A few months ago we reported on FDA’s recent enforcement efforts targeting electronic nicotine delivery systems (ENDS), such as e-cigarettes, and warned that the Agency is watching retailers and manufacturers closely (see here and here). In a September 12, 2018 announcement, FDA summarized its enforcement efforts …
A district court in Massachusetts scolded FDA for failing to meet a two-year deadline for issuing a final rule mandating color graphic warnings on cigarettes. This decision is important for the public health interests associated with the graphic warnings, but interesting for the loss dealt …
On May 30, 2018, the federal “Right to Try” law was enacted, creating a new legal framework for access to investigational drugs in limited situations outside of a clinical trial. See S. Rep. No. 204, 115 Cong. (2018). “Right to Try” was intended to reduce …
Vape shops in several states have banded together in litigation challenging the constitutionality of FDA’s Deeming Rule (for background information on that regulation, see our prior posting here). Plaintiffs are pursuing the litigation simultaneously in several federal district courts – perhaps with the objective of …
In a stunning development, newly appointed FDA Commissioner Scott Gottlieb, M.D. held a briefing last Friday to announce a multi-year plan for tobacco and nicotine regulation. The Commissioner’s remarks are available here, and a press release announcing the policy is available here. The Agency’s new approach …
As we previously reported, FDA issued a final rule in May 2016 that extended the agency’s authority to regulate all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. The final rule contained numerous compliance deadlines for manufacturers and retailers of these …
On January 18, 2017, the U.S. Department of Health and Human Services along with 15 other federal agencies issued the Final Rule to revise the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” This 1991 set of regulations created a …
