22nd Century set to try again with very-low-nicotine cigarette Brand A

US biotech company 22nd Century Group has insisted that it plans to resubmit a very-low-nicotine cigarette (VLNC) to the Food and Drug Administration (FDA) by the end of this year, while rebutting criticisms made on an influential investment website.

22nd Century originally filed modified risk tobacco product applications (MRTPs) and premarket tobacco applications (PMTAs) for its “Brand A” product at the end of 2015 but withdrew them a year later.

It said then it had received helpful advice from the FDA, and now it intends to put Brand A forward for approval again.

The product, which is a cigarette made from tobacco but containing “95% less” nicotine than typical combustibles currently on the market, would have to pass through the PMTA process in order to be sold in the US at all.

Successfully completing the MRTP process, which is regarded as much more difficult, would allow Brand A to be marketed overtly as a reduced-risk product.

Read full article
I'm already a subscriber

Barnaby Page

Editorial director
Before joining ECigIntelligence in early 2014 as one of its first employees, Barnaby had a 30-year career as a reporter and editor for newspapers, magazines and online services, working in Canada, the US and the Middle East as well as his current British location. He has edited publications covering fields including technology and the advertising industry, and was launch editor of the first large daily online news service in the British regional media. Barnaby also writes on classical music and film for a number of publications. Barnaby manages the editorial and reporting teams and works closely with the analyst teams, to ensure that all content meets high standards of quality and relevance. He also writes for the site occasionally, mostly on science-related issues, and is a member of the Association of British Science Writers.

Our Key Benefits

The global e-cigarette market is in an opaque regulatory environment that requires professionals to be on top of industry developments to make informed decisions and optimise their strategy.

ECigIntelligence provides organisations with leading market and regulatory data analysis to anticipate and understand market developments globally and the impact of regulatory changes to the business.

  • Stay informed of any legal and market change in the sector that impacts your organisation
  • Maximise resources by getting market and legal data analysis daily in one place
  • Make smart decisions by understanding how the regulatory and market landscape evolves
  • Anticipate risks in your decisions by monitoring regulatory changes that impact your organization