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In Congress, deeming reformers welcome FDA’s policy shift

Written by Jim Myers || 31st July 2017 || Regulatory briefing |

North America
United States
Policy and Politics
Regulatory briefing
The bipartisan duo attempting to modify the FDA’s deeming regulations in the US Congress reacted with cautious optimism to commissioner Scott Gottlieb’s sweeping new policy plan, which many see as a nod for safer alternatives to traditional tobacco...

No relief from deeming regs as US Senate approves key spending bill

Written by Jim Myers || 21st July 2017 || Regulatory briefing |

North America
United States
Washington
Washington D.C.
Policy and Politics
Regulation and Legislation
Regulatory briefing
The industry’s hopes that a US federal spending bill would reduce the impact of the Food and Drug Administration’s (FDA’s) deeming regulations were disappointed this week when a Senate committee approved a version that makes no reference to...

Gottlieb: “Give me time to make decisions on deeming rule”

Written by Jim Myers || 26th May 2017 || Regulatory briefing |

North America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory briefing
The newly installed commissioner of the U.S. Food and Drug Administration (FDA) repeatedly told anxious law-makers on Thursday that he needs more time before deciding what he will do, if anything, about his agency’s controversial deeming regulation on...

Senate confirms e-cig industry’s friend Gottlieb as FDA chief

Written by Jim Myers || 10th May 2017 || Regulatory briefing |

North America
United States
Regulation and Legislation
Regulatory briefing
Scott Gottlieb, who plans a review of the deeming regulation that has caused so much concern for the e-cigarette industry, is set to become the next commissioner of the U.S. Food and Drug Administration (FDA) after winning Senate...
Scott Gottlieb

Gottlieb backed to head FDA, with support from Democrat senators

Written by Jim Myers || 2nd May 2017 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
A key U.S. Senate committee voted in favour of making Dr. Scott Gottlieb the next FDA commissioner after he laid out plans to review the deeming rule that has generated so much controversy within the e-cigarette...

Trump’s FDA nominee likely to be seen as mainstream choice

Written by Jim Myers || 11th March 2017 || Regulatory briefing |

United States
Policy and Politics
Public Health and Medicine
Regulatory briefing
U.S. president Donald Trump on Friday announced his intention to nominate Scott Gottlieb as the next commissioner of the Food and Drug Administration (FDA), ending a months-long process watched closely by the e-cigarette...

Regulatory reformer O’Neill could be Trump’s man for the FDA

Written by Jim Myers || 19th December 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
U.S. media are buzzing with speculation that Donald Trump once again could be thinking outside the box as he seeks a reform-minded nominee to head the Food and Drug Administration, which recently extended its authority over...

Surgeon general criticised and praised over youth vaping report

Written by Jim Myers || 9th December 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Public Health and Medicine
Regulatory briefing
U.S. Surgeon General Vivek Murthy’s report on the use of e-cigarettes by young people has drawn both criticism and praise. Representatives of the industry claimed the report ignored the benefits e-cigarettes can provide to those trying to avoid...

Cole amendment misses deadline, but its backers won’t give up yet

Written by Jim Myers || 4th October 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
Legislative language that would have changed the so-called grandfathering date on e-cigarettes set by the U.S. Food and Drug Administration (FDA) did not make it into a must-pass bill to keep the federal government open beyond the end...

Chances of grandfathering date change appear to lessen

Written by Jim Myers || 23rd September 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
A bid to change the grandfathering date of the U.S. Food and Drug Administration’s deeming regulations may not make it into the appropriations bill that faces an imminent deadline in...

West Virginia politician is latest to contest deeming rule in court

Written by Jim Myers || 19th June 2016 || Regulatory briefing |

North America
United States
West Virginia
Regulation and Legislation
Regulatory briefing
The U.S. Food and Drug Administration (FDA) is facing another legal challenge to its new deeming regulation on e-cigarettes. Filed in the Southern District of West Virginia on 10th June, the action was taken by Larry W. Faircloth,...

Democrats welcome FDA regulations, and ask for more

Written by Jim Myers || 12th May 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
Members of the U.S. Congress, mostly Democrats, continue to welcome the Food and Drug Administration’s deeming rule extending its authority over tobacco to e-cigarettes and other...

Washington reaction: “mystery chemicals” and “over-reach”

Written by Jim Myers || 6th May 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
Several members of Congress welcomed what they view as a long-overdue rule by the U.S. Food and Drug Administration (FDA) to regulate e-cigarettes, but the initial responses also provided another opportunity for Democrats and Republicans to show how...

Congressional committee votes to move U.S. grandfather date

Written by Jim Myers || 20th April 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
The U.S. e-cigarette industry is this week one step closer to avoiding the expensive process currently proposed for federal approval of existing products, following a Congressional committee...

