June 27, 2014

Stanton A. Glantz, PhD

FDA Should Deem Hookah Tobacco, Hookah Device, and Hookah Charcoal as a Tobacco Product

My colleagues Gideon St.Helen, Peyton  Jacob III,  and Neal L Benowitz just submitted this comment to the FDA:
 
June 27, 2014
 
Hookah smoking is an alternative form of tobacco use traditionally associated with eastern societies, whose recent rapid spread globally and in the U.S. is a cause of public health concern 1. The spread and surge in popularity in the U.S. may be driven by the introduction of flavored tobacco preparations, reduced-harm perception, social café culture, exotic appeal, and marketing of hookah bars 2,3. Given the widespread use and accumulating scientific evidence showing significant intake of nicotine and carcinogens and some epidemiologic data showing harm, we support the FDA’s proposed deeming rule to regulate hookah tobacco and devices. However, to fully protect the public health, FDA needs to include hookah charcoal as a component of hookah devices for FDA regulation; mandate health warning labels on hookah tobacco and all components/parts; and, ban flavoring additives to hookah tobacco and flavorings on hookah charcoal and water.

Hookah use is widespread and is thought of as relatively harmless
 
In the U.S., 1.5% of the adult population smoke hookah compared to 19.5% who smoke cigarettes, but the prevalence of hookah smoking is higher among young adults aged 18–24 (7.8%) 4. The popularity of hookahs is even higher among U.S. college students, with as many as 40% reporting ever smoking hookahs and up to 20% reporting current hookah use (past 30 days) on some college campuses 5,6. Surveys also show a significant prevalence of hookah smoking among middle and high school students; hookah is the third most common source of tobacco after cigarettes and cigars among this group in Arizona 7. Other studies indicate that dual hookah and cigarette use was more prevalent than exclusive hookah use and dual users tended to be younger individuals,8 raising concerns about the addictiveness of hookah smoking among youth and young adults.

Users of hookahs perceive hookah smoking to be much less harmful than cigarette smoking, a  view shared even by non-smokers 3. It is commonly thought that the water filters out toxicants from the smoke. The idea that hookah smoking is relatively harmless is further solidified in the public consciousness by extensive exemptions to clean indoor air laws that allow hookah smoking in bars and establishments where cigarette smoking is prohibited 9.
 
Our exposure biomarker studies show significant nicotine and carcinogen intake during hookah use, and that exposure to tobacco smoke toxicants is similar qualitatively but different quantitatively from cigarette smoke, indicating that hookah smoking is not risk free.

Several studies have measured tobacco-related toxicants in hookah smoke, including polycyclic aromatic hydrocarbons (PAHs), volatile organic compounds (VOCs) such as formaldehyde, acetone, and acrolein, and carcinogenic tobacco-specific nitrosamines (TSNAs) 10-12. However, to date, we have conducted the most comprehensive studies of systemic intake of tobacco-related toxicants from hookah use (copies of these studies are attached). In the first study, involving a single use of hookahs in a hospital research ward, we measured plasma nicotine levels that were comparable to levels attained after smoking cigarettes; carbon  onoxide levels were much higher than in cigarette smokers; and we measured significant increases in urine NNAL, a breakdown product of NNK (NNK is a nicotine-derived nitrosamine and known pulmonary carcinogen), as well as breakdown products of PAHs 13.

We expanded on this study by conducting a crossover study, the most informative to date, to compare nicotine intake and carcinogen exposure from hookah and cigarette smoking. This study was also conducted in a hospital research ward. Compared to cigarette smoking, we reported lower nicotine intake, greater carbon monoxide exposure, and a different pattern of carcinogen exposure, with greater exposure to benzene and high molecular weight PAHs, and less exposure to tobacco-specific nitrosamines, 1,3-butadiene and acrolein, acrylonitrile, propylene oxide, ethylene oxide, and low molecular weight PAHs following hookah smoking  14. This study showed that exposure to tobacco smoke toxicants in hookah smoke is similar qualitatively but different quantitatively from cigarette smoke. Importantly exposure to benzene, a chemical known to cause human leukemia, and high molecular weight PAHs, a class that contains human carcinogens, were relatively higher while smoking hookah.

The third study entailed assessing nicotine intake and exposure to TSNAs and VOCs from hookah smoking in a naturalistic setting (i.e. hookah bars or lounges) as opposed to a hospital research ward. In the natural setting, hookah users share hookahs with multiple users. Again, this study showed substantial nicotine intake comparable to at least one cigarette as well as significant exposure to NNK (measured using urine NNAL) and breakdown products of carcinogenic VOCs such as benzene, 1,3-butadiene, acrylonitrile, and ethylene oxide 15. There is no risk-free level of exposure to carcinogens.

