Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Search

FDA Urges Nicotine Pouch Manufacturers to Use Child-Resistant Packaging as Exposure Cases Increase

Sep.03.2025
FDA Urges Nicotine Pouch Manufacturers to Use Child-Resistant Packaging as Exposure Cases Increase
The US FDA asks nicotine pouch makers to use child-resistant packaging. From April 2022 to March 2025, US poison centers reported more cases of children under 5 being exposed to nicotine pouches. These pouches are very dangerous for kids. The FDA has approved 20 products with this packaging and shared safety tips.

Key Points:

 

·Rising Cases: From 2022 to 2025, there has been an increase in cases of nicotine pouch exposure reported to the American Poison Control Center, with 72% involving children under the age of 5. 

·Health Risks: Even a small amount (1-4mg) can be toxic, leading to symptoms such as confusion, vomiting, and loss of consciousness. 

·FDA Concerns: The fruity flavors and bright packaging of these products resemble candy, making them appealing to children. 

·Protective Measures: The FDA is urging manufacturers to use child-resistant packaging and for parents to store these products safely out of reach of children.

 

 

On September 3, 2025 - According to a message posted on the FDA's official website on September 2, the U.S. Food and Drug Administration (FDA) is urging nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental harmful exposure. The number of reported nicotine pouch exposure cases has been steadily increasing from April 1, 2022, to March 31, 2025, as reported by the American Association of Poison Control Centers. Approximately 72% of nicotine pouch exposure cases occurred in children under the age of 5.

 

The FDA stated that nicotine pouches contain high concentrations of nicotine, which can be harmful or even fatal to children even in small amounts. Reports have indicated that doses of 1 to 4 milligrams of nicotine can have toxic effects on children. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness.

 

I am concerned about the increasing reports of children being exposed to nicotine through nicotine pouches," said FDA Commissioner Marty Makary. "The fruity flavors and vibrant colors of nicotine pouch products may resemble candy and be attractive to children. Manufacturers should consider taking measures to prevent accidental exposure and ingestion.

 

The FDA has also issued information on how to properly store nicotine pouches to prevent accidental exposure to children. Parents and caregivers should store all nicotine products, including nicotine pouches, securely in their original packaging out of reach of children, and seek medical attention immediately if accidental ingestion occurs. If anyone ingests a nicotine pouch by mistake, they should call the Poison Control Hotline at 1-800-222-1222 immediately.

 

The FDA states that child-resistant packaging is a key safety barrier to prevent children from accidentally ingesting nicotine products, and also reflects manufacturers' commitment to protecting public health. Manufacturers of nicotine pouch products intending to adopt child-resistant packaging or other measures to reduce the risk of children's accidental exposure should contact the FDA through a designated regulatory health project manager or the email AskCTP@fda.hhs.gov, or by phone at 877-CTP-1373.

 

The FDA also stated that they have authorized 20 varieties of nicotine pouch products that use child-resistant packaging.

 

FDA Urges Nicotine Pouch Manufacturers to Use Child-Resistant Packaging as Exposure Cases Increase
20 authorized nicotine pouch products | Image source: FDA.

 

2Firsts noted that all authorized nicotine pouch products belong to the ZYN brand, produced by Swedish Match Company, a subsidiary of Philip Morris International (PMI).

 

References:
[1] FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure
Also Read:
[1] The U.S. FDA is publicly recruiting members for its Tobacco Products Scientific Advisory Committee, with nominations accepted from both individuals and organizations
[2] The U.S. FDA has issued two notices: seeking public comments on regulations regarding tobacco retailer training programs and sales restrictions

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn

Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
American Vapor Manufacturers (AVM) and Altria subsidiaries Helix Innovations and NJOY filed separate motions on October 7, 2026, seeking to intervene on the FDA's side in a lawsuit challenging its enforcement guidance for certain e-cigarette and nicotine pouch products with pending premarket tobacco product applications (PMTAs). Seven public health and tobacco-control organizations, including the Campaign for Tobacco-Free Kids, sued the agency in July to overturn the policy. AVM argues that vacating the guidance could disrupt orders, inventory, retail distribution and investments in regulatory submissions.
Regulations
Oct.09
Pennsylvania Vape Directory Law Survives Court Challenge From Nova Distro and Others Amid Similar Rulings Across States
Pennsylvania Vape Directory Law Survives Court Challenge From Nova Distro and Others Amid Similar Rulings Across States
A U.S. federal court upheld Pennsylvania's vape directory law on October 14, rejecting a challenge brought by Nova Distro, 101 Distributors and companies operating Tobacco Hut retail stores. Court records show that vaping accounts for about 60% of Tobacco Hut's profits and that the chain held approximately $2 million in inventory potentially subject to seizure under the law as of June 2. Pennsylvania began enforcement on October 19. The ruling follows similar appellate decisions in other states, even as new research shows that unlisted vaping products continue to account for substantial sales in states with established directories.
Regulations
Oct.22
Product | Philip Morris Korea Launches Two TEREA ONYX Capsule Tobacco Sticks, Expanding Portfolio to Five Lines
Product | Philip Morris Korea Launches Two TEREA ONYX Capsule Tobacco Sticks, Expanding Portfolio to Five Lines
Philip Morris Korea launched TEREA ONYX, a new tobacco stick line for IQOS ILUMA devices, on October 15, 2026. The initial products, AMANG PEARL and CALI PEARL, feature tropical-inspired flavors, Fresh Filters and capsules designed to deliver different flavor experiences before and after activation. Both are priced at KRW 4,800 per pack and are available at convenience stores nationwide and IQOS-operated stores in South Korea. The launch expands the Korean TEREA portfolio from four product lines to five, following earlier capsule tobacco stick additions in 2026.
product
Oct.23
Product | Philip Morris Japan Teams Up With Renowned French Audio Brand DEVIALET for Limited-Edition IQOS Priced 60% Above Standard Model
Product | Philip Morris Japan Teams Up With Renowned French Audio Brand DEVIALET for Limited-Edition IQOS Priced 60% Above Standard Model
Philip Morris Japan (PMJ) launched the limited-edition IQOS ILUMA i PRIME Soundsorial Model in collaboration with French audio brand DEVIALET on October 1, 2026. Featuring sound-wave patterns, a silver-and-black finish and a gradient holder, the heated tobacco device is priced at JPY 15,980, including tax, and is available at four IQOS stores in Japan. According to Japanese media citing a PMJ representative, about 1,900 units were allocated to the Japanese retail market. A separate Soundsorial Collection, combining the device with DEVIALET Gemini II earbuds, includes 440 sets allocated to Japan for a membership prize draw.
product
Oct.23
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
Japan Tobacco International's Irish business has proposed a €0.25 tax increase on a pack of 20 cigarettes in its pre-Budget 2027 submission, below the €0.50-or-more increases typically imposed in recent Irish budgets. JTI says the proposal could generate around €45 million in additional Exchequer revenue while limiting further movement toward illicit and non-Irish-tax-paid tobacco. Revenue's existing estimate for a comparable €0.25 increase, including pro-rata rises on other tobacco products, is about €18 million for a full year.
JTI
Sep.18 by 2Firsts Perspectives
Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy's proposed 2027–2029 budget would bring forward scheduled tax increases for e-cigarette liquids and heated tobacco products from January 1, 2028, to July 1, 2027. The consumption tax coefficient for nicotine-containing e-liquids would rise from 20% to 22%, that for nicotine-free liquids and applicable flavorings from 15% to 17%, and the heated-tobacco coefficient from 41% to 42%. The bill would also introduce official retail price schedules for e-liquids, restrict exclusive agreements between retailers and suppliers, and limit single-brand-dominated displays, sales incentives and bundled offers. Importing, authorized warehousing and retailer sourcing arrangements would also change. The proposals remain subject to parliamentary approval and subsequent implementing regulations.
Regulations
Nov.04
Related Topics
News Regulation
Related Read
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
Pennsylvania Vape Directory Law Survives Court Challenge From Nova Distro and Others Amid Similar Rulings Across States
Pennsylvania Vape Directory Law Survives Court Challenge From Nova Distro and Others Amid Similar Rulings Across States
Product | Philip Morris Korea Launches Two TEREA ONYX Capsule Tobacco Sticks, Expanding Portfolio to Five Lines
Product | Philip Morris Korea Launches Two TEREA ONYX Capsule Tobacco Sticks, Expanding Portfolio to Five Lines
Product | Philip Morris Japan Teams Up With Renowned French Audio Brand DEVIALET for Limited-Edition IQOS Priced 60% Above Standard Model
Product | Philip Morris Japan Teams Up With Renowned French Audio Brand DEVIALET for Limited-Edition IQOS Priced 60% Above Standard Model
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
2Firsts Perspectives
Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
FOLLOW US ON SOCIAL MEDIA
Contact: info@2firsts.com
Stay up to date.
Submit your email to receive weekly newsletter on the most relevant news of the e-cigarette industry.
© 2026 2FIRSTS. All Right Reserved.
2FIRSTS is only accessible to industry practitioners, researchers, media and other professionals. Access by minors is prohibited.
This website provides services to users outside the Chinese mainland.
English
English
中文