated 
products would be treated no better and no worse than immediately 
regulated products.

                          ____________________