Removal of the BIDI® Sticks from the Market Before an APPH Determination is Made
In Fall 2020, Bidi Vapor prioritized compliance over business objectives by halting production of the BIDI® Sticks for two months to revise its packaging and labeling to incorporate new product names to better align with FDA’s Enforcement Priorities Guidance.
Additionally, BIDI® Sticks has implemented a comprehensive labeling system wherein much of its viable packaging surface area is covered with warnings, instructions, and product information text intended to protect and inform consumers.
Bidi Vapor has also discontinued its direct-to-consumer (DTC) sales through its age-gated website. Moreover, Bidi Vapor has partnered with GoPuff, an online platform that helps consumers purchase products online.
Wholesalers and direct retailers are required to sign the Company’s Wholesaler & Direct Retailer Agreement, which, among other things, requires parties to comply with all applicable regulations and abide by our comprehensive age verification procedures.
Lastly, Bidi Vapor has taken the necessary steps in practicing responsible marketing. We have not used social media, influencers, and brand ambassadors to advertise to consumers.
Bidi Vapor CEO, Niraj Patel, and QuikfillRx’s CEO, Russell Quick joins Angel Abcede to discuss the current state of the vaping industry, the challenges of flavor restrictions, and how to keep up with changing vaping landscape.
Bidi Vapor is currently undergoing several clinical studies and surveys to support its PMTAs, and is working closely with the FDA through this process.
To learn more about Bidi Vapor’s PMTA status, click here.
Bidi Vapor has always remained its position of leading by example and goes above and beyond to comply with regulatory requirements.
Bidi Vapor hopes that FDA will consider our efforts in preventing youth from using our products, as well as the potential adverse consequences of an immediate market removal, when determining whether to allow the continued marketing of the BIDI® Sticks following the September 9, 2021 review deadline. Bidi Vapor has sent a request to FDA to provide written confirmation for us to continue to exercise enforcement discretion for all eleven (11) currently marketed varieties of the BIDI® Stick ENDS to permit their continued marketing for the duration of FDA’s scientific review until the Agency reaches a final marketing authorization determination.
In Fall 2020, Bidi Vapor prioritized compliance over business objectives by halting production of the BIDI® Sticks for two months in order to revise its packaging and labeling to incorporate new product names to better align with FDA’s Enforcement Priorities Guidance.
Additionally, BIDI® Sticks has implemented a comprehensive labeling system wherein much of its viable packaging surface area is covered with warnings, instructions, and product information text intended to protect and inform consumers.
Bidi Vapor has also discontinued its direct-to-consumer (DTC) sales through its age-gated website. Moreover, Bidi Vapor has also partnered with GoPuff, an online platform that help consumers purchase products online.
Wholesalers and direct retailers are required to sign the Company’s Wholesaler & Direct Retailer Agreement which, among other things, requires parties to comply with all applicable regulations and abide in our comprehensive age verification procedures.
Lastly, Bidi Vapor has taken the necessary steps in practicing responsible marketing. We have not use social media, influencer, and brand ambassadors to advertise to consumers.
The rise of underage vaping has become a challenge for the vaping industry. As such, Bidi Vapor ensured stringent measures with our BIDI® Youth Access Prevention Measures to verify the identity of each customer and prevent unauthorized access to our BIDI® Sticks by underage vapers.
Our direct retailers are also required to uphold our age verification procedures by signing a Wholesaler & Direct Retailer Agreement Terms. They must require each customer to present a valid government-issued identification card which indicates their age and other necessary information. Direct retailers also have the right to put the transaction on hold when in doubt of the customers age eligibility.
Bidi Vapor understands the implications and the negative impacts of underage vaping, and we firmly take a stand against it for the safety of the youth. You can learn more about our BIDI® Youth Access Measures here.
Illegal manufacturers are now exploiting the vaping industry with fake BIDI® Sticks. To protect consumers, Bidi Vapor warns them about counterfeit products and its possible dangers. In addition, Bidi Vapor integrated an anti-fake sticker and QR code in its packaging to validate the authenticity of the BIDI® Stick. Make sure to confirm whether you have a counterfeit or genuine product.
With the ever-changing regulations on vapor products, Bidi Vapor ensures to follow a strict set of guidelines for all social media platforms and channels. These guidelines include the following:
We collect information that identifies you personally (referred to herein as “personal information”), and we may collect other information, from and about you when you access and use the Service. We collect information that you voluntarily provide, we collect certain information automatically, and we may receive personal information about you from third parties. The categories of information we may collect include the following:
Contact Information, such as an individual’s name, mailing address, email address, and telephone number.
Demographic Information, such as your date of birth, interests, tastes, and preferences
Location Information collected automatically from your device when you access and use the Service, and location information you provide when you use a store locator feature.
Other Information you provide, such as photos, videos, and other content and information you post through the Service or provide through communications with us.
We may use the information we collect from and about you to:
We and our analytics and advertising providers generally use the following types of cookies and other technologies. Please note that providers and their practices may change, so this list may not always be accurate or complete. In addition, not all of the technologies described below may be used with all of the Services.
Advertising. These cookies are set by our advertising partners and are used to track users across websites and display ads that are relevant and engaging for the user.
Ways to update your preferences and disable cookies
In addition, you can still disable cookies in your web browser. In order to facilitate the way of managing cookies, below are links to some pages dedicated to specific browsers:
Users can also set their browsers in a way so that they have to accept cookies each time. Then, the browser will ask the user for permission each time before granting access to the cookie. This gives the user control over what is stored on the user’s device, however, it has the disadvantage that it slows down the ability to navigate the Service.
If you access the Service from a different device, login under a different name, or change web browsers, you will need to opt out again.
The Services may also use Google Analytics to track your use of the Services] . You can use this browser add-on provided by Google to opt-out of such tracking.
You can also opt out of the use of your personal information for interest-based advertising in the following ways:
● Use privacy browsers or ad-blocking browser plug-ins that let you block advertising trackers.
If you have created an account with the Service, you can update or delete certain Account Information by logging in to your account. You can also unsubscribe from marketing email messages at any time using the unsubscribe mechanism provided in an email. Please note, however, that if you opt-out of marketing email messages you may continue to receive non-commercial communications that we are entitled to send. If you are a resident of California or Nevada or a resident of the European Economic Area (“EEA”), you have additional privacy rights, as described below.
We transfer your personal information to our servers in the United States, and we may transfer personal information to other countries. The data protection laws of some countries, such as the United States, may not offer a level of privacy protection equivalent to that within the European Economic Area or your home country. By using the Service, you consent to the transfer of your personal information to such other countries.
We strive to implement commercially reasonable administrative, physical, and technical security measures to protect your personal information. Unfortunately, however, no data transmission over the Internet can be guaranteed to be 100% secure. Accordingly, we cannot guarantee or warrant the absolute security of your personal information.
Important Product Notices
NOT FOR SALE TO INDIVIDUALS UNDER 21. THE PRODUCTS ARE INTENDED FOR PURCHASE AND USE BY INDIVIDUALS OF 21 YEARS OF AGE OR OLDER. IF WE HAVE REASON TO BELIEVE THAT YOU ARE UNDER 21, OR REASON TO BELIEVE THAT YOU ARE PURCHASING THE PRODUCTS FOR THE USE OF AN INDIVIDUAL (OR INDIVIDUALS) UNDER 21, WE RESERVE THE RIGHT TO TAKE ADVANTAGE OF ANY OTHER REMEDY AVAILABLE TO US AT LAW OR EQUITY.
NO FDA APPROVAL. THE PRODUCTS HAVE NOT BEEN APPROVED BY THE FDA FOR THE TREATMENT OF ANY HEALTH CONDITION, NOR DOES KAIVAL BELIEVE OR SUPPORT THE PROPOSITION THAT THE PRODUCTS MAY BE USED FOR ANY HEALTH BENEFIT. YOU SHOULD CONSULT WITH YOUR DOCTOR BEFORE PURCHASING OR USING ANY OF THE PRODUCTS.
CALIFORNIA PROPOSITION 65 WARNING. THE PRODUCTS ON THE SITE CONTAIN NICOTINE, A DANGEROUS CHEMICAL KNOWN TO THE STATE OF CALIFORNIA TO CAUSE BIRTH DEFECTS AND/OR OTHER REPRODUCTIVE AND DEVELOPMENTAL HARM. SEE HTTPS://OEHHA.CA.GOV/PROPOSITION-65/PROPOSITION-65-LIST/ FOR A FULL LIST OF CHEMICALS SUBJECT TO PROPOSITION 65 WARNINGS.
NOT A SMOKING CESSATION AID. IN THE EVENT YOU ARE HAVING TROUBLE QUITTING SMOKING, YOU SHOULD CONSULT WITH YOUR DOCTOR. NONE OF THE PRODUCTS ARE INTENDED FOR USE AS A SMOKING CESSATION AID, AND MANY INDIVIDUALS WHO USE VAPOR PRODUCTS TO QUIT SMOKING (OR QUIT USING OTHER TOBACCO PRODUCTS) END UP SWITCHING BACK TO TOBACCO PRODUCTS.
NICOTINE IS A DANGEROUS CHEMICAL. IF YOU ARE EXPERIENCING ANY OF THE SYMPTOMS OF NICOTINE POISONING (SEE HTTPS://WWW.WEBMD.COM/SMOKING-CESSATION/NICOTINE-POISONING-CAN-YOU-OVERDOSE#1), YOU SHOULD CALL 911 IMMEDIATELY, OR THE UNITED STATES POISON CONTROL CENTER (1-800-222-1222). NICOTINE IS A DANGEROUS CHEMICAL THAT SHOULD NOT COME INTO CONTACT WITH YOUR SKIN. IN THE EVENT YOU DO SPILL NICOTINE LIQUID ON YOUR SKIN, THE NATIONAL INSTITUTES OF HEALTH RECOMMEND THAT YOU WASH THE AFFECTED AREA FOR 15 MINUTES WITH SOAP AND WATER.
General Terms and Conditions
These General Terms and Conditions (this “Agreement”) are by and between you (“you”) and Kaival Brands Innovations Group, Inc., a Delaware corporation (“Kaival”, “we”, or “us”).
Your understanding and acceptance of this Agreement is a condition required for your use of the Kaival Site and Service, and is binding on you. This Agreement may be modified from time to time by us, and will be binding when posted on the Site. You will receive reasonable notice of any material changes to this Agreement, and will be given an opportunity to read and agree to such material changes.
Additional definitions applicable to this Agreement are at the end of this Agreement.
Scope of Agreement
Though you may be affiliated with a business entity, a User (and a Registered User) is by definition an individual, and as such, you shall be personally liable to Kaival for any breach of this Agreement.
In the event your associated entity is approved to purchase and/or sell Kaival products (the “Products”), the terms of such purchase and sale shall be governed by our General Terms and Conditions of Sale, a form of which can be found through this https://bidivapor.com/terms-and-conditions/, or the Sub-Distribution Agreement executed by your associated business entity and Kaival.
Password, User Information, and Security
You hereby agree to maintain the security of your password and all other information assigned to you for the purpose of verifying the integrity of the Site. You are responsible for maintaining the confidentiality all passwords and unique identifiers, and are fully responsible for all activities that occur under your password or user name. You agree promptly to notify Kaival of any unauthorized use of your password or account or any other breach of security. Kaival cannot and will not be liable for any loss or damage arising from your failure to comply with this requirement.
General Authorization: Collection and Disclosure of Information
Responsibility for Minors and Individuals under 21
In the event that your minor child (or your child under 21) accesses the Site in violation of these Terms, you recognize that you are fully responsible for: (i) the online conduct of your child; (ii) controlling your child’s access to and use of the Services; and (iii) the consequences of any use or misuse of the Services by your child.
Kaival shall not be responsible for monitoring your minor child’s use of the Site, nor shall we be responsible for Products on the Site that are, in your opinion, inappropriate for your child’s use. Kaival shall have no liability for damages on account of your child’s use of the Site.
Payment Processing and Refunds
Authorize.net, a subsidiary of Visa Inc. (the “Processor”), is Kaival’s payment processor. Processor will collect your credit card information and store it on file for use in authentication and for the purpose of processing your payments to Kaival. Kaival does not see, store, or process your credit card, bank account, or payment information, and shall not be liable for the safe keeping thereof.
In addition to the terms herein, payment processing through the Site is subject to the Processor’s standard terms and conditions, which may be modified in the Processor’s sole discretion: https://www.authorize.net/about-us/terms.html
In the event an order is cancelled, Kaival will refund payments to Users (or retain payments) in its sole discretion. Any refund may be net of Kaival’s fees to the Processor.
Kaival is not responsible for any act or omission of its payment processor or any other third party. Kaival makes no representation or warranty as to the adequacy or performance of the Processor or any other third party.
Security and User Authentication
You agree to provide Kaival with sufficient information about you personally to allow Kaival to maintain the security of the Site; and you agree to participate in any and all security verification steps that Kaival may require.
Kaival makes commercially reasonable efforts to ensure that the Products are not sold to individuals under 21 years of age. Kaival may choose (at Kaival’s own expense) to offer its Users the ability to prove their age through a third-party service, or Kaival may choose to offer no such third-party services. Kaival does not perform authentication of Users in-house, makes no representation or warranty as to the efficacy or sufficiency of the authentication mechanisms offered through the Site, and shall not be responsible for the accuracy of any authentication service. Kaival is entitled to rely on the results generated by the authentication service of its choosing.
Kaival may post, modify or cancel Listings in its sole discretion. If you have a complaint about a listing, please notify us via email at email@example.com. Please put “COMPLAINT” in the subject line.
Product Purchases; Disclaimer of Warranties and Limitation of Liability Regarding the Products
Purchases of Products through the Site are subject to the following conditions:
Authorization to Contact You For Administrative Matters
You hereby authorize us to contact you, at the email address(es) and telephone number(s) you provide, regarding the following issues:
We will not share your contact information with any third party, except for the purpose of debt collection regarding any fees owed to us under this or any other agreement between you and Kaival.
The Site and Service may only be used for the intended purpose for which this Site and Service are being made available. The intended purpose of Site and Service is to provide information about the Products and an online marketplace for the Products.
You agree not to:
Any and all intellectual property rights, including all patents, trademarks, works of authorship, trade names, trade secrets, and any and all related rights, pertaining to the Products, the Site, and the Services (“Kaival IP”) are the sole and exclusive property of Kaival. No license or transfer of the Kaival IP is effected by this Agreement, the operation of the Site or Services, or otherwise absent Kaival’s express written consent.
Use of any trademark, service mark, or name of Kaival for commercial purposes is forbidden without written consent.
You agree that you shall not:
Disclaimer of Warranties and Limitation of Liability Regarding the Site and Services
We work hard to keep our Site and Services functioning properly, but we cannot guarantee the availability or sufficiency of our Site or Services. The Services may be subject to interruptions, errors, or delays outside of our control.
You hereby agree that you are making use of the Site and Services at your own risk, and that they are being provided to you on an “AS-IS” and “AS AVAILABLE” basis. To the extent permitted by applicable law, we hereby disclaim all express or implied warranties, including implied warranties of merchantability, fitness for a particular purpose, and non-infringement.
We make no representation or warranty that the Site or Services will be suitable for use by any person or organization.
In addition, neither we nor our affiliates, officers, directors, agents, employees, or assigns shall be liable for:
Notwithstanding the foregoing, if we are found to be liable for damages to you under any theory of liability, our liability to you or any third party shall be limited to the greater of (1) your payments to us in the twelve (12) months preceding the filing of the claim at issue and (2) $100.
If you have a dispute with one or more Users or third parties, you release us (and our affiliates, officers, directors, agents, employees, and assigns) from any and all claims, demand, or damages of every kind and nature, known and unknown, arising out of or in any way connected with such disputes. In entering into this release you expressly waive any protections, statutory or otherwise, that would otherwise limit the coverage of this release to include only those claims which you may know or suspect to exist in your favor at the time of agreeing to this release.
General Limitation of Damages
UNDER NO CIRCUMSTANCES, INCLUDING NEGLIGENCE, SHALL KAIVAL BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES THAT MAY RESULT FROM THE USE OR INABILITY TO USE THE SITE AND/OR SERVICES, INCLUDING WITHOUT LIMITATION USE OF OR RELIANCE ON THE SITE AND/OR SERVICES, INTERRUPTIONS, ERRORS, DEFECTS, MISTAKES, OMISSIONS, DELETIONS OF FILES, DELAYS IN OPERATION OR TRANSMISSION, NONDELIVERY OF INFORMATION, DISCLOSURE OF COMMUNICATIONS, OR ANY OTHER FAILURE OF PERFORMANCE.
Release and Indemnity
YOU HEREBY RELEASE AND WAIVE ANY AND ALL CLAIMS AND/OR LIABILITY AGAINST KAIVAL ARISING FROM OR IN CONNECTION WITH YOUR OR YOUR CHILD’S USE OF THE SITE OR SERVICES. YOU ALSO AGREE TO DEFEND, INDEMNIFY AND HOLD HARMLESS, KAIVAL, FROM AND AGAINST, ANY AND ALL CLAIMS OR LIABILITY, INCLUDING COSTS AND ATTORNEYS FEES, ARISING FROM OR IN CONNECTION WITH YOUR OR YOUR CHILD’S USE OF THE SITE OR SERVICE OR FAILURE TO ABIDE BY APPLICABLE LAW.
PLEASE READ THIS SECTION CAREFULLY, AS IT AFFECTS YOUR RIGHTS AND WILL HAVE A SUBSTANTIAL IMPACT ON HOW CLAIMS BETWEEN YOU AND KAIVAL WILL BE RESOLVED.
You and Kaival agree that any claim arising from this Agreement, any other agreement between you and Kaival, or your use of the Site or Services will be resolved in accordance with this Section.
Applicable Law: You agree that any claim or dispute arising between you and Kaival shall be governed by the laws of the State of Florida, without reference to the conflict of laws principles of the State of Florida.
Agreement to Arbitrate: You and Kaival agree that any claim or dispute arising between you and Kaival regarding this Agreement, any other agreement between you and Kaival, or your use of the Site or Services shall be resolved through final and binding arbitration, rather than in court. The Federal Arbitration Act shall govern the interpretation and enforcement of this Agreement to Arbitrate.
Prohibition of Class and Representative Actions and Non-Individualized Relief
You and Kaival agree that each of us may bring claims against the other only on an individual basis and not as a plaintiff or class member in any purported class or representative action or proceeding. Unless both you and Kaival agree otherwise, the arbitrator may not consolidate or join more than one person’s or party’s claims, and may not otherwise preside over any form of a consolidated, representative, or class proceeding. Also, the arbitrator may award relief only in favor of the individual party seeking relief and only to the extent necessary to provide relief necessitated by such party’s individual claim. No relief awarded may affect other Users.
An arbitrator shall apply the terms of this Agreement and any other agreement between you and Kaival as a court would. A court of competent jurisdiction shall decide the issue of arbitrability, if applicable.
The arbitration shall be conducted by the American Arbitration Association (“AAA”) under its rules and procedures, as modified by this Agreement, including AAA’s Supplementary Procedures for Consumer Related Disputes.
A party seeking arbitration must first send to the other, by certified mail, a completed Notice of Dispute. Notices of Dispute against Kaival must be sent to: Kaival Inc., 401 N WICKHAM RD – STE 130, MELBOURNE, FLORIDA, 32935
The forum of arbitration shall be Orlando, Florida.
If a dispute cannot be resolved within 30 days after a notice is sent, either party may initiate arbitration proceedings. Arbitration forms may be found on the AAA’s website at: www.adr.org. The initiating party must send the initiation form certified mail to the other party.
The arbitrator shall decide the substance of all claims in accordance with the laws of the State of New York, including recognized principles of equity, and will honor all claims of privilege recognized by law. The arbitrator shall not be bound by rulings in prior arbitrations involving different Users, but shall be bound by the principles of claim preclusion and issue preclusion.
Severability; Judicial Forum
In the event an arbitrator or court decides that any part of this Agreement to Arbitrate is invalid or unenforceable, the other parts of this Agreement to Arbitrate shall still apply.
In the event an arbitrator or court finds this Agreement to Arbitrate unenforceable such that your case will not be tried by an arbitrator, you agree that all claims brought against Kaival shall be brought in the Federal District Court for the Middle District of Florida (or if no subject matter jurisdiction is found, in the state courts located in Orlando, Florida); and you hereby submit to the personal and subject matter jurisdiction of such court.
Kaival is located at 401 N WICKHAM RD – STE 130, MELBOURNE, FLORIDA, 32935.
Except as otherwise provided in this Agreement, if any provision of this Agreement is held to be invalid, void or for any reason unenforceable, such provision shall be struck out and shall not affect the validity and enforceability of the remaining provisions. In our sole discretion, we may assign this Agreement, by providing notice of such assignment.
Headings are for reference purposes only and do not limit the scope or extent of such Section. Our failure to act with respect to a breach by you or others does not waive our right to act with respect to subsequent or similar breaches. We do not guarantee we will take action against all breaches of this User Agreement.
We may amend this Agreement at any time by posting the amended terms on www.bidivapor.com. Our right to amend this Agreement includes the right to modify, add to, or remove terms in the Agreement. We will provide you 30-day notice by posting the amended terms. Additionally, we will notify you through your Account. Your continued access or use of our Services constitutes your acceptance of the amended terms. We may also ask you to acknowledge your acceptance of the Agreement through an electronic click-through. This Agreement may not otherwise be amended except through mutual agreement by you and a Kaival representative who intends to amend this Agreement and is duly authorized to agree to such an amendment.
The policies posted on our Sites may be changed from time to time. Changes take effect when we post them on the Kaival Site.
No agency, partnership, joint venture, employee-employer or franchiser-franchisee relationship is intended or created by this User Agreement.
The following Sections survive any termination of this User Agreement: Fees, Content, Disclaimer of Warranties (for Products and the Site and Services); Limitation of Liability (for Products and the Site and Services); Indemnity, and Legal Disputes.
“Account” is an account on the Site.
“Content” means information, text, music, sound, photographs, pictures, graphics, video, messages, files, or other materials.
“Fee” means the money paid through, or to, Kaival or any third party, in exchange for the Services, the provision of a Class or Classes, or any other service (i.e. payment processing).
“Listing” means a web page or advertisement for a Product.
“Party” or “party” means you or Kaival.
“Profile” means a web page customized by a User, which page may include, without limitation the User’s User Name, contact information, and preferences.
“Service” means the maintenance of an informational site, online marketplace and all associated services and activities, as may be modified at any time in the sole discretion of Kaival.
“Site” means “Bidivapor.com” and/or its affiliated websites, mobile apps, web apps and other means established by Kaival for accessing the Service.
“User” means an individual who has access to the Site.
“User Name” means an alias created for use on the Site.