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PMTA Submissions

Submitting a PMTA is the first step for someone seeking FDA approval for the development and marketing of a new tobacco product. According to the FDA, a PMTA “must provide scientific data that demonstrates a product is appropriate for the protection of public health.”

What does this mean for you?

As you know, cigarette smoking, the use of vape products, and tobacco smoking can be dangerous to the public. At IC Tobacco Consulting, we help you prepare, gather, and accurately present information such as the risks and benefits of your tobacco or vape product through your PMTA.

Compliance officers view these applications under increasing scrutiny, which is where IC Tobacco industry experts can help you avoid oversights and strategically communicate your product’s benefits, features, and vital information. Through our tried-and-true premarket tobacco application practices, we help you quickly attain FDA approval for your tobacco or vape product.

Premarket Tobacco Product Applications (PMTA Applications)

PMTA Framework and Project Management and Oversight

  • Planning

  • Fully integrated summary

  • Literature reviews

  • Toxicological assessment

  • Product Testing

    • HPHC (including Stability testing)

    • Toxicology

    • Extractables and Leachables

    • Microbiology

Scientist on Computer
Virtual Meeting

  • Population studies and literature reviews

  • Clinical studies

  • Environmental Assessment and CMC

  • Collation of qualitative and quantitative data

  • Writing

  • Technical and scientific review

  • Publishing and filing

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