It’s no secret that the FDA’s requirements for investigational tobacco product (ITP) applications can be confusing. But what if you could unlock the benefits of ITP? In this guide we outline the necessary steps and their potential advantages. Alternatively, you can entrust McKinney RSA with the responsibility, allowing us to manage and build your ITP Application. Collaborating with seasoned partners such as McKinney RSA ensures meticulous and punctual submission of all required paperwork and documentation.

Keep reading to find out more and take the first steps toward unlocking the benefits of ITP Applications!

Introduction to Investigational Tobacco Product (ITP) Applications and FDA Requirements

The FDA requires that all tobacco products be reviewed and authorized before they can be legally marketed or sold in the United States. As part of the data submitted for a marketing decision through the PMTA, MRTP or SE pathways, you may need to conduct a clinical study in the US. The ITP application is the first step in this process. An ITP application is a comprehensive document that includes information about the product, its ingredients, manufacturing process, proposed use in the clinical study and study participants.

The FDA has strict requirements for ITP applications. You need to ensure that your application is complete and follows all relevant regulations. This includes providing detailed information about the product, its ingredients, packaging and labeling, manufacturing processes, clinical study protocol design, and justification for why you are conducting this study in the first place. Additionally, depending on the nature of the clinical study, FDA may require additional information such as marketing research, environmental documentation or literature reviews.

Benefits of Submitting an ITP Application

Submitting an ITP application can be time-consuming and complex. But that doesn’t mean you should shy away from doing it. On the contrary, there are several benefits to submitting an ITP application:

  • You can present your data in the best possible light to support a favorable outcome.
  • It allows you to conduct clinical studies on new products and technologies before marketing them.
  • The FDA will provide feedback on any deficiencies, which can help inform future ITP applications or regulatory filings such as a PMTA submission.
  • It helps protect public health by encouraging research that meets FDA’s standards.
  • It can help you gain a competitive edge by providing supporting evidence for product claims early on in the process.

How to Prepare for Submitting an ITP Application

Navigating FDA’s requirements for ITP applications can be daunting, but with the right preparation you can simplify the process. You need to understand FDA’s regulations and gather the necessary documents for your application. You also need to have everything in place to run the clinical study. Here are some steps to take:

  • Research FDA requirements and guidelines for ITP applications.
  • Develop a timeline of when documents need to be submitted.
  • Gather all the required documents for submission and review them carefully.
  • Ensure that any software used in your clinical study is compliant with FDA regulations and is up-to-date.
  • Design an appropriate protocol for the clinical study that follows FDA’s guidelines.
  • Establish clear rules and regulations to govern the conduct of the clinical trial (including data collection, storage, and reporting).
  • Choose a qualified team to carry out the study and ensure they are properly trained.
  • Make sure all necessary safety measures are in place.
  • Monitor the study regularly and take corrective action as needed.
  • Create a report that includes summary findings and conclusions about the product or technology.

With careful preparation, you can ensure your ITP application runs smoothly and that your study meets all FDA requirements. Taking these steps will help you to take advantage of the latest advances in technology.

What to Expect During an ITP Review Process

Once your ITP application is submitted, it goes through a review process conducted by the FDA. During this process, the agency will assess whether the product or technology meets the requirements. The process typically takes about two to four months, but this is under FDAs discretion.

Tips for Ensuring a Smooth Submission Process

To ensure a smooth submission process, make sure you have all the necessary documents, understand the FDA’s ITP requirements, and understand the benefits of submitting an ITP application.

Common Mistakes to Avoid When Submitting an ITP Application

Many applicants make common mistakes that can cause delays in their application process. Make sure you understand FDA’s requirements, file the appropriate forms correctly, provide all the supporting evidence, and double-check that the information you provide is accurate and up-to-date.

Alternatively, if you prefer a hassle-free experience and would like to avoid potential errors, consider engaging McKinney RSA to handle your ITP application process.


Whether you’re looking to gain access to a new market, develop innovative products, or just make sure you’re compliant with the FDA’s regulations, an ITP application can be a great step in the right direction. Don’t let the process intimidate you; with the right guidance, you can unlock the potential benefits of an ITP application.

Unlock the true potential of your ITP applications with McKinney RSA! Contact us today at 804-461-3208 or email us at to embark on this journey with a reliable partner by your side. Our experts are standing by and eager to assist you in every step of your application process.

We look forward to helping you take the next step in your journey!