FDA's Center for Tobacco Products' Statement on Premarket Authorization for Premium Cigars
On August 19, 2020, after a ruling from the U.S. District Court of the District of Columbia, the US Food and Drug Administration (FDA) was prohibited from enforcing the Tobacco Control Act (TCA) requirement of premarket authorization for premium cigars until a "streamlined substantial equivalence process specifically for premium cigars" was developed.
The court was concerned about the need for a more refined process specifically for premium cigars in comparison to other tobacco products. The court discussed defining "premium cigars" and outlining the key aspects of a substantially equivalent process.
In response, the FDA has stated that their premarket review requirement will not be enforced against any manufacturers of premium cigars until after September 9, 2020.
NOTE: This remains a requirement, FDA has simply put enforcement "on pause" for now.
For the purposes of this administrative update, the ruling defined a "premium cigar" as a product that meets all of the following:
Is wrapped in whole tobacco leaf;
Contains a 100 percent leaf tobacco binder;
Contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
Has no filter, nontobacco tip, or nontobacco mouthpiece;
Does not have a characterizing flavor other than tobacco;
Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and
Weighs more than 6 pounds per 1,000 units.
In a letter that was submitted to the U.S. District Court of Maryland before the D.C. District Court ruling, the FDA outlined a research plan for "premium cigars" that will result in the creation of a new premarket review system. This research plan includes exploring the health effects, patterns of use and a variety of other factors related to premium cigars.
Now that the deadline has passed you can look here for next steps if this process is relevant to your business.
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