Posted on: October 14, 2018 Posted by: James McQuiston Comments: 0

Vaporizers, vapes, e-cigarettes, vape pens, hookah pens are a few of the several terms that are used to describe Electronic Nicotine Delivery Systems or ENDS. These are all noncombustible tobacco products that make the two ‘ends’ meet. One is that you get the same feeling as smoking a regular cigarette and at the same time your aim to give up smoking is also facilitated by these harmless tobacco products.

These tobacco products contain different components to make a complete vape pod. Typically it contains an “e-liquid” that may contain:

  • Nicotine to a specific level
  • Varying compositions of different popular flavorings
  • Propylene glycol
  • Vegetable glycerin and
  • Several other ingredients depending on the manufacturer you choose it from.

The liquid gets heated when you puff the vape pod, and that creates an aerosol which you eventually inhale.

These ENDS are manufactured in such a way that it looks more like conventional cigarettes, cigars, and pipes, but there are a few manufacturers that may design in some other way. These specially designed vapes look more like a pen or a USB flash drive.

If you want, you can also choose larger devices such as mods and tank systems that usually bear no or very little resemblance to regular cigarettes.

Usage among youth

According to the statistics about e-cigarettes use, it is found that the young generation all over the world is taking on to vaping more and more. There are millions of middle and high school students currently using these e-cigarettes. The figure says:

  • The use of e-cigarette rose from 1.5 percent to 11.7 percent among the high school students and
  • From 0.6 percent to 3.3 percent amongst the middle school students within a span of six years from 2011.

The most significant reason for this ever-growing popularity and fancy among the young generation is the fact that these ENDS are available in the most appealing flavors. This fact is corroborated by almost 81% of the youth e-cigarette users currently according to the 2013-2014 survey.

FDA Regulation on ENDS

The FDA has set some rules and regulations for the Electronic Nicotine Delivery Systems in 2016. These rules extend the regulatory authority of CTP to cover all such tobacco products that meet the definition of it. The FDA standardizes the manufacture, packaging, labeling, import, advertising, sale, promotion, and distribution of ENDS. The rule is also applicable to all components and parts of ENDS, but it exempts the accessories from it.

The components and parts of this tobacco product that falls under this rule include:

  • E-liquids
  • Cartridges
  • The glass or plastic vial that contains the e-liquid
  • Atomizers
  • Specific batteries
  • Tank systems
  • Cartomizers
  • Clearomizers
  • Drip trips
  • Lights or digital display to adjust settings
  • Flavorings used for the pod vape and other tobacco products and the
  • Programmable software.

However, all tobacco products that are marketed for any therapeutic purposes such as helping people to quit smoking are regulated by the FDA through the Center for Drug Evaluation and Research or CDER.

You can find all these rules that clarify the jurisdiction over tobacco products, devices, and drugs in the FDA publication.

The manufacturing process

The FDA also regulates the manufacturing of the Electronic Nicotine Delivery Systems and the e-Liquids. The rule applies even one makes, modifies, mixes manufactures, fabricates, assembles, processes, labels, repacks, re-labels, or imports ENDS.

One who is unaware of the requirements for manufacturing ENDS must contact the CTP’s Office of Small Business Assistance to get the answers to specific questions and know what to do to comply with the law and requirements. The office also provides help through their online educational resources to understand FDA policies and regulations.

Apart from that, manufacturers must also know about the required nicotine level and addictiveness warning on their packages as well as their advertisements. According to the rule, all ‘covered’ tobacco products must essentially bear the necessary nicotine awareness warning statement on their products labeling and ads beginning from 2018.

Rules for the manufacturers and others

All manufacturers must follow the rules set by the FDA in all aspects right from manufacturing to selling and imports. These rules can be downloaded from the internet in a PDF format or are also available in flyers that you can order. The responsibilities of the manufacturers fall under the final rule Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act to sell ENDS and e-liquids or their components and parts derived or made directly from tobacco.

  • Even the shops that prepares or mixes liquid nicotine or e-liquids containing nicotine or modifies and creates any type of ENDS are considered to be a manufacturer or tobacco products. As a result, these vape shops too have legal responsibilities to follow as both retailers as well as manufacturers of tobacco products. All guidelines regarding these responsibilities are available in Interpretation of and Compliance Policy for Certain Label Requirement as well as Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.
  • As for the importers of vapes or even those who offer ENDS for import must also follow the applicable rules under the Federal Food, Drug, and Cosmetic Act. The FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions contain more details about the importation process. If you have any questions regarding importing a certain tobacco product, you must contact the FDA district in which you want to import the product.
  • As for the users of ENDS, if they experience any safety issue or unexpected health problems they must report it to the FDA regarding the problem. There may be a potential violation with the specific tobacco product that must be looked into.

The FDA encourages such reports of adverse experiences to identify health or any safety issues due to the use of these products. Apart from that, the FDA strictly wants that these tobacco products are not sold to any minor.

Therefore, to make your ENDS meet, be cautious as a user or as a manufacturer and read about the rules, regulations and even about the adverse experience reports in the FOIA Electronic Reading Room.

 

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