Uzbekistan’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Updating and Revising Draft Guidance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 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.
Read moreAs of October 1, 2015, new legislation in England and Wales makes it illegal to smoke in a vehicle carrying someone under the age of 18. The law also requires drivers to prevent smoking in these circumstances, with both offenses carrying a £50 fine. This landmark change aims to protect children and young people from the harmful effects of secondhand smoke, which can lead to serious health conditions such as meningitis, cancer, bronchitis, pneumonia, and exacerbated asthma.
Read moreThe South African Bureau of Standards (SABS) has officially published its long-anticipated standard for vaping products, marking a significant milestone for both manufacturers and consumers. Asanda Gcoyi, CEO of the Vapour Products Association of South Africa (VPASA), emphasizes that this move will elevate consumer safety within the vaping industry.
Read moreBrazil, the largest country in South America, has taken a firm stance on the vaping issue, implementing some of the strictest laws and regulations concerning e-cigarettes and vaping devices. This article aims to provide a comprehensive overview of Brazil’s vaping landscape, exploring the current legal framework, recent developments, and the ongoing public health debate surrounding these products.
Read moreChild health and rights experts in Thailand have sounded the alarm on the dangers of vaping at home, particularly in the presence of children. They warn that exposing children to second-hand vapor could be considered a violation of child protection laws, with Thai authorities even suggesting that vaping around children might constitute domestic violence under national legislation. Read more
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