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TPD and PMTA: What Are the Standards for Vapes?

TPD and PMTA: What Are the Standards for Vapes?

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When it comes to products such as nicotine vapes and e-liquids there are several standards they must meet. The vape marketing world can be tricky, and you must make sure your products meet every standard to be approved. 

Depending on what part of the world you live in, there are different regulations. At VAZO, we make sure all of our products meet the standards for the UK and US. If you’re unfamiliar, let’s go over the standards for the TPD and PMTA. 

The Tobacco Product Directive -UK/EU

To start, The Tobacco Product Directive (TPD)  is the European Union’s regulatory act on nicotine vape and e-liquid products. It was put into place on May 20th of 2016 to ensure the safety of nicotine products and their users. According to the European Commission, the TPD’s goal is to “improve the functioning of the internet market for tobacco and related products while ensuring a high level of health protection for European citizens.” 

The TPD is there to protect consumers and has created standards that every nicotine company must meet in order to market their product in the UK and EU. To be compliant with TPD, companies must meet several standards. VAZO has worked hard to ensure that our products meet every requirement to be TPD compliant. 

Products Must be Registered with the MHRA

To be compliant with TPD standards, e-liquid and nicotine vape products need to be registered with The Medicine and Healthcare Products Regulatory Agency (MHRA). This needs to be done 6 months before anything can be sold. 

Nicotine Vape and E-Liquid Products 

Along with being registered with MHRA, products must adhere to these regulations: 

  • The products must pass emissions testing 
  • E-liquid strength cannot exceed 20mg, or 20% nicotine 
  • The product must include a health warning leaflet 
  • The product cannot include caffeine, dyes, or taurine

Packaging Regulations 

Packaging and labeling for e-liquid and nicotine vape products are also regulated. For the TPD to approve a product, the package must: 

  • Packaging must be child-resistant 
  • The package must include a warning pamphlet
  • The exact words “this product contains nicotine which is a highly addictive substance” must be on the package and cover 30% of it

Advertising Restrictions 

Along with packaging, advertising for nicotine vapes and e-liquids is also regulated by the TPD. There is a list of what is allowed and what isn’t. 

Not Allowed 

  • TV and radio ads 
  • Newspaper ads
  • Product placement 
  • Cold calling
  • Social media marketing ads 

Allowed Advertising

  • Posters
  • Billboards 
  • Trade shows 
  • Factual information videos 

Premarket Tobacco Product Application – US

A premarket tobacco application (PMTA) is an application that needs to be approved by the Food and Drug Administration (FDA) in the US before a tobacco product can be legally sold. A PMTA needs to provide scientific data that demonstrates that the product won’t pose any new risks to public health.

To be approved for a PMTA, the FDA looks at:

  • Risks and benefits to the population including people who don’t use the products 
  • Whether nicotine users would be more or less likely to stop using vapes and e-liquids if the product was available 
  • Whether the product will encourage those who don’t use nicotine to start

It is difficult to get a PMTA approved, and may take some time.VAZO is in the process of getting PMTA’s approved for all products as the FDA has a strict review process for the applications. 

Final Thoughts

To sum up, TPD and PMTA restrictions are important for health and safety. Currently, all VAZO e-liquid and nicotine vape products are TPD approved, but waiting on PMTA’s. You can check out VAZO’s TPD approved merchandise here

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