Many observers assume the FDA will deem little cigars to be within its jurisdictional purview once the so-called “deeming regulations” are issued. Given the physical similarity to cigarettes, one would also assume that the FDA will require reporting of harmful and potentially harmful constituents (HPHCs) on the products.
The analytical methods for conducting this type of testing on little cigars are very similar to cigarettes and manufacturers can expect very similar pricing from laboratories. Since its March 2012 DRAFT Guidance for Industry, the FDA has not issued any further requirements for HPHC testing, including extending reporting to the complete HPHC list or adding an annual, biannual or other frequency to the reporting requirement.
The FDA’s long silence has resulted in no additional laboratory capacity being added and perhaps even some contraction in the industry, meaning that FDA should allow for additional time to complete the analytical work for additional product categories. However, impacted manufacturers would be wise to develop contingency plans. Please contact us for details.