Week of May 5 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Trump administration taking action on ‘port shopping’ to combat Chinese vape ‘attack’ - Washington Examiner

Makary, who leads the FDA, told the Washington Examiner Friday that the administration is specifically looking to end the “port shopping” of incoming black market vape shipments.

“When I came into office, what I learned is that we were just sending them back to the manufacturer, who would put them on a ship, and they would go to the next U.S. port, something called port shopping,” he explained. “They’re laughing at us because the FDA can only get through two to five percent of products that come into our ports, so basically 100% of the stuff was getting in. It was a porous border. So we’re taking action to look at confiscating and destroying these products.”

Chinese producers are believed to control anywhere between 70% and 90% of America’s black market vape trade. Polaris National Security, a think tank founded by the deputy U.S. special envoy to the Middle East, Morgan Ortagus, published a report last month predicting that Chinese manufacturers will reach $200 billion in annual illicit vape sales by 2030.

• The Concentration of Nicotine in E-cigarettes Continues to Soar, Putting Young People at Higher Risk of Addiction - Truth Initiative

A new study published in the American Journal of Preventive Medicine reveals that total nicotine content in U.S. e-cigarette sales has increased by nearly 250% since 2020, with the sharpest increases found in disposable e-cigarettes.

• Bigger devices, cheaper nicotine: The nicotine content in disposable e-cigarettes jumped by 2,364.5%, while cartridge-based devices increased by just 1.3%. By mid-2024, disposables contained nine times more e-liquid than cartridge-based devices and were nearly four times cheaper per milligram of nicotine.

• Disposables dominate: Disposable e-cigarettes, favored by youth, accounted for 74% of nicotine content sold and 58% of units sold by mid-2024.

• Flavored products remain widespread: In 2023, nearly 90% of nicotine sold came from non-tobacco flavored products, which, based on other research, remain a key driver of youth use.

• Report spotlights lobbying by White House chief’s former clients
  The Washington Post
  

In the first three months of the new Trump administration, several former lobbying clients of White House Chief of Staff Susie Wiles met with White House staff, drawing concern from a consumer advocacy group about potential conflicts of interest.

Public Citizen also flagged Wiles’s previous work with Swisher, a Jacksonville, Florida-based tobacco company that reported lobbying the executive office of the president in the first few months of this year. The company did not respond to a request for comment.

Swisher is regulated by the Food and Drug Administration, and its recent lobbying efforts focused in part on “issues related to FDA and the Center for Tobacco products reforms,” according to its disclosures. Swisher has battled against proposed bans on Swisher Sweets, its popular flavored cigars, which critics argue have an inherent appeal to children.

Wiles lobbied the government on behalf of Swisher for five years, through 2024. She has previously said she has not had any policy conversations with Trump about nicotine-related issues, and that she had not influenced Trump’s position on tobacco regulation. The tobacco industry spent millions backing Trump’s successful bid for a second term, campaign finance records show.

• FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline - FDA (see analysis of potential FDA CTP use cases below)

In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.

To reflect the urgency of this effort, Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.

“There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking. It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay,” said Dr. Makary.

Next Steps

Looking ahead, the FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.