Spain's Health Ministry Proposes Labeling and Sales Rules for Nicotine Pouches

Nov.22.2024
Spain's Health Ministry Proposes Labeling and Sales Rules for Nicotine Pouches
The Spanish Ministry of Health has announced a draft of the new Royal Decree, which includes implementing plain packaging for tobacco products, restricting the use of nicotine pouches and vapes, and limiting the addition of flavorings in tobacco products.

According to El Espanol on November 21st, the Spanish Ministry of Health has released a new draft Royal Decree aimed at updating regulations on tobacco and related products. The draft includes measures such as standardized packaging for tobacco products, restrictions on nicotine pouches, specific regulations for nicotine-free e-cigarettes, and limitations on the use of additives in all tobacco products.

 

The Ministry of Health indicated that this measure is part of the "2024-2027 Comprehensive Smoking Prevention and Control Plan", focusing on product content, quality and safety standards, as well as packaging requirements.

 

Minister of Health Monica Garcia emphasized that: "One of the most prominent things brought by the Royal Decree is plain packaging, which will make all cigarette packs look the same. This is not a spur-of-the-moment decision, as there is ample scientific evidence showing that additional branding inside the cigarette packs can also be harmful."

 

The draft bill has made a series of amendments to the existing Royal Decree No. 579/2017. These amendments require that both cigarettes and loose tobacco must use standardized packaging, removing design elements and colors that may attract consumers. For nicotine-free e-cigarettes, it is stipulated that ingredients, health warnings (such as "consumption of this product is harmful to health"), and relevant instructions for use and storage must be clearly labelled.

 

At the same time, the draft restricts the use of flavorings in e-cigarettes, only allowing tobacco flavor to be used. Additionally, two new product categories are introduced: nicotine pouches and heated herbal products, with safety, labeling, and sales requirements set for them.

 

According to transitional arrangements, manufacturers have ten months to adapt to new labeling, packaging, and production standards, while businesses have twelve months to sell existing inventory.

 

On the other hand, the minister stated that they are continuing to make progress in expanding smoke-free areas.

 

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

Canada Health Minister Says She Is Not Considering Looser Nicotine Pouch Retail Rules as PMI-Linked Group Pushes for Wider Access
Canada Health Minister Says She Is Not Considering Looser Nicotine Pouch Retail Rules as PMI-Linked Group Pushes for Wider Access
Canadian Health Minister Marjorie Michel says she is not considering loosening retail restrictions on nicotine pouches. Canada regulates pouches containing 4 mg or less of nicotine per unit as non-prescription nicotine replacement therapy and requires newer NRT formats such as pouches to be sold from behind pharmacy counters. Meanwhile, Unsmoke Canada, linked to Philip Morris International's Canadian business, is pushing to allow pouches in convenience stores and other general retail outlets. Health Canada also acknowledges continued unauthorized sales, while recent research shows rising pouch use among Canadian youth aged 16 to 19.
Sep.24
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
Acme Vape Ltd, the company behind UK vaping brand IVG, has received HM Revenue & Customs approval to operate an excise warehouse for vaping products and participate in the Vaping Duty Stamps Scheme. The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Acme Vape Ltd says its approved warehouse in Preston will become operational under the new regime on the same date.
Regulations
Sep.18 by 2Firsts Perspectives
Product | KIWI Launches Spark 2 and Spark 2 Pro in Germany, Two Hardware Tiers Share Backward-Compatible 2ml Pods
Product | KIWI Launches Spark 2 and Spark 2 Pro in Germany, Two Hardware Tiers Share Backward-Compatible 2ml Pods
KIWI has launched the Spark 2 and Spark 2 Pro refillable pod systems in Germany at official prices of €18 and €29, respectively. Spark 2 uses an 800mAh removable lithium-ion battery in a pen-style body, while Spark 2 Pro features a 1,400mAh removable battery, a box-shaped design and vibration feedback every 20 puffs. Both devices use the same 2ml Spark V2 pods in 0.8Ω and 1.2Ω versions, with AirSync airflow adjustment and a choice between Cotton Tips and conventional Drip Tips. The new pods also remain compatible with the original KIWI Spark.
News
Sep.29 by 2Firsts Perspectives
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Mesa Underwriters Specialty Insurance Company has asked a federal court in Washington to declare that it has no duty to defend or indemnify vape distributor i5 Distribution in a product liability case involving an Elf Bar BC5000. The plaintiff alleges that the disposable vape caught fire and exploded in his pocket, causing severe burns and ultimately requiring an above-the-knee amputation of his left leg. MUSIC is relying on a tobacco, nicotine or nicotine replacement products exclusion and a premises limitation endorsement. The court has not ruled on the coverage dispute.
News
Sep.10
Wall Street Journal: U.S. FDA Plans Faster Vape and Nicotine Pouch Reviews, Revisit of 2021 PMTA Rule
Wall Street Journal: U.S. FDA Plans Faster Vape and Nicotine Pouch Reviews, Revisit of 2021 PMTA Rule
The Trump administration is preparing changes intended to accelerate FDA market authorization reviews for e-cigarettes and nicotine pouches, according to The Wall Street Journal. The FDA is expected to revisit its 2021 PMTA rule and may simplify some scientific study requirements and shorten review times. The agency has not formally announced the changes. Over the past year, the FDA has already accelerated nicotine-pouch reviews, expanded ENDS authorizations and upgraded its CTP Portal NextGen application system. As of August 2026, 43 nicotine pouch products and 48 e-cigarette products had received FDA marketing authorization.
Sep.24
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
The FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods on Aug. 28, bringing the number of authorized e-cigarette products to 48. The agency highlighted complete switching among adult smokers, with six-week switching rates reaching 28.4%–49.3% for the menthol pod. The decision comes as FDA works to speed PMTA reviews, reduce application backlogs and expand authorized e-cigarette and nicotine-pouch products while maintaining enforcement priorities for unauthorized products.
Regulations
Aug.29