PMTA Filing & Consulting Services

FDA Compliance for ENDS, Nicotine Pouches, Lozenges, Gums & More

Are you selling nicotine products in the U.S.? If your product contains tobacco-derived or synthetic nicotine, it likely requires a PMTA (Premarket Tobacco Product Application) to remain legally on the market. The FDA Center for Tobacco Products (CTP) enforces strict requirements for product registration, ingredient listing, and full PMTA submissions under the Tobacco Control Act and subsequent amendments.

At Gegahelix, we offer complete PMTA consulting services—from product classification and toxicological evaluations to full technical file preparation and submission. Our regulatory team has completed 150+ successful PMTA submissions, all of which received Accepted for Review (AFR) status, enabling our clients to continue selling their products during FDA review.

What Is a PMTA?

The Premarket Tobacco Product Application (PMTA) is the only legal pathway to market a new tobacco product in the United States. It is a scientific submission to the FDA that proves:

  • Your product is appropriate for the protection of public health
  • It meets all ingredient, manufacturing, toxicology, and marketing regulations
  • It does not appeal disproportionately to youth or non-users
  • It contains complete data on health risks, exposures, and safety

Which Products Require a PMTA?

Any nicotine or tobacco product introduced to the U.S. market after February 15, 2007 (the "grandfather date") requires an approved PMTA unless it qualifies for exemption (which is rare).

PMTA is required for:

ENDS (Electronic Nicotine Delivery Systems)

  • Disposable vapes
  • Pod systems
  • Open-system tanks
  • Refillable e-liquid devices

E-liquids and E-juices

  • Nicotine-containing
  • Synthetic nicotine
  • Flavor variations

Nicotine Pouches & Oral Products

  • Nicotine Pouches (tobacco-derived or synthetic)
  • Lozenges
  • Gums
  • Tablets
  • Sublingual films
  • Sprays

Other Products

  • Heated Tobacco Products (HTPs)
  • Heat-not-burn sticks and devices
  • Any New Form of Nicotine Delivery not approved as a drug or legacy tobacco product

What Were the FDA Deadlines?

  • The original PMTA deadline for ENDS products was September 9, 2020
  • In March 2022, the deadline was extended to April 2022 for synthetic nicotine products under the new Consolidated Appropriations Act
  • Products already on the market before the deadline could remain for sale if a PMTA was filed and Accepted for Review
  • No new nicotine product can legally be sold without a PMTA unless it was on the market and submitted before the deadline

The Full PMTA Submission Process

Here's how a compliant PMTA journey unfolds—Gegahelix supports every stage:

1. Product Classification & Regulatory Strategy

  • Does your product qualify under tobacco regulation?
  • Is it nicotine-containing or nicotine-free?
  • Synthetic nicotine requires same PMTA process as tobacco-derived

2. FDA Registration & Product Listing

  • Register as a manufacturer, importer, or distributor
  • Submit product details to the FDA Unified Registration and Listing System (FURLS)

3. Ingredient Reporting

  • Submit all ingredients and components to TPD Ingredient Listing Portal
  • Detail component roles, CAS numbers, suppliers, and manufacturing processes

4. Toxicology & Health Risk Assessment

  • Conduct Toxicological Summaries
  • Perform Toxicological Risk Assessments (TRA)
  • Determine PDEs (Permissible Daily Exposures)
  • Evaluate HPHCs (Harmful and Potentially Harmful Constituents)

5. Environmental Risk Assessment (ERA)

  • Provide data on environmental impact of ingredients, devices, packaging
  • Justify Categorical Exclusion or submit Full EA under 21 CFR Part 25

6. Nonclinical & Clinical Studies

  • Gegahelix prepares literature-based justifications if full studies aren't required
  • Include inhalation, oral toxicity, bioavailability, and irritation data as needed

7. Product Characterization

  • Detail every physical, chemical, and functional property
  • Coil materials, airflow design, heating mechanisms, device specs, puff volume, etc.

8. Manufacturing Process Documentation

  • Provide batch records, SOPs, cGMP practices, QA protocols
  • List all facilities, materials, testing procedures, and safety controls

9. Labeling & Marketing Practices

  • Submit all marketing materials for FDA review
  • Demonstrate youth deterrence, warning label compliance, and no false health claims

10. PMTA Compilation & Submission

  • Assemble all 8 PMTA modules
  • Ensure eCopy format compatibility
  • Submit via FDA ESG or CDER NextGen Portal

PMTA Structure: The 8 Modules

A typical PMTA can exceed 100,000 pages of supporting documentation. Gegahelix has the tools, experience, and staff to manage this scale.

  • Module 1 – Administrative Information
  • Module 2 – Summaries
  • Module 3 – Product Description & Specifications
  • Module 4 – Manufacturing & Process Controls
  • Module 5 – Labeling, Packaging, & Marketing Materials
  • Module 6 – Nonclinical Toxicology & Ingredient Safety
  • Module 7 – Health Risk Assessment
  • Module 8 – Environmental Risk Assessment

Why PMTA Filing Matters Now More Than Ever

  • States are increasingly policing unregistered products through AG enforcement, compliance sweeps, and local bans
  • Distributors and contract manufacturers require AFR (Accepted for Review) status for onboarding new SKUs
  • Retailers are refusing to stock unregistered products without proof of PMTA submission or CTP status
  • Only products with a valid PMTA on file and accepted into review may continue to sell in the U.S. during FDA processing

Why Choose Gegahelix?

150+ PMTAs Submitted — All Accepted to Review

Gegahelix has a 100% success rate in getting PMTA applications past the FDA's Acceptance for Review stage.

Full In-House Expertise

From toxicology and regulatory strategy to scientific writing and submission formatting—we do it all.

Real FDA Experience

Our team includes former FDA reviewers, toxicologists, and regulatory scientists.

Support for Startups & Scale-Ups

Whether you're a white-label startup or an enterprise manufacturer, we scale our service to your needs.

Rapid, Audit-Ready Documentation

We manage over 100,000 pages of documentation per product class—and we deliver it on time.

Ready to File or Need Help with Compliance?

Contact us for a free regulatory consultation or to request a proposal for your PMTA filing.

Gegahelix: Your end-to-end partner for nicotine product FDA compliance.

Talk to a PMTA Expert

Our dedicated FDA regulatory experts partner closely with your team, guiding you step-by-step through the PMTA submission process. Receive tailored support in toxicological assessments, ingredient evaluations, and compliance strategies, ensuring your ENDS, e-liquid, nicotine pouch, or nicotine patch products confidently navigate FDA approval.

Navigate FDA submissions with clarity—partner with Gegahelix to streamline your path to regulatory compliance and sustained market success.

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