Kaival Brands Innovations Group, Inc. | NASDAQ: KAVL
Kaival Brands Innovations Group, Inc.
Kaival Brands (Melbourne, Florida) is a company focused on developing innovative products and is the exclusive distributor of the BIDI® Stick. Manufactured by Bidi Vapor, LLC, BIDI® Stick is an innovative nicotine vaping device. Bidi Vapor designed the BIDI® Stick in its mission to provide adult smokers a premium vaping experience.
The BIDI® Stick is a one-time use only, closed system, disposable vaping device that is tamper-resistant and recyclable. The BIDI® Stick is intended for adult users only. With its quality, the BIDI® Stick ensures premium nicotine levels in each drag. As a responsible industry actor, Bidi Vapor has set strict and responsible age verification processes and has complied with government laws and regulations.
Bidi Vapor products are sold primarily through national convenience stores as well as online exclusively through authorized direct retailers, and GoPuff. Bidi Vapor requires its direct retail partners to sign a Wholesaler & Direct Retailer Agreement that ensures customers are asked to provide valid government-issued identification to prove age eligibility.
See more in the video below about the Bidi Vapor takes to ensure strict compliance, responsibility, integrity to provide premium vaping experience.
The BIDI® is dedicated to using the latest technology to bring a premium experience for adult tobacco and vape users.
Bidi Vapor launched a unique recycling program that promotes sustainability and environmental consciousness through BIDI® Cares.
The BIDI® Cares initiative promotes sustainable practices pioneering in the vaping industry. Proper disposal of empty BIDI® Sticks lessens its carbon footprint while providing ways to reuse recyclable components.
Components of the BIDI® Stick range from 60% to up to 90% recycling utilization rate. For every ten (10) used BIDI® Sticks, customers are encouraged to participate in the BIDI® Cares initiative by filling up a Recycling Form, generating a Return Label, and shipping the used vaping devices back to Bidi Vapor for verification.
Kaival Brands acts as the sole exclusive worldwide distributor of the BIDI® Stick in partnership with Bidi Vapor, LLC. In 2020, Bidi Vapor submitted its premarket tobacco application (PMTA) to the U.S. Food and Drug Administration (FDA) for review.
The application detailed the BIDI® Stick’s 11 flavor varieties with 6% nicotine e-liquid formulation. Bidi Vapor engineered its electronic nicotine delivery system (ENDS) products using patented technology, ensuring quality control throughout the production cycle – from purchased raw chemicals and components through the manufacturing process – in a cGMP (current Good Manufacturing Practice) facility. The product then goes through various in vitro and in vivo toxicity testing (including genotoxicity tests) at a GLP (Good Laboratory Practice) approved lab and undergoes HPHC (Harmful and Potentially Harmful Constituents) tests for aerosol and e-liquid at ISO 17025 certified labs. Also included in the PMTA submission were three independent surveys and one “combined” consumer survey for people aged 21 and over.
Bidi Vapor’s application ran over 285,000 pages, providing science-based evidence to be authorized as Appropriate for the Protection of Public Health (APPH) and further supporting the public need to give options to adult smokers of combustible tobacco products. Despite these efforts, however, the FDA issued a Marketing Denial Order (MDO) for most flavored vape manufacturers, including Bidi Vapor, in 2021.
Bidi Vapor appealed the decision and emerged triumphant in a judicial stay of the MDO in February 2022, and more recently, in August 2022 as the 11th Circuit Court of Appeals set aside the MDO and remanded Bidi Vapor’s PMTA back to FDA for further scientific review. To date, the BIDI® Stick’s flavored options can continue being legally sold across the United States, subject to FDA enforcement discretion.
The BIDI® Stick features tamper-resistant packaging guarding against youth access and counterfeits.
6% nicotine satisfies current adult smokers; there are no low nicotine options to lure minors or non-smokers.
From its leak-proof, patented mouthpiece, medical-grade paper and cotton filter pads, and precise e-juice heating system, the BIDI® Stick is first in class.
The BIDI® Stick is fully charged and ready to use, with its lithium batteries meeting UL standards as well as international, national, and regional regulations.
Light on the hand and smooth to the touch, the BIDI® Stick has a streamlined ergonomic design that strongly appeals to adults.
The BIDI® Stick is disposable, but it contains recyclable components. BIDI® Cares innovates ways to reuse empty BIDI® Stick components.
Analytical Evaluation Stability Program Conclusions
BIDI® Stick nicotine levels were within the product release specifications and in line with packaging labels (60 mg/mL).
BIDI® Stick is consistently manufactured and stable for up to 22 months when stored at ambient temperatures.
BIDI® Stick aerosol HPHCs are below or similar to HPHC levels in FDA authorized products (e.g., combustible cigarettes, IQOS).
BIDI® Stick e-liquid does NOT support microbial growth.
Kantar Health Llc (Now Verner Enviza)
Tobacco/nicotine product non-users, both former and never users, reported no interest in using BIDI® Stick based on average Juster scale ratings below 1.0 on the 11-point scale, representing “no chance” of using the product.
Study findings suggest the low appeal of the BIDI® Stick to all cohorts, including non-users, former users, and youth, across all flavors (flavored, tobacco flavored, and menthol flavored products).
Flavored ENDS or ENDS with a 6% nicotine level helps consumers transition away from combusted cigarettes.
The BIDI® Stick outperforms others for non-counterfeit authentication methods, adult-only positioning, customer service, and device recyclability.
BIDI® Stick awareness and usage are the lowest among all brands listed.
Regarding the concern about minors possibly having access to vaping products, BIDI® Vapor uses several stages of legal-age and identity verification with its products:
In June 2022, the Centre for Substance Use Research Ltd (CSUR; Glasgow, United Kingdom) conducted an online survey to estimate the prevalence of use of 19 currently marketed brands of ENDS among nationally representative samples of U.S. adolescents (13-17 years), young adults (18-24 years), and older adults (25 years and older). Included in the list of assessed brands was the BIDI® Stick ENDS in each of 11 currently marketed flavor variants.
In June 2022, the prevalence of underage current use of a BIDI® Stick ENDS in the United States was very low for all 11 flavor variants.
Current use of a BIDI® Stick ENDS is most prevalent among legal age young adults.
The significant increase in underage current use of disposable ENDS that has been observed nationally in recent years does not appear to be attributable to the market availability of BIDI® Stick ENDS.
This study was a cross-sectional, internet-based, product-specific survey study of risk perceptions and behavioral intentions in relation to the BIDI® Stick ENDS in 11 flavor profiles among a broad (~7,000) U.S. nationally representative samples of adult current combusted cigarette smokers, former smokers, and non-smokers. Significantly, these study results were largely consistent across all 11 flavor profiles. For this study, Bidi Vapor worked with Russell Burnett Research and Consultancy Ltd and McKinney Regulatory Science Advisors.
Perception And Behavioral Intentions (PBI) Study of the BIDI® Stick
Exposure to the BIDI® Stick ENDS generated high levels of positive intention to trial a BIDI® Stick ENDS among legal age adults who are Current Smokers and/or Current Users of e-cigarettes – i.e., the intended users of the BIDI® Stick ENDS.
Exposure to the BIDI® Stick ENDS simultaneously generated low levels of positive intention to trial the BIDI® Stick ENDS among legal age adults who have never smoked, have never regularly smoked, or do not currently smoke conventional cigarettes and/or use e-cigarettes.
Current Smokers perceived a switch from smoking cigarettes to using a BIDI® Stick ENDS as the third best option available to them behind a switch to nicotine replacement therapy (NRT) products (second best option) and cessation of all tobacco and nicotine product use (best option).
Non-smokers, including young adults serving as a proxy for youth, generally showed low intention to try the BIDI® Stick across all flavors.