Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

Dedicated to the compliance of
Nicotine Containing Products

e-liquid pens

Welcome To
Inter Regulatory

Inter Regulatory offers support to companies developing, manufacturing and marketing nicotine-containing products. We specialise in the provision of regulatory engagement, professional services and support to the ENDS and nicotine-containing products categories, globally.

Our goal is to serve our clients through professional, expert services enabling our clients to get to market and maintain compliance, quickly and without risk. 

We strive to take care of our clients business as if it were our own and we strive to maintain the highest level of quality and professionalism at all times, simplifying your regulatory needs. 

We are not just another faceless company, feel free to reach out to us and see how our team will take care of your needs.

three leaves

About us

Inter Regulatory recognise that all companies are different from size to culture. Whether a small company in the Middle-East or a multi-national based in California, we tailor our services to meet your needs. By making it our business to take care of yours, we seek to understand your needs and deliver the services that you need.

We pride ourselves on our quality and professionalism which are at the core of everything we do. 

Commitment to Quality

Here at Inter Regulatory, we are passionate about Quality. It is at the heart of what we do, and what we offer to you. It is for this reason that we operate under an ISO9001:2015 certified Quality Management System. We are certified by the British Standards Institute (BSI) for the provision of regulatory engagement, professional services and support to the ENDS and nicotine-containing products categories globally.

Our commitment to quality extends from the scoping of projects and services to the notification of data to regulators. It is through our approach to quality that we seek to exceed your expectations.



   FS 681824

nicotine
science behind nicotine

Our Quality Policy

Inter Regulatory is committed to both its clients and strives to be a world-class leader in regulatory advice, consultancy and engagement to the ENDS and Nicotine Containing Products category and to contribute to the protection of public health from the risks of combustible tobacco.

In its commitment to its employees, Inter Regulatory is dedicated to engaging all employees in strategic decisions of the company, providing a safe, welcoming and non-discriminatory workplace through the promotion of the highest level of professionalism.

Inter Regulatory is committed to maintaining the confidentiality of its client's intellectual property and continually reviews and improves its systems and policies to ensure safety and security.

Inter Regulatory is committed to continually improving its systems and services to achieve the highest level of customer satisfaction while meeting all regulatory, legal and environmental obligations.

Pre-Market Tobacco Applications

In May 2016, the Food and Drug Administration finalised its "deeming" rule, subjecting nicotine products to scrutiny under the Federal Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. Products marketed after February 2007 must submit a Premarket Tobacco Product Application (PMTA) before the product can be sold in the US.

Inter Regulatory adopt a risk-based approach to the requirements of PMTA. The absence of finalised guidance from the FDA has led to industry making many assumptions as to the extent and cost of PTMA generation. Inter Regulatory is committed to finding pragmatic solutions to ensure that from small self-mixing vape stores right through to multi-national firms, that the market continues to offer smokers a safer alternative to combustible tobacco. 

Core to our strategy is the early engagement with the Food and Drug Administration (FDA). As such, Inter Regulatory have developed a 4-Stage approach to PMTA development;

1) Strategy Formation and Regulatory Engagement
2) Generation of New Data to Support Products
3) Compilation of Publically Available Data 
4) Compilation of PMTA, Review and Submission

Our aim is simple; to ease the burden of the PMTA process and to find a cost-effective and reduced-risk pathway for everyone in the industry. 

Inter Regulatory has partnered closely with an A2LA/UKAS accredited laboratory operating to ISO 17025, a key requirement for laboratories responsible for the generation of data to support a PMTA, to provide a seamless service. 

Inter Regulatory also offer Quality Management System (QMS) support to e-liquid manufacturers seeking to go through the PMTA process. Working with our experts we will develop and implement a QMS suitable for FDA compliance (to ISO9001) and train you and your staff to take ownership of the system. Through this process, we will work with you to develop the required validation processes and data to meet PMTA requirements. 

Why choose Inter Regulatory as your Regulatory compliance partner for PMTA;

  • A company with experience in regulatory companies and FDA filings 
  • Partnered with a laboratory that has internationally recognised accreditation (A2LA/UKAS)
  • A company with truely Global regulatory experience 
  • A company led by quality 
  • A company dedicated to the compliance of nicotine-containing products
  • Pioneering experts in ENDS regulation, responsible for the first and only medically regulated ENDS product
  • Dedicated project manager responsible for your project

Stage 1 is the kick-off stage of the PTMA generation and sets the ground-work for the overall application. Determination of client needs, generate a scientific briefing package and file an OS meeting request with the FDA. Core to this stage is HPHC testing strategy, abuse liability approach, approach to topography and consumer perception and development of a project plan are all conducted as part of Stage 1. 

Stage 2 involves the generation of new data which is not currently held on the product. This will likely include; HPHC analysis of products, the commencement of stability study, evaluation of product physical properties, topography evaluation, testing of products for abuse liability and consumer perception studies.

Stage 3 involves the use of publically available data that is pertinent to the products being filed. The following areas will be addressed as part of Stage 3; 
- Abuse liability evaluation (supplemented by Stage 2) 
- Human health impact evaluation (supplemented by Stage 2)
- Likelihood of initiation and cessation (supplemented by Stage 2) 
- Human factors (supplemented by Stage 2) 
- Biomarkers of Harm and Exposure
- Health Outcomes 

Stage 4 involves the compilation of the scientific data pertaining to the product and the overall evaluation of the benefit of the product to public health. The PMTA will be formatted and filed digitally to the FDA using Inter Regulators WebTrader system.

Deadlines

Products introduced after 8th August 2016, must submit the ingredient listing 90 days before marketing.

8th November 2019
Submit the quantities of Harmful and Potentially Harmful Constituents (HPHCs).

11th May 2020
Deadline to submit a premarket application for new noncombustible tobacco products.

8th August 2021
Deadline to submit a premarket application for new combustible tobacco products.

FAQs

How Do I Demonstrate that the New Tobacco Product Is Appropriate for the Protection of Public Health?

Premarket Tobacco Applications must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users. This demonstration shall take into account the increased or decreased likelihood that existing tobacco users will stop using such products and the increased or decreased likelihood that those who do not use tobacco products will start using them.

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What information is needed in a Premarket Tobacco Application?

Premarket Tobacco Applications must include the information, as required by Section 910(b)(1) of the FD&C Act:

full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations that have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;

  • a full statement of the tobacco products:
    • components
    • ingredients
    • additives
    • properties
    • principle(s) of operation
  • a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of such tobacco product;
  • an identifying reference to any tobacco product standard, under section 907, which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
  • such samples of such tobacco product and of components thereof as the Secretary may reasonably require;
  • specimens of the labelling proposed to be used for such tobacco product, and such other information relevant to the subject matter of the application as the Secretary may require.
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When should a Premarket Tobacco Application be submitted?

The applicant must obtain an order from FDA authorizing marketing of the new product before it can be introduced or delivered for introduction into interstate commerce as per Section 910(a)(2) of the FD&C Act. To receive a marketing order, a premarket tobacco application must be submitted by the applicant, reviewed by FDA, and determined to be appropriate for the protection of public health.

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What happens after a Premarket Tobacco Application is submitted?

Upon receipt of an application, the FDA will determine if the application can be accepted and then filed for substantive review. FDA has refused to accept procedures for premarket tobacco product submissions.

If the application is accepted, the FDA then will conduct a filing review to determine whether the application is complete, i.e., whether it contains all the items under Section 910(b)(1) of the FD&C Act. If not, the application is incomplete, and we will refuse to file it.

If the application is complete, FDA will file the application and begin substantive review.

As part of its review, the FDA may refer the applications to the Tobacco Product Scientific Advisory Committee(TPSAC). You may also request that FDA refer the application to TPSAC.

After completing its review, the FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.

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What is the deadline for PMTA submission?

