November 11, 2013

Stanton A. Glantz, PhD

White House held up release of FDA scientific report on menthol for a year

Public health advocates have, for a long time, felt that the Obama White House intervened to slow down FDA action on menthol.  Heavily redacted documents recently released under the Freedom of Information Act shows that the White House, operating through it Office of Management and Budget (OMB), did delay release of the FDA’s scientific report on menthol for over a year, until well after the 2012 election.
The report was complete by late 2011 and the documents indicate that FDA was ready to release it in the first half of 2012.

Emails show two active rounds of correspondence between FDA and OMB.  The first round in May and June 2012 strongly suggests that FDA was ready to release the report in May 2012 and was not sure if the report required OMB approval. (Timeline)

OMB indicated it would need to review the report.  FDA attempted to push back, but OMB did not budge.  There are records of calls between OMB and FDA on this topic, but it does not appear that the report was submitted to OMB in 2012.

The correspondence then goes blank for the rest of the year and restarts in January 2013

The report was finally submitted to OMB in February 2013 and came out in July 2013.

The FDA has announced that it is now accepting public comment on what steps to take regarding menthol, with the public comment period closing November 22, 2013.

As I have noted before, the FDA should simply prohibit use of menthol (and menthol analogs) in cigarettes and, once it has won jurisdiction, other tobacco products.

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