Based on my research, the FDA started regulating tobacco in 2009 by the passage of the Family Smoking Prevention and Tobacco Control Act. What I found interesting is that the Family Smoking Prevention and Tobacco Control Act specifically states that FDA cannot ban an entire category of tobacco products, such as cigarettes. FDA’s regulatory role for drugs and devices is usually based on a safety and effectiveness standard. The tobacco control act establishes a new standard: to regulate tobacco products based on a public health and population health standard.
FDA regulates all tobacco products, including e-cigarettes, hookah tobacco, and cigars. If you sell tobacco products, you must comply with all applicable federal laws and regulations for retailers.
In 2016, FDA finalized a rule extending CTP’s regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS . However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). I think it is necessary to ensure that ingredients in ENDS products are studied, evaluated and determined to be safe for use. With this regulatory oversight, there is hope that more information about ENDS, those long-term effects, and potential harms vs. benefits will be available soon. FDA’s oversight will also prevent companies from making misleading claims about electronic nicotine delivery systems and will help restrict youth access to these products.
In my opinion companies making e-cigs should work with companies like J&J or Merck to get their e-cigs on the market as a medically sound product with proper testing and research.
1- http://www.cnn.com/2016/05/06/opinions/fda-electronic-cigarettes-caudle/index.html
2- https://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htm