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

South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's Ministry of Gender Equality and Family said on September 14 that it plans to designate unmanned e-cigarette stores as businesses where minors are prohibited from entering or working. Operators would be required to verify customers' ages and display notices restricting access by minors. The proposal is open for public comment through October 6. The move follows an April expansion of South Korea's statutory tobacco definition that brought products made with natural or synthetic nicotine under the Tobacco Business Act. Nicotine-free liquids and products using nicotine analogues such as 6-methylnicotine, however, remain an emerging regulatory issue.
Sep.21
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?
SCIENCE
Sep.23
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
PMI's IQOS Extends ZAMNA Electronic-Music Partnership to Spain as Vogue España Publishes Branded Content
Philip Morris International's IQOS has extended its partnership with electronic-music event brand ZAMNA to Spain, setting up a House of IQOS at ZAMNA Madrid. Vogue España and Time Out Madrid subsequently published branded content clearly labeled as collaborations with IQOS. PMI has also expanded its company-owned IQOS boutique network in Spain to seven cities this year. The company says IQOS's adjusted heated-tobacco market share in Europe reached 12.6% in the first quarter of 2026, with Spain among its stronger-performing European markets.
Sep.20
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
AIRSCREAM’s production hub in the Czech Republic brings nicotine pouch manufacturing, e-liquid bottling, product documentation, warehousing and international logistics into one operation, giving brands and commercial partners a practical platform from which to launch, expand and enter new markets.
Market
Sep.16 by 2Firsts Perspectives
Los Angeles Cracks Down on Illicit Flavored Vapes and Counterfeit Goods: 12 Businesses Searched, 24 Arrested, Eight Truckloads Seized
Los Angeles Cracks Down on Illicit Flavored Vapes and Counterfeit Goods: 12 Businesses Searched, 24 Arrested, Eight Truckloads Seized
Los Angeles authorities searched 12 businesses and arrested 24 people during a multi-agency operation targeting illicit flavored vaping products, flavored cigarettes and counterfeit merchandise on October 22, 2026. The Los Angeles County Sheriff's Department said approximately eight tractor-trailer loads of merchandise were seized. Alleged violations involved flavored tobacco sales restrictions, tobacco licensing requirements and counterfeit trademark laws. Local, state and federal agencies participated. Authorities have not disclosed the number, brands or value of vaping products seized. Investigations remain ongoing.
Enforcement
Oct.28
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.
Sep.14