Synthetic Nicotine Placed Under FDA Authority

Bidi Vapor leadership supports move to regulate nicotine-delivery devices

MELBOURNE, Fla. (March 11, 2022) – In a $1.5 trillion federal funding bill passed on March 10, 2022, Congress included a measure to grant the U.S. Food and Drug Administration (FDA) authority over synthetic nicotine, according to the Winston-Salem Journal. Pres. Biden signed the funding package into law on March 15.

In response to the development, Niraj Patel, president and CEO of Bidi Vapor, LLC, Melbourne, Fla., posted the following statement through LinkedIn on March 11, 2022:

Statement on Synthetic Nicotine:  As CEO of Bidi Vapor, LLC, I applaud the latest move by Congress to give the U.S. Food and Drug Administration (FDA) authority over synthetic nicotine. We at Bidi Vapor prioritize regulatory compliance to ensure high standards for product quality. In that spirit, we encourage Pres. Biden to sign the bill into law as quickly as possible.

Our team at Bidi Vapor expressed support for the change in synthetic nicotine status at a formal listening session for FDA staff on September 2, 2021. We then announced our official position in our financial report published on September 14, 2021. Finally, we shared our opinion directly with FDA leadership, first in a letter to Mitch Zeller, outgoing director of the Center for Tobacco Products in November of 2021, then most recently to Dr. Robert Califf, the incoming FDA commissioner, in a letter sent earlier this month.

At Bidi Vapor, our goal has always been to offer adult smokers ages 21 and older a viable alternative to combustible cigarettes. Giving the FDA authority over the different ways to derive nicotine helps our ability to carry out our mission. Soon, all products containing nicotine will have to undergo the same rigorous authorization process to legally go to market here in the United States. More importantly, it focuses manufacturers who use synthetic nicotine to align with the FDA’s priority of making these types of consumer products appropriate for the protection of the public health.