In June 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law, and amended the Federal Food, Drug and Cosmetic Act to give the Agency authority to regulate the manufacture, labeling, distribution, and marketing of tobacco products in the United States. Specifically, although a “tobacco product” is defined broadly, in pertinent part, as “any product made or derived from tobacco that is intended for human consumption,” the law only provides FDA with authority to regulate, through the its new Center for Tobacco Products (CTP), cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
However, any “other tobacco products,” such as electronic cigarettes and their components may become subject to regulation if FDA “deems” such products to be subject to the new law. This webinar will focus on the potential FDA regulatory premarket application requirements that will apply to those products that are deemed to be within FDA’s authority. The instructor will discuss Family Smoking Prevention and Tobacco Control Act requirements, focusing on the premarket review of new and modified tobacco products under Section 910 of the Act.
Why Should you Attend:
It is critical for manufacturers and importers of cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products to be prepared to submit premarket applications to FDA to bring their products to the market.
This webinar will focus on the potential FDA regulatory premarket application requirements that will apply to those products that are “deemed” to be within FDA’s authority by the upcoming Deeming Regulation. The instructor will discuss Family Smoking Prevention and Tobacco Control Act requirements, focusing on the premarket review of new and modified tobacco products under Section 910 of the Act.
Objectives of the Presentation:
FDA has indicated that the premarket application requirements set forth in the Tobacco Control Act will apply to the new tobacco products (including electronic cigarettes, cigars and dissolvable tobacco) that are captured by the Deeming Regulation. Learn about the different premarket pathways, including the Premarket Tobacco Application, the Substantial Equivalence Report and the Minor Modification Exemption.
Who can Benefit:
- Overview of the Family Smoking Prevention and Tobacco Control Act
- Premarket Review of New and Modified Tobacco Products
- Premarket Tobacco Applications
- Substantial Equivalence Reports
- Minor Modification Exemption
- General Counsel and Management of tobacco companies, e-cigarette companies, etc
- Regulatory Compliance Associates and Managers
- Medical professionals, public health and consumer advocates, and other individuals working in the smoking control/ harm reduction area
- Regulatory affairs professionals and scientists who work in this area
- Manufacturers and importers of e-cigarettes and other novel tobacco products
- Suppliers to Tobacco Industry