DURHAM — When the U.S. Food and Drug Administration unveiled its long-awaited draft regulations for e-cigarettes last week, it quickly became clear that the proposal left several regulatory blanks to be filled in.
That generated little surprise in more than half a dozen labs and research offices around the Triangle where scientists were already hard at work developing the data that will allow the agency to do just that.
The science thats expected to eventually add muscle to the bones of the e-cigarette regulations has become nothing short of a small industry here financed by more than $80 million in grants and contracts.
Last September, the FDA announced that it would fund two Tobacco Centers of Regulatory Science at UNC-Chapel Hill with grants of up to $20 million each, spread over five years. The same month, a Durham company called SciMetrika began work on a $40 million, five-year FDA contract to perform research to support decisions on regulation, particularly of e-cigarettes and flavored tobacco products.
Other federally-sponsored research on e-cigarettes in the area includes several projects at RTI International at Research Triangle Park, valued at about $3 million.
The two university-based centers are expected to employ nearly 100 people between them, and SciMetrika officials said Monday that its contract could eventually require about 40 full-time employees. RTI, meanwhile, already has nearly 40 people at work on its e-cigarette studies.
A booming market of flavors
E-cigarettes have jumped in popularity with such speed that they caught regulators off guard. The market zoomed from $100 million in 2010 to nearly $2 billion last year.
They and a host of similar devices such as e-hookahs heat a liquid into vapor, which users then inhale. The liquid usually contains nicotine, a highly-addictive stimulant found in tobacco. It also comes in hundreds of flavors, from those that evoke tobacco to fruits and almost whimsical varieties such as custard or apple pie.
The proposed regulations which also affect other tobacco products such as traditional hookahs, pipe tobacco and cigars are so basic that some tobacco policy experts have referred to them as simply a blueprint. For example, there are no restrictions on e-cigarette flavorings, but the regulations leave the door open to them, if research shows its warranted.
Flavorings are a topic of keen interest to public health advocates, who have long warned that the flavors make tobacco products attractive to kids.
SciMetrikas research could play a central role in any future FDA restrictions on e-cigarette flavoring. The first task it has been assigned by the FDA is to bore deep into the existing research, particularly in peer-reviewed journals, about how flavoring in tobacco products is used and consumers views on it.
Flavoring is an important aspect of consumer products, and the FDA wants to understand what the marketing strategies are and how they might affect the buying habits of youth, said Mike Samuhel, a senior fellow with the company.
The companys role, Samuhel said, is to stay above the fray between pro- and anti-e-cigarette advocates, and simply provide facts for the agency to use in reaching properly-informed decisions.
The manager of the literature review project, Chris Bartlett, said that as a scientist it will be fascinating to follow the process as the regulations are refined over time. You can kind of see throughout the rule where theyre asking for specific public comments or other information, to help them inform the rule-making process that theyll eventually go through, Bartlett said. There are a couple of sections where they are asking for specific information on flavors and their role in the marketing of tobacco products, so from a scientists perspective it will be interesting to see what they may collect, and what that ultimately will inform.
UNC-CH at the forefront
At RTI International, a massive nonprofit research institute, the study topics include the effects of advertisements on the purchase of traditional and e-cigarettes as well as website e-cigarette promotion and its effects on sales. It also has a study funded from other sources on the effects of e-cigarette vapor on the lungs.
RTI spokeswoman Lisa Bistreich-Wolfe said RTI expects e-cigarettes to be a growing area of research for its scientists.
The FDA created 14 of the centers for tobacco regulatory science, and UNC-CH was the only institution in the country to win two of them.
One, based at the School of Medicine and led by Robert Tarran, an associate professor of cell biology and physiology, is studying the effects of tobacco products such as e-cigarette vapor on human lung tissue. The other, headed by Kurt Ribisl, a professor of health behavior at the Gillings School of Global Public Health, is based at the Lineberger Comprehensive Cancer Center and is looking into effective methods of communicating the risks of tobacco products especially emerging types such as e-cigarettes to consumers via sources such as warning labels and media campaigns.
Dr. Adam Goldstein, Director of the UNC School of Medicines Tobacco Prevention and Evaluation Program and its Nicotine Dependence Program, heads one of main projects in Ribisls center. Goldstein said that even with the blanks, the new regulations seem like a great start for regulating e-cigarettes and the other tobacco products that will fall under them.
It looks like they are really being comprehensive, and they are basing it on science but also that they understand this is not a simple process, Goldstein said. So, at least from a public health framework, theres a lot to like here.
The needed research on things like flavorings, he said, is clearly on the way.
There are so many people doing really good, independent research who arent industry funded, that you will get the data, he said.
One valuable aspect of even the draft form, he said, is that it would bar e-cigarette companies from making health claims about their products unless they have research to back those claims. Many people believe e-cigarettes are safer but, like the possible issues with flavorings, theres little data to support it yet.
Goldstein thinks that this note of caution in the regulations may lead health care providers to be more careful about advocating the use of e-cigarettes as an aid to stop smoking, at least until more is known.