FDA Issues Final Small Entity Compliance Guide for Certain Tobacco Products

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FDA Issues Final Small Entity Compliance Guide for Certain Tobacco Products

The U.S. Food and Drug Administration (FDA) has updated its Small Entity Compliance Guide to reflect the recent court cases that impact the deeming rule as it applies to premium cigars and pipe tobacco.

The Deeming Rule, which went into effect on Aug. 8, 2016, granted the FDA the power and authority to regulate “deemed” tobacco products, including premium cigars, pipe tobacco and e-cigarettes. Any product that was not on the market as of that date was considered to be new and manufacturers of those products were expected to submit applications to the FDA to gain authorization to sell and market their products in the U.S. As part of this compliance, manufacturers of deemed products had to submit of premarket tobacco application (PMTA) to the FDA by Sept. 9, 2020–with the exception of premium cigars, who gained extra time following a decision made by the U.S. District Court of the District of Columbia on Aug. 19, 2020 [read more here]. This court decision would allow the FDA additional time develop a streamlined process for these products to gain FDA approval.

The updated compliance guide also addresses FDA-warning labels that were originally required for cigar products. A U.S. Court of Appeals decision issued in July struck down this requirement for cigars [read more here], a win for the industry that will require the FDA to re-evaluate their original plans if they choose to push it in the future.