FDA Announces Decisions on New Tobacco Products


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For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA 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 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.

“[This] 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, MD. “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.”

Once a company receives an SE Marketing Order for a product, it means only that the FDA has found that the new tobacco product is substantially equivalent to a predicate product and in compliance with the requirements of the Federal Food, Drug & Cosmetic Act (FD&C Act). An SE Marketing Order is not a finding that the product it is safe or safer than its predicate product, or less harmful in general. In addition the law makes clear that companies cannot say their products are FDA approved. ■



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