FDA announces first decisions on new tobacco products through the substantial equivalence pathway
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the U.S. Food and Drug Administration the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence (SE) pathway.
Under the law, one way manufacturers can legally sell a new tobacco product is to establish that their product is substantially equivalent to a valid predicate product already on the market. The FDA works to ensure that any new tobacco product authorized through the substantial equivalence pathway will not present more harm to public health than the product with which it was compared.
“Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”
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