May 5

UPDATE: FDA defers enforcement of all future PMTA compliance deadlines!

FDA Announced on 3rd May, 2017 that all outstanding compliance deadlines for PMTA have been extended by 3 Months 

The FDA have extended the 30th June 2017 Deadline for registering your products and establishment for the PMTA by 3 months. This leaves the new deadline as 30th September 2017.

On May 10th, 2016, FDA issued a final rule extending its tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), including electronic nicotine delivery systems (ENDS) – for example: e-cigarettes and vape pens. 

Tobacco products for which timely premarket submissions have been submitted by the applicable compliance date will be subject to a ‘continued compliance period’ for 12 months after the initial compliance period. Once the continued compliance period ends, new tobacco products on the market without authorisation will be subject to enforcement.

The new deadline was released by a statement by the FDA:

"The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.

This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.

This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.

This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court."

See the original statement here: FDA Statement 3rd May 2017

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The extension is intended to help the industry to prepare value-added data for PMTA.

We are therefore advising manufacturers and importers to take advantage of this extended compliance period with timely premarket submissions.

Download our updated white paper to understand further PMTA and why it is important.

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About the Author

Dr. Paul Moran is the Founder and Chief Executive Officer of Broughton Nicotine Services. Paul started Broughton in 2006 after several years’ experience across the medical device, pharmaceutical and animal health industries. His educational background includes a BSc (Hons) in Applied Chemistry and a PhD in Chemistry / Biotechnology from The University of Huddersfield. He is also a Chartered Chemist and a Member of the Royal Society of Chemistry. Paul has significant operational management and analytical experience in senior leadership roles. Originally, Paul began his career in Quality Control at Johnson and Johnson. From there, he obtained Six Sigma Black Belt Certification, and moved on to support the successful growth of a contract laboratory leading to its merger in 2005. Since starting Broughton in 2006, Paul’s focus is to actively identify opportunities and provide distinctive vision to address changing markets and growing customer needs. His vigorous yet stoic leadership style is effective and drives our team and customers to continual success.