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.
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.
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:
The FDA’s regulatory process over ENDS.
All ENDS with synthetic nicotine are banned1.
Requires proper registration for interstate commerce.
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.”
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
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.
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.
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: