Vape News

December 5, 2022   Dear Ann Simoneau, J.D.: Please see Cali Steam LLC’s response to the warning letter received on November 10, 2022. The referenced warning letter stated the following: “FDA received your Premarket Tobacco Product Application (PMTA) assigned STN PM0001175 on September 7, 2020. However, FDA issued a negative action for PMTA STN PM0001175 in the form of a Refuse to File determination on August 9, 2021, which covers 33 products.” We have no receipt of this determination. We weren’t aware that we didn’t meet the threshold determination of whether the application contains sufficient information to permit a substantive...

The state of California is taking a strong stance on regulating vaping products. In an effort to reduce the number of people vaping and to protect public health, the state is implementing a number of regulations that will affect both manufacturers and consumers. The first regulation is an age restriction. The state has raised the minimum legal age for purchasing and using vaping products from 18 to 21. This means that anyone under 21 years of age is not allowed to purchase, possess, or use any vaping product. Violators of this law are subject to fines and other penalties. The...

Thursday night, March 10, the US Senate passed H.R. 2471, the “Consolidated Appropriations Act of 2022,” also known as the Omnibus Budget bill, by a vote of 68-31. The vote took place nearly a day earlier than anticipated and easily garnered the 60-vote threshold with the promise of spring break on the other side. The rider to grant FDA regulatory authority over synthetic nicotine is included in the final bill passed by the senate.The omnibus budget bill was signed into law by President Biden on March 15, 2022.When President Biden signs the budget bill (enactment) it starts the clock on...

Now that the PMTA deadline has passed in the United States what happens now? The Sept. 9 premarket submission deadline for certain deemed new tobacco products marked a major milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by FDA.Now that the deadline has passed, and the submissions are with FDA, many may be wondering about the upcoming steps for both submitters and the Agency. As Mitch Zeller, CTP Director, stated in a recent perspective piece, FDA strives to be as transparent as possible with regards to the status of these submissions...

The biggest hurdle comes later this year when Juul and other e juice companies must submit an application to the Food and Drug Administration seeking permission to remain on the market. Crosthwaite, CEO of Juul, says he is “very excited” to make its case. He plans to submit scientific studies showing Juul products can be a beneficial alternative for smokers, and will highlight the company’s plans to limit vaping by minors.In his nine months at the helm, Crosthwaite has joined President Donald Trump at the White House and testified before a House committee. He declined to elaborate on any additional...