U.S. transportation secretary finally bans e-cigs on planes

Written by Jim Myers || 3rd March 2016 || Regulatory briefing |

North America
United States
Washington D.C.
World
Regulation and Legislation
Regulatory briefing
U.S. transportation secretary Anthony Foxx announced a final rule Wednesday to ban the use of e-cigarettes on all commercial flights in the U.S., aiming to avoid confusion over the legal position. “This final rule is important because it...

Califf’s FDA nomination may move quickly to final vote

Written by Jim Myers || 14th February 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulatory briefing
The stalled nomination of Robert Califf to become the next commissioner of the U.S. Food and Drug Administration (FDA) received another major boost last week when a motion was filed to limit debate on Califf’s...

Califf edges closer to securing FDA job, but salmon threaten

Written by Jim Myers || 17th January 2016 || Regulatory briefing |

North America
United States
Policy and Politics
Regulatory briefing
Robert Califf’s nomination to become the next commissioner of the U.S. Food and Drug Administration (FDA) has won an easy vote in a Senate committee – but may still face a roadblock that could delay the final approval...

Nelson bill passes: U.S. set to require child-proofing on e-liquid

Written by Jim Myers || 12th January 2016 || Regulatory briefing |

North America
United States
Public Health and Medicine
Regulation and Legislation
Regulatory briefing
The U.S. House of Representatives on Monday gave final legislative approval to a bipartisan bill requiring child-resistant packaging on liquid nicotine sold in the U.S., paving the way for it to become law...

E-liquid marketing “uses candy and cereal brands misleadingly”

Written by Jim Myers || 24th December 2015 || Regulatory briefing |

North America
United States
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing
Nine Democratic senators in the U.S. have urged a federal agency to investigate e-liquid sellers for deceptively advertising their products using recognisable brand names of candy, breakfast cereals and other foods and...

Califf survives Senate hearing on FDA job, seemingly unscathed

Written by Jim Myers || 22nd November 2015 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
Robert Califf, president Barack Obama’s pick to lead the U.S. Food and Drug Administration (FDA), has expressed his support for the agency’s approach to reviewing innovative tobacco products such as...

“Leaked deeming regulations” raise questions, offer few answers

Written by Jim Myers || 29th October 2015 || Regulatory briefing |

North America
United States
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing
An e-cigarette industry association this week claimed to be in possession of the U.S. Food and Drug Administration’s forthcoming deeming regulations, but the provenance and authenticity of the brief excerpts that it published remain...

Obama names deputy commissioner Califf to head FDA

Written by Jim Myers || 16th September 2015 || Regulatory briefing |

United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory briefing
U.S. president Barack Obama has chosen Rob Califf, currently the deputy commissioner for medical products and tobacco at the Food and Drug Administration (FDA), to head up the...

Leno bill dies in California; grandfathering change survives

Written by Jim Myers || 10th July 2015 || Regulatory briefing |

California
North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
There was good news for e-cig advocates on both coasts of the U.S. this week, as a Congressional committee in Washington waved through proposed legislation that would exempt many e-cigarettes from aspects of the Food and Drug Administration’s...

Congress opens new attack on FDA grandfathering date

Written by Jim Myers || 30th June 2015 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
A crucial appropriations bill in the U.S. Congress is being used to launch a pre-emptive strike against the grandfather date for e-cigarette products proposed by the...

U.S. could set more recent date for grandfathering of e-cigs

Written by Jim Myers || 1st May 2015 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
A bill has been introduced in the U.S. Congress which could give e-cigarettes a much more recent “grandfathering” date when federal regulations are introduced, meaning that many established products would not be subject to the new...

FDA struggling to complete deeming regulations by June?

Written by Jim Myers || 22nd April 2015 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
The much-anticipated “deeming regulations” giving the U.S. Food and Drug Administration (FDA) authority over e-cigarettes should be ready by their June deadline – but could still be delayed, the agency’s head has...

FDA’s Zeller: youth figures don’t prove the gateway hypothesis

Written by Jim Myers || 22nd April 2015 || Regulatory briefing |

North America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory briefing
Newly published data showing a dramatic increase in e-cigarette use among U.S. children does not answer the question of whether e-cigs are a gateway into tobacco smoking, a key Food and Drug Administration (FDA) official said this...
American eagle - Pete Markham 300x180

Hamburg: deeming regulations will be published in June

Written by Jim Myers || 16th March 2015 || Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing
The U.S. Food and Drug Administration (FDA) is committed to a June release of its long-awaited – and some claim much-delayed – deeming regulations on e-cigarettes and other tobacco-related products, the agency’s departing commissioner assured senators last...

FDA’s departing commissioner praised, censured on e-cigs

Written by Jim Myers || 10th March 2015 || Regulatory briefing |

Maryland
North America
United States
Washington D.C.
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory briefing
In her final days as head of the U.S. Food and Drug Administration (FDA), Margaret Hamburg is receiving accolades from Republicans and Democrats alike on her six years in what many call one of the toughest jobs in...
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