Regulatory Intelligence Insights for August 11

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Week of August 4 Regulatory Intelligence Recap

  • Exclusive: USPS blocks shipping of illicit vapes in boost for Big Tobacco - Reuters

The U.S. Postal Service has cracked down on distributors of unregulated vapes using its services for business shipments, letters reviewed by Reuters show, in a blow to a multi-billion dollar industry that has dented Big Tobacco's sales.

USPS revoked Demand Vape's mailing exception last month after it received evidence the company shipped vapes lacking FDA authorisation and that violated a local flavour ban, a letter from USPS to the company, dated July 15, showed.

  • Juul Moves to Block New NJoy Daily, Ace Vapes With Patent Claims - Bloomberg Law

Juul Labs Inc. accused an Altria Group Inc. unit of infringing a recently issued nicotine-salt patent, the latest salvo in a multi-pronged legal conflict over NJoy’s new vaping products. The NJoy Daily and a redesigned version of the Ace use nicotine-salt formulations to deliver cigarette-like “satisfaction,” infringing Juul’s US Patent No. 12,156,533, according to a complaint filed Friday in the US District Court for the District of Arizona. Juul said it filed the suit in tandem with a complaint at the US International Trade Commission seeking to block imports of the same products.

Juul’s new complaint said the accused devices fall outside the scope of a March 31 import ban the ITC imposed after finding NJoy’s earlier Ace vaporizers infringed four other Juul patents. Juul called the new infringement willful, citing Altria’s prior investment in the company and its access to Juul’s patent portfolio.

  • EXCLUSIVE: Biden failed to stop China's toxic nicotine invasion — and your kids paid the price, expert warns - Fox News

Chinese-made nicotine and electronic cigarette products illegally flooded U.S. markets under former President Joe Biden, endangering both adults and children and posing an "urgent threat to U.S. sovereignty, public health, and law enforcement capacity," according to nicotine awareness activist and former GOP senator Richard Burr.

In an interview with Fox News Digital, Burr, who is chair of the Coalition for Smarter Regulation of Nicotine, said that even as the Biden administration cracked down on "reputable" companies like Juul, it took no action to control the flow of off-brand competitor products, most of which were manufactured and exported to the U.S. by Chinese companies through the open borders.

According to Burr, Biden’s director of the FDA’s Center for Tobacco Products (CTP), Brian King, bears special blame for overseeing an agency so crippled by inaction that, Burr said, "most of the products that are on the marketplace today not only are illegal, they have never even attempted to go through an application process at the FDA."

Burr sent a letter to Trump’s FDA commissioner, Martin Makary, as well as Health and Human Services Secretary Robert F. Kennedy Jr. and U.S. Attorney General Pam Bondi, urging them to take urgent action to "restore order" to the marketplace by reforming the government’s review process of nicotine and e-cigarette products and then fully enforcing against the entities responsible for growing the illicit market.

In his letter, Burr describes the U.S. as being "in the midst of a crisis created by the free flow of illegal nicotine products into the U.S. marketplace, the majority of which are supplied by Chinese companies that are knowingly breaking U.S. laws."

To this end, Burr urged the FDA to "advance a comprehensive, effective regulatory framework," which he said consists of streamlining the FDA’s approval process for less harmful smoke-free nicotine products, providing clear regulations to the industry and enforcing the law against companies selling illicit products, providing adult smokers with accurate information on the benefits of switching from cigarettes to FDA-authorized, smoke-free products and using regulation and oversight to drive down underage use.

  • Despite FDA Authorization, the Damage of the Juul Frenzy Lingers - Filter

The backstory to this long battle is the power, money and influence of a uniquely dangerous Tobacco Control cult, to which the 480,000 people who die from smoking in the United States each year are invisible. Without it, far fewer would die. FDA officials, politicians, “public health” groups and much of the medical community and mainstream media are among its bought-and-paid-for members. 

Juul was the victim of a massive attack that is without precedent in its senselessness and hostility. No other company making products that can save lives has been so successfully and publicly punished, humiliated and driven to the edge. Even coal and oil companies, health insurance corporations or Big Tobacco have largely avoided being so hammered in the media and the courts, despite campaigners’ efforts. State Attorneys General filed thousands of lawsuits against Juul. By the end of 2023, the company had paid out nearly $3 billion in legal settlements across the US. 

The juggernaut of the Juul teen-vaping frenzy changed the trajectory of the market. Instead of regulating, promoting, and making them legally available in a national network of community-based vape shops or other outlets, the US is filled with unregulated, disposable, flavored vapes, as consumers circumvent bans. It’s estimated that the illicit market sells 60 percent of all vapes in the US.

The good news is millions of people have ignored the bans and switched to vaping. They are courageously practicing tobacco harm reduction in the midst of prohibition, to save their lives.

  • Tobacco and Nicotine Addiction Quitting through vaping vs nicotine replacement, bupropion, or varenicline - Psychology Today

The role of electronic nicotine delivery systems (ENDS), otherwise known as vapes, has evolved rapidly. Some researchers regard vaping as a harm-reducing, safer form of nicotine maintenance for cigarette smokers. Others compare vapes to methadone maintenance for people addicted to opioids.

Yet real evidence summarized in a 2025 Cochrane Review found that nicotine-containing e-cigarettes might help adult smokers reduce or eliminate cigarette use compared to nicotine replacement therapy (NRT) and non-nicotine vaping products. This conclusion is consistent with other recent 2025 studies, including the JUUL2 Actual Use Study by Goldenson and a JAMA Network Open article showing daily vaping was associated with a greater likelihood of long-term cessation when compared to smokers who were non-vapers or intermittent users.

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