For the first time, the FDA has authorized the marketing of a new tobacco product via its substantial equivalence (SE) pathway, opening the door for Lorillard (LO.DL) to begin selling its new Newport Non-Menthol Gold Box and Gold Box 100 products, the company announced this week.
The new non-menthol alternatives have been deemed "substantially equivalent to tobacco products previously commercially marketed in interstate commerce in the U.S." by the FDA, according to the company. Following the FDA's decision, Lorillard said it would begin marketing its second non-menthol cigarette brand to smokers "in the near future." Newport menthol, Lorillard's flagship brand, is currently the second-largest cigarette brand in the industry, according to the company.
Commenting on the FDA's decision, Lorillard CEO Murray Kessler said, "We are proud to be the first company in the industry to receive authorization to begin marketing these new products in the U.S. through theFDA's substantial equivalence pathway."
The FDA was given the authority to monitor and regulate domestic tobacco products in 2009 as part of the Family Smoking Prevention and Tobacco Control Act. The FDA said in a statement this week that it had authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway.
According to the FDA, "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."
