Recent amendments to China’s Tobacco Monopoly Law present an opportunity for responsible companies to demonstrate how alternative high-quality products are an important and appropriate element of tobacco harm reduction, according to Broughton.
Writing on the website of the contract research organization, Broughton’s head of regulatory affairs, Lloyd Smart, and regulatory consultant Xiangyin Wei summarize China’s tobacco monopoly law changes and explain what they means for electronic nicotine delivery systems (ENDS).
On Nov. 26, 2021, China’s State Council amended the country’s tobacco law, giving the State Tobacco Monopoly Administration jurisdiction over e-cigarettes. Next-generation products will now be managed in the same way as combustible cigarettes.
Among other things, this means that ENDS companies, including exporters, will need to apply for a license. A single transaction platform will be implemented for product distribution and all products must comply with a new national standard. Regulation of products likely to be introduced following an initial transition period of between three and five months, during which no new products may be brought to market. Products with synthetic nicotine will be banned in China.
According to Broughton, the recently announced changes to e-cigarette regulation in China offer an excellent business opportunity for companies that want to build consumer trust by showcasing their product’s high quality and safety standards.
“As with all regulatory requirements, the most important initial step is to understand fully what’s needed—to provide reassurance or identify gaps that need to be addressed. And to act quickly; seizing the opportunity while making sure you don’t get left behind as the market changes,” write Smart and Xiangyin.
Broughton has unveiled a rebrand that reflects its evolving service offerings to support clients through their whole product life cycle journey. The company states that it is on a mission “to help our clients deliver life-enhancing products to market, by providing the most trusted integrated services in the world.”
Building on years of experience in the pharmaceutical and next generation nicotine products space, Broughton offers its clients fully integrated scientific and regulatory consultancy, combined with comprehensive in-house laboratory services. The launch coincides with the announcement that the business is expanding its services into the rapidly evolving cannabinoids industry.
Moving forward the company will focus on accelerating life-enhancing products to market within strategic markets including pharmaceuticals, nicotine and cannabinoids. Its combined expertise in formulation science, device technology, software applications and aerosol science makes Broughton the ideal strategic outsourcing partner to support client pipeline portfolios of future next generation products.
“The launch of the Broughton brand formalizes our rapidly developing position as a full-service solutions provider to the life sciences sector,” said CEO Paul Moran, who founded Broughton Laboratories in 2006. “We will continue our commitment to investing further into global operations delivering scientific and regulatory consultancy combined with comprehensive product development and laboratory services.
“This next phase of our expansion is a natural evolution to grow capacity and capabilities into the broad life sciences sector as technologies improve to target unmet market needs.”
“One exciting aspect of this change is that it facilitates the expansion of our existing pharmaceutical quality and product stability services to support providers of pharmaceutical inhalation products,” said Broughton Chief Scientific Officer Chris Allen. “With expertise in device optimization, human factor studies, navigating complex regulatory pathways for combination products and a track record of quality compliance, our broad expert team can support device development from concept to commercialization.’’
“The expanding team at Broughton hold extensive knowledge of their specialist fields,” said Moran. “This rebrand brings together this expertise with a fresh focus on the journey of our clients’ products to meet an unmet market need. This is an exciting time for the business that will enable us to continue to innovate as we contribute to global health and wellbeing.”
In this article, Broughton Nicotine Services Head of Scientific Affairs Paul Hardman outlines the factors that can lead to data gaps in premarket tobacco product applications (PMTAs), what prompts a deficiency letter and how you can respond quickly and appropriately.
What is a deficiency letter?
Deficiency letters are sent to those who have submitted a PMTA with incomplete or insufficient data for the U.S. Food and Drug Administration to make a decision on whether the product is “appropriate for the protection of the U.S. public health.”
Why have I received a deficiency letter?
There are common causes of deficiencies that prompt the arrival of a letter. These could include a PMTA that lacks information that was mistakenly considered unimportant by the electronic nicotine-delivery systems (ENDS) company but is actually required by the FDA.
Applicants may also have been rushed to meet last year’s Sept. 9 deadline, leaving the company submitting the PMTA with insufficient time to collate and provide the required data. Similarly, the timeframe required to submit the application may not have left enough time to complete stability studies of the required length to provide a range of data. The FDA is, understandably, keen to understand the stability of a product over its expected shelf life.
Other reasons include:
A lack of integration between different studies—often submissions provide extensive data for some workstreams but are light in others. It is important that appropriate data is provided for all product analysis, nonclinical and human subject studies—and that data and approaches are integrated across all areas.
Different interpretation of “scientifically justified”—many elements of the PMTA guidelines indicate that approaches applied need to be justified by scientific data. However, as all products differ, there is a level of ambiguity in terms of what this looks like and what is required.
Poor “bridging” of data—the FDA welcomes the bridging of scientific data between similar products where appropriate. However, bridging that is not, in the opinion of the FDA, sufficiently scientifically justified will be highlighted and raised as a deficiency.
