June 2016

The staff at the White House Office of Management and Budget (OMB) made substantial changes to the final "deeming rule" that exerts FDA's authority to regulate all tobacco products including e-cigarettes, cigars, cigarillos, hookahs and other novel tobacco products.  As part of the transparency-in-government effort, the White House regularly releases the "redline" version of major final regulations that show what last minute policy changes were made by the White House beyond what was proposed by the regulating agency.

Prior to the policy changes by the White House, the FDA Center for Tobacco Products drafted the final rule to remove all flavored e-cigarette products from the U.S. market within 180 days of the final rule.  E-cigarette products could not return to the market until these products had undergone FDA premarket review and approval.  The rule drafted by the FDA Center for Tobacco Products included extensive justification for this decision, including the dramatic 10-fold increase in e-cigarette use in high school kids reporting using e-cigarette in the past 30 days from 2011 (1.6 percent) to 2015 (16 percent).  Both the decision to remove the flavored e-cigarettes from the market and the justification for such a policy decision were struck by the White House from the final rule.

The decision to strike immediate regulation of e-cigarette flavors from final rule does not preclude FDA from regulating e-cigarette products through the product review powers.  However, it does likely add three years to the process of the FDA reaching such a decision.

The ATS is extremely disappointed in the White House's decision to strike immediate regulation of flavored e-cigarette products from the final deeming rule.  The ATS will continue to urge the White House and FDA to take immediate regulatory action on all tobacco products.