• Tobacco industry
• Non-cigarette tobacco products
• Illegal tobacco products

Until the enactment of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act or TCA), the tobacco industry was not required to inform the public or any governmental agency when it introduced new products, changed old products or made changes to the design of products, even when the new or modified products were more deadly, more addictive or appealed to children. The tobacco industry was free to introduce new products and make changes in secret without regard to the public health impact of its actions. The implications for public health have been devastating. Today's cigarettes carry an even greater risk of causing lung cancer than cigarettes from decades ago;ⁱ they deliver nicotine in far more sophisticated ways; and until the 2009 Act came in flavours that were highly appealing to children.

The 2009 Tobacco Control Act for the first time required the tobacco companies to notify the government before it introduced new products or changed existing products, explain the nature of the changes and provide the government with information about the impact of those changes on the toxicity, addictiveness and appeal of the product before moving forward. The statute also placed the burden on the tobacco industry to prove to the Food and Drug Administration (FDA) that the introduction of a new product is ‘appropriate for the protection of the public health’ and that the introduction of changed products does not raise ‘different questions of public health’.

Although the statute was enacted on 20 June 2009, it applied the new public health and premarket review requirement retroactively to any products introduced or changes made subsequent to 15 February 2007. However, it allowed products introduced between 15 February 2007 and 21 months after the date of enactment to remain on the market until …