Chemular - Regulatory Compliance Experts

Regulatory Services

US FDA and EU TPD2 Regulatory Services

Our Relationships Matter

We have a history of more than 20 years collaborating and working directly with the U.S. FDA and the European Commission on matters relating to reporting and notification obligations, submission of new or modified product applications, and inspection and enforcement. We speak "regulatory-ese" and know how to navigate the complex regulatory maze. In addition, we have extensive experience writing complete, detailed and accurate regulatory submissions.

Chemular's regulatory services include:

  • US FDA Substantial Equivalence (SE) Reports
  • US FDA Substantial Equivalence (SE) Exemption Requests
  • US FDA PreMarket Tobacco Applications
  • EU TPD2 New Product Notifications
  • Product Testing and Validation Support
  • Hazards Risk Analysis

Product Testing and Validation

Through our partners, we are able to provide a wide range of test and validation services to support your PMTA and TPD2 submissions and applications, including:

  • Product Toxicology Testing
  • Stability Testing
  • Clinical / Non-Clinical Trials or Studies

Click here for more information on our product testing and validation services.

Hazards Risk Analysis

The US FDA and the European Commission expect manufacturers to conduct and document an analysis of the risks associated with the use of their products, prior to placing the products on the market. 

Chemular will assist you in developing a process for identifying, analyzing and prioritizing risks, followed by a concerted effort and commitment of resources to minimize, monitor, and control the probability and/or impact of hazardous situations or to maximize the realization of opportunities.

Chemular will prepare your risk assessment for submission to US FDA on a Substantial Equivalence Application or PreMarket Tobacco Application, describing the product and all the parameters, such as test results, the type(s) of consumers selected for injury scenario(s), and the probabilities with the underlying data and assumptions.

The resulting product risk profiles will become part of your product submissions and will be the primary mechanism for determining when to report suspected adverse effects to the FDA and Competent Authorities.

Click here to learn more about Risk Management.

US FDA Substantial Equivalence (SE) Reports

A product is considered substantially equivalent when it has the same characteristics as a predicate tobacco product that has been approved by FDA or has different characteristics and the information submitted contains information, including clinical data if deemed necessary by FDA, that demonstrates that it is not appropriate to regulate the product because the product does not raise different questions of public health.

Chemular will prepare and submit your Substantial Equivalence application using the FDA e-submitter, including:

  • Summary of the data included in the report, as well as the predicate product
  • Summary of the business information and details
  • A summary of the similarities and differences with respect to: design features, ingredients, materials, heating source, composition, and other features, including the presence of harmful and potentially harmful constituents (HPHC)
  • Rationale for the basis of the SE determination
  • Description of the design features
  • Listing of materials and ingredients (components, subcomponents, ingredients, common names, CAS numbers, function of the ingredients, units of measure, nicotine levels) with comparisons to the predicate product
  • Technical specifications
  • Description of Composition, including an explanation of how the design, materials, ingredients, and heating source of the product are integrated to produce the final product
  • Listing of Harmful and Potentially Harmful Constituents with a side-by-side comparison of the predicate tobacco product (quantitative levels in smoke using both the International Organization for Standardization (ISO) and Canadian Intense smoking regimens).
  • Description of storage conditions
  • Any of the following as needed:
    • Consumer Perception Studies
    • Clinical data 
    • Abuse liability data 
    • Toxicology data
    • Response to FDA inquiries

Contact Us today to discuss how we can assist in your SE submission or manage it for you.

Exemption from Substantial Equivalence Requirements (for Modified Tobacco Products)

Minor modifications to currently marketed, approved tobacco products can be granted an exemption from Substantial Equivalence (SE) reporting requirements if the modifications are minor, such as adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive.

FDA must concur with your determination that the modification is minor and a SE Report is not required.

Chemular will prepare and submit your Request for an Exemption under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act through the FDA e-submitter application. The Exemption Request includes:

  • A written summary including your business information
  • A complete description of the products
  • A detailed explanation for and description of the modifications
  • A detailed explanation of the purpose of the modification
  • A legal explanation of why the modification is a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act
  • A detailed justification explanation of why a SE Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health
  • A certification summarizing the supporting evidence and providing the rationale for the determination that the modification does not increase the tobacco product's appeal to or use by minors, toxicity, addictiveness, or abuse liability
  • An environmental assessment

Contact Us today to discuss how we can assist SE Exemption Request or manage it for you.

US FDA PreMarket Tobacco Application (PMTA)

The PreMarket Tobacco Application (PMTA) is an extremely complex, science-based compilation of documentation which completely describes a product and its impact on human health and safety, and requires input from subject matter experts and the corroboration of accredited laboratories and scientists. The application must be formatted and delivered to FDA according to an established specification and submitted through FDA’s e-submitter application on the internet. Operation of e-submitter requires specialized training.

Chemular will prepare your complete PMTA submission according to FDA Draft Guidance for Industry: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, and submit to FDA using the e-submitter on the FDA website.

The estimated time frame for the complete compilation of the PMTA, including the time needed for toxicological analyses, stability testing, emissions testing, etc. is 16-20 months. 

We will compile multiple products on a single, combined cover letter to reduce cost, and utilize our vast library of publications, articles, and clinical study reports to mitigate clinical and non-clinical testing burdens.

Chemular will assist you in developing an accurate and concise application to comply with e-submitter criteria, write all elements of the entire PMTA submission, and perform the following:

  • Literature review and research
  • Compile general information about the company and products
  • Write descriptive information on the product, including packaging, labeling, quantity, nicotine content and characterizing flavor
  • Coordinate environmental assessment of your facility
  • Summarize the nonclinical and clinical studies relevant to your PMTA 
  • Perform analysis of scientific studies
  • Product and manufacturing analyses
  • Document the properties of the e-liquid
  • Conduct and document a hazards risk analysis
  • Describe your manufacturing processes and assist in the validation of processes
  • Characterization of constituents 
  • Toxicological review
  • Scientific review
  • Submission formatting and e-submitter submission
  • FDA Inquiry Response

Contact Us today to discuss how we can assist in your PMTA submission or manage it for you.

EU TPD2 New Product Notifications

The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). The directive establishes:

  • minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
  • that information will be provided to consumers so that they can make informed choices
  • an environment that protects children from starting to use these products

The UK Tobacco and Related Products Regulations 2016 come into force on May 20, 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.

For most countries, the Product Notification must be submitted through the European Common Entry Gate (EU-CEG) notification portal. 

Chemular will prepare the product notification, including:

  • information and background of the company and authorized representative information
  • complete listing of ingredients and summary of emissions testing
  • PhD review and summary of toxicological data
  • nicotine dose confirmation and summary
  • complete product description
  • GMP gap analysis and complete description of production processes
  • declaration of conformity
  • response to Member State inquiries for additional information

We can handle your Product Notifications from start to finish, including product testing, or just handle the paperwork. Click here for more information on our product testing and validation services.