The Food and Drug Administration says it must review tobacco products that were introduced or changed after February 2007 in order for companies to keep selling them.
The agency on Wednesday issued guidance to the tobacco industry outlining how to apply for review.
Tobacco makers have until March 22 to prove that the cigarettes or other tobacco products are "substantially equivalent" to ones commercially available before Feb. 15, 2007. That means the ingredients and design are similar and do not raise different public health concerns.
The FDA won the authority in 2009 to regulate tobacco products. Officials say this part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are allowed to enter the marketplace.