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Jun 27

FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products

On June 25, 2013, the U.S. Food and Drug Administration (FDA) issued substantially equivalent (SE) marketing orders for two new tobacco products marketed by Lorillard Tobacco Company, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. This is the first time that the FDA has approved the marketing of new tobacco products since the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products in 2009. The announcement is provided at this link, and you can read the marketing orders for the new tobacco products here and here.

Pursuant to section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the FSPTCA, a manufacturer who wants to marketnew tobacco products must receive a written marketing order from the FDA under one of three pathways: premarket tobacco application, substantial equivalence, or an exemption from substantial equivalence. In particular, to receive an SE marketing order, the new product must be in compliance with FDCA requirements and either have the same characteristic as a predicate product that is already marketed in interstate commerce or have different characteristics but not raise different questions of public health.

In this case, the FDA determined that the new tobacco products were substantially equivalent because although they had different characteristics than the predicate products, they did not raise different questions of public health. A marketing order does not mean, however, that the new product is safe or approved by the FDA and the tobacco companies are not allowed to say that their products are FDA approved.

To be eligible to obtain an SE marketing order, the manufacturer must submit a substantial equivalence report under FDCA section 905(j). More information about the requirements for tobacco marketing orders can be found here. If you have any questions about marketing a new tobacco product or complying with FDA regulations, please contact us at: contact@giannamore-law.com.

FDA Attorney  150x150 FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products

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