Released in 2009, the Family Smoking Prevention and Tobacco Control (FSP&TC) Act gave the U.S. Food and Drug Administration (FDA) under the Centre for Tobacco Products (CTP), the authority to regulate the manufacture, distribution, and marketing of cigarettes, roll-your-own and smokeless tobacco.

On 10 May 2016, the FDA published its final “Deeming Rule” which brought additional tobacco products, including waterpipe tobacco, under the jurisdiction of the FDA. The “Deeming Rule” subjects waterpipe tobacco products to the existing Food, Drug and Cosmetics Act (FD&CA) requirements, including the provision of data regarding the relative quantities of HPHCs under sections 904(a)(3), 905(j), and 910.

In the absence of validated and standardised methods, the analysis of HPHCs in waterpipe aerosol would be of limited value, since the data will be inconsistent and therefore unsuitable for product comparison purposes, as required under FD&CA sections 905(j) and 910.

The present study focused on the determination of the relative quantities of selected HPHCs in waterpipe tobacco from a range of products commercially available in the United States of America.

Whilst the determination of certain HPHC constituent levels in waterpipe tobacco (e.g. heavy metals, nitrosamines, and polycyclic aromatic hydrocarbons [PAHs]) remains a challenge when levels are consistently below the Limit of Quantification (LOQ) of the analytical technique, tobacco analysis may represent a more robust approach when compared to aerosol analysis, in meeting the requirements of FD&CA where product comparisons have been mandated.