Regulatory reports / Americas

Deeming regs: challenges to the sampling ban

29th July 2016 | Regulatory reports , Topic regulatory reports |

When the U.S. deeming regulations come into effect on 8th of August, the distribution of free e-liquid samples will be prohibited in the U.S. The U.S. Food and Drug Administration (FDA) justifies this ban as necessary for the protection of the public health but retailers believe it will undermine their profits without having a noticeable public health benefit. What challenges follow?

Challenging the U.S. deeming rule: the legal options and their chances

1st July 2016 | Regulatory reports , Topic regulatory reports |

The U.S. FDA’s final deeming rule is likely to be the subject of a number of legal challenges if finalised in its current form. This could delay the application of any final regulations by several years, and could ultimately lead to a court setting the deeming rule aside – at least with regard to e-cigs.

This report examines the “next steps” for industry, the current and potential challenges, as well as the possibility of congressional relief.

The deeming rule and PMTAs: what it all means for manufacturers

26th June 2016 | Regulatory reports , Topic regulatory reports |

    There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page.       Introduction   On 10th May, the U.S. Food and Drug Administration (FDA) finalised its regulations that deemed tobacco products to be subject to the federal Food, Drug, and Cosmetic Act. This rule extended the FDA’s » Continue Reading.