Regulatory Outlook

The regulatory landscape facing the e-cigarette industry is complex and dynamic. 

The FDA "deeming regulations" and the European Commission "Tobacco Products Directive" remain the most important regulations currently facing the industry. These two documents are linked below. 

EU Commission TPD  (opens in a new window)

FDA Deeming Regulations  (opens in a new window)

In the United States

On a federal level, the Food and Drug Administration oversees regulations for e-cigarettes. With the "deeming regulations" that went into effect on August 8, 2016, industry now focuses on compliance. 

In order to assist with compliance, the Center for Tobacco Products of the FDA provides numerous resources, including webinars, to provide guidance and insight. Below are some of the FDA's resources. 

In the European Union

The European Commission began regulating e-cigarettes as of 19 May 2014. The Tobacco Products Directive became applicable to all EU member states as of 20 May 2016. The TPD provides rules overseeing, among other things, electronic cigarettes (e-cigs or e-cigarettes). Notably, the TPD sets out safety and quality requirements for consumer electronic cigarettes, as well as provides the requirements for certification for e-cigarettes. 

The main requirements for compliance of TPD Article 20, specifically focused on e-cigarettes, include submission of a technical dossier to relevant authorities, restricted additives, maximum strength for nicotine-containing liquid, restricted advertising, and more. 

In a press release in May 2016, the European Commission identified ten key factors for tobacco products sold in the EU. In that, they specifically listed safety and quality requirements for e-cigarettes, packaging and labeling requirements for e-cigarettes and monitoring/reporting developments.  To read the press release in full, click here

State-level Regulations

Since their introduction in the USA in the mid-00s, states have taken varying approaches to regulating e-cigarettes. 

The landscape of state - and local - regulations is complex and ever-changing. There are also areas of overlap with the FDA deeming regulations.  For a state-by-state roundup of regulations, accurate as of March 15, 2016, click here to visit the Public Health Law Center at Mitchell Hamline School of Law.