Guidance on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

Guidance on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

September 21st, 2017 by

On Friday, September 15, 2017, the U.S. Food and Drug Administration (FDA) published revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. What does it mean? Section 905(b) of the Tobacco Control Act requires every person who owns or operates any “establishment” in the United States […]

US regulatory deadline extended

August 15th, 2017 by

The changing face of regulation In recent years, there has been significant international growth for products that deliver nicotine without the requirement to burn tobacco. As a result, there has also been a significant and varied increase in regulation, leading to a marked difference between the way nicotine and tobacco-containing products are regulated and perceived […]

PMTA Bridging Strategy

July 27th, 2017 by

Any company that’s been looking at the amount of product testing required by the Food and Drug Administration (FDA) for Premarket Tobacco Applications (PMTA) will understand just how extensive and expensive this can be. At Nerudia, we have used our extensive experience in the vaping and pharmaceutical industries to develop a Bridging Strategy aimed at […]

PMTA update

May 22nd, 2017 by

Whilst there are still uncertainties around some of the ongoing challenges to the FDA’s Deeming Regulations, many of our clients have realised that they cannot wait any longer and have decided to initiate their PMTA process regardless. Most are aware of the detail and depth of the process, and of the 362 Refuse to Accept […]

FDA announce 3 month extension to compliance deadlines

May 4th, 2017 by

Yesterday the FDA (Food and Drug Administration) announced a 3 month extension to many of the deadlines imposed under the emerging regulations for e-cigarettes. For many companies the extension will provide an additional opportunity to plan their PMTA applications and a gives little potential breathing space. However, as we have previously suggested, these were already very tight […]

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