FDA Aims to Reduce Tobacco-Related Disease & Death with New Plan for Tobacco & Nicotine Regulation


FDA Issues New Regulatory Plan for Tobacco & Nicotine

On Friday, July 28, 2017, the FDA released a new, comprehensive plan concerning the regulation of tobacco and nicotine.  This multi-year regulatory plan is part of the Agency’s attempt to protect children against tobacco and nicotine use, and to significantly reduce the prevalence of tobacco-related disease and death.

Leading Cause of Preventable Disease & Death in the US

Tobacco use is responsible for more than 480,000 deaths each year in the United States, making it the leading cause of preventable disease and death.  In addition to the health risks posed by cigarettes, the FDA stated that the financial burden caused by tobacco use and cigarette smoking (due to the direct health care and lost productivity costs) totals almost $300 billion each year.  As such, in its recent press release, the Agency notes that a key component in its new plan is “demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”

Path to Drug Development & FDA Approval in the US

FDA’s New Regulatory Plan

Decreasing Nicotine Addiction Among Future Generations

Nearly 90% of adult smokers began smoking before the age of 18.  Furthermore, every day in the US, about 2,500 children under the age of 18 smoke their first cigarette.  As such, the FDA feels that “lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.”

The FDA plans to engage the public in a dialogue focused on lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.  The FDA states that it will issue an Advance Notice of Proposed Rulemaking (ANPRM) on the topic, which will open the floor to the public and allow the FDA to gain “input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.”

The FDA states that nicotine is both the problem as well as the solution with regards to addiction, and it feels as though addressing the addictive levels of nicotine in combustible cigarettes must be part of its strategy for addressing the issue of addiction that is threatening American families.  Furthermore, Scott Gottlieb, MD, FDA Commissioner, states that the Agency’s 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.’

Encouraging Innovations to Protect Children & Encourage Smokers to Quit

“The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes.”  In an attempt to guarantee that this effort is a success, the FDA will be extending the timelines for the submission of tobacco product review applications for newly regulated products on the market as of August 8, 2016.  Extending the timeline for submission will give the FDA the necessary time to “explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive.”

FDA states that applications for newly-regulated combustible products (i.e., cigars, pipe tobacco, and bookah tobacco) must be submitted to the Agency by August 8, 2021.  Applications for non-combustible products (i.e., ENDS, e-cigarettes) have an additional year, and should be submitted to the FDA by August 8, 2022.  While the Agency is reviewing product applications, the FDA states that it expects that products would continue to be marketed.

Coming Soon: FDA Guidance

The FDA plans to issue a guidance document describing the new enforcement policy.  Although the Agency did not provide a time frame in which to expect this new guidance document, it states that it will be coming shortly.

The FDA emphasizes that the new enforcement policy will impact only the newly-regulated tobacco products such as cigars and e-cigarettes; it will not affect the current requirements for cigarettes and smokeless tobacco.  “This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.”  Additionally, the new policy will not affect future deadlines for other provisions of the rule, including, but not limited to, the following:

  • Required warning statements
  • Ingredient listing
  • Health document submissions
  • Harmful and potentially constituent reports
  • Removal of modified risk claims (i.e., “light,” “low,” or “mild”)

Additional ANPRMs to be Issued

In order to gain public input on significant topics, the FDA plans to issue the following ANPRMs:

  1. “Seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery.”
  2. “Solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule.”

“Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.”

FDA to Issue Foundational Rules

In order to make the review process as efficient, predictable, and transparent as possible for manufacturers, the Agency plans to issue foundational rules relating to these policy considerations.  “Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.”

For additional information on the FDA’s new regulatory plan concerning tobacco and nicotine, view FDA’s press release.