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Understanding the Regulatory Environment for Nicotine Products
The regulatory environment for nicotine products has evolved significantly over the years. In the 20th century, cigarettes were unregulated until the Surgeon General warning in the 50s, highlighting the link between cigarettes and cancer. The Master Settlement Agreement in the 90s saw tobacco companies paying billions to the US government for the negative impact on healthcare. The invention of e-cigarettes led to FDA attempts to regulate them as drug and medical devices, but Enjoy won a Supreme Court case against this classification. The Tobacco Control Act of 2008 gave the FDA authority over all nicotine-containing products, leading to different regulatory approaches for drugs, medical devices, and other product categories within the FDA.