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 – Despite a federal ban on electronic nicotine delivery systems (ENDS) that use nicotine derived from synthetic sources, confusion remains over what’s legal and what’s not. Azim Chowdhury, a regulatory specialist from the law firm Keller and Heckman based in Washington, D.C., recently participated in a Bidi Vapor webcast, informing the audience on pertinent legal matters concerning the industry.
At the beginning of 2022, because of the flood of synthetic nicotine products coming to the market, Congress changed the definition of tobacco products, Chowdhury told listeners to the February webcast. The previous description in the Food, Drug and Cosmetic Act (FDCA) was limited to products containing tobacco-derived substances and nicotine. In March 2022, he said Congress amended the definition, expanding it to include not just tobacco-derived substances but also any product that contains nicotine from any source.
“With that stroke of a pen, synthetic nicotine products became regulated tobacco products subject to all those exact requirements under the Tobacco Control Act, including premarket review,” Chowdhury said, referring to the FDA’s Premarket Tobacco Product Application (PMTA) process. “Of importance, though, not only did Congress expand the definition and capture all these products, but it also created a new PMTA deadline.”
The PMTA deadline for products using nicotine derived from tobacco was back in 2020, but after Congress made its decision on synthetic nicotine in March of 2022, the FDA allowed firms making devices with synthetic nicotine to submit new PMTAs by May 14, 2022. Companies that were able to submit new PMTAs by that deadline were given until July 13, 2022, to market their devices without threat of enforcement.
“After July 13th, the statute says that products without authorization from the FDA and actual PMTA Marketing Granted Orders are illegal and must come off the market,” Chowdhury said. “That’s the case for all products not subject to authorization. It’s up to the FDA to enforce.”
That’s where companies like Bidi Vapor and others striving for compliance hope to see additional enforcement from the FDA and other authorities, according to Niraj Patel, founder and president of Bidi Vapor, LLC, Melbourne, Florida.
In the webcast, Patel noted that Bidi Vapor products are derived from tobacco leaves and are not subject to the new authorization process around synthetic nicotine. He added that their flavored products—which use nicotine derived from tobacco—are currently under the FDA’s scientific review and are legal to sell in U.S. markets, subject to the agency’s enforcement discretion.
To listen to the Bidi Vapor webcast, click here.