24.08.2021 – 14:31
Poda to Commence PMTA Process in the USA
Vancouver, Bc (ots/PRNewswire)
PODA LIFESTYLE AND WELLNESS LTD. ("Poda" or the "Company") (CSE: PODA) (FSE: 99L) (OTC: PODAF) is pleased to announce that it has entered into a professional services agreement (the "Consulting Agreement") with NKO Consulting Corp. ("NKO") to actively manage the application process for the Company to obtain marketing authorization for certain Poda products pursuant to the Premarket Tobacco Product Application ("PMTA") program of the US Food and Drug Administration ("US FDA").
Under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, anyone can submit a PMTA for any new tobacco product seeking a US FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, the US FDA considers, among other things:
- Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as non-users;
- Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
- Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
- The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
Pursuant to the Consulting Agreement, NKO will help to coordinate and oversee the entire PMTA process for certain Poda products. It is anticipated that the entire PMTA process will take at least 18 months. Prior to receiving PMTA approval, however, Poda may be able to sell certain of its products in the USA that are not subject to PMTA authorization requirements.
NKO is a consulting company founded by Mr. Nicholas ("Nick") Kadysh. Nick is a member of Poda's Global Advisory Board. With over a decade of experience as a public affairs and regulatory expert, Nick has led government relations and regulatory departments for a number of large corporations, including acting as Head of Corporate Affairs for JUUL Labs Inc., as Government Affairs & Public Policy Leader for General Electric Canada, and as Director of Public Affairs for Red Bull Canada. Through NKO, Nick is able to deliver a wide range of services and expertise that will be invaluable for Poda during the PMTA process.
Ryan Selby, CEO, commented, "Obtaining PMTA approval in the USA for certain Poda products is an important goal for the Company. NKO has the experience and expertise needed to make the PMTA process as fast and effective as possible, and I am very pleased to have entered into this Consulting Agreement with them. Poda is committed to the goal of making our revolutionary heat-not-burn products available to every current adult smoker globally, and the USA contains a large population of adult smokers who I believe could benefit from access to a wide variety of Poda's potentially reduced-risk products. Obtaining marketing authorization under the PMTA for certain Poda products in the USA will allow us to expand our offerings in this Country."
On Behalf of the Board, Ryan Selby CEO, Director, and Chairman of the Board
Poda Lifestyle and Wellness Ltd. Toll-free North America: +1-833-TRY-PODA (879-7632) Outside North America: +1-406-TRY-PODA (879-7632) email@example.com www.podalifestyle.com
ABOUT PODA LIFESTYLE
Poda Lifestyle is actively engaged in the global commercialization of HNB smoking products, which have the potential to reduce the risks associated with combustible smoking products. The Company has developed a patented HNB system that uses proprietary biodegradable single-use pods, which are both consumer and environmentally friendly. The innovative design of the Company's HNB platform prevents cross-contamination between the heating devices and the pods, eliminating all cleaning requirements and providing users with the most convenient and enjoyable potentially-reduced-risk smoking experience. Poda Lifestyle's HNB system is fully patented in Canada and is patent pending in over 60 additional countries, covering almost 70% of the global population. The Company's Poda Pods are the first and only cigarettes to have a completely closed end. This exclusive design eliminates all cleaning requirements and provides a truly ashless HNB cigarette. Poda Lifestyle's fully patented system is one of a kind and solves the major pain-point that ALL other HNB products suffer from: daily cleaning requirements. The Company's flagship Beyond Burn(TM) Poda Pods contain a unique tobacco-free blend of pelletized tea leaves infused with synthetic nicotine, which provides adult smokers with a smoke-free alternative to their regular habit without sacrificing satisfaction. Beyond Burn(TM) Poda Pods have been expertly crafted to mimic the sensorial experience of traditional cigarettes without the smoke, without the smell, and without the tobacco.
This news release contains "forward-looking information" within the meaning of applicable securities laws. Although Poda Lifestyle believes in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate, that the expectations reflected in this forward-looking information are reasonable, undue reliance should not be placed on them because Poda Lifestyle can give no assurance that they will prove to be correct. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. The statements in this press release are made as of the date of this release. Poda Lifestyle undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Poda Lifestyle, its securities, or financial or operating results (as applicable). Poda Lifestyle disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.
The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.