Approval granted for 14 heated tobacco products
In a significant move to regulate the sale of heated tobacco products, the Taiwanese government has amended the Tobacco Hazards Prevention Act in 2023, setting forth stringent conditions for their conditional approval.
The products must undergo rigorous health risk assessments, including evaluations of toxicology, clinical pharmacology, addiction potential, and overall public health impact. The assessments are aimed at ensuring that these products are as safe as possible for consumers.
Companies seeking approval must meet packaging and labeling standards similar to those for traditional tobacco products. Misleading claims, such as "safer than cigarettes," are explicitly forbidden.
Sales are subject to strict age restrictions, prohibiting sales to anyone under 20 years old, and must protect vulnerable groups such as youths and pregnant women.
Vendors must establish systems for monitoring and reporting, including contracting independent third parties to conduct ongoing research. Statistically relevant data submitted regularly to health authorities will help track the impact of these products on public health.
Companies must implement adverse event reporting mechanisms and notify authorities about any new findings on product addictiveness or safety.
Any changes in product composition or design require a full re-evaluation before continuing sales. The approval is explicitly conditional and not a free pass; failure to comply with these requirements can result in revocation of the approval.
Imports and personal possession remain tightly controlled; individuals cannot legally import products, and customs enforce seizure rules on unapproved items.
This conditional approval system allows the legal sale of heated tobacco products only after manufacturers and distributors satisfy these stringent requirements and undergo final packaging and regulatory review processes.
Heated tobacco products seized before March 22, 2023, may be reclaimed within three months of approval, while unclaimed items could be destroyed. Distributors must receive official notice and implement changes to labeling and packaging for the products to be considered legal.
Two tobacco companies were among seven that applied for inspections, demonstrating a commitment to comply with the new regulations. The conditional approval system aims to strike a balance between regulating these products and providing a legal avenue for their sale, ensuring consumer safety and public health.
In line with the new regulations, companies advocating for 'science-based' evaluation and development of 'health-and-wellness'-focused 'therapies-and-treatments' for heated tobacco products must adhere to stringent conditions. These stringent conditions involve rigorous health risk assessments, meeting packaging and labeling standards, complying with age restrictions, implementing adverse event reporting mechanisms, and undergoing regular data submissions to health authorities for monitoring public health.
