In a March 2019 update to its guidance regarding “Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,” the FDA has extended the deadline for manufacturers of “Deemed Products” to report harmful and potentially harmful constituents (“HPHCs”) in their products. “Deemed Products” are those that were first regulated by the FDA under the Deeming Regulations, and generally include e-cigarettes and other electronic nicotine delivery systems, cigars, pipe tobacco and hookah tobacco.
The deadline for reporting HPHCs for newly-deemed products was fast approaching. In the preamble to the Deeming Regulations, the FDA had indicated that it would issue guidance (and eventually regulations) regarding HPHC reporting for newly-deemed products. However, the FDA has not issued such guidance and there is no indication when it will. Such guidance is important because the FDA has not outlined its expectations for this testing, and for certain products (such as hookah tobacco) there is a lack of standardized test methods.
The FDA’s new policy appears to be in response to complaints from the industry, which has raised the legitimate issue that manufacturers cannot be expected to test when the FDA has not outlined the information it wants or how the products should be tested. These variables can add significant time and expense to the HPHC testing process. And given the apparent lack of laboratory capacity for all of the products that must be tested, it was difficult to understand how the necessary testing could be accomplished if the FDA did not issue timely guidance.
Under the FDA’s updated guidance, the HPHC reporting deadline is now six months after the FDA’s publication of final guidance regarding HPHC reporting. For small tobacco product manufacturers, the reporting deadline is nine months after the publication of the final guidance. (Small manufacturers are those with fewer than 350 employees.) For newly-deemed products entering the market after the publication of the final guidance, manufacturers must report HPHCs to the FDA 90 days before marketing the products. (Note that this is in addition to applicable premarket review requirements.)