Following the July 11th 2019 court ruling the deadline for submission has been brought foward to May 11th 2020. The ruling ordered that:

1. The FDA (Food and Drug Administration) shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming rule (“New Products”), applications for marketing orders must be filed within 10 months of the date of this Memorandum Opinion and Order;

2. New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion;

3. New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;

4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.

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Tobacco Products Directive (TPD)


All nicotine-containing products which are sold in the European Union are required to comply with the Tobacco Products Directive (TPD), with the exception of products which are considered medicines. The Tobacco Products Directive (TPD) regulates the notification and sale of combustible tobacco, heat-not-burn (HnB), novel tobacco products and electronic nicotine delivery systems (ENDS). 

For ENDS products, the TPD requires manufacturers or importers to submit a notification to each member state, 6-months in advance of placing the product on the market. Each member state has discretion in its implementation of the Directive and so state-by-state variations exist. 

Included in the notification, the manufacturer is required to provide: 

  • Chemical analysis of product emissions
  • Declaration of ingredients included in any e-liquid
  • Toxicological review of each of the ingredients 
  • Sample packaging bearing the appropriate warnings 
  • Statement on the manufacturing process 
  • Manufacturer/importer declaration assuming responsibility for the product

Inter Regulatory offer a complete TPD notification service for all European Member States from product testing to the notification.

Manufacturers and importers are also required to provide, on an annual basis, the sales by volume for each of their notified products and to ensure that appropriate product vigilance is in place in the event of an adverse event. 

Our in-house experts have been involved in TPD from the onset and continue to be involved in the European and International standardization processes which are ongoing and are perfectly placed to advise you on your products needs. 

If you are looking to place products on the market within the European Union or if you have existing products on the market and are looking to add to your range, contact us today to see how we can help simplify the process. 

TPD Process Overview 
Ingredient Disclosure

Aerosol Testing and Analysis

Toxicology Report Generation

Submission of Required Documents

Product Notification

Product Verification/ Placing product on the market

Our services include:

  • End-to-end TPD notifications
  • Chemical analysis and characterisation
  • Generation of toxicological reviews
  • Packaging review
  • Data Submission to the Common Entry Gateway
  • Annual reporting 
  • Adverse event management 

Toxicology

Reports detailing the toxicological profiles of chemical ingredients are required for TRPR and TPD. This involves reviewing whether the chemical has any addictive, CMR, emissions, and cardiopulmonary toxicities. Toxicology reports are available for most chemical ingredients, and are available as single reports or batches. Feel free to contact us to discuss any requirements.

FAQs

What is the TRPR?

TRPR stands for Tobacco and Related Products Regulations. The TRPR is derived from an EU directive (the TPD) that came into effect on May 20th 2016. The TRPR introduced new laws for e-cigarettes, vaping devices and e-liquids.

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What does the TRPR involve?

The TRPR states that a notification shall include the following information:

The name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;

  • A list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
  • Toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;
  • Information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
  • A description of the components of the product; including, where applicable the opening and refill mechanism of the electronic cigarette or refill containers;
  • A description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article.
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What is the EU-CEG?

EU-CEG stands for the European Union Common Entry Gate. It is an online tool designed to ensure uniform reporting of information regarding tobacco products. The information required to complete a notification entry through the EU-CEG is follows from Article 5(5) and 20(13) of the Tobacco Products Directive (2014/40/EU).

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What happens after notification?

  • The notification will be reviewed by the relevant authorities, should there be any information missing from the notification then contact may be made in order to obtain this.
  • Once a notification is completed, Inter Regulatory will continue to provide services to navigate through the post-notification requirements and product development as you expand.
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What is the route from product creation to market?

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News & Updates

FDA are now cracking down on e-liquids that look like foods products

FDA are now cracking down on e-liquids that look like foods products

FDA are now cracking down on e-liquids that look like foods products

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L19 2RF

FS 681824 Inter Regulatory. A company registered in England and Wales, Company registration number: 10841512

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