The Family Smoking Prevention & Tobacco Control Act mandates that all new tobacco products must receive a premarket tobacco application authorization to be sold on the U.S. market. Any product without a PMTA approval cannot be legally sold in the United States and is considered “adulterated” or “illicit” under federal statute. Believe it or not, the FDA and economic advisers to President Barack Obama at the time feared that quickly implementing the new tobacco regulations would result in catastrophe for a blossoming vaping industry.
Despite his campaign against nicotine user rights, President Donald Trump did his best to extend the PMTA deadline as much as possible. According to the law, new tobacco products need to be authorized for virtually every other marketing component a product may undergo.
This includes adjustments in packaging, manufacturing processes, and product design. FDA is also granted the right to exercise enforcement discretion, which permitted the deferment of enforcement on premarket authorization requirements for products available on the market, as of Aug. 8, 2016. This systemic grandfathering date still offered no assurances, given that the ability to introduce new products and liquids would require costly PMTA approval.
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