What will be in a deficiency letter?
Despite the name, it won’t just be a letter. The deficiency packs issued by the FDA are very detailed, outlining positive aspects about your application and areas for improvement and attention.
There will be multiple pages covering different points, with sections covering all products or particular products in a bundled PMTA and perhaps highlighting deficiencies for particular timepoints.
What is the aim of the deficiency letter?
Once a PMTA application has been accepted for filing, the next stage is substantive scientific review, which results in either a deficiency letter, a request for environmental information, a market order granted or a market order denied. The FDA will notify the submitting company when their application enters substantive scientific review.
The FDA intention of the deficiency letter pack is to support you in providing the required information. Each will typically cover what you need to do to remedy the deficiency and what data you need to provide to allow the FDA to carry on with a substantive scientific review—and the FDA has confirmed that, for deemed products (those on sale in the U.S. on or before Aug. 8, 2016), you will only receive one deficiency letter based on the agency’s current high workload with the many applications in process. The FDA has said this may be reviewed in the future once the backlog is cleared. Generally, for deemed products, you will have only 90 days to respond to the deficiency letter with all the relevant data that has been requested.
Information could include examples of what meets the FDA’s requirements and advice on how you could better explain or justify the information provided. There is no set response to a PMTA application. The FDA has received an extensive number of applications, which are reviewed by a team of people, so inconsistencies may arise between different responses. Also, take note that answering all the queries in a deficiency letter does not necessarily guarantee that your application will eventually be granted a marketing order.
How can I prepare for a deficiency letter?
As an ENDS company, you might have a good idea of possible data gaps within your submission and understand whether you are likely to receive a deficiency letter. Or, you may believe that what you have provided is appropriate and adequate. Either way, it is best to be prepared.
Steps can be taken to ensure you are ready for any eventuality, the most important one being to ask for help. Scientific and regulatory ENDS specialists can undertake gap analysis to identify any possible deficiencies so that steps can be taken now to provide what is required.
You can also ensure you fill any missing data gaps. If there is information that is clearly missing or inadequate, put studies in place to collect the data now. Remember, there are only 90 days to respond to a deficiency letter, which may not be sufficient time to obtain the information required.
Another piece of advice would be to start stability studies now if you are in any doubt that the stability data you provided may not be sufficient in terms of duration. Putting studies in place now will help you stay ahead of the game if this aspect of your submission is questioned.
Finally, you should always cross-check requirements. It is surprising how many companies miss out key sections, such as an executive summary or environmental assessment. Although omission of key sections is likely to lead to the FDA refusing to accept or refusing to file the application prior to reaching the substantive review phase, it makes sense to compare the detail of what you have provided with the list of requirements from the FDA to check if you have overlooked anything.
Recently, the FDA confirmed that addendums of additional data can be submitted to them before the commencement of the substantive scientific review stage for the process. This is fantastic news for manufacturers who had submitted dossiers that were not as comprehensive as they would have liked; if your application has not yet entered substantive scientific review, you now have the opportunity to submit additional data at no penalty to your application. However, if you plan to do this, it is important to contact the FDA and describe the anticipated plan of data generation and submission—and be quick. If you leave this too late and your application does enter substantive scientific review, you run the risk of any addendums being detrimental to your application and a shortening of the FDA’s enforcement discretion.
How can I be prepared for, or minimize the chance of, receiving a deficiency letter?
ENDS companies most prepared to respond appropriately will be those that are expecting the letter and have the required data ready or those that avoid receiving a letter altogether by providing information upfront. Companies such as Broughton Nicotine Services can help at any stage of the process, either prior to submission or during substantive scientific review, troubleshooting when there is a refuse to file/accept decision and also helping with preparation for and response to deficiency letters.
Broughton Nicotine Services can help you undertake a gap analysis on your submission and generate the required information. Contact our regulatory consulting team to book a meeting so that we can help you advance a smoke-free future.
This article was supplied on behalf of Broughton Nicotine Services.
Broughton Nicotine Services has appointed Paul Hardman as head of scientific affairs, the latest in a series of senior level appointments, as it continues to expand its services.
The business, which has helps electronic nicotine device companies bring noncombustible products to market, is currently expanding its full-service regulatory consultancy into modern oral nicotine products, heated tobacco products and Cannabidiol products.
A scientist with extensive experience in inhaled product development across pharmaceutical and consumer products, Hardman will have the task of growing the scientific affairs team to enable the business to grow and offer a premium consultancy experience for clients in the industry.
“We’re delighted to have welcomed someone of his caliber into this new role,” said Nveed Chaudhary, chief regulatory officer of Broughton Nicotine Services. “His addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy. Paul will take responsibility for delivering product development and optimization activities, drawing on his years of industry leadership and experience.”
Prior to joining Broughton, Hardman was scientific lead with Imperial Brands, where he was responsible for designing the testing strategy for the chemistry of inhaled and oral next-generation nicotine products, from assessing a variety of prototypes at the early stages of development through to characterization of products for submission through the U.S. Premarket Tobacco Product Application process.
