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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."
On Twitter @aliciaault
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."
On Twitter @aliciaault
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."
On Twitter @aliciaault
