Reducing the risks of e-cigarettes to smokers, encouraging the smoking-cessation potential, and restricting access by nonsmokers offer a regulatory trifecta that can be implemented immediately, according to a former FDA official.
The "roadmap" to effective regulation hinges on implementation of the pending FDA deeming rule, which is expected to go into effect later this year. Regulation could begin almost immediately without the need for additional research, Eric Lindblom, JD, of Georgetown University Law Center in Washington, argues in the March issue of Food and Drug Law Journal.
"The minute [the deeming rule] comes out, the FDA has a terrific opportunity to immediately start regulating e-cigarettes," Lindblom, former director of the policy office at the FDA's Center for Tobacco Control, told MedPage Today.
"Right now, it's sort of like the Wild West, as has been often said about e-cigarette regulation in the U.S.," he added. "There really isn't any right now.
"Some in the industry think that any regulation at all is bad, but I think some thoughtful regulation could get rid of the bad actors and minimize the risks and potential harms and actual harms from e-cigarette use. At the same time, they can realize their potential to help people quit or as a less harmful alternative for smokers. Let's let them do that, but let's do it in a careful, regulated way that doesn't cause any unnecessary harms."
By itself, the deeming rule will not reduce the potential harms or maximize potential benefits, he added. Implementation of the rule will extend the FDA's regulatory reach to a wide range of tobacco products, including e-cigarettes and hookah or water-pipe tobacco. Whether the agency chooses to exercise its regulatory authority without additional studies remains to be seen.
The debate over e-cigarette regulation has gained momentum as the popularity and sales of the the various devices and products have taken off. In his article, Lindblom notes that public health officials remain divided over the form that regulation should take.
Supporters of a "soft approach" want to ensure that regulation does not become an obstacle to e-cigarettes' potential to help smokers quit or switch to potentially less harmful alternatives to conventional cigarettes. The "hard approach" camp emphasizes that nicotine -- in any form -- remains addictive and poses substantial harms as compared with no smoking. They also have expressed concern that smokers may use e-cigarettes or other alternatives to augment their smoking habits without giving up conventional cigarettes.
Regulatory examples around the world run the gamut from absolute bans on e-cigarettes to limited control. Lindblom argues that a "thoughtful middle-ground approach" is needed to minimize the risks and maximize the potential benefits of e-cigarettes and other alternatives to conventional tobacco products.
In outlining his three-pronged approach to regulation, Lindblom asserts that "we already know enough about e-cigarettes to regulate them more effectively." A common element of discussions about regulating e-cigarettes and related products is the need for more information and research to resolve lingering unknowns about the effects of e-cigarette use and marketing on harms and patterns of use and to interpret existing data.
"While clearer, more complete answers to these questions would be interesting and informative, they are not necessary for determining the most effective way to structure the regulation of e-cigarettes and their marketing," Lindblom said in the article. "Nor do these kinds of questions need to be answered before effective new e-cigarette regulations are drafted and implemented."
Basic principles for moving forward expeditiously have already emerged.
- Irrespective of arguments about the relative safety of various e-cigarette products, e-cigarettes are less harmful than conventional cigarettes
- E-cigarettes can be made less harmful and risky
- E-cigarettes pose more risk to users and exposed nonusers than total abstention from tobacco use
Armed with those principles, the FDA has the justification to begin implementing regulations right away.
Lindblom goes into considerable detail to explain how his proposed model might work (making e-cigarettes safer, increasing their use as a smoking-cessation aid or smoking substitute, and minimizing e-cigarette use among all other persons).
To make e-cigarettes safer, regulatory authorities could mandate child-proof packaging, prohibit introduction or generation of potentially harmful contaminants in nicotine-containing products, and limit the voltage and temperature specs of e-cigarette devices (associated with generation of and exposure to formaldehyde).
Implementation of the other two components of the model is more complicated because both involve regulation of advertising, Lindblom acknowledges. Nonetheless, he makes a case for carefully crafted regulations that achieve the goals of increasing appropriate use of e-cigarettes by smokers and minimizing use and exposure to everyone else without trampling on First Amendment protections that pertain to advertising and promotion.
"Established procedures in the Tobacco Control Act reduce those constraints [on advertising] in this context, providing the FDA with a tremendous opportunity to place the kinds of careful restrictions and requirements on e-cigarette advertising necessary to minimize their harmful aspects and maximize their potential to produce substantial net public health gains," he wrote.
Without ruling out strong pushback from industry, Lindblom said "the kinds of restrictions and regulations I talk about in my paper should be very easy for the companies to comply with, unless they're sort of bottom-dwellers who are trying to play fast and loose with the rules."
"It is to their advantage, to some extent, because it gives them extra leeway to try to market specifically to smokers to get them to switch to e-cigarettes," he added. "That will be constrained as soon as deeming goes into effect."
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