Premarket Tobacco Application (PMTA Testing)

All manufacturers of ENDS products in the US, both liquids and devices, must complete PMTA (Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems) submissions by 8th November 2018.

At Eos Scientific we can help your business with the rigorous testing processes for the Premarket Tobacco Product Application by ensuring your vape juice is able to be approved by passing the rigorous testing standards laid down by the FDA.

Using our state of the art instruments for eliquid and eliquid vapour analysis, Eos Scientific offers ingredient, toxicology, stability and emissions testing for PMTA submissions. We ensure all documentation is delivered in an FDA approved format, making your submission even easier. Our state of the art lab tests eliquids efficiently, ensuring timely testing, submission and FDA compliance.

Our scientific consultancy ensures you are supported during every step of the project, from initial quality testing through storage testing and beyond, offering on-site storage and repeat sample testing if required. We understand how confusing the new FDA regulations on vaping can seem and so we aim to help you get your vape juice FDA approved efficiently.

PMTA at Eos Scientific

  • Project management of the PMTA project
  • Regular communication and project status
  • Toxicology, stability and emissions testing for PMTA submissions

Final Rule

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.

See document

About the PMTA

Under the Tobacco Control Act any product introduced to the market after February 15 2007, is considered a new product and is therefore required to submit a premarket tobacco product application (PMTA) to the FDA.

In 2016, FDA extended its authority to all tobacco products (except for accessories of newly deemed tobacco products), which included electronic nicotine delivery systems (ENDS), such as ecigarettes and vape pens.

The PMTA assesses the quality of products and will help produce a standard to which all future eliquids and devices should adhere.

If you are a retailer that mixes and prepares eliquids, or if you create or modify vapourisers under the rules you will be regulated as both retailer and manufacturer.

Businesses that import tobacco products are also responsible for ensuring the product’s compliance with the legislation.

 

Compliance Deadlines

Unless FDA has issued an order denying or refusing to accept the submission, newly deemed tobacco products for which timely premarket submissions have been submitted will be subject to a continued compliance period for 12 months after the initial compliance period described above. For such products, FDA does not intend to initiate enforcement for failure to have premarket authorization during the continued compliance periods.  For PMTA submissions this is as follows:

  • PMTAs – 36 months from the effective date of the Deeming Rule (12 months after the compliance period for submission of such applications).

Once the continued compliance period ends, new tobacco products on the market without authorization will be subject to enforcement, even if the review of the respective submission has not been completed.

  • September 30th, 2017 – Register your business and submit product list including labelling and advertisements.
  • November 8th, 2017 – Submit ingredient listing (extended to May 8, 2018 for small-scale tobacco product manufacturers).
  • November 8th, 2018 – Submit a Premarket Tobacco Product Application (PMTA) for new tobacco products.
  • November 8th, 2019 – Submit quantities of Harmful and Potentially Harmful Constituents (HPHC).
  • November 8th, 2019 – 12-month continued compliance period ends.

Do you have any questions?