FDA’s Pathways To Market: Cigars Have Few Channels For Product Approval

Last month, the U.S. Food and Drug Administration expanded its authority over tobacco products and issued new regulations that affect how a cigar company can sell its premium or machine-made cigars. As part of the new rules, cigarmakers must seek approval from the FDA in order to launch a new cigar or continue selling a cigar that’s currently on the market. The FDA offers three pathways to product approval: Substantial Equivalence, Exemption from Substantial Equivalence (SE) and a Premarket Tobacco Application (PMTA). The approval process will require cigar companies to submit costly and time-consuming health and information reports to the FDA. Many cigar companies are looking at an initial reporting cost of more than $22,000 for a single SKU.

However, not all cigars will be forced to undergo such rigorous evaluation. Cigars that were on the market on February 15, 2007 are exempt from the FDA’s premarket reporting requirements. Still, companies with grandfathered cigars will have to submit information to the FDA proving the age and longevity of their products. A cigar that was introduced to market before February 15, 2007 but then lapsed in commercial availability must have returned to market by that date in order for it to be grandfathered. Cigarmakers may use dated receipts, advertisements and invoices to prove a cigar’s age statement.

Read more here -> http://www.cigaraficionado.com/webfeatures/show/id/fda-pathways-to-market-cigars-have-few-channels-for-product-approval-18874

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