FDA Releases Draft Guidance on Nonclinical Testing of Nicotine Products

August 15, 2018

On Friday, August 3rd, the FDA released a new draft guidance regarding nonclinical testing of orally inhaled nicotine-containing drug products. The draft guidance focuses on providing the nonclinical information needed to develop products for smoking cessation.

Recommendations for Nonclinical Development

According to the recently issued document, nonclinical toxicity assessments should include:

  • General toxicity studies
  • Developmental and reproductive toxicity studies
  • Assessments on carcinogenic potential
  • Toxicokinetic and pharmacokinetic studies
  • Genetic toxicology studies*

*Genetic toxicology studies may be necessary depending on the tobacco use and smoking status of clinical trial subjects.

Nicotine Replacement Drug Therapies

In a statement that the Agency issued to accompany the draft guidance, FDA Commissioner Scott Gottlieb, M.D., commented on the development of novel nicotine replacement drug therapies to help smokers quit cigarettes. Specifically, Dr. Gottlieb states: “we’re working on multiple fronts to recognize the role that more novel forms of nicotine delivery could play in achieving our public health goals, as part of an appropriately regulated marketplace. This not only includes encouraging innovation of potentially less harmful tobacco products for those adults who still seek to use nicotine (such as e-cigarettes), but also taking a closer look at our overall approach to the development and regulation of NRT products that are regulated as drugs, and designed to safely reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.”

This draft guidance is the first of two that will provide information for sponsors interested in developing new inhaled nicotine replacement therapies. The second guidance is expected sometime this fall and will address alternative treatment regimens as well as clinically relevant outcomes for smoking cessation products.

FDA is accepting public comment on this draft guidance for up to sixty days following the announcement of its availability in the Federal Register.

Are you in the process of developing a tobacco product or do you already manufacture a tobacco product that is subject to FDA’s regulations? We are leaders in the developing category of tobacco related submissions.  To learn more about our services and how we can help your product successfully move through FDA, contact us today.


October 29, 2015

FDA Guidance: Nonclinical Safety Evaluation of Reformulated Drug Products & Products Intended for Administration by an Alternate Route

Published on October 27, 2015, the guidance document outlines a number of recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route...

November 19, 2015

FDA Holds Public Workshops to Discuss Regulatory Strategies for Next Generation Sequencing Diagnostics, Part 2

As we discussed in previous FDA News articles (here and here), the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s...

February 3, 2017

FDA Releases CDER’s 2017 Guidance Agenda

Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...