Could FDA e-Cigarette Regulation Ultimately Benefit Big Tobacco?
Last April, the FDA defined e-cigarettes as a “tobacco product,” in advance of its preparation to develop regulations for their sale. The FDA issue snapshot says in part:
Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements:
- Register with FDA and report product and ingredient listings.
- Only market new tobacco products after FDA review.
- Only make claims of reduced risk if FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
- Not distribute free samples.
- Minimum age and identification restrictions to prevent sales to underage youth.
- Requirements to include health warnings.
- Prohibition of vending machine sales, unless in a facility that never admits youth.
In September of last year, R.J. Reynolds, the second largest Big Tobacco company in the US, asked the FDA to ban vapor e-cigarettes, amazingly citing “unique public health risks:”
“We believe FDA should not allow such products to be sold or marketed,” Reynolds spokesman David Howard said in discussing the company’s submission. “We believe open-system vapor products create unique public health risks.
“These systems are highly subject to adulteration and tampering, they are manufactured largely overseas in facilities that would, as proposed, fall outside regulatory inspection and oversight, and many nicotine liquids are sold in non-child-resistant packaging in flavors that may be appealing to youth.”
In light of the source, this comes across as a low blow. R.J. Reynolds, who is voicing concern that vapor flavors may be inappropriately “appealing to youth” is the same company that launched the Joe Camel marketing campaign. Joe Camel is the cartoon mascot figure that more children by age six could associate with cigarettes than could associate the Disney logo with Mickey Mouse. The same company once used Fred Flintstone to market Winston cigarettes.
Big Tobacco sells a product that is unhealthy (or lethal) that depends on customers getting and staying dependent on that product. A perpetual population of young smokers who will start and stay hooked as well as long-term smokers who continue to buy cigarettes is essential to the company’s viability. Vapor e-cigarettes attract a customer base that is already smoking and either wishes to quit or wants to reduce the smell in the clothes, stop dealing with piled up ashes, or reduce other smoking-related behaviors. The vapor cigarette vendor, who is currently for the most part a small business owner, provides a product to people who are transitioning away from combustible tobacco and all of its associated unpleasantness. Presumably, age-limiting the sale of e-cigarettes will discourage young people from beginning a new nicotine habit.
The e-cigarette industry is lucrative, but at the same time, compliance with regulation is tedious and expensive. Unless there is a way to somehow initiate reasonable regulations that allows small vendors to continue doing business, small business owners cannot realistically come up with the resources to begin a business and then participate in and lobby, study and navigate the cumbersome and resource-consuming FDA structure. Big Tobacco, on the other hand, has lawyers, lobbyists, money, marketing departments, expense accounts, labs, researchers, travel and conference budgets and sales reps. R.J. Reynolds, for example, even as it is trying to stamp out e-cigs by manipulating the FDA, is already selling and marketing its own “digital vapor cigarette” called Vuse.
In an article titled,”The FDA, e-cigarettes, and the Demise of Combusted Tobacco”, The New England Journal of Medicine writes:
One might ask what harm more-addictive products might cause: surely any world where refined nicotine displaces lethal cigarettes will experience less harm, disease, and deaths? That scenario is one endgame model for tobacco control: smokers flee cigarettes en masse for refined nicotine and ultimately quit all use entirely. This vision, however, ignores Big Tobacco’s power and corporate self-interest in retaining the existing $85 billion U.S. combusted-cigarette market. Emerging companies that sell only refined-nicotine products can build smaller yet profitable businesses by appropriating customers from Big Tobacco and retaining them only until they transition to complete cessation. Tobacco companies and their investors, however, need millions of heavily addicted smokers to remain customers for decades, including a replenishing stream of young people. No publicly traded company could tolerate the downsizing implicit in shifting from long-term addiction to harm reduction and cessation. If afforded the opportunity, tobacco companies may try to avoid disruption of their business model by marketing innovations designed to sustain high levels of addiction and synergistic “polyuse” of their existing combusted products. If effective, such a strategy could severely hamper any transition to an endgame while effectively eliminating competition from NRT and independent e-cigarette makers.
The question is, should Big Tobacco be the stewards of shaping regulation of tobacco products? While e-cigarette opponents voice concern that teen use of the product is on the rise, it is unlikely that Big Tobacco is going down. Their request that the FDA ban e-cigarettes appears more like seizing an opportunity to ban the competition.
NEJM: The FDA, e-cigarettes, and the Demise of Combustible Tobacco
Seeking Swifter Action in e-Cigarette Regulation
Vintage Flintstones Winston cigarette commercial.
Creative Commons photo courtesy of A.Currell on flickr.