Jon Dice

I've worked in the nicotine and tobacco industry for over 20 years and have been involved with regulatory efforts at Altria and JUUL for over 10 years. Prior to that I worked as a bench chemist for 10 years in support of R&D and Quality at UST. I worked on the first substantial equivalence (SE) authorizations for Altria as well as helping build out their premarket tobacco product application (PMTA) and modified-risk tobacco product application (MRTPA) programs.

While at  JUUL I worked on the first PMTA submitted in July 2020 and also helped build out their regulatory intelligence infrastructure.

The regulatory landscape at FDA CTP has evolved drastically since 2009 and I see close parallels in evolution between SE process development and what could potentially happen with PMTA process going forward. The current stalemate in the U.S. will not continue forever in my opinion. When the process becomes more predictable, those who embrace integrated product development with superior regulatory and knowledge management will be most successful.

I enjoy building systems in this era of regulatory and litigation uncertainty. This website is an easy way for me to organize my thoughts in a rapidly-changing environment. 

I provide consulting services encompassing various areas:

• PMTA strategy formulation

• Crafting application key messaging

• Developing style guides, along with implementing submission publishing programs

• Generating Investigational Tobacco Product (ITP) applications

• Submitting product listings, establishment registrations, ingredient reports and HPHC reports through TRLM-NG and CTP Portal.

• Establishing a regulatory surveillance program that provide access to an extensive regulatory intelligence database, encompassing thousands of PMTA, MRTPA, and SE application-related documents. 

Feel free to contact me at jon@diceregulatory.com for further information.