The new deeming regulations: all our stories so far

This page provides you with links to all ECigIntelligence coverage of the U.S. deeming regulations since the final version of the rule was published on 5th May, as well as the main government documents setting out the regulations and providing guidance on interpreting them.

 

The key points of the new deeming regulations

 

ECigIntelligence coverage

 

29th July: Industry challenges the FDA’s sampling ban

19th July: Altria criticises deeming regulations for burden, lack of clarity

12th July: Lawsuits against the FDA mount up

1st July: The options for legal challenge, and their chances

28th June: Warning labels and zero-nicotine products

26th June: PMTAs: what they mean for manufacturers

26th June: PMTA applications: how FDA policy has developed

19th June: State politician launches another lawsuit against FDA

14th June: Many vapers unaware of deeming regulations, most in favour

25th May: Second e-liquid company sues FDA over deeming regulations

24th May: PMTAs and substantial equivalence: deadlines and grace periods

20th May: Infographic: compliance timeline for existing products

20th May: Regulations in detail: the timeline for initial compliance

19th May: The bottom line: FDA’s estimates on compliance costs, decrease in product variety

14th May: Anger, disappointment and fear in the vape stores

13th May: Regulation of zero-nicotine e-liquid and synthetic nicotine

12th May: More industry reaction – some are worried, some not so much

12th May: More Washington reaction – Democrats welcome regulations

10th May: How the U.S. media reacted

10th May: Nicopure files lawsuit against deeming regulations

10th May: PMTAs can use many kinds of scientific support

10th May: FDA will encourage sharing of scientific information

9th May: Two years of changes in the deeming regulations

9th May: Labelling a focus of federal-state conflicts

6th May: An end to store-brand e-liquids?

6th May: The deeming regulations and TPD compared

6th May: Washington reaction

6th May: Industry reaction

5th May: FDA faced hard decisions, criticism in crafting regulations

 

Official FDA publications

 

The deeming rule itself

Requirements for tobacco manufacturers

Compliance guidance for small businesses

Guidance on premarket tobacco product applications (PMTAs)

Analysis of the deeming rule’s impact on the industry

Guidance on tobacco product master files (TPMFs)

Guidance on labelling

Compliance dates

Letter to tribal leaders

 

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