THE JONES LABS ANNOUNCES ACCEPTANCE OF REGULATORY SUBMISSIONS BY THE U.S. FOOD AND DRUG ADMINISTRATION

THE JONES LABS ANNOUNCES ACCEPTANCE OF REGULATORY SUBMISSIONS BY THE U.S. FOOD AND DRUG ADMINISTRATION

 

Applications Request Approvals for Pre-Market Authorization and Modified-Risk Tobacco Product Authorization of Marketing Orders

 

The Jones Labs, Inc. today announced that a Pre-Market Tobacco Authorization (PMTA) and a Modified-Risk Tobacco Product Authorization (MRTPA) for The Jones product family has been accepted for filing and review by the U.S. Food and Drug Administration (FDA). The Jones product family is being evaluated for safety and efficacy as alternatives to combustible cigarettes and their comparable safety to smoking the Harmful or Potential Harmful Constituents (HPHCs) of combustible cigarettes.

 

As a leader of Pre-8/8 compliance, The Jones Labs registered with the FDA in July 2016 in preparation for Electronic Nicotine Delivery System regulations. Although electronic cigarettes and vaping are strictly recreational activities, at The Jones Labs their potential as Electronic Drug-Delivery Systems remains the core of our technology. Due to our record of compliance with the Center for Tobacco Products (CTP), our products are eligible for enforcement discretion until our application process has been completed.

 

The core technology of the submissions is discussed in a Buffered Aerosol Drug-Delivery, A Review article published in the inaugural edition of the United Journal of Drug Development and Industrial Pharmacy. The technology submitted for review is being further developed in parallel to address other cessation and medicine-assisted therapeutic needs in the market. With this unique drug-delivery platform technology they stand to disrupt the established order of all smoking and smokeless products, cannabis or tobacco. 

 

https://unitedpharma.us/current-issue-drug-development-industrial-pharmacy/

https://unitedpharma.us/wp-content/uploads/2021/01/DD_02_final.pdf

 

The Jones Labs, Inc. offers universally compatible tobacco vapables as an alternative to smoking combustible cigarettes. With multiple present and future product offerings similar to The Jones Pods (www.thejonespod.com), we are developing rise. By The Jones (www.risebythejones.com), a state-of-the-art smoking cessation platform that utilizes the core technology for replacement and cessation therapies across the board.

 

About Smoking-Related Diseases

 

1.1 billion people are addicted to cigarettes. Roughly 480,000 Americans and 8,000,000 people worldwide die every year from smoking related diseases. The current options for cessation are expensive, complicated, and insufficient. Relapse rates in most cases are between 60-90%.

 

Isn’t it time for a solution that actually works?