Reuters: FDA relaxes requirements for nicotine pouch pilot program, cancels special research on some products

Key points:

·Trial core adjustments: FDA cancels the requirement for nicotine pouch manufacturers to submit specialized studies claiming "product helps smokers reduce smoking effectively", opting instead for existing general research data; while also clarifying the intent to shorten review periods, increase communication frequency with applicants, and streamline the review process.

·Policy Position Significance: This is the first clear signal during the Trump administration that the United States is adopting a more lenient regulatory stance on smoking alternatives. Previously, the FDA had strict reviews of nicotine products and often required manufacturers to conduct costly studies on the impact on high-risk populations.

·Industry Impact: Tobacco companies such as Philip Morris International (PMI) (Zyn), Altria (On!), and British American Tobacco (Velo) will directly benefit from the increase in sales of nicotine pouch products, as they have previously faced issues related to long FDA approval processes or rejected applications. This pilot project is expected to drive growth in the nicotine pouch category.

·Controversy focuses on differing viewpoints

Supporters (FDA): Nicotine pouches have lower risks compared to other nicotine products, and have not yet led to an increase in youth usage rates. Streamlining the process can increase low-risk options for smokers. 

Critics (former officials/scholars): There is a lack of specialized research on the product, making it difficult to assess its actual health benefits. Additionally, nicotine pouches are easily used discreetly by teenagers, raising concerns about potential abuse.

Reviewing actual difficulty: Consultancy company ARAC pointed out that even under pilot testing, the "most time-consuming and resource-intensive clinical trials" still need to be retained, and the difficulty of manufacturers submitting applications has not been completely reduced.

According to Reuters, The U.S. Food and Drug Administration will ease requirements on nicotine pouch manufacturers under a new pilot program, internal meeting transcripts show, in the first clear sign of a softer stance on smoking alternatives under Trump's White House.

For an extended period of time, the FDA has conducted rigorous testing on all new nicotine products before they are approved for sale in America. This includes requiring manufacturers to conduct expensive research and provide detailed information on the product's impact on the population.

The FDA has always aimed to ensure that these products bring a net benefit to public health, helping smokers quit cigarettes without causing new issues such as a significant increase in youth usage.

However, according to records of an internal meeting obtained by Reuters earlier this month, under the pilot program, the FDA will eliminate a requirement - that manufacturers must submit special reports on product research in multiple areas.

Has the Trump administration changed its position?

In the various adjustments, manufacturers are no longer required to submit research reports on the effectiveness of their products in helping smokers reduce their smoking.

Meeting notes indicate that the FDA will instead rely on existing research on nicotine pouches to address such questions. Nicotine pouches are held under the lip by users to obtain nicotine.

Reuters previously reported that the FDA plans to expedite the review process for nicotine pouches under this pilot program.

This Thursday, the FDA confirmed details of the plan, such as increased communication with applicants and shorter review periods.

However, the FDA did not specify the shift from "product-specific evidence" to "more general evidence" in key areas.

Although the program is currently in the testing phase, this move suggests that the FDA may relax its strict approval process to some extent. This process is seen as one of the main obstacles to operating in the world's largest market for smoking alternatives.

Tobacco companies like Philip Morris International (PMI), Altria, and British American Tobacco often have to wait several years to receive FDA approval for their applications, and sometimes they are even rejected.

The nicotine pouch brands Zyn, On!, and Velo owned by these companies will benefit from the pilot program.

Both Philip Morris International (PMI) and Altria declined to comment until the full details of the pilot program are released.

The British American Tobacco company stated that it has long advocated for improvements in the review process and that reasonable regulation is crucial to the health of the American public.

The FDA upholds scientific standards.

Meeting minutes show that Bret Keplow, Acting Director of the FDA Center for Tobacco Products, stated during the meeting that the pilot program could serve as a reference for updating the review process for other categories of products at the FDA.

These categories include e-cigarettes, and the FDA currently maintains a cautious stance towards the e-cigarette industry.

Capro did not respond to a request for comment sent via LinkedIn.

The US Department of Health and Human Services (which oversees the FDA and handles media inquiries for the agency) referenced comments previously made by Pfizer on the pilot program in response to questions from Reuters.

In a previous statement, Kaplow stated that the FDA's Center for Tobacco Products (CTP) has not been pressured by the Trump administration or agency leadership to lower scientific standards.

The Trump administration had previously dismissed key officials at the center and cracked down on the unregulated large-scale sales of e-cigarettes. However, before the launch of the nicotine product trial program, it was unclear whether the government would respond to calls for "streamlining the review process.

Nicotine pouches: weighing risks and benefits.

At a meeting held this month, FDA officials stated that overall, the risks of nicotine pouches are low compared to other categories of nicotine products, as users are exposed to fewer toxic chemicals, and there is currently no significant increase in youth usage rates.

Reuters briefed Mary Hrywna, associate professor at Rutgers University, who has done extensive research on nicotine pouches, on the content of the FDA meeting.