1. Regulatory Consultation & Strategy Development:Evaluate product pathways (PMTA/SE/Exemption).

2. TPMF/PMTA Dossier Preparation:Compile, review, and submit registration documents.

3. FDA Communication & Agent Services:Designate US Agent for FDA liaison; address review inquiries and supplemental data requests.

4. Compliance Support:Annual report preparation and post-market monitoring system establishment.

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1. Definition and Background

PMTA (Premarket Tobacco Product Application)

A mandatory FDA premarket review pathway for new tobacco products (e.g., e-cigarettes, vaping products, HTPs). Authorized by the Family Smoking Prevention and Tobacco Control Act (2009), PMTA requires manufacturers to demonstrate products meet the "Appropriate for the Protection of Public Health" (APPH) standard – proving benefits to adult smokers outweigh youth risks.

TPMF (Tobacco Product Master File)

A confidential technical dossier submitted to FDA, containing product ingredients, manufacturing processes, and quality controls. TPMF supports PMTA applications to streamline multi-product submissions.

The 2016 Deeming Rule brought e-cigarettes under FDA jurisdiction, requiring PMTAs for all tobacco products marketed after August 8, 2016. Non-compliant products face market removal.

2. Applicable Scope

Covered Products:

·ENDS, e-liquids, HTPs, nicotine pouches

·Flavored products (non-tobacco/non-menthol flavors require proof of "net benefits" for adults)

Exemptions:

·Products commercially marketed before August 8, 2016 (PMTA deadline: September 9, 2020)

·Some low-risk products may qualify for Substantial Equivalence (SE) pathway

3. Basic Requirements

Scientific Evidence:

·Non-tobacco flavors: Must submit RCTs/longitudinal studies proving "net benefits" (e.g., smoking cessation) vs. tobacco-flavored products; absence is a "fatal flaw."

·Youth access prevention: Products with age-verification tech receive priority review (no lowered standards).

Data Requirements:

·Chemical analyses (constituent release, HPHCs)

·Toxicology studies (long-term health impacts)

·Behavioral data (usage patterns & youth appeal)

4. Registration Process

1）Preparation:

·Determine product classification (PMTA/SE/Exemption)

·Establish TPMF (optional)

2）Submission:

·File PMTA (product description, research data, labeling)

·Non-tobacco flavors: Additional long-term clinical data

3）FDA Review:

·Phase 1: Administrative review (completeness check)

·Phase 2: Substantive scientific review

·Phase 3: Final decision (approval/denial/supplement request)

4）Post-Approval:

·Ongoing compliance (annual reports, adverse event monitoring)

·Priority: Products with age-verification may expedite Phase 3.

5. Regulatory Basis

Primary Laws:

·Family Smoking Prevention and Tobacco Control Act (2009)

·FD&C Act Section 910

Implementing Rules:

·2016 Deeming Rule

·2022 synthetic nicotine regulatory extension