The Food and Drug Administration has denied the ability of manufacturers to market or sell four new tobacco products because the products did not meet their requirements for “substantial equivalency.”
The agency does not release details on the manufacturers or products that fail to qualify.
The Family Smoking Prevention and Tobacco Control Act of 2009 authorized the FDA to regulate the marketing and sale of tobacco products. Under the substantial equivalency pathway, the FDA has the right to deny the marketing of tobacco products that are not that aren’t similar to existing, approved products or that raise new public health concerns.
The announcement is the second since June 25, when the FDA denied substantial equivalency status to four other tobacco products. They cited “a lack of evidence to support that the addition of specific ingredients did not raise different questions of public health, a lack of information about the design of the product, and incomplete test data.”
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