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Halo PMTA


This is where you will find the most up-to-date information about our PMTA journey.

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PMTA Updates

Our press releases are in chronological order below:

FDA Accepts Nicopure’s initial PMTA Filings for Halo!

SEPTEMBER 6, 2020: The FDA accepted the first stage of Nicopure Labs Pre-Market Tobacco Application for official e-Liquids product review. This is exciting news because it means Nicopure Labs' vape products have the green light to proceed to the next stage of FDA approval.

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FDA Advances Nicopure’s Initial PMTA Filings into the final stage: Substantive Scientific Review!

SEPTEMBER 9, 2020: The FDA has moved Nicpoure Labs PMTA e-liquid product filing to the next phase for substantive scientific review. While this process can take time to complete, Nicopure Labs was notified by the FDA of their advancement to the next filing stage just days after the PMTA filing was accepted.

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PMTA Letter from the CEO

SEPTEMBER 10, 2020: According to industry statistics, this new FDA regulation regarding vaping devices and e-liquids will result in the removal of 99.99% of the vaping industry's current products. Read the press release below for details on the response from Nicopure Labs.

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FDA Advances Additional Nicopure PMTA Filings into the final stage: Substantive Scientific Review

MARCH 16, 2021: Just over 6 months after submission, Nicopure Labs’ Pre-Market Tobacco Applications for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit, and all supporting consumable components, have been Accepted and advanced to the final phase, Substantive Scientific Review by the FDA.

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What is a PMTA And What Does It Mean For The Vaping Industry?

In order to continue to legally sell product within the US, all e-liquid and vaping device manufacturers were required to submit a Pre-Market Tobacco Product Application (PMTA) to the FDA by September 9th 2020. Any e-liquid product or vaping device that was not filed for is now considered illegal to sell in the US Market. The FDA requires that PMTA submissions provide detailed scientific data proving a product is appropriate for the safety and protection of public health.

  • Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers
  • Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available
  • Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available
  • The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product

FDA Acceptance vs. FDA Authorization

Upon PMTA submission, there are multiple stages of review prior to FDA Authorization. Before advancing to the final stage of review (Substantive Scientific Review), the Manufacturer will need to receive a letter of acceptance for both Acceptance Review and Filing Review. Once all stages of review have been met, the FDA will issue an official letter of approval or denial, by SKU.

The FDA PMTA Approval Process

The FDA requires companies to participate in a thorough approval process involving several steps. During this process the submitted products are subject to intense scrutiny involving several areas including:

  • Principals of Operation
  • Manufacturing Processes
  • Product Samples (including labels)
  • Scientific Analysis (including test results)
  • Usage Patterns
  • Appeal and consumer perceptions
  • Opportunity for misuse