Commentary on Wagener et al. (2012): Laissez-faire regulation: turning back the clock on the Food and Drug Administration and public health


  • Nathan K. Cobb,

    1. The Schroeder Institute for Tobacco Research and Policy Studies, American Legacy Foundation, Washington, DC
    2. Division of Pulmonary and Critical Care, Department of Medicine, Georgetown University Medical Center, Washington, DC
    3. Department of Oncology, Georgetown University Medical Center/Lombardi Comprehensive Cancer Center, Washington, DC
    4. Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
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  • David B. Abrams

    1. The Schroeder Institute for Tobacco Research and Policy Studies, American Legacy Foundation, Washington, DC
    2. Department of Oncology, Georgetown University Medical Center/Lombardi Comprehensive Cancer Center, Washington, DC
    3. Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
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In 1906, in an effort to end the sale of unsafe and ineffective patent medicines, the US Congress passed the Food and Drug Act, bringing regulation to what had been a chaotic and dangerous laissez-faire market-place. Thirty years later mass poisonings from a diethylene glycol antibiotic solution led to the subsequent creation of the Food and Drug Administration (FDA), and a move to proactive monitoring and oversight [1]. Wagener, Siegel & Borrelli appear to be in favor of turning back the clock, disputing selected arguments behind our call for the FDA to regulate ‘e-cigarettes’ in the United States [2] and claiming that, in the meantime, ‘removing e-cigarettes from the market or discouraging their use could harm public health’ [3]. However, there is no rigorous evidence for the additive benefit of ‘e-cigarettes’ over evidence-based nicotine replacement therapy (NRT) for cessation or harm reduction, and consumers are not in a good position to evaluate unregulated drugs and devices sold alongside regulated competitors. Moreover, no addictive and potentially lethal drug such as nicotine should ever be commercially marketed without formal regulatory oversight. This debate is timely, as in the United States the 2009 passage of the Family Smoking Protection Tobacco Control Act (FSPTCA) provides a regulatory pathway for potentially reduced-harm tobacco products [4]—but only after formal scrutiny and validation.

Given that the paper refers heavily to our previously published commentary in a US medical journal, we urge readers to read our original opinions [2, 5] as well as the reviews by other authors and the World Health Organization [6, 7]. The ‘straw man’ arguments framed by the authors bear little resemblance to our central concerns driving the call for regulation of the industry. Readers not familiar with our position might be surprised that we believe that refined nicotine has a substantial role to play in harm reduction and, like NRT, ‘e-cigarettes’ can in all likelihood be constructed and manufactured in a safe manner. Where we differ is on the specific question of whether a subset of nicotine products should remain on the market exempt from oversight, or if they should be withdrawn pending their regulation.

At the root of this issue is money. In the United States and some other countries, devices labeled ‘e-cigarettes’ are advertised and sold widely and without oversight, regardless of their origin, contