All Your Tobacco & Nicotine Testing & Regulatory Consulting Services from One Company

Labstat is your single source for all the tobacco and nicotine product testing and regulatory consulting your company needs to streamline product development and meet regulatory requirements. From the early stages of R&D to filing submissions with the appropriate regulatory bodies, we have you covered.

Don’t see what you need listed below? Contact us for special methods development or contract research projects.

Tobacco & Nicotine Testing & Regulatory Consulting Services

In Vitro Toxicology for Tobacco & Nicotine Products

We partner with our clients early in the product development process to develop and execute testing strategies that meet the industry’s most complex challenges, such as providing reliable, defensible data to regulators. Our experts can provide guidance on which toxicology assays are appropriate for your products.

Labstat offers the ToxTracker assay, which provides critical information during your R&D process, allowing you to make product modifications earlier in your process.

Full Range of Toxicology Assays for Tobacco & Nicotine Products

ToxTracker® genotoxicity assay


Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537

Neutral Red Uptake

Validated cell lines: BALB/c 3T3, A549, CHO-WBL

Mouse Lymphoma Assay

L5178Y TK+/- clone (3.7.2C)


Validated cell lines: TK6, V79, CHO

Tobacco & Nicotine Product Stability Testing

We have developed our stability program with regulatory submissions in mind to help you obtain the data you need to develop your products.

  • Multiple walk-in climate-controlled units
  • 700-liter standalone climatic chambers that can be set to varying humidity and temperature settings to meet customized or ICH storage requirements
  • All storage chambers monitored 24/7 and control-charted to ensure traceability
  • All chambers and walk-in units connected to back-up generators to maintain prescribed conditions in the event of a power failure

Microbiology Testing for Tobacco & Nicotine Products

We offer a full suite of validated microbiological tests that can assist with your PMTA submissions, including the following:


Mycotoxins (Aflatoxins)

LC/MS/MS method capable of quantifying the Aflatoxins: B1, B2, G1, and G2 to the levels specified in USP <561>


Total Yeast and Mold Count (TYMC)


USP <2021> and <2022>



TPC, TYM, gram-negative bile tolerant, Escherichia coli, Salmonella spp., Pseudomonas, Staphylococcus aureus) for flower and e-liquid


Total Aerobic Microbial Count (TAMC)


Enterobacterial Count

(Bile-Tolerant Gram-Negative Bacteria)


Microbial suitability testing, USP <61>

Flavourants Testing

We offer a range of testing services for a variety of flavors for tobacco and nicotine products, including non-targeted analysis. We also offer custom method development to meet your unique needs for prototype development, market research, and quality and regulatory requirements. 

Our standard methodologies include more than 150 flavor compounds; contact us to discuss your project needs. 

HPHC Testing

We offer methods for every chemical on the FDA’s HPHC list (Harmful and Potentially Harmful Constituents). Our validation process is designed to meet regulatory standards to ensure that submitted data is reliable and defensible.

PMTA Testing

We offer methods for all of FDA’s PMTA ENDS (Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems) testing in support of PMTA or Substantial Equivalence sumbmissions.

Health Canada Testing for Tobacco & Nicotine Products

Our tobacco constituents, in vitro toxicology, mainstream smoke, and sidestream smoke methods are validated to official Health Canada methods. They are also included on our ISO 17025 scope of accreditation to ensure compliance with reporting requirements.


In Vitro Toxicology

  • Ames (Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537)
  • Neutral Red Uptake (cell line: CHO-WBL, 3T3/balb, A549)
  • Micronucleus with standard microscopy counting (cell line: CHO-WBL, TK-6 and V79)
  • Mouse Lymphoma (MLA) (cell line: L5178Y TK+/- clone (3.7.2C)
  • ToxTracker® genotoxicity assay

Mainstream Smoke

Sidestream Smoke

We Can Handle PMTA Submissions for You

Labstat’s experienced toxicologists, device experts, and chemists provide comprehensive PMTA preparation and filing services. Our team has prepared and filed a significant number of PMTAs for multiple manufacturers. Unburden your company from the hassle of preparing a PMTA submission.

PMTA Framework, Project Management, & Oversight

We handle all aspects of a PMTA submission for you, giving you one less thing to worry about.


Product Testing

  • HPHC (including Stability Testing)
  • Toxicology
  • Extractables and Leachables
  • Microbiology

Collation of qualitative and quantitative data

Fully integrated summary

Population studies and literature reviews

Collation of qualitative and quantitative data

Technical and scientific review

Literature reviews

Clinical studies

Toxicological assessment

Environmental assessment and CMC

Publishing and filing

GMP Preparation & Auditing Services

Maintaining compliance with the requirements of the Family Smoking Prevention and Tobacco Control Act of 2009 and the Deeming Rule can be a challenge. EAS Consulting Group, A Certified Group Company, can help ensure your company meets strict FDA requirements through the following services:

Tobacco product manufacturing practices and quality systems

Tobacco label and market reviews

U.S. agent and import assistance

Tobacco registration and submissions assistance

483 and warning letter remediation

Expert witness services

Facility compliance audits

Recall assistance

In-house and public trainings

Due diligence assessments

Get a Quote for Tobacco & Nicotine Testing

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