My Public Comment to OIRA on FDA Deeming Regulations

This morning, I met with several staff of the Office on Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) of the White House Executive Office to provide feedback on the proposed FDA deeming regulations for electronic cigarettes (RIN#0910-AG38). I am grateful for having had the opportunity to share my analysis of the regulations as pertaining to the provisions of Executive Order 12866, which outlines the criteria a regulation must meet in order to be approved by OIRA.

The OIRA staff was very interested in my analysis and appreciative of the insights I was able to provide, especially as they related to the specific provisions of Executive Order 12866 which I believe the deeming regulations violate.

The Rest of the Story

Here is a link to my public comment. It may be helpful to others as it articulates the specific provisions of Executive Order 12866 which I believe the FDA deeming regulations violate.

Please note that OIRA cannot disapprove the regulation and return it simply because it disagrees with the approach. There are specific criteria that the OIRA must follow in its review, and these are outlined in the Executive Order.

In particular, I believe that the deeming regulations are in violation of the following sections of Executive Order 12866:

• 1(b)(5) 
• 1(b)(6)
• 1(b)(8)
• 1(b)(11)
• 1(b)(12)

In my public comment, I explain each of these violations in detail, based on my scientific analysis of the deeming regulations.