FDA’s Call for Child-Resistant Packaging: Why Manufacturers Should Not Wait for a Mandate

By Paul Hardman, Chemistry Consultant at Broughton
With expert regulatory commentary from Lilian Ortega, Owner and Chief Regulatory Compliance Strategist at WOW Solutions LLC

On 2 September 2025, the United States Food and Drug Administration (FDA) issued a public statement urging manufacturers of oral nicotine products to adopt child-resistant packaging. This is not a new regulation, nor is it formal guidance. It is, however, a clear signal of the agency’s expectations. Should manufacturers disregard this recommendation?

The short answer is no.

Although not legally binding, the FDA’s position reflects its broader public health priorities. As part of its evaluation of whether a product is Appropriate for the Protection of Public Health (APPH), the agency considers the risks posed to consumers in comparison to other products already on the market. This includes the risk of accidental exposure to children.

The FDA’s closing remark is particularly noteworthy:

“To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging.”

This statement establishes a precedent. For products with similar risk profiles, the absence of child-resistant features may be interpreted as a higher risk to children. This could negatively impact the APPH assessment and potentially delay or prevent product authorization.

Regulatory Perspective: Questions That Remain Unanswered

Recent commentary from Lilian Ortega, Regulatory Expert and Former FDA Official, highlights several important regulatory considerations that manufacturers may wish to explore further:

• Compliance Policy: Will FDA update the Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products guidance to include child-resistant packaging for nicotine pouches?
• Whether incorporating child-resistant packaging during PMTA review would be considered the creation of a new tobacco product
• What options are available to manufacturers with pending applications, including whether to amend the application or commit to post-market changes supported by stability data

Historically, changes to the container closure system (CCS) have often been considered significant enough to constitute a new tobacco product. FDA’s limited modifications policy has allowed certain safety updates such as UL 8139 battery safety upgrades and flow restrictors for liquid nicotine containers to process via amendment. It is not yet clear whether a similar approach will apply to child-resistant packaging.

Nicotine Pouch Manufacturers with pending applications may benefit from engaging with their assigned Regulatory Health Project Manager (RHPM) to clarify expectations and determine the most appropriate regulatory pathway

Considerations When Evaluating Packaging Changes

Packaging modifications should not be assumed to be straightforward. A number of technical and regulatory factors must be carefully assessed, including:

• The nature of any changes to packaging materials and their chemical compatibility with the product: new packaging materials may be detrimental to the product due to chemical interactions or by compromising how the pouches are protected.
• The potential for chemical migration from the packaging into the product: If different materials are used, different compounds may leach into the pouches, which may alter their overall safety profile.
• The impact of packaging changes on product shelf life and overall stability: Protecting the pouches over their shelf life is essential in demonstrating that the product is APPH.
• Any implications for the Environmental Assessment associated with the product: Different materials have varying implications for the environmental assessment, which should be considered.
• Do any manufacturing processes, equipment, or locations change to accommodate the change in packaging?

Regardless of the stage within the PMTA process, manufacturers must undertake a thorough evaluation of any proposed packaging changes. It remains the responsibility of the applicant to demonstrate that such modifications do not result in the creation of a new tobacco product under FDA regulations.

A Structured, Risk-Based Approach Is Essential

Packaging changes do not need to be overly complex, but they must be approached with care. A structured, risk-based process is essential to ensure that all regulatory, safety, and product integrity considerations are addressed. A well-structured risk assessment may consider different packaging options to allow the selection of a new pack type based on minimizing risk to both users and non-users and minimizing changes in terms of manufacturing processes, while demonstrating the product is APPH to FDA in an efficient way.

At Broughton, we support clients in evaluating packaging and product changes, assessing regulatory impact, and preparing the necessary documentation to support amendments or post-market commitments.

Need Support?
If you are considering packaging changes or require regulatory guidance for nicotine pouch products, please contact us directly to learn how Broughton can support your regulatory strategy.