According to the National Association of Tobacco Outlets (NATO), the U.S. Food and Drug Administration (FDA) has finalized determinations on more than 99% of the nearly 26 million new tobacco products for which pre-market tobacco applications (PMTAs) were filed by manufacturers with the FDA.
The vast majority of these FDA determinations are in the form of Refuse to Accept (RTA) letters, Refuse to File (RTF) letters or Marketing Denial Orders (MDOs). An RTA letter means that the PTMA lacked the required contents or documents. An RTF letter means that the agency examined the PMTA, and the application did not meet agency standards or requirements. An MDO means that after the PMTA went through the FDA’s review process, the agency determined that the product did not meet the congressionally mandated standard of being “appropriate for the protection of the public health.” A product that receives an RTA, an RTF or an MDO cannot be lawfully marketed in the U.S.
To date, the FDA has issued Marketing Granted Orders (MGOs) to 45 tobacco products and electronic cigarette/vapor products. An MGO determination means that the FDA finds the product to be “appropriate for the protection of the public health” and can be lawfully marketed in the U.S.
NATO also noted that the FDA has proposed new requirements for tobacco manufacturers with regard to the design, manufacture, packing and storage of tobacco products. These proposed requirements apply to manufacturers of finished and bulk tobacco products.
The proposed requirements, which include establishing tobacco product design and development controls and more, would help protect the public health by minimizing or preventing contamination and limiting additional risks by ensuring product consistency.
The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups and the public.
NATO also listed an update on the FDA decision to issue MDOs for R.J. Reynolds Vapor Co.’s Vuse G1 Solo menthol replacement cartridge (with a nicotine content of 4.8%) and Vuse G2 Solo menthol replacement cartridge (with a nicotine content of 4.8%). R.J Reynolds then filed a petition with the U.S. Court of Appeals for the Fifth Circuit requesting an emergency stay of the FDA’s MDO which was granted.
Along with the MDOs being issued to R.J Reynolds Vapor Co., a U.S. Federal District Court for the Southern District of California has dismissed an industry lawsuit to overturn the California statewide flavored tobacco product ban law, which was put in place on Nov. 9, 2022, after California voters approved a state ballot referendum question to enact the statewide flavored tobacco ban law.
Lastly, NATO stated that the FDA has authorized U.S. Smokeless Tobacco Co. to market its Copenhagen Classic Snuff as a modified risk tobacco product (MRTP). This MRTP authorization allows the product to be marketed as a modified-risk tobacco product.
The National Association of Tobacco Outlets Inc. is a national trade association organized to enhance the common business interests of all tobacco retailers and to monitor and assist members in responding to tobacco-related legislation on the local, state and federal levels.
