FDA’s First-Ever NSE Orders for Marketed Tobacco Products

By: Ann Simoneau, J.D.

Ensuring compliance with the law is critical to FDA’s mission to protect public health. As part of that mission, FDA is committed to making sure that all tobacco products that are sold and distributed to the public meet the requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Ann SimoneauIn support of this commitment, we recently announced that four tobacco products now on the market – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone – do not meet the criteria in the law to remain on the market. These products entered the market during a grace period set up in the Tobacco Control Act. However, after a thorough review of the submitted applications, FDA determined that Jash International, the manufacturer of the four new products, did not provide sufficient evidence to demonstrate that they are “substantially equivalent” to eligible products that were previously marketed (otherwise known as predicate products). Specifically, the company did not identify eligible predicate tobacco products and was unresponsive to multiple requests for information that was necessary for FDA to determine whether the new products raised different questions of public health. This marks the first time that we have used our authority under the Tobacco Control Act to stop the continued sale and distribution of currently marketed tobacco products because they were not found “substantially equivalent” – and it is not an action we take lightly.

New tobacco products that FDA determines to be “Not Substantially Equivalent” (NSE) to predicate products can no longer be legally imported, sold, or distributed in interstate commerce, and failure to comply may result in FDA initiating enforcement action—such as seizures or injunctions – without further notice.

We have released a draft guidance document that explains the enforcement policy the agency intends to follow with respect to tobacco products that entered the market during the grace period and later receive NSE orders. The draft guidance is available for public comment and details our current thinking on this topic, including:

  • Products determined to be NSE cannot be sold or distributed in interstate commerce and may be subject to seizure at any time;
  • Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by FDA;
  • FDA does not intend to take enforcement action at the retail level for 30 days after an NSE order is issued, understanding that retailers may have existing inventories of NSE products in specific retail locations as of today; and
  • Retailers are encouraged to contact their supplier or manufacturer to discuss possible options for the NSE products in their current inventory.

We have also developed a new webpage, entitled Misbranded and Adulterated NSE Tobacco Products, to inform the public and companies in the distribution chain about products that have been on the market but are now considered misbranded and adulterated due to the failure of the manufacturer to satisfy the requirements for an SE marketing order. The webpage will be updated whenever any currently marketed products receive an NSE order.

Today’s announcement is an important step for the FDA as we continue to review new product applications, make science-based decisions, and take enforcement actions to ensure the protection of the nation’s public health.

Ann Simoneau is the Director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products

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