On April 22, 2020, the U.S. District Court for the District of Maryland modified its July 12, 2019 Remedies Order (the “Remedies Order”) in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.) to extend the May 12, 2020 premarket application deadline to September 9, 2020 for all deemed
On January 8, 2020 FDA published its latest compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Pursuant to the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement
Keller and Heckman’s 4th annual E-Vapor and Tobacco Law Symposium is just around the corner. Take advantage of the early bird discount and register today for the most comprehensive 2-day seminar focused on legal and regulatory issues critical to e-vapor, tobacco and CBD industries. Topics that will be covered include:
In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new
Keller and Heckman LLP is announcing its 4th annual E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will address critical legal issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including youth prevention, FDA compliance, premarket applications, flavor bans, litigation, global and state compliance laws, and more.
Click here to register.
Reposted from Keller and Heckman’s Blog, The Daily Intake
On September 4, 2019, Michigan Governor Gretchen Whitmer announced soon-to-be-filed Emergency Rules banning the sale of flavored e-cigarettes in Michigan.[1] The proposed flavor ban, the first of its kind at the state-level, is being promulgated without any public notice and comment using the Michigan Department of Health and Human Services’ (MDHHS) emergency rulemaking powers.
Electronic cigarettes may soon become much more widely available in the world’s largest tobacco market: The People’s Republic of China. With over 300 million smokers, China has the world’s largest smoking population – which directly results in approximately 1 million deaths annually. [1] While the global e-cigarette market has experienced rapid growth over the last
As we reported previously, the Consumer Product Safety Commission (CPSC) recently announced that it considers flow restricted containers for nicotine containing e-liquids to be required under the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). Boaz Green was interviewed by Regulator Watch regarding CPSC’s recent enforcement actions, industry’s response, and the options available
Azim Chowdhury was interviewed by “Regulator Watch” regarding the recent court case, American Academy of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 81652 (D. Md. May 15, 2019).
To watch the full interview, click here.