FDA TobaccoAkun terverifikasi

FDA wants to know about tobacco-related health or quality problems. Report adverse experiences to the Safety Reporting Portal: https://www.safetyreporting.hhs.gov 

This webinar provides a brief overview of section 905 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which describes the establishment registration and product listing requirements for Tobacco Product manufacturers.

FDA also issued 10 Marketing Denial Orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce.

While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or “FDA approved.” All tobacco products are harmful and addictive and those who do not use tobacco products should not start.

As the RJR Vapor Company submitted data to FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S.

FDA issued Marketing Granted Orders to R.J. Reynolds Vapor Company for its Vuse Solo closed ENDS device & accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 & Vuse Replacement Cartridge Original 4.8% G2.