Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Federal court lifts import ban on e-cigarettes

This article was originally published in The Tan Sheet

Executive Summary

The U.S. District Court for the District of Columbia grants electronic cigarette distributors a preliminary injunction that allows them to be classified as tobacco products. The decision overturns FDA's interpretation that the products were unapproved drug devices and agrees with arguments made by law firm Latham & Watkins on behalf of Sottera, a distributor of e-cigarette brand Njoy, according to a Jan. 14 release. FDA in July warned consumers about the e-cigarettes and stopped shipments from entering the U.S. because tested lots contained toxic materials (1"The Tan Sheet" July 27, 2009)

You may also be interested in...



Viewpoints Cover The Waterfront At FDA Nicotine Replacement Therapy Policy Hearing

FDA added to the docket for its initiative evaluating nicotine replacement therapies reference materials including a meta-analysis on efficacy of NRTs in smoking cessation and a report on quitting smoking among adults in the US, 2000-2015.

Viewpoints Cover The Waterfront At FDA Nicotine Replacement Therapy Policy Hearing

FDA added to the docket for its initiative evaluating nicotine replacement therapies reference materials including a meta-analysis on efficacy of NRTs in smoking cessation and a report on quitting smoking among adults in the US, 2000-2015.

E-cigarette detainees light up ombudsman's list

FDA's Center for Drug Evaluation and Research's Ombudsman's Office's report says e-cigarette companies' import and export issues related to detained products and seizures were among the most common topics it was contacted about in 2009. FDA in July stopped the products from entering the U.S. after testing lots that yielded toxic materials (1"The Tan Sheet" Jan. 18, 2010, In Brief). Other issues industry contacted CDER about include delays in generic drug applications related to citizen petitions and delayed reviews by the Office of New Drugs. Common consumer complaints included adverse events, issues with accessing information on FDA's Web site and misleading product Web sites, the report says. The Ombudsman's Office said its contacts included 9 percent FDA employees, 30 percent from the pharmaceutical industry, law firms and researchers, and 61 percent from consumers, advocacy groups and health care professionals

Related Content

Topics

UsernamePublicRestriction

Register

PS103703

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel