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Great news!

We are happy to announce that Bidi Vapor has been granted a stay order by the FDA.

Which means all 11 flavors of the BIDI®️ Stick are now legal to market and distribute as the FDA is currently reviewing the previously released MDO.

Infographic: What’s Legal, What’s Not in Vape 

Key facts laid out in visual summary of what retailers can and cannot sell 

MELBOURNE, Florida – Following up on its recent webcast on the state of vape in 2023, the leadership at Bidi Vapor, LLC, developed a companion infographic summarizing compliance and legal issues surrounding the category. The illustration is available in multiple formats to help the industry understand complexities of bringing electronic nicotine delivery systems or ENDS to market. Click here for downloadable options.

For more information about Bidi Vapor, visit https://bidivapor.com. To view the webcast that is the source for this infographic, click the button to your right.

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VAPE:
WHAT'S LEGAL, WHAT'S NOT

As of the spring of 2023, noncompliant and illegal electronic nicotine delivery systems or “ENDS” devices continue to flood the U.S. market, especially regarding flavors. Confused?

Here’s the law in a snapshot:

 

3 Zones of Compliance

FDA: PMTA

The FDA’s regulatory process over ENDS.

Synthetic Nicotine

All ENDS with synthetic nicotine are banned1.

PACT Act

Requires proper registration for interstate commerce.

Footnote 1: Subject to Premarket Tobacco Product Application (PMTA) filing, scientific review and authorization. No product with synthetic nicotine has been granted market authorization as of the publishing of this infographic on March 13, 2023.

TOBACCO ROAD

The regulatory history of ENDS using nicotine derived from tobacco leaves

Only tobacco-based nicotine products sold before August 8, 2016 could apply for FDA authorization and continue sales without enforcement (while under review)2. All others should NOT BE ON THE MARKET.

Footnote 2: According to the Tobacco Control Act and the FDA’s “deeming rule.”

The deadline for all manufacturers to submit a Premarket Tobacco Product Application (PMTA) for their tobacco-based products was September 9, 2020. If accepted, companies could sell for a year.
The FDA issued Marketing Denial Orders (MDOs) on nearly all PMTAs for flavored ENDS in September of 2021. 

Legal battles kept only a few flavored products on the market. On August 23, 2022, a federal court set aside the MDOs on Bidi Vapor’s flavors, allowing for continued sales.

Footnote 3: Bidi Vapor’s PMTAs for its flavored products are back in scientific review. During
that process, the company can market BIDI® Sticks without threat of enforcement, subject to
FDA discretion.

The Story of Synthetic Nicotine

How some manufacturers bypassed the FDA and how Congress fought back
Prior to the 2020 PMTA deadlines for tobacco-based vape, companies began marketing ENDS devices using synthetic nicotine to bypass FDA rules.

Congress gave FDA authority over all products containing nicotine, regardless of the source.

 

FDA created a new deadline for PMTAs covering ENDS using synthetic nicotine. Those that complied received a marketing grace period of 60 days.

 

Grace period ended. After this date, all products containing synthetic nicotine had to COME OFF THE MARKET.

“With that stroke of a pen, synthetic nicotine products became regulated tobacco products4 …”

  • Azim Chowdhury, Keller and Heckman, Washington, D.C. 

 

What is the PACT Act

The Preventing All Cigarette Trafficking Act (PACT Act) was created by Congress in 2010 and it authorizes the Bureau of Alcohol Tobacco, Firearms and Explosives (ATF) to prevent criminal organizations from profiting from the illegal sales of tobacco products and imposes penalties for avoiding sales tax payments. On March 27, 2021, Congress included ENDS.

Four major requirements of the PACT Act:

Prohibit the use of the U.S. Postal Service to deliver cigarettes, smokeless tobacco and ENDS products.
Raise criminal penalties for felony violations to up to 3 years imprisonment.
Individuals or businesses that sell, transfer or ship for profit any ENDS in interstate commerce, must now register with the ATF.
Provide ATF with the inspection authority to examine any records required to be maintained and any cigarettes or smokeless tobacco kept on the premises.

On March 27, 2021, Congress amended the PACT Act to include new regulations regarding the delivery and sales of electronic nicotine delivery systems (ENDS), which include flavored and non-flavored e-cigarettes and vapes (whether or not they contain nicotine), in addition to traditional cigarettes and smokeless tobacco products. Individuals or businesses that sell, transfer or ship for profit any ENDS in interstate commerce, must now register with ATF in accordance with 15 U.S.C. §§ 375 and 376. They must also register with any states that they ship vapes into, as well as report their monthly sales, pay excise taxes and be properly licensed, where applicable. As part of the enforcement mission, ATF regularly collaborates with the U.S. Postal Service (USPS) and Food and Drug Administration's Tobacco 21 enforcement teams to prevent sales and shipments of vapes and e-cigarettes to minors.

Footnote 4: Subject to requirements under the Tobacco Control Act, including premarket review.

Source: Bidi Vapor Webcast: What’s Legal What’s Not? February 7, 2023, Convenience Store Decisions; Featuring Niraj Patel, founder and president of Bidi Vapor, LLC; Russell Quick, president of Kaival Marketing Services (KMS); Azim Chowdhury, partner, Keller and Heckman LLP; and Angel Abecede, press manager, KMS. Link:
https://youtu.be/sXM4BnBZ1RA

How Illegal Products Come to Market

  • To avoid fees and taxes, device components enter into the U.S. under false labeling. Assembly happens here. 
  • Companies receiving warning letters shut down and reopen under a different name. 
  • Dishonest wholesalers operate separate warehouses off the books.

What are the Penalties?

  • Warning letter from the FDA. 
  • Seizure of product. 
  • Court-ordered injunctions to stop selling product. 
  • Criminal prosecution, ranging from misdemeanors to felonies. 
  • Department of Justice has sued companies that market products without submitting PMTAs.

 

Where Does Bidi Vapor Stand?

  • Its flavored products are legal to sell, subject to FDA enforcement discretion.
  • Prioritizes compliance with all federal, state and local regulations and taxes. 
  • Has a favorable court verdict, setting aside its MDO. 
  • Focuses on eliminating youth appeal and access. 
  • Pioneering sustainability and recycling of its products.
  • BIDI® Sticks are subject to a comprehensive, pending PMTA with FDA.
  • Focus is adult smokers who are unable or willing to quit tobacco or nicotine use entirely.
  • Bidi Vapor is continuing to develop science and is publishing studies for peer review.
For more information about Bidi Vapor, visit http://bidivapor.com. To view the webcast that is the source for this infographic, visit https://www.youtube.com/watch?v=sXM4BnBZ1RA.
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ADVISORY: We will temporarily stop all sales and shipping of Bidi Vapor products from March 27-31, 2021, due to systems upgrades and tax integration. We will resume regular business operations on April 1, 2021.

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