An Updated Guide on FDA’s Position

  1. FDA Vaping Regulations - An Updated Guide on FDA’s Position

The United States’ laws on smoking are very clear, but when it comes to e-cigs and vaping, the regulations become less conspicuous. However, in the recent times, the U.S. Food and Drug Administration (FDA) has become increasingly restrictive on when and where its citizens can light up, and its penalties for non-compliance are sternly punitive. For instance, as of August 8, 2016, the FDA established new e-cigarette regulations classifying them as ‘tobacco products’ based on the fact that there is nicotine present in some of the devices.

As such, e-cigarettes use will be regulated to prevent purchase by persons under the age of 18, as well as to limit the exposure to secondhand smoke in public areas. For vapers and retailers, this means the purchase of e-cigarettes will be no different than that of traditional cigarettes or cigars. Buyers will be required to verify their age using a valid photo ID as mandated by the Tobacco Control Act of 2009. This regulation is just a miniature section of the released a document particularizing the new regulations governing the vaping industry. Does this mean the ‘vapocalypse’ is finally here? Only time will tell!

Although vaping and its health impact have instigated hot topics in recent years, there is a wealth of proof that shows that e-cigarettes are not only an effective way of smoking but one that is considerably less harmful. Therefore, these sweeping FDA regulations are not only going to impact the vaping industry at large, but they are also going to deprive vapers the realest smoking alternative ever devised.

What are These FDA Vaping Regulations?

Last year, the FDA confirmed a rule that extended the CTP’s regulatory authority to cover all tobacco products, including the Electronic Nicotine Delivery Systems (ENDS). This finalized the proposed rule that regulates everything in vaping from manufacturing to distribution of ENDS—including their parts and components. The only thing that the FDA isn’t regulating is the ENDS accessories, which includes stuff like lanyards and screwdrivers! Such parts and components of ENDS as listed by the FDA include:

  • E-liquids
  • Drip tips
  • Tank systems
  • Certain types of batteries
  • Atomizers
  • Cartridges
  • A plastic or glass e-liquid vial container
  • Programmable software
  • Flavorings for ENDS

FDA Vaping Regulations to the Retailer

Here is a list of FDA’s regulations on ENDS to be followed by the retailers. Note that some of the examples of ENDS as described by the FDA include electronic pipes, personalized vaporizers, e-cigars, e-hookahs, vape pens, and e-cigarettes. Some of these regulations don’t take effect until the start of 2018.

  • If a shop mixes or prepares liquid nicotine or creates or modifies any ENDS, then the retail shop will be considered a tobacco product manufacturer and must comply with the regulations set aside for tobacco product manufacturers.
  • Beginning 2018, an advertisement for ENDS must contain a health warning statement.
  • Beginning 2018, retailers must not sell or distribute ENDS without a health warning on the package. The warning will read: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  • ENDS should never be sold in a vending machine unless in an adult-only establishment.
  • Retailers must not give away free samples of ENDS, including their parts and components.
  • ENDS should only be sold to persons aged 18 or over, and therefore, retailers are required to check ID before dealing any ENDS.

FDA Vaping Regulations to the Manufacturers

The manufacturers must make sure that each of their vaping product go through the agency’s expensive review process. According to the FDA, the manufacturer must adhere to the following requirements:

  • Register their establishments and submit their product listing to the FDA.
  • Ingredients used in the ENDS must be submitted to the FDA as well as the information on the harmful and potentially harmful constituents.
  • Market tobacco products (those containing nicotine) in compliance with the applicable regulations, rules, and requirements.
  • Manufacture nicotine products with the mandatory warning statements on advertisement and packaging.
  • Never introduce products that are related to tobacco (or contain nicotine) as ‘less harmful’ or ‘reduce risk.’

It should be noted that the manufacturers FDA regulations also apply to the local vape shops that mix their own e-liquids. In these regulations, the local shops are considered manufacturers and will have to undergo the same FDA approval process. Section 910(a)(1) of this document states that “if an establishment prepares or mixes e-liquids or creates or modifies aerosolizing apparatus for direct sale to the consumers for use in ENDS, the establishment will be considered as a tobacco product manufacturer.”

FDA Vaping Regulations on ENDS Importation

Importing ENDS and other vaping products now falls under the same laws of importing tobacco and tobacco products. According to the agency, tobacco products imported or offered for import must comply with all the applicable requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). If one does not comply with these requirements, their products are subject to refusal of admission under the section 801 of the FD&C Act.

How will the FDA vaping laws affect vapers?

Manufacturers and retailers vaping regulations are just the start. Manufacturers fear that the need to undergo inflated FDA approval process will be passed down to the vapers. This means that the ENDS will significantly become pricier than they already are. Besides, most see it (the regulation) as an erosion of the freedom vapers have had until now as one must be cognizant of when and where he/she can vape.

FDA Vaping Regulations Winners and Losers

The rules finalized by the FDA will decimate much of the vaping industry in the coming years, from manufacturers to retailers. Therefore, the losers are definitely the manufacturers, retailers, and especially the vapers. The winners will be the Big Tobacco a company that will likely enjoy less competition from the vaping industry—an industry that is responsible for more than 30 percent of cigarette consumption reduction according to an EU study. State governments will also count themselves ‘winners’ as they look to benefit from the hefty regulatory costs imposed by these regulations.

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