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PMTA and the Vaping Industry

  • The FDA has enacted a requirement that all E-liquid products and vaping devices must have a Pre-Market Tobacco Application (PMTA) submitted and on file with the FDA. In order for vape products to continue to be sold legally within the US, respective PMTA(s) must have been submitted prior to or by the September 9th, 2020 deadline.
  • Any E-liquid product or vaping device without an on-time PMTA submitted and on file with the FDA, is considered to be illegal and unauthorized to be sold within the US. The FDA has started auditing vape product manufacturers, online retailers, and brick and mortar vape shops and removing these illegal products and retailers from the market.
  • The PMTA submission process is close to $1 million per E-liquid flavor or device type. This is due to the cost of the application process itself, plus consultant fees and extensive testing procedures needed to execute the application process properly. Because of the exorbitant filing cost, most e-liquid and vaping device brands have not submitted a PMTA. Although many brands either claim to have submitted a PMTA, or avoid the topic completely – keep this in mind as the FDA continues to crack down on products being illegally sold in the US - those brands will start to disappear!

 

  • Since the September 9th, 2020 PMTA submission deadline, the FDA has been reviewing applications and issuing Marketing Denial Orders to manufacturers and brand owners who have submitted PMTAs for products that do not meet the FDA’s requirements to continue to be sold within the US market. The FDA also continues to audit and issue official Warning Letters to any brand owner or retailer who opts to sell illegal product (either products that have not been submitted for review via a PMTA or products that have been submitted for review via a PMTA, but have since received a Marketing Denial Order).
  • Vaprzon is proud to be the exclusive online retailer of Halo products. Halo’s PMTAs (filed under Nicopure Labs) are currently in the final stages of FDA review. Halo has submitted a PMTA for the following products:

E-liquid:

  • Halo Tribeca Tobacco
  • Halo SubZero Menthol
  • Halo Turkish Tobacco
  • Fusion Unflavored Tobacco

Hardware:

  • Halo Triton II Starter Kit (and supporting consumable components)
  • Halo Zero Starter Kit (and supporting consumable components)

 

 Vaprzon will continue to keep you updated regarding breaking regulatory news affecting the vaping industry, as well as the status of your favorite Halo products!