FDA Tobacco Product Review Applications: What You Need to Know

In 2009, the Family Smoking Prevention and Tobacco Control Act authorized the U.S. Food and Drug Administration (FDA) to regulate cigarettes, smokeless tobacco and roll-your-own (RYO) tobacco products. This federal law required cigarettes, smokeless and RYO tobacco first introduced into the marketplace or modified after Feb. 15, 2007, to receive marketing authorization from the FDA prior to being offered for sale. This same marketing authorization requirement was later extended by the FDA to cigars, pipe tobaccos, electronic cigarettes, vapor products, hookah products and alternative nicotine products—referred to as “deemed” products—and made effective Aug. 8, 2016.

In the coming months, the FDA will be requiring manufacturers of deemed tobacco products (that is, all products other than cigarettes, smokeless tobacco and RYO) to file marketing authorization requests by Sept. 9, 2020, or be subject to FDA enforcement. Note that the original filing deadline was May 12, 2020, but the FDA obtained court permission to extend the deadline by 120 days due to the impact of the Coronavirus.

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