He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.
Paul’s addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy.
He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.
“I am passionate about the opportunity to work with multiple clients and really get to the heart of their products so that Broughton Nicotine Services can best serve these businesses by championing those points in their regulatory submissions,” said Hardman.
“My role will involve growing the team to enable us to deliver a highly effective offering as Broughton moves into new areas, and I am eager to build on the success the business has already achieved.”
Broughton Nicotine Services (BNS) has launched its Blue-Sky Thinking Hub, an “open innovation community” for companies to collaborate and develop ideas within the electronic nicotine-delivery system (ENDS), pharmaceutical and cannabis markets.
BNS is a contract research organization with more than 10 years’ experience helping ENDS companies bring tobacco-free nicotine-delivery products to market.
The company has recently added services aligned with a number of new product categories, including modern oral nicotine products, cannabidiol (CBD) and cannabis-delivery devices and work with clients based in the U.S., China, U.K., Europe and the Middle East.
The Blue-Sky Thinking Hub seeks to engage companies with innovative ideas.
The Blue-Sky Thinking Hub encourages manufacturers and regulators to build strong relationships to overcome product development and regulatory challenges and work toward total harm reduction. An additional benefit is around considering solutions to potential regulatory concerns as part of the product development.
“Broughton Nicotine Services is dedicated to helping manufacturers meet regulatory requirements and delivering reduced-harm products to market,” said Nveed Chaudhary, chief regulatory officer at BNS.
“The Blue-Sky Thinking Hub seeks to engage companies with innovative ideas, which could be anything from new formulations to plastic-free or biodegradable products, technology to discourage and reduce youth access or even alternative charging for devices.
“Broughton helps these ideas to come to life by providing expert scientific and regulatory advice, contributing to the end goal of global total harm reduction.”
We invite industry professionals to discuss, debate and develop their ideas for new products aligned with regulatory requirements and to hopefully help influence and shape new policies.
“We are delighted to be launching the Blue-Sky Thinking Hub, which is the first of its kind in the industry,” said Paul Moran, chief executive at BNS.
“We invite industry professionals to discuss, debate and develop their ideas for new products aligned with regulatory requirements and to hopefully help influence and shape new policies.
“Together we can achieve total harm reduction and a smoke-free future.”
Broughton Nicotine Services has appointed Nveed Chaudhary as chief regulatory officer.
This appointment is the latest in a series of high-profile additions to the team at the contract research organization specializing in electronic nicotine delivery systems (ENDS), as it embarks on its next phase of growth.
Having built a leading reputation for advancing a smoke-free future by helping ENDS companies bring non-combustible products to market, the business is now also moving into modern oral nicotine products, heated tobacco products and cannabidiol products.
“We are absolutely delighted to have brought Nveed on-board,” said Paul Moran, CEO of Broughton Nicotine Services. “He is one of a small number of experts in the industry to have developed scientific and regulatory strategies that have delivered the highly sought-after marketing order for both premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) applications. Nveed’s depth of knowledge and experience will further help Broughton’s clients shape the future of next generation nicotine products.”
Previously head of harm reduction science at Imperial Brands and director of strategic communications at Philip Morris International, Nveed was a core team member of the successful IQOS PMTA and MRTP regulatory submissions and director for the Myblu PMTA submission program. He is a recognized expert in the nicotine sector, author of over 25 peer-reviewed publications and speaker at international lung disease and tobacco harm reduction conferences.
“My career goal has always been to reduce the burden that lung disease has on patients, society and public health,” said Chaudhary. “To combat the harm effects caused by smoking it’s important to offer consumers high quality, rigorously tested and regulated non-combustible products.
“Broughton Nicotine Services act as the bridge between the industry and global regulators. By applying experience and knowledge we partner with manufacturers to help them secure Marketing Orders for safer next generation products.
“It’s clear that the business shares my drive to accelerate the creation of a smoke-free future and I’m excited to be part of the team.”
Broughton Nicotine Services has published a summary of the U.S. Food and Drug Administration’s rule for the premarket review of new tobacco products.
Released on Jan. 19, the FDA’s final rule makes amendments and recommendations to the previous rule and helps ensure that PMTAs contain sufficient information for the agency to determine whether a marketing granted order should be issued for a new tobacco product.
The purpose of the rule is to improve the efficiency of the submission and review of PMTAs as well as providing applicants with a better understanding of the information a PMTA must contain.
Amongst other topics, the rule addresses:
The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
Whether the product presents the same or different risks compared to other tobacco products. The FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
Electronic submission of the PMTA.
Post-market reporting requirements for applicants that receive marketing granted orders.
Retention of records requirements for PMTAs
Procedures by which the FDA reviews a PMTA
Broughton Nicotine Services summarized the 516-page recommendations and requirements report into a digestible guide, which is available for download here.
