Topics: Regulation and Legislation

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Gavel - Flickr - Sal Falko 300 x 180

Fontem patents could give Imperial an advantage at FDA

19th May 2014 - Business briefing |

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E-cigarette patents held by Imperial Tobacco could give the company an advantage in the U.S. market, if the Food and Drug Administration (FDA) goes ahead with plans to make obtaining regulatory approval easier for pre-2007 products.

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FDA lambasted over comments process, inaction on flavours

18th May 2014 - Regulatory briefing |

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The U.S. Food and Drug Administration (FDA) is reviewing requests to extend the public comment period on its proposal to regulate e-cigarettes as tobacco products, a senior FDA official told a a key U.S. Senate committee on Thursday, drawing a decidedly mixed response from the panel’s top Democrat and Republican alike.

Laying down the law: regulation to dominate industry confabs

14th May 2014 - Business briefing , Regulatory briefing |

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E-cigarettes are on the agenda for a host of trade and professional conferences over the coming weeks, reflecting the urgent need for understanding of new regulatory measures as well as the sector’s development and improving scientific knowledge about the products.

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Illinois to make child-proofing mandatory for e-liquid bottles?

13th May 2014 - Business briefing , Regulatory briefing |

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The U.S. state of Illinois is considering making child locks for bottles of e-liquid mandatory, a move which would give the state stricter rules than those planned by the federal Food and Drug Administration (FDA).

Obama’s choice for health job is pushed for view on flavours

9th May 2014 - Regulatory briefing |

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A Republican senator this week used a hearing on president Obama’s nominee to lead the U.S. Department of Health and Human Services (HHS) to raise concern that flavourings were omitted from federal proposals to regulate e-cigarettes.

The U.S. deeming regulations: timeline of the next stages

25th April 2014 - Business briefing , Regulatory briefing |

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The new regulations for e-cigarettes and other tobacco products from the U.S. Food and Drug Administration (FDA) were published today in the Federal Register, beginning the process that will eventually lead to their approval and implementation.

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FDA’s product approval process is biggest worry for e-cig sector

25th April 2014 - Business briefing |

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The deeming regulations on e-cigarettes issued yesterday by the U.S. Food and Drug Administration (FDA) were largely expected by the industry and greeted without panic, although concerns were raised over the product approval process and the underlying philosophy of regulating all nicotine-containing products in a similar way.

Deeming regulations: FDA still unsure on many questions

25th April 2014 - Business briefing , Regulatory briefing |

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The proposed regulations for e-cigarettes released yesterday by the U.S. Food and Drug Administration (FDA) are only proposals, and the FDA still appears uncertain about how to regulate many aspects of the new products.

FDA’s leader promised action… and the audience just laughed

25th April 2014 - Regulatory briefing |

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The commissioner of the U.S. Food and Drug Administration (FDA) drew laughter from a Washington, D.C. audience this week when she promised that the agency’s long-delayed deeming rules on e-cigarettes and other products were imminent.

New FDA rules and Europe’s directive: how do they compare?

25th April 2014 - Business briefing , Regulatory briefing |

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The new regulations for e-cigarettes proposed yesterday by the U.S. Food and Drug Administration (FDA) are the second major regulatory framework for the products to appear in two months, following the European Union’s release of its revised Tobacco Products Directive (TPD) earlier this year. How do the two compare in key areas?

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D.C. reaction: age rules praised, tolerance of flavours criticised

24th April 2014 - Business briefing , Regulatory briefing |

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Key Democratic members of Congress on Thursday eagerly welcomed the long-delayed proposal by the Food and Drug Administration (FDA) to extend the agency’s regulatory authority over the e-cigarette industry and other tobacco products, while Republican law-makers remained more muted.

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Deeming regs: states are free to act on vaping in public places

24th April 2014 - Business briefing , Regulatory briefing |

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The new U.S. e-cigarette regulations proposed today by the Food and Drug Administration (FDA) leave much space for states to impose their own local rules, particularly in the areas of advertising, minimum purchase ages, and public place usage.

EU will not publish detailed guidance on TPD e-cig rules

23rd April 2014 - Regulatory briefing |

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The European Union (EU) does not plan to issue detailed guidance on how e-cigarette regulations in the recent Tobacco Products Directive (TPD) should be interpreted, according to a source close to the EU’s Directorate General for Health and Consumer Affairs (SANCO)

Association fears FDA rules could hamper sector´s growth

22nd April 2014 - Business briefing |

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The intentions of the U.S. Food and Drug Administration (FDA) on e-cigarette regulation remain opaque today, after an industry association abandoned plans to publish the agency’s proposed rule on new smoking products.

Could EU directive be a model
for U.S. treatment of e-cigs?

16th April 2014 - Business briefing , Regulatory briefing |

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The European Parliament’s new rules on e-cigarettes in the Tobacco Products Directive (TPD) have grabbed the attention of key members of the U.S. Senate, generating mixed reactions on whether it should influence the efforts of the Food and Drug Administration (FDA) to regulate the products.

FDA nagged again by Congress
over inaction on e-cigarettes

14th April 2014 - Business briefing , Regulatory briefing |

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Further pressure is being brought to bear on the U.S. Food and Drug Administration (FDA) this week, with the release of a report from 11 members of Congress arguing that regulation of e-cigarette companies is needed to stop them marketing to minors.

WHO “considering treating
e-cigarettes as tobacco”

14th April 2014 - Business briefing , Regulatory briefing |

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The man who leads the Framework Convention on Tobacco Control (FCTC) at the World Health Organization (WHO) wants to see e-cigarettes brought into the international agreement, according to a news report today.

Smoke-Free Alternatives Trade Association (SFATA)

2nd April 2014 - Resources |

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Founded in 2011, SFATA serves as an educational and lobbying resource for manufacturers, wholesalers, retail sellers and distributors of personal electronic vaporising units (PEVUs) such as electronic cigarettes (e-cigs). It is dedicated to fostering communication, sharing reliable information and providing forums where SFATA members and state and federal agencies can engage in meaningful dialogue regarding […]

American Pharmacists Association (ASHP)

2nd April 2014 - Resources |

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The ASHP is a national professional organisation whose nearly 40,000 members include pharmacists, pharmacy technicians, and pharmacy students providing patient care services in hospitals, health systems, and ambulatory clinics. www.ashp.org

BeTobaccoFree.gov

2nd April 2014 - Resources |

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BeTobaccoFree.gov provides information from various Department of Health and Human Services (HHS) operating and staff divisions. Topics covered include: about tobacco, health effects, quit now, and don’t start. betobaccofree.hhs.gov via Department of Health and Human Services – 200 Independence Avenue, S.W., Washington, DC 20201, USA

Tobacco-Free Kids

2nd April 2014 - Resources |

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The mission of Tobacco-Free Kids is to work to save lives by advocating for public policies that prevent kids from smoking, help smokers quit and protect everyone from secondhand smoke. www.tobaccofreekids.org 1400 Eye Street., N.W., Suite 1200, Washington, DC 20005, USA

Internal Revenue Service (IRS)

2nd April 2014 - Resources |

United States
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The IRS the revenue service of the United States federal government. The agency is a bureau of the Department of the Treasury, and is under the immediate direction of the Commissioner of Internal Revenue. The IRS is responsible for collecting taxes and the interpretation and enforcement of the Internal Revenue Code. www.irs.gov

Department of Health and Human Services (HHS)

2nd April 2014 - Resources |

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The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of Americans and providing essential human services. www.hhs.gov 200 Independence Avenue, S.W., Washington, DC 20201, USA

National Institutes of Health (NIH)

2nd April 2014 - Resources |

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A part of the U.S. Department of Health and Human Services, this is the nation’s medical research agency. www.nih.gov 9000 Rockville Pike, Bethesda, Maryland 20892, USA NIHinfo@od.nih.gov

Food and Drug Administration (FDA)

2nd April 2014 - Resources |

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The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. www.fda.gov 10903 New Hampshire Ave, […]

U.S. Government

2nd April 2014 - Resources |

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As the U.S. government’s official Web portal, USA.gov makes it easy for the public to get U.S. government information and services on the Web. www.usa.gov U.S. General Services Administration, Office of Citizen Services and Innovative Technologies, 1800 F Street, NW, Washington, DC 20405, USA