FDA Tightens Import Controls on Certain Tobacco Products

Mar.11.2025
FDA Tightens Import Controls on Certain Tobacco Products
FDA strengthens import regulations on specific tobacco products, updating the "98-06 Import Alert" list, allowing automatic detention without extra inspection.

Key points:

 

1. The U.S. Food and Drug Administration (FDA) has updated its "98-06 Import Alert" list, tightening regulations on certain tobacco products. It also allows for the automatic detention of listed products without additional inspection.

 

2. The update affects several European brands, primarily from Poland and Sweden, including smokeless tobacco and nicotine delivery products, including 77 Pouches, Loop, and Lundgrens.

 


 

The U.S. Food and Drug Administration (FDA) has recently updated its "98-06 Import Alert" list (also known as the "Red List"), further strengthening import regulation of specific tobacco products. 

 

Under new guidelines, the FDA can automatically detain tobacco products included in the list without the need for additional physical inspections

 

The update includes several brands and manufacturers, such as 77 Pouches, Loop, and Lundgrens. The products are mainly distributed in Europe, with a focus on Poland and Sweden, and primarily consist of smokeless tobacco and nicotine delivery products.

 

The following is a specific list.

 

1. 77 Pouches (Poland)

  • Company address: Al. 29 Listopada 94, Cracow, Malopolskie, Poland.
  • Product description: "77" brand of smokeless tobacco and nicotine delivery products.
  • Publication Date: March 7, 2025.

 

2. Luna Corporate (Poland)

  • Company address: Ul. Obornicka 174, Suchy Las, Wielkopolskie, Poland.
  • Product Description: "77" brand's smokeless tobacco and nicotine delivery products.
  • Publication date: March 7, 2025.

 

FDA Tightens Import Controls on Certain Tobacco Products
77 Pouches | Image Source: nicopods

 

3. Another Snus Factory Stockholm AB (Sweden)

  • Company address: Stora Nygatan 33, Stockholm, Stockholms Lan, Sweden.
  • Product description: Loop brand tobacco products.
  • Publication date: March 7, 2025.

 

FDA Tightens Import Controls on Certain Tobacco Products
Loop | Image Source: nicopods

 

4. British American Tobacco (Sweden)

  • Company Address: Hyllie Stationsvag 14, 31st Floor, Malmo, Skane Lan SWEDEN.
  • Product description: Lundgrens brand of smoke-free tobacco and nicotine delivery products.
  • Publication date: March 7, 2025.

 

FDA Tightens Import Controls on Certain Tobacco Products
LUNDGRENS | Image source: nicopods

 

The FDA stressed that companies seeking to have their products removed from the red list must provide sufficient information to demonstrate that the issues leading to the violation have been addressed and ensure future imports comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Relevant applications should be sent to Importalerts2@fda.hhs.gov.

 

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

PMI to Launch IQOS in Argentina by End-2026 After Regulatory Shift, Targeting About 7 Million Smokers
PMI to Launch IQOS in Argentina by End-2026 After Regulatory Shift, Targeting About 7 Million Smokers
Philip Morris International (PMI) has confirmed plans to bring its IQOS heated tobacco device to Argentina by the end of 2026, after the Argentine government lifted long-standing restrictions and created a regulatory framework for heated tobacco, e-cigarettes and nicotine pouches.
News
Jun.26 by 2Firsts Perspectives
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
China’s Shanghai Tobacco Group Launches CNY 10.98 Million (Approximately US$1.53 Million) Procurement for Heated Tobacco Production Utility Equipment
Shanghai Tobacco Group Co., Ltd., a tobacco manufacturing company under China National Tobacco Corporation (CNTC), has launched a public tender for heated tobacco products (HTPs) production utility equipment at its Shanghai Cigarette Factory. The project is valued at CNY 10.98 million and covers six combined air-conditioning units, electrical cabinets and control systems for production facilities. The procurement includes equipment design, supply, installation, commissioning and related training services.
Aug.07
Exclusive: China Tobacco Launches Locally Made MODEN FREE Nicotine Pouches in Indonesia
Exclusive: China Tobacco Launches Locally Made MODEN FREE Nicotine Pouches in Indonesia
2Firsts exclusively reports that China Tobacco Zhejiang Industrial has launched MODEN FREE nicotine pouches in Indonesia. The locally manufactured product is sold through Sixhill, a next-generation tobacco channel under CFU Group, at about $1.80 per 18-pouch can. The launch moves China Tobacco’s nicotine pouch activity beyond trade-show displays and testing into local production and public retail.
Jul.16
PMI Expands Colorado Investment to $1.2 Billion to Boost ZYN Nicotine Pouch Production
PMI Expands Colorado Investment to $1.2 Billion to Boost ZYN Nicotine Pouch Production
Philip Morris International (PMI) is expanding its investment in its Golden, Colorado campus, bringing total investment to approximately $1.2 billion to support its smoke-free products business. The investment will strengthen PMI’s research, production and innovation capabilities in smoke-free products. As one of the world’s largest tobacco companies, PMI has continued advancing its “Smoke-Free Future” strategy through heated tobacco, oral nicotine and other reduced-risk product categories.
PMI
Jul.28
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam tightens e-cigarette rules. Health Ministry proposes banning production, trade, transport, storage, ads, promotion, sponsorship, and use of e-cigarettes, heated tobacco, and new products. Hanoi also urges residents to report illegal activities, showing enforcement moves from lawmaking to local action.
Jul.08
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13