The approval process for the launch of e-cigarettes in the United States is based on the Family Smoking Prevention and Tobacco Control Act issued by the US government in 2009, which grants FDA the authority to regulate tobacco products. However, the scope of regulation is limited to cigarettes, tobacco plants, smokeless tobacco, and homemade cigarettes.

The formal regulation of e-cigarettes in the United States began in May 2016. The FDA officially announced that a new rule will be implemented on August 8, 2016 to regulate all tobacco products, including e-cigarettes, cigars, hookahs, and pipe cigarettes. Prior to the implementation of this rule, there was no federal law prohibiting retailers from selling e-cigarettes, hookahs, tobacco, or cigars to people under the age of 18.

After the implementation of this law, the FDA can legally regulate the manufacturing, import, packaging, labeling, advertising, promotion, sales, and distribution of Electronic Nicotine Delivery Systems (ENDS). For example:

(1) Manufacturers in the United States are required to register every tobacco production site with the FDA and report any harmful and potentially harmful substances. (Companies outside of the United States do not currently need to be registered, but they will also need to be registered in the near future)

(2) American manufacturers are required to submit a list of tobacco products produced to the FDA.

(3) ENDS manufacturers are required to submit a list of ingredients for each product to the FDA.

(4) Dangerous modifiers such as light, low, and mill cannot be used to describe tobacco products.

(5) Free samples considered as tobacco products (such as e-cigarettes) are not allowed for sale (excluding B2B), etc.

It is worth noting that in this rule, it is also stipulated that unless tobacco products are launched before February 15, 2007, all new tobacco products need to undergo PMTA (Pre Marketing Application for Tobacco Products) review. Due to almost all e-cigarettes being launched after this date, e-cigarettes are fully included in PMTA.

According to the FDA, the PMTA application is relatively complex and requires a large amount of information, including ingredients, product design, and potential health risks, which can cost hundreds of thousands of dollars.