Much attention has been given to the impact of the FDA’s proposed deeming regulations on the e-cigarette and cigar industries. But the deeming regulations almost certainly will give the FDA the authority to regulate much more — any product that is made or derived from tobacco and intended for human consumption. This includes tobacco used in a waterpipe (known as a hookah). The tobacco, known as shisha (which is usually flavored), is vaporized through the hookah pipe.
Signaling its intent to regulate this industry, the FDA recently announced its intention to host a public workshop on March 17-18, 2016 to gather scientific information about waterpipes and waterpipe tobacco. The workshop will address issues pertinent to hookahs and shisha tobacco, including presentations and panel discussions about the current state of the science, product design, smoke constituents and emissions of harmful and potentially harmful constituents (HPHCs), HPHC exposures to users and non-users, environmental impacts, prevalence and patterns of use, perceptions, addiction, and the impact of marketing these products on population health including both users and nonusers.
The FDA has invited presenters to address the following topics:
- Chemistry And Toxicology
- Engineering And Design
- Clinical Pharmacology, Dependence, And Abuse Liability
- Environmental Impacts
- Perceptions And Marketing
- Prevalence And Patterns Of Use
- Health Effects Of Waterpipe Smoking
While it is almost certain that the FDA will regulate the shisha tobacco that is used in a waterpipe, it is less clear whether the FDA will attempt to regulate the pipes themselves. It does not appear that the FDA has this authority. As noted above, the FDA’s authority is limited to products that are made or derived from tobacco and the pipe itself does not contain tobacco.
For more information about the workshop, click here.
Please feel free to contact us if you are interested in more information about the FDA’s deeming regulations will impact this industry.