FDA Rules and Regulations

Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), and e-pipes are some of the many terms used to describe electronic nicotine delivery systems (ENDS). ENDS are noncombustible tobacco products.

These products use a liquid “e-liquid” that may contain nicotine, as well as varying compositions of flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated into an aerosol that the user inhales.

ENDS may be manufactured to look like conventional cigarettes, cigars, or pipes. Some resemble pens or other everyday items. Larger devices, such as tank systems or mods, bear little or no resemblance to cigarettes.

Statistics about Electronic Nicotine Delivery System Use

• More than two million middle and high school students were current users of e-cigarettes in 2016.
• 11 percent of high school and 4.3 percent of middle school students were current users of e-cigarettes in 2016.
• E-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6percent to 5.3 percent among middle school students from 2011 to 2015.
• According to a 2013-2014 survey, 81 percent of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.

FDA Regulation of Electronic Nicotine Delivery System

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 regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories. Examples of components and parts of ENDS include:

• E-liquids
• A glass or plastic vial container of e-liquid
• Cartridges
• Atomizers
• Certain batteries
• Cartomizers and clearomizers
• Digital display or lights to adjust settings
• Tank systems
• Drip tips
• Flavorings for ENDS
• Programmable software

However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by FDA through the Center for Drug Evaluation and Research (CDER). FDA published a rule clarifying the jurisdiction over tobacco products, drugs, and devices.

Just to get you caught up with the rules and regulations the FDA, to help fight for your right to vape, join a vaping advocacy group and keep on vaping!

Vaping Advocacy Groups:

Maryland Vape Professionals

Vapor Association of Indiana

Florida Smoke Free Association

Consumer Advocates for Smoke-Free Alternatives Association

Just to name a couple, there are quite a few.

August 2017 Update: Extended timelines to submit tobacco product review applications for deemed tobacco products that were on the market as of August 8, 2016.