4种烟草制品被FDA禁售

自2009年获得监管烟草制品的授权以来，美国食品药品管理局(FDA)首次行使这一职权，禁止销售和分销一些特殊烟草制品。

2月21日，FDA要求 Sutra Bidis Red、Sutra Bidis Menthol、Sutra Bidis Red Cone和Sutra Bidis Menthol Cone的生产商Jash International公司停止销售和分销上述产品，原因是这些产品与其他市售烟草产品并不实质等同。据FDA称，生产商不符合《烟草控制法案》的要求。

该公司没有向FDA提供审查所必需的信息资料。按照该法案，如果生产商没有向FDA提供有关新烟草制品或改良烟草制品采取适当保护公共健康措施或与市售产品实质等同的证据，FDA将禁止生产商销售这些产品。

FDA烟草产品中心主任Mitch Zeller在书面声明中指出：“企业有责任遵守该法案，就本案而言，应提供支持实质等同申请的证据。鉴于该公司未能符合法案的要求，FDA的决定意味着，无论是在什么时间生产的上述4款产品，出口或在美国跨州销售或分销均不再合法。”

FDA给予零售商30天的时间用以销售库存的4款烟草制品。FDA声称有权没收分销商库存产品，如果有关公司继续销售或分销这些产品，将可能面临强制措施。

“无烟草青少年运动”主席Matthew L. Myers在书面声明中指出，“今天的这一决定向烟草企业发出了一个强有力的信息，即FDA将严格执行该法案的关键规定，以遏制生产商销售对儿童危害性、成瘾性或吸引力更大的产品。我们赞赏FDA的行动，并希望这是阻止违法烟草产品销售行动的开始。”

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By: ALICIA AULT, Cardiology News Digital Network

For the first time since it was granted the authority to regulate tobacco in 2009, the Food and Drug Administration has used its powers to stop the sale and distribution of a particular tobacco product.

On Feb. 21, the agency ordered the manufacturer of Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone to cease sales and distribution of the products, saying that they are not substantially equivalent to other tobacco products on the market. According to the FDA, the manufacturer, Jash International, did not meet the requirements of the Tobacco Control Act.

The company did not provide the FDA the necessary information for an agency review. The law prohibits manufacturers from introducing a new or changed tobacco product unless they can prove to the FDA that it is either appropriate for the protection of public health or substantially equivalent to a marketed product.

"Companies have an obligation to comply with the law – in this case, by providing evidence to support a substantial equivalence application," Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a written statement. "Because the company failed to meet the requirement of the Tobacco Control Act, the FDA’s decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States."

The agency has given retailers 30 days to sell off remaining stocks of the four tobacco products. The FDA said it has the right to seize the existing inventory of the products at distributors and noted that companies that continue to sell and distribute them may be subject to enforcement actions.

"Today’s action sends a strong message to tobacco companies that the FDA will seriously enforce this critical provision of the law, which is aimed at preventing manufacturers from introducing products that are even more harmful, addictive or appealing to children," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a written statement.

"We commend the FDA and hope this is the first of many actions to stop the marketing and sale of tobacco products that violate the law."