The US Food and Drug Administration (FDA) has announced a comprehensive new regulatory plan to pursue lowering nicotine levels in cigarettes to non-addictive levels to and create ‘more predictability in tobacco regulation’.

 

This new approach is described by the FDA as ‘a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year road map to better protect kids and significantly reduce tobacco-related disease and death’.

 

The US Food and Drug body claims this new approach will position nicotine and its addictive properties at the heart of the agency’s tobacco regulation efforts in future.

 

FLAVOURS IN TOBACCO PRODUCTS….

It adds that this should ’ensure’ that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.” The FDA has also announced that it is to seek input ‘on critical public health issues’, such as the role of flavours in tobacco products.

 

The FDA claims that tobacco currently accounts for approximately 480,000 American fatalities on an annual basis, plus an estimated $300bn (£228bn) in medical costs.

 

FDA Commissioner Scott Gottlieb, MD commented: “Unless we change course, 5.6m young people alive today will die prematurely later in life from tobacco use.”

 

‘NON-ADDICTIVE NICOTINE LEVELS’

According to its statement, the FDA plan is to open a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.

 

The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.

 

Commissioner Gottlieb added: “Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families.

 

FOLLOWING THE CIGAR DEADLINE APPROACH

“Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”

 

The agency says that to make this successful, it intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of August 8, 2016.

 

It says this will ‘afford the agency time’ to explore clear and meaningful measures to make tobacco products ‘less toxic, appealing and addictive’.

 

As such, the FDA says it plans to develop product standards to protect against known public health risks such as electronic nicotine delivery systems, battery issues and concerns about children’s exposure to liquid nicotine.

 

It is also aiming to provide manufacturers with additional time to develop higher quality, more complete applications, informed by additional guidance from the agency.

 

‘COMPREHENSIVE’ TOBACCO PLAN

The agency plans to issue this guidance describing a new enforcement policy shortly.

 

However, it says that the anticipated 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.

 

“This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” said Mitch Zeller, J.D., Director of the FDA’s Center for Tobacco Products.

 

“Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”

 

Needless to say, virtually all the quoted tobacco companies saw their share prices fall dramatically when this statement was first released on 28 July last week, although all have since more or less recovered.