FDA says no co-packaging with tobacco
This article was originally published in The Tan Sheet
Executive Summary
FDA says in draft guidance that the Family Smoking Prevention and Tobacco Control Act prohibits sales of tobacco products made or packaged with other agency-regulated products. The Center for Tobacco Products' draft, prepared for the Oct. 5 Federal Register, says co-packaging of mouthwash or skin cream with cigarettes, adding tobacco to gum or nicotine to water, juice or soft drinks are examples of prohibited combinations. The law also prohibits including coupons with tobacco products for discounts on other FDA-regulated products. The center is not targeting any product on the market, and the draft does not concern regulation of electronic cigarettes, an FDA staffer said. Comments on the draft guidance are due by early January 2010
You may also be interested in...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.