Week of July 28 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• What’s So Bad About Nicotine? - The Atlantic

For the better part of the past century, the case against nicotine was simple: Smoking a cigarette might feel nice, but it will eventually kill you. Nearly one in five deaths in the United States is caused by complications from cigarette smoke. Chewing tobacco is less dangerous, but still deadly: It has long been associated with head and neck cancers.

But in 2025, nicotine isn’t so straightforward. Smoking is so deadly not because of nicotine, per se, but because of tobacco: Lighting a cigarette burns tobacco, releasing nicotine into the body. Chewing tobacco entails gnawing on actual tobacco leaves. Nowadays, it’s easier than ever to get a nicotine buzz without any tobacco at all: Just puff on a vape or pop a tiny nicotine pouch between your teeth and upper lip. These cigarette alternatives have been around for a while, but only recently have they gone fully mainstream. In January, the FDA officially sanctioned the sale of Zyn, among the most recognizable nicotine-pouch brands. In the past three months alone, Philip Morris International, which makes Zyn, shipped 190 million cans of the stuff to stores. And last month, the agency reversed a prior ruling and authorized Juul e-cigarettes. These products, the FDA has concluded, “generally have lower health risks than cigarettes.”

These downsides might seem minuscule compared with those of cigarettes. A rotting lung is considerably worse than a $10-a-day nicotine habit. But they shouldn’t be ignored. If cigarette-smoking rates continue their decades-long drop, it’s reasonable to assume that vaping and pouches will become the dominant ways people consume nicotine. New nicotine products might have solved the biggest problem with smoking. Many other, more subtle problems still remain.

• Downtrading, illicit e-cigarette market weighing on c-store retailers - CSP

Convenience-store retailers have a cautious view on the outlook for the tobacco category, according to Goldman Sachs’ second-quarter 2025 Nicotine Nuggets survey. This was mainly due to inflation, economic uncertainty and tighter regulations, which are driving lower usage of cigarettes and further downtrading. 

The survey, analyzed by New York-based Goldman Sachs Managing Director Bonnie Herzog, represents about 46,000 c-store locations across the United States.

Turning to vapor products, Herzog said that while difficult to quantify given limited data, several respondents noted that customers have moved to illicit vapes.

If illicit e-cigarettes were completely removed from the markets, 35% of retailers indicated they believe consumers would pivot to legal vapor products, while another 30% expect consumers to shift to nicotine pouches.

Retailers and wholesalers remain optimistic about smokeless nicotine offerings, particularly the oral nicotine pouch category.

• FDA has announced a Tobacco Products Scientific Advisory Committee (TPSAC) meeting on 10/7 to discuss the renewal of modified risk granted orders (MRGOs) issued to Philip Morris Products S.A. - Federal Register

The TPSAC meeting will discuss the renewal of MRGOs for the following products:

Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks, Marlboro Blue Menthol HeatSticks, IQOS 2.4 System Holder and Charger, IQOS 3.0 System Holder and Charger

The IQOS system received exposure modification orders under Section 911(g)(2) of the FD&C Act, allowing Philip Morris Products S.A. to use the following exact reduced exposure information in their marketing:

"AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.

• This significantly reduces the production of harmful and potentially harmful chemicals.

• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body's exposure to harmful or potentially harmful chemicals."

• Altria reported Q2 2025 Earnings on July 30, 2025 - Altria

Nicotine pouch brand on! shipment volume was 52.1 million cans. This is an increase from 41.2 million cans in the second quarter of 2024. The total number of e-vapor users in the U.S. increased to 20.5 million for the twelve months ending June 30, 2025, with disposable products driving this growth. After a patent dispute with JUUL, Altria has completed a new product design for a "modified NJOY ACE solution" that the company believes resolves the issue. In the first half of 2025, Altria's adjusted cigarette shipment volume declined by 11.0%. The company also raised its full-year 2025 adjusted diluted EPS guidance to a range of $5.35 to $5.45

• Durbin, Senators Request Answers From FDA Regarding Dangerous Decision Allowing JUUL E-Cigarettes To Stay On The Market, Addict Children - Senator Dick Durbin (D-IL) Press Release [link to letter]

Based upon this troubling history and the risk to public health from this recent FDA decision, we request responses to the following questions by August 22, 2025. Given this Administration’s stated priority of “radical transparency”, we trust that detailed and complete responses will be provided.

1. FDA issued a marketing denial order to JUUL on June 23, 2022, for its premarket tobacco product application, on the basis that it “lacked sufficient evidence” to demonstrate that the company’s e-cigarette was appropriate for the protection of public health. Please explain in detail how JUUL remedied its PMTA such that it merited Authorization….

6. To the extent permissible by law, please provide all correspondence between JUUL, any of its representatives, and FDA between January 20, 2025, and July 17, 2025.

7. Please provide all studies, scientific materials, and marketing information submitted by JUUL, and any of its representatives, redacted as appropriate by law, to FDA between January 20, 2025, and July 17, 2025.