Regulation and Legislation

In depth: potential legal challenges to FDA e-cig rules

21st June 2014 - Regulatory reports , Topic regulatory reports |

Tobacco: precedents for challenge • Potential challenges to the deeming regulations • Challenges to scientific foundation • Challenges to pre-market approval and substantial equivalence • Challenges to health warning labels • Challenges to the deeming of e-cigs as tobacco products • Challenges on the grounds that the regulations constitute a ban • Temporary suspension of the rules via injunctive relief • Potential loophole: nicotine not derived from tobacco

FDA lambasted over comments process, inaction on flavours

18th May 2014 - News analysis |

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.

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

25th April 2014 - News analysis |

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.

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

25th April 2014 - News analysis |

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?