Topics: Regulation and Legislation

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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 |

North America
United States
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Regulatory briefing

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 |

EU
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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?

Capitol Hill - Flickr - KP Tripathi

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.

US states - Flickr - Kevin Hutchinson

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 |

EU
Europe
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Regulatory briefing

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 |

United States
Policy and Politics
Regulation and Legislation
Business briefing

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 |

EU
Europe
United States
Policy and Politics
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Business 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 |

United States
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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 |

United States
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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
Regulation and Legislation
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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 |

United States
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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 |

United States
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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

Association of Convenience Stores (ACS)

2nd April 2014 - Resources |

United Kingdom
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The ACS is the voice of more than 33,500 local shops, supporting members through effective lobbying, comprehensive advice and innovative networking opportunities. Its core purpose is to lobby government on the issues that make a difference to local shops. It represents the interests of retailers on a range of issues, including regulation, planning, alcohol and […]

National Federation of Retail Newsagents (NFRN)

2nd April 2014 - Resources |

United Kingdom
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The NFRN exists to help the independent retailer compete more effectively in today’s highly competitive market by providing practical help and assistance, commercial support, deals and buying opportunities, training, expertise and services. The NFRN also actively represents its members’ interests at governmental and parliamentary level. It is the oficial government referral body for the sector […]

The Committees of Advertising Practice (CAP and BCAP)

2nd April 2014 - Resources |

United Kingdom
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The Committees write and maintain the UK Advertising Codes, which are administered by the Advertising Standards Authority. They also offer the industry authoritative advice and guidance on how to create campaigns that comply with the rules. www.cap.org.uk Mid City Place, 71 High Holborn, London, WC1V 6QT

Electronic Cigarette Industry Trade Association (ECITA)

2nd April 2014 - Resources |

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ECITA helps members to operate a legally-compliant, ethical, and above all, successful business. www.ecita.org.uk katherine.devlin@ecita.org.uk

Freedom Organisation for the Right to Enjoy Smoking Tobacco (FOREST)

2nd April 2014 - Resources |

United Kingdom
Policy and Politics
Regulation and Legislation
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Forest represents adults who choose to consume tobacco and non-smoking adults who are tolerant of other people’s enjoyment of tobacco. europeansmokers.com Sheraton House, Castle Park, Cambridge CB3 0AX, UK contact@forestonline.org

National Association of Cigarette Machine Operators (NACMO)

2nd April 2014 - Resources |

United Kingdom
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NACMO exists to generate and represent the standards and conditions that will benefit of their members and the trade as a whole; form policy on trade issues and then promote these issues to all allied parties; generate information, support and assistance of benefit of their members; and develop the integrity of the trade in the […]

Tobacco Retailers’ Alliance (TRA)

1st April 2014 - Resources |

United Kingdom
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Funded by the Tobacco Manufacturers’ Association, this organisation offers a free membership to all independent retailers who sell tobacco. It campaigns on issues of relevance to both their businesses and to the industry. www.tobaccoretailersalliance.org.uk PO Box 61705, London SW1H 0XS, UK info@the-tra.org.uk

British Association of Pharmaceutical Wholesalers (BAPW)

1st April 2014 - Resources |

United Kingdom
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The BAPW represents full-line pharmaceutical distributors which between them provide 90% of the nation’s medicines, covering all of the UK’s population. A forum is provided for discussion across the industries involved in the provision of pharmaceuticals to Britain’s health services. Full-line wholesalers act as a one-stop shop for almost all pharmaceutical products and services. Their […]

Association of the British Pharmaceutical Industry (ABPI)

1st April 2014 - Resources |

United Kingdom
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ABPI represents research-based biopharmaceutical companies, large, medium and small. The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements, including the pricing scheme for medicines in the UK. www.abpi.org.uk 7th floor, Southside, 105 Victoria Street, London SW1E 6QT

Academy of Pharmaceutical Sciences

1st April 2014 - Resources |

United Kingdom
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The Academy of Pharmaceutical Sciences is the professional body for the pharmaceutical sciences in Great Britain. The objectives of the Academy are to promote the pharmaceutical sciences in all areas of professional practice by pharmaceutical scientists, including academia, industry, regulation and commerce, and to encourage high standards of working practices within the discipline. www.apsgb.org

Action on Smoking and Health (ASH)

1st April 2014 - Resources |

United Kingdom
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ASH is a campaigning public health charity that works to eliminate the harm caused by tobacco. www.ash.org.uk 6th floor, Suites 59-63, New House, 67-68 Hatton Garden, London EC1N 8JY, UK enquiries@ash.org.uk

The General Pharmaceutical Council (GPhC)

1st April 2014 - Resources |

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Responsible for the independent regulation of over 70,000 pharmacists, pharmacy technicians and pharmacy premises in England, Scotland and Wales. www.pharmacyregulation.org 129 Lambeth Rd, London SE1 7BT, UK

Medicines and Healthcare Products Regulatory Agency (MHRA)

1st April 2014 - Resources |

United Kingdom
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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency, which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an […]

Health and Safety Executive (HSE)

1st April 2014 - Resources |

United Kingdom
Policy and Politics
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The HSE is the national independent watchdog for work-related health, safety and illness. It is an independent regulator and acts in the public interest to reduce work-related death and serious injury across Great Britain’s workplaces. www.hse.gov.uk

The Scottish Government

1st April 2014 - Resources |

United Kingdom
Policy and Politics
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The devolved government for Scotland is responsible for most of the issues of day-to-day concern to the people of Scotland, including health, education, justice, rural affairs, and transport. www.scotland.gov.uk General Enquiries, St. Andrew’s House, Regent Road, Edinburgh, EH1 3DG ceu@scotland.gsi.gov.uk