Week of August 25 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Altria, Reynolds moving new products to market without FDA OK - Richmond Times-Dispatch

In a filing with the U.S. Securities and Exchange Commission this summer, Altria said the 180-day deadline for the Secretary to act and the fast-track appeal of a denial order basically set a timeline for firms seeking to market new products.

“We are unaware of any FDA enforcement actions relating to products" for which a Premarket Tobacco Product Application "has been pending longer than the 180-day review period,” the company said in the filing.

Altria said while it may be possible that the FDA would do so in the future, “we believe that any enforcement action against sales in the United States of products with PMTAs pending for more than 180 days would conflict with" the 2009 law giving FDA authority over tobacco "and FDA enforcement practice to date.”

• From Banana Taffy To Dragon Drink: The Illegal Chinese Vapes Flooding The U.S. Market - The Daily Wire

While American manufacturers like JUUL only sell vapes in menthol and tobacco flavors — the only legal flavors in the United States — wholesalers skirt Food and Drug Administration (FDA) regulations by importing vape products from China. These unregulated Chinese vapes are flooding the United States, despite warning letters and threats of seizure by the FDA. At the Alternative Products Expo, wholesalers promoted their illegal, Chinese vape products completely out in the open.

The Expo promoted the illegal vapes giveaway with a large sign and a locked case of vapes just inside the entrance to the convention center. It also marketed the giveaway online and in the official show book.

The advertised flavors included Blue Razz Ice, Fire and Ice, and Miami Mint. An additional flavor, Strawberry Burst, did not contain nicotine.

The Expo was not only for vapes, but also “the full spectrum of alternative products,” including CBD-based products, mushrooms, and Kratom, another drug that’s become dangerously popular with America’s teenagers.

Many of these vapes are smuggled into the United States. A previous Daily Wire investigation found that over 90% of imported Chinese vape products in 2024 were not included in U.S. import data. The companies often disguise their products by labeling them as battery chargers and flashlights.

“[What] we have been doing is laughable,” Makary said. “We’re going to start confiscating and seizing. We’re going to take this seriously.”

• ELFBAR Launches ELFX Ultra with Child Lock and Advanced Controls - Wholesale Manager [UK]

Settings on the ELFX Ultra can be adjusted using the device’s intuitive 2.4″ touchscreen. The device can also be paired via Bluetooth to the InnoGate app for smartphone control. The app is available as a free download on Google Play and the Apple App Store.

Equipped with an integrated child lock, the device can be secured by setting a passcode on the touchscreen or remotely with a simple swipe on the InnoGate app.

Users can view puff count and usage patterns, as well as set limits directly on the device or through InnoGate. The app also displays consumption analysis.

• GUEST VIEW: Vape regulation is failing - OA Online

The United States is facing a crisis of its making. A booming underground industry for unregulated, youth-targeted disposable vapes rakes in nearly $2.4 billion annually. Many of these products, primarily imported from China, slip through customs, bypass age restrictions and are designed — intentionally or not — to attract teens with bright packaging and candy-like flavors… Thankfully, the tide may be turning. Since January, the FDA leadership has taken meaningful steps toward restoring a science-based regulatory path. The recent authorization of several JUUL menthol and tobacco products signals a long-overdue course correction, and an opportunity to finish what the Trump administration started in 2020 — to protect teens, support smokers, especially those looking to quit combustible cigarettes, and clear the market of illegal vapes… We don’t have to choose between protecting kids and supporting smokers. With smart, timely regulation, we can do both. Every month of delay deepens the crisis. Illegal sales grow, and adults looking for safer alternatives are left with fewer, and often riskier, choices. The FDA has a real chance to fix this. That means clearing out unlawful products, streamlining processes to make sure innovative products from U.S. manufacturers reach Americans, and authorizing technology-led solutions that are built to meet today’s realities.

• Fed Up with the FDA, Big Tobacco Goes Nuclear - Vaping360

Altria Group vape subsidiary NJOY has filed a federal lawsuit alleging the FDA has violated the Tobacco Control Act by delaying marketing decisions on NJOY vape products. The lawsuit, filed Aug. 21 in the U.S. District Court for Western Louisiana by NJOY and three local businesses, charges the FDA has allowed an appeal for supervisory review of marketing denial orders (MDOs) for flavored NJOY DAILY products to hang in limbo for nearly three years---even after Altria addressed a major deficiency listed in the denial. On the same day the lawsuit was filed, Altria announced it would launch a new nicotine pouch brand without first receiving FDA authorization. Rival tobacco company R.J. Reynolds has also launched flavored disposable vapes without prior marketing authorization from the FDA.