FDA Deeming Regulation

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FDA Issues New Rule on Tobacco Products

On May 5, 2016, the United States Food and Drug Administration (FDA) finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco, among others. The rule requires manufacturers to show that their products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of February 15, 2007. Following an August 2017 extension from the FDA, product manufacturers have until August 2021 (combustible tobacco products) and August 2022 (noncombustible tobacco products) to comply with the rule. Learn more about the compliance deadline extension.

The rule also focuses on preventing the sale of products like e-cigarettes, hookah tobacco, or cigars to people under age 18. Those portions of the rule focusing on youth tobacco access went into effect on August 8, 2016.

Advertising or flavoring restrictions for other tobacco products are not included in the new rule.

Learn more about the ruling: