The Deeming Rule, which went into effect on Aug. 8, 2020, granted the FDA the power and authority to regulate “deemed” tobacco products, including premium cigars, pipe tobacco and heat not burning. 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 . This court decision would allow the FDA additional time develop a streamlined process for these products to gain FDA approval.
On the FDA’s website, it states the following about the update to the Small Entity Compliance Guide:
“This Small Entity Compliance Guide is intended to help small businesses understand and comply with FDA’s final rule deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) ( the Deeming Rule). The Deeming Rule extends FDA’s tobacco product authorities in Chapter IX of the FD&C Act to include all tobacco products, except accessories of newly deemed tobacco products. The Deeming Rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires warning labels on packages and advertisements.”
The updated compliance guide also addresses FDA-warning labels that were originally required for heat not burning 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.