FOIA Updates from CTP and How to Evaluate a TPL

March 6, 2024

Freedom of Information Act (FOIA) logs were updated for January and February 2024 and I compiled the relevant nicotine and tobacco-related items on my website. I’ve also written previously on strategies to effectively use FOIA to build a regulatory intelligence program.

It is apparent that FOIA requests are becoming a singularly available (and desperate) part of the regulatory intelligence collection process for manufacturers submitting applications to CTP. This is likely due to the lack of transparency in releasing guidance documents/reviewer memos through other distribution channels and the ongoing litigation for various ENDS product MDOs preventing CTP from acting. This application information is vital for manufacturers to understand the review processes being deployed to evaluate applications at CTP.

Freedom of Information Act (FOIA) requests can be an important component of a comprehensive regulatory intelligence program. Requests can be made to FDA or any other government agency. It is important to craft the request in a way that is specific to a particular data set and that the request is time-bound. Including relevant submission tracking numbers (STNs) can also be immensely helpful in achieving a successful outcome.

By my estimation there were over 30 nicotine and tobacco-relevant new FOIAs submitted and at least 13 closed-out FOIAs in January and February 2024. Several requests were made for the SMOK MDOs issued by CTP on January 16, 2024 as well as the blu PLUS+ MDOs issued on January 22, 2024. Multiple requests for the same information should increase the likelihood of success with these requests.

Among the closed-out FOIAs it seems the FOIA process is becoming slower. The volume of requests to the FOIA Office has increased over the last year. A response time of 6 months used to be the average but some requests from 2022 are recently being fulfilled, indicating perhaps a year of backlog. At some point in the future I will share the FOIAs I’ve received.

What is the goal of requesting FOIA documents and what documents do companies typically FOIA?

There are many reasons to request a FOIA - competitive business and regulatory intelligence, future application input as well as compliance monitoring - and all provide valuable insights into FDA process and procedure. The most commonly requested documents are technical project lead memos, application content, meeting minutes for FDA officials, compliance check reports, CTP reviewer memos as well as regulatory health project manager (RHPM) checklists. All of these documents would be appropriately redacted or outright denied based on certain privilege and confidentiality stipulations.

How to review a FOIA request once you've received it?

Let's take the NJOY ACE Device and Classic Tobacco 2.4% and 5% Tobacco e-liquids technical project lead (TPL) memo for the MGO issued by FDA CTP on April 26, 2022 as an example. This TPL was FOIA'd several times after the initial decision and CTP ultimately published it on the website for the public to review.

There are several key areas to review within this framework of TPL analysis:

• Regulatory Activity - Provides key dates in the regulatory process including submitted date as well as accepted, filed and Deficiency letter issued dates. (page 7 of the NJOY ACE TPL)

• Scope of Review - This review outlines the various compliance and scientific reviews completed including dates. The NJOY ACE TPL went through 2 cycles of review for most scientific disciplines, indicating the data was reviewed again after a deficiency letter response was received. (page 7-8 of the NJOY ACE TPL)

• Comparison Products - While PMTA is not technically a comparative evaluation like SE, it can help to frame the presentation of the PMTA data with comparator ENDS and combustible cigarette product data. (pages 8-12 of the NJOY ACE TPL)

• Scientific Disciplinary Review Summaries - Each scientific discipline provides key finding summaries of their respective reviews in the TPL. In these sections it would be necessary to involve a SME to determine if they have any additional questions related to the science evaluated. From there it might be necessary to further consult the specific science disciplinary reviewer notes (ex. toxicology) if available. These documents can also be FOIA'd with some success. (pages 12-34 of the NJOY ACE TPL).

• Conclusion - The rationale for the determination of appropriate for the protection of public health (APPH) is provided in this section. Typically it summarizes the risk to youth and non-users and sufficiency of product design characterizations among other evaluation data discussed earlier in the TPL across scientific disciplines. (page 35 of the NJOY ACE TPL).