The FDA can neither reduce nicotine levels to zero, nor can it ban cigarettes.
Over the next few months, the FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts-and we believe it's vital that we pursue this common ground". Eric Donny, a University of Pittsburgh researcher on smoking and nicotine, told the Houston Chronicle that lower nicotine levels won't cause people to smoke more. Setting a "non-addictive" threshold might prove impossible, especially since some smokers inhale more nicotine from the same cigarette while others metabolize slower.
Jamie Hartmann-Boyce, an expert at Britain's Oxford University and at the Cochrane Tobacco Addiction Group who was not involved in the BMJ research, said the findings suggested e-cigarettes may prove a useful tool in bringing tobacco use down.
Richmond, Va. -based Altria Group Inc. called the FDA's move "an important evolution in the agency's approach to regulating tobacco products and a meaningful step forward in developing a comprehensive regulatory policy that acknowledges the continuum of risk".
British American Tobacco shares, trading close to all-time highs, fell 6.8 percent to post their biggest one-day loss in nine 9 years. The whole plan is a result of regulatory powers given to the agency in 2009.
The new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. Approval of the application is expected late in 2017 and sets the stage for BRAND-A to become the first approved tobacco product on the market that complies with the new guidelines. It plans to frame rules combining safety with e-cigarettes' role to help smokers give up smoking.
In addition, regulations that outline the details on the information the agency expects to be included in the Modified Risk Tobacco Product (MRTP), Premarket Tobacco Applications (PMTAs), and reports to demonstrate Substantial Equivalence (SE) are meant to be released by the agency. The FDA says it intends to develop product standards to "protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children's exposure to liquid nicotine".