The Long Road to Tobacco Regulatory 'Deeming'
June 24, 2009
President Barack Obama signs the Family Smoking Prevention and Tobacco Control Act into law, creating the FDA Center for Tobacco Products (CTP) and granting the agency authority to regulate tobacco products.
April 24, 2014
The CTP announces its proposed 'deeming' regulations to expand the agency’s regulatory authority over cigars, pipe and hookah tobacco, e-cigarettes and alternative tobacco products.
Aug. 8, 2014
The public comment period on the proposed 'deeming' regulations comes to a close, with more than 135,000 comments submitted to the FDA.
Oct. 20, 2015
The FDA submits its revised final 'deeming' regulations to the White House Office of Management & Budget for final review and approval.
April 19, 2016
The House Appropriations Committee passes the Cole/Bishop Amendment, which would move the predicate product date from February 2007 to the date the FDA 'deeming' regulations go into effect.
May 5, 2016
The final 'deeming' rule is published in the Federal Register and announced to the public by the FDA.
Aug. 8, 2016
The 'deeming' rule goes into effect. Immediately, newly deemed products cannot be sold to anyone under 18, given away as samples or sold in vending machines (unless in an age-restricted location). Any products launched after this date will require FDA approval before going to market.
Feb. 8, 2018
Substantial-equivalence (SE) applications for newly 'deemed' products are due to the FDA. Products can remain on the market while the agency reviews applications.
Aug. 8, 2018
Premarket tobacco applications (PMTA) for newly 'deemed' products are due to the FDA. Products can remain on the market while the agency reviews applications.