Fontem US LLC Submits Premarket Tobacco Applications for myblu Electronic Vaping Products

Fontem US LLC (Fontem US) today announces that it has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its myblu electronic vaping products.

Metadata
Provider: 
Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Tuesday, April 28, 2020
Information
Tags: 
FDA, Health, Retail, Tobacco, Clinical trials, Cigarettes, Tobacco, Electronic cigarettes, Smoking, Electronic cigarette, blu eCigs, Food and Drug Administration
Geotags: 
North Carolina, United States
⚠ generated by AI ↴
Organisation: 
FONTEM US LLC
Summary
Key Points: 
  • Fontem US LLC (Fontem US) today announces that it has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its myblu electronic vaping products.
  • Fontem USs blu products play a fundamental role in the companys goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products.
  • Fontem US believes the evidence provided shows that blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA.
  • Fontem US now awaits the FDAs review of the applications and will provide additional information sought by the agency as part of the PMTA process.


Fontem US LLC (Fontem US) today announces that it has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its myblu electronic vaping products.

Fontem US’s blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products.

The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.

Fontem US believes the evidence provided shows that blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA. Fontem US now awaits the FDA’s review of the applications and will provide additional information sought by the agency as part of the PMTA process.

“We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem US. “Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”

About Fontem US LLC

Designed for smokers, by smokers, blu is a trusted leader of adult consumer satisfaction. blu products are available online and in stores across the U.S. market. Fontem US LLC is an affiliate of ITG Brands. To learn more about ITG Brands please visit www.itgbrands.com.

Copyright: 
Copyright Business Wire 2020