Regulation and Legislation

Swedish pharma regulator granted control over e-cigs

23rd July 2014 - News analysis |

A Swedish court has upheld attempts by the country’s medical products regulator to treat nicotine-containing e-cigarettes as pharmaceuticals, meaning that they must go through a licensing process and cannot be sold in outlets such as groceries and convenience stores.

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.