FDA Mandates Biannual Reporting of Tobacco Product Changes — What You Need to Know
In a major regulatory shift, the U.S. Food and Drug Administration (FDA) now requires tobacco product manufacturers to report any product changes twice per year—a move aimed at improving transparency, traceability, and enforcement.
The update was announced by the FDA’s Center for Tobacco Products (CTP) and applies to all companies with PMTA (Premarket Tobacco Product Application)-approved or -pending products. Manufacturers must submit comprehensive updates every six months detailing any changes in formulation, device design, labeling, packaging, or manufacturing process.
Who Must Comply?
Any company marketing tobacco or nicotine products under the PMTA pathway must adhere to this new reporting cadence. This includes:
- Closed and open system ENDS (electronic nicotine delivery systems)
- Disposable e-cigarettes
- Nicotine pouches and oral tobacco products
- Heated tobacco products
What Must Be Reported?
According to the FDA, manufacturers must disclose all product changes made since the previous reporting period, including:
- Ingredient or material substitutions
- Changes to nicotine concentration or delivery method
- Device functionality or firmware updates
- Packaging modifications, warnings, or branding updates
- Shifts in manufacturing sites or quality control procedures
Even if no changes have occurred, manufacturers are still expected to submit a statement affirming “no change” to maintain compliance.
Why This Matters
This move by the FDA reinforces its commitment to postmarket surveillance. It helps the agency monitor whether PMTA products remain "appropriate for the protection of public health" even after launch. Failure to comply with this new biannual requirement could result in FDA enforcement action—including product removal from the market.
The update also supports growing efforts by states such as Mississippi, California, and Utah to enforce stricter oversight of tobacco product registrations and compliance timelines.
How GegaHelix Can Help
At GegaHelix Consulting, we don’t just support your PMTA submission—we help ensure your business stays compliant long after authorization. Our postmarket compliance services include:
- Change Tracking Systems – We help implement SOPs to document and report changes before each cycle.
- Reporting Preparation – We prepare and submit your biannual FDA updates to ensure accuracy and completeness.
- Risk Mitigation – We identify compliance gaps and help you avoid enforcement risks.
Our team has guided over 150 PMTA applications through review and continues to monitor evolving federal and state-level regulations so you don’t have to.
Get Ahead of the Next Deadline
The first round of reports under this rule is expected by the end of 2025. Let GegaHelix help you prepare a compliant, defensible postmarket submission—so you can focus on scaling your product safely.
Need help with PMTA or FDA reporting?
Contact GegaHelix Consulting to schedule a free strategy session with our regulatory experts.
Disclaimer: This article is intended for informational use only and does not constitute legal or regulatory advice. Nicotine-containing products are intended only for adult use and may pose health risks. GegaHelix Consulting supports full compliance with FDA and state regulations.