Smoking Cessation Claims For E-Cigarettes Draw FDA Warnings
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is in discussions with multiple firms about new drug applications for electronic cigarettes as it warns five firms that smoking cessation claims make their e-cigarettes unapproved new drugs.
You may also be interested in...
FDA appeals e-cigarette ruling
FDA Feb. 1 appeals the U.S. District Court for the District of Columbia's decision in January that electronic cigarettes are tobacco products despite the agency's interpretation the products are unapproved drug devices. FDA in July warned consumers about e-cigarettes and stopped shipments from entering the U.S. because tested lots contained toxic materials (1"The Tan Sheet" Jan. 18, 2010, In Brief). In the agency's motion to appeal the Jan. 14 decision, FDA asks the court for "an immediate temporary stay to permit consideration of this stay motion," explaining that the Family Smoking Prevention and Tobacco Control Act excludes under the "tobacco products" definition any item that is a drug, device or combination product under the Food, Drug and Cosmetic Act
Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims
“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.
MLM Group Not Buying FTC Executive’s Concerns About Its Income Disclosure Guidance
FTC Division of Marketing Practices assistant director concerned direct selling self-regulation group’s guidance “will encourage deceptive conduct and facilitate deceptive earnings claims.” DSA president says the concerns might reflect the thinking of agency’s staff more than the intent of the agency’s regulations.