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 – With products containing synthetic nicotine now under the authority of the U.S. Food and Drug Administration (FDA), retailers selling flavored vaping devices containing lab-derived nicotine face uncertainty over whether or not what they’re selling is legal.
FDA’s new authority over these products began on March 15, 2022, when President Joe Biden signed a $1.5 trillion omnibus spending bill to fund the federal government through September of this year. According to the Washington, D.C.-based law firm, Keller and Heckman LLP, the bill, as passed, includes a provision expanding the definition of “tobacco product” in Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FDCA) to “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.” 21 U.S.C. 321(rr).
Now that it is law, this provision closes the synthetic nicotine “loophole” and puts synthetic nicotine products under the FDA’s tobacco regulatory authority, the law firm said.
Enactment and enforcement of that authority will occur over a defined timeframe. First, the law became effective 30 days after the bill’s enactment, making April 14, 2022, the law’s “effective date”. Any synthetic nicotine product currently on the U.S. market as of April 14, 2022, can remain on the market only if they submit a Premarket Tobacco Product Application (PMTA), which are due 30 days later on May 14, 2022, i.e., the “Synthetic Nicotine PMTA Submission Deadline.”
Since May 14 is a Saturday, companies that are not planning to submit PMTAs via the Center for Tobacco Products’ electronic portal, can submit physical applications by 4:00 pm ET on Friday, May 13, 2022 (but note that any non-electronic PMTA submissions require a waiver from the FDA).
If a PMTA is submitted in a timely manner, any product may remain on the market for an additional 90 days after the effective date, so until July 13, 2022. After July 13, 2022, any synthetic nicotine product not authorized by FDA must come off the market, according to Keller and Heckman.
“C-store retailers should pay close attention to what products are permitted for sale and are compliant with the requirements of the Food and Drug Administration, the PACT Act and numerous state and local licensing and tax laws,” said Niraj Patel, president and CEO of Bidi Vapor, LLC, Melbourne, Fla. “We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for compliant and legal vaping products.”
Companies selling flavored vaping products have struggled to remain compliant with the FDA, Patel said. But Bidi Vapor remains one of the few independent vaping companies left on the market. Here are key points about the BIDI® Stick:
“We hope retailers take a serious look at who their partners are,” Patel said. “You want to partner with companies that comply with regulations and produce high-quality products. That’s the only way the industry will survive and thrive in the future and continue to benefit adult smokers.”
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