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...

Vaping has become a contentious issue worldwide, with different countries adopting different approaches to regulating the industry. While the United States has been at the forefront of the vaping controversy, with a number of states passing legislation to regulate or ban the practice, other countries have been taking a more measured approach. In this article, we'll explore the current state of vaping outside the United States. Firstly, it's important to note that vaping is a global phenomenon. According to a report by the World Health Organization, there are over 35 million vapers worldwide. The report also found that the number...

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...

On December 27th, 2020 the vape mail ban (S.1253) was signed into law. This new law prohibits any vapor-related products from being shipped with USPS. Following the passage of the new law, the major private delivery companies announced that they too would stop delivering vaping products, not just to homes but also to businesses. FedEx stopped shipping vape products on March 1, and UPS will stop shipping vape products on April 5.The overall effect of this ban will make it nearly impossible to ship vapor products directly to customers. Also the costs associated with FDA compliance and absurd taxation is...

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...

Australia is tentatively planning to make nicotine-containing vaping products available with a prescription at pharmacies beginning next June. The Therapeutic Goods Administration (TGA) announced but will accept public comment on the process until Nov. 6, and issue a final rule by the end of the year.Sale of vaping products containing nicotine is currently illegal in Australia, and even possession is outlawed in all but one state. The law, as it stands now, allows vapers to import up to a three-month supply of nicotine with a doctor’s prescription—but that is largely ignored by both vapers and the authorities.Just one to two...