The Department of Trade and Industry (DTI) has begun implementing regulations on Vaporized Nicotine and Non-Nicotine Products, as well as Heated Tobacco Products (HTPs), in line with DAO No. 22-06 (2022) and DAO No. 24-02 (2024). The DTI mandates businesses to obtain a valid Philippine Standard (PS) License for all covered products by December 31, 2024.
Read moreConstitutional Reforms Prohibit E-Cigarettes, Vaping Devices, and Illicit Fentanyl Use
The Permanent Commission of the Congress of the Union, in its session on Wednesday, declared the addition of a fifth paragraph to Article 4 and a second paragraph to Article 5 of the Political Constitution, which prohibit electronic cigarettes, vaping devices, and the illicit use of fentanyl.
Read moreBelarus plans to introduce tougher regulations for the smoking and vaping industry, as outlined in a new draft law on the regulation of the tobacco market and nicotine-containing products. The proposed legislation, currently open for public discussion, also seeks to ban smoking on the doorsteps of multi-story buildings and nearby areas.
Read moreUzbekistan’s impending ban on the circulation of electronic cigarettes will encompass vapes but not heated tobacco products, according to Health Minister Asilbek Khudayarov. The minister made this clarification during a session of the Legislative Chamber of the Oliy Majlis on January 7.
Read moreThe U.S. Food and Drug Administration (FDA) has issued a final guidance titled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides tobacco manufacturers with information and recommendations to support their tobacco product application submissions, including premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, and modified risk tobacco product (MRTP) applications.
The guidance outlines how manufacturers can provide the FDA with validated and verified data for the analytical procedures and test methods used in their application submissions. This information is crucial for companies seeking to legally market new tobacco products or modified risk tobacco products in the United States, as they must first submit an application to and receive authorization from the FDA.
Updating and Revising Draft Guidance
The FDA previously issued a draft version of this guidance in 2021, allowing the public to comment on its content. The agency considered these comments and made several changes in the final guidance, including:
- Updating the definition of “tobacco product” to include non-tobacco nicotine
- Revising the document to reflect provisions from the final PMTA and SE rules
- Updating and adding definitions for several terms
- Including updated examples for alternative validation approaches
The recommendations in the guidance are non-binding and do not establish legally enforceable responsibilities. The FDA acknowledges that there may be alternative validation procedures that differ from those outlined in the guidance, such as different statistical tests.
Commitment to Providing Resources
For applicants seeking to market new tobacco products, the FDA remains committed to providing information and resources, including this latest guidance. The agency has issued final regulations, such as the PMTA final rule, and regularly posts additional resources, such as application tips and webinars, on its website and social media channels.
As the vaping industry continues to evolve and navigate the regulatory landscape, it is essential for manufacturers to stay informed about the latest guidance and requirements from the FDA. By following the recommendations outlined in this guidance, manufacturers can ensure that their tobacco product applications contain scientifically valid information, increasing the likelihood of a successful submission.
Department Administrative Order No. 24-11 Updates Testing and Certification Process
The Office for the Special Mandate on Vaporized Nicotine and Non-Nicotine Products (OSMV) under the Department of Trade and Industry (DTI) of the Philippines issued Supplemental Technical Regulations Department Administrative Order No. 24-11 on January 2, 2025. This order aims to regulate the mandatory product certification of e-cigarettes and non-nicotine products.
Read moreThe New Zealand government has implemented significant changes to the Smokefree Environments and Regulated Products 1990 Act, aiming to better protect children and young people from the potential harms of vaping. These amendments introduce stricter regulations on advertising, retail display, penalties for selling to minors, and a ban on disposable vaping devices. The new measures come into force in two stages, with some taking effect immediately and others after a six-month grace period to allow retailers to adapt to the new requirements.
Read moreA recent study published in the journal BMC Medicine1 by researchers at University College London sheds light on the growing trend of vaping among ex-smokers in England over the past decade. The study, which analyzed data from 2013 to 2024, found a significant increase in vaping prevalence, particularly among younger adults. This rise coincides with the growing popularity of disposable e-cigarettes and shifting social trends.
Read morePresident Sadyr Japarov of the Kyrgyz Republic has signed a law amending several legislative acts to safeguard citizens’ health from the consequences of using electronic cigarettes with nicotine-containing liquids. The Jogorku Kenesh, the Kyrgyz Parliament, adopted the law on October 23, 2024.
Read moreIndonesia, long recognized as one of the world’s largest tobacco markets with a deep-rooted smoking culture, has recently passed a sweeping new law aimed at curbing the consumption of tobacco products and reducing smoking-related health risks. The law introduces stringent restrictions on the sale, marketing, and packaging of both traditional cigarettes and e-cigarettes, marking a significant shift in the country’s approach to tobacco regulation.
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