FDA 允许 Zyn 尼古丁袋标注“危害低于香烟”
FDA Allows Label Saying Zyn Nicotine Pouches Less Harmful Than Cigarettes

原始链接: https://www.zerohedge.com/medical/fda-allows-label-saying-zyn-nicotine-pouches-less-harmful-cigarettes

美国食品药品监督管理局(FDA)已授权菲利普莫里斯国际公司(Philip Morris International)将其 Zyn 尼古丁袋作为卷烟的低风险替代品进行销售。经过广泛的科学审查,该机构认定该产品所含的有害化学物质较少,并允许其在包装上注明:改用 Zyn 可降低患严重疾病的风险,包括肺癌、口腔癌、心脏病、中风、肺气肿和慢性支气管炎。 FDA 强调,此项决定旨在为成年吸烟者提供准确且基于科学的信息,以帮助他们做出明智的健康选择。尽管菲利普莫里斯首席执行官斯泰西·肯尼迪(Stacey Kennedy)称赞该授权是一种透明的风险沟通方式,但此举也遭到了“无烟草儿童运动”(Campaign for Tobacco-Free Kids)等团体的反对,他们质疑该产品是否具有明确的公共健康益处。 为确保公共安全,这项为期五年的授权包含对消费者行为进行持续监测和研究的严格要求。如果 FDA 认定以这些宣称进行营销会导致负面的公共健康结果,特别是在青少年使用率增加方面,该机构保留撤销此项批准的权力。

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原文

Authored by Zachary Stieber via The Epoch Times,

The Food and Drug Administration is letting Philip Morris International market its Zyn nicotine pouches as being safer than cigarettes.

Zyn nicotine cases and pouches on a table in New York City on Jan. 29, 2024. Michael M. Santiago/Getty Images

The FDA said on June 30 that the pouches can now feature the statement, "Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."

The authorization of the modified risk statement followed an extensive scientific review, regulators said.

That process concluded that Philip Morris subsidiary Swedish Match demonstrated the claim was scientifically accurate, that consumers understand the claim, and that marketing the products with the claim would benefit the population.

"FDA's review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices," Bret Koplow, acting director of the FDA's Center for Tobacco Products, said in a statement.

"Today's decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products."

The FDA initially cleared Zyn pouches in 2025. Officials at the time said that the benefits to adult cigarette smokers outweighed the risks to adults and youth, based in part on the finding that the pouches contain fewer harmful chemicals than cigarettes.

An FDA advisory panel in January said the proposed statement was likely accurate.

The Campaign for Tobacco Free Kids opposed the proposal at the time. The nonprofit said that Swedish Match did not meet the standard for authorization, in part because there was no demonstrated benefit.

The authorization of the new claim includes the requirement that the pouch manufacturer carry out studies and surveillance, including assessing how people interact with the updated products and understand the updated risk-related information.

The authorization lasts for five years and can be extended.

If the FDA determines that the marketing under the adjusted statement no longer benefits the population, such as a scenario that involved a spike in uptake among young people, the agency may withdraw the authorization, officials said.

Philip Morris CEO Stacey Kennedy hailed the development. Kennedy said in a statement it "ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to Zyn reduces the risk of smoking-related diseases like heart disease and lung cancer."

"More broadly, it reinforces the agency's science-based approach to evaluating products across the continuum of risk and communicating those findings transparently," she said.

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