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Troutman Pepper

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

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FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Troutman Pepper

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Troutman Pepper

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Morgan Lewis

FDA Grants First E‑Cigarette PMTA Authorization

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The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2019 #3

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Food/Dietary Supplements - FDA Publishes Updates to Manufacturer Food Regulatory Program – The FDA made available “revised food safety standards for state regulatory programs that oversee food facilities that manufacture,...more

Morgan Lewis

FDA Clarifies Premarket Path for Ecigarette Products

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The US Food and Drug Administration (FDA or the Agency) on June 11 issued the final guidance: “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” (the ENDS Guidance), which is intended to assist...more

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