On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all tobacco products. Accordingly, manufacturers of e-cigarettes now have until May 2020 to submit ...
Recent Updates
- Bill Gates Gazes into the AI Crystal Ball: What are the Implications on the Healthcare and Life Sciences Industry
- 250+ Health Care Entities Targeted by HHS, DOJ Over Gender-Affirming Care for Minors
- Exclusion Authority (It’s Not Just the HHS-OIG Anymore …)
- The Sixth Circuit Revives the Medicare Waiver of Liability for Overpayments and Appeals
- Federal Court Holds Idaho’s Near-Total Abortion Ban Unconstitutional for Lack of Health Exception