Based on exposure and limited epidemiologic data, there is significant risk of smoking related diseases in hookah users, although the magnitude of risk will depend on pattern and extent of use.
 
Our systemic intake studies and previously published studies from other research groups on tobacco toxicants in hookah smoke show that hookah smoking is not risk-free. Hookahs generate high levels of carbon monoxide, which raise concerns for carbon monoxide-induced cardiovascular toxicity and harm during pregnancy, as well as benzene. Indeed, clinical studies have shown that hookah smoking compromises cardiac autonomic function and does so independent of nicotine 16,17. Benzene is a known leukemogen.
 
Epidemiologic studies conducted outside of the U.S. show elevated cancer risks from hookah use. One case-control study conducted in Kashmir Valley, India, with high prevalence of hookah use as well as more frequent use found significant associations between hookah use and esophageal squamous cell carcinoma 18. Another case-control study in the same region found a 6-fold increase in risk of lung cancer from hookah use 19. A review on the associations between
hookah use and lung cancer reported an odds ratio of  2.12 (1.32-3.42) 20. Given differences between hookah tobacco products and devices used across countries as well as patterns of use, these studies may not be generalizable to U.S. hookah smokers but they are further evidence that hookah smoking is not risk-free. The magnitude of disease risks are dependent on the patterns and extent of hookah use.
 
Hookah tobacco should be regulated, and their evaluation should include exposure biomarker studies with usual patterns of use.
 
We support the FDA’s proposed deeming of hookah tobacco as a “tobacco product” and subjecting hookah tobacco products to the same FD&C Act provisions that cigarettes, roll-yourown tobacco, and smokeless tobacco are subject to. Further, while the composition of these products should be disclosed, FDA should also include, as part of their evaluation, human biomarker studies to assess the delivery of nicotine and toxicants from hookah tobacco with usual patterns of use. This should be done before they are introduced into the market.
 
FDA should include hookah charcoal as a component of the hookah device and regulate its sale and use.
 
While the proposed FDA deeming rule has rightly included hookah devices and flavorings used in flavored hookah charcoals as component/parts of “tobacco products”, it does not appear that the deeming rule extends to hookah charcoal. In the proposed deeming rule, the FDA defines components and parts of tobacco products as “those items that are included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco products” (FR 23153). Hookah charcoal should be included as a component of hookah devices and regulated by the FDA. Studies show that hookah charcoal combustion is the primary source of carbon monoxide and carcinogenic PAHs 21 as well as benzene exposure. Regulation must include types of hookah charcoals marketed, additives, and accelerants.

FDA should mandate health warning labels on hookah tobacco and all components/parts. In addition to health warning labels on packages of hookah tobacco, we strongly urge the FDA,

in order to protect the public through dissuasion of initiation and continued use of hookahs, to mandate health warning labels on hookah devices as well as on packages of hookah charcoal. We further urge the FDA to mandate display of health warning labels in commercial establishments where hookahs are purchased and used. Warnings labels should be clearly visible, large, and include warnings on intake of chemicals known to cause cancer as well as on the potential
addictiveness of hookah smoking.
 
FDA should prohibit all flavoring additives to hookah tobacco and flavorings used in hookah charcoal and water.
 
Our colleagues at UCSF have previously submitted an extensive comment titled “FDA Should Prohibit Flavors in all Tobacco Products in the Current Rule Making” which calls on FDA to immediately prohibit the use of flavorings in all tobacco products, including hookah tobacco, under the current rulemaking (comment ID: FDA-2014-N-0189-11558, Tracking Number: 1jy- 8chl-vs81). We fully support this call. FDA should immediately ban the use of flavoring additives to hookah tobacco, which is known to be attractive to youth and young adults. In addition, we strongly urge the FDA to prohibit the use of flavors in the hookah charcoal and
water in hookah used in commercial establishments such as hookah bars and lounges.
 
In summary, our exposure studies show significant intake of nicotine and tobacco-related carcinogens from hookah use. These studies and limited epidemiologic data show that hookah use can harm public health. Therefore, we strongly support the FDA’s proposed deeming of hookah and components/devices as ‘tobacco products’ for regulation. To fully protect the public health, FDA needs to go further and include hookah charcoal as a component of hookah devices for FDA regulation; mandate health warning labels on hookah tobacco and all components/parts, as well as in commercial establishments where hookahs are sold and used; and, ban flavoring additives to hookah tobacco and flavorings on hookah charcoal and water.
 
For references and attachements, see PDF of this comment.

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