The U.S. Food and Drug Administration issued a draft guidance Thursday on its enforcement policy for tobacco products, saying retailers have 30 days to sell off products that are not similar to FDA-approved products.

Retailers may receive a letter to stop selling not substantially equivalent, or NSE, products, meaning the products are not similar to already legally marketed products, therefore retailers can't sell those products until they are cleared by the FDA.

“When final, this new draft guidance will explain to regulated industry, including manufacturers and retailers, the FDA's current thinking regarding its enforcement policy for certain marketed tobacco products for which the agency issues an order finding the product doesn't meet the public health standards under the law,” FDA Commissioner Scott Gottlieb said in the press release announcing the proposed rule.

In 2009, the Tobacco Control Act was passed and gave the FDA authority over regulating tobacco products. Products including cigarettes, smokeless tobacco and roll-your-own tobacco products that were in the market before 2007 were grandfathered in and did not need to be approved by the FDA to be sold. Newer products in the marketplace needed to be approved by the FDA.

One of the ways companies could keep certain products on their shelves was to show that a new product was the same as a predicate product or show that it was substantially equivalent. The FDA allowed for companies to submit provisional applications up until March 2011 to let them continue selling their products.

Azim Chowdhury, a partner at Keller and Heckman in Washington, D.C., said he expects the FDA will be issuing several approvals of NSE products from the provisional applications once the guidance becomes finalized.

“As someone who has clients who have submitted provisional applications, I think the FDA is very soon going to start issuing a whole bunch of approvals and NSEs,” Chowdhury explained.

Stacy Ehrlich, a partner at Kleinfeld Kaplan & Becker in Washington, D.C., said the draft guidance is the FDA's way of letting retailers know they have time.

“I think retailers were nervous,” Ehrlich said. “Now they know the FDA won't take action on the date the notice is posted to the FDA's website. They can still sell through for 30 days.”

Ehrlich said that while people can comment on the draft guidance, she's not sure if that 30-day window will be extended.

“They might file comments arguing that it's not long enough, but the FDA doesn't have to allow anytime,” Ehrlich explained. “They don't have to allow any.”

The FDA is seeking comments on the guidance and will issue a final guidance once all comments have been collected.

“We understand that such a change in the marketing status for a product may require companies to take a series of steps to implement its complete market withdrawal, and the process could take time to fully implement,” Gottlieb said in the press release. “With that in mind, the agency's new policy would include a revised short sell-off period for retailers before the FDA intends to take action to ensure the products are no longer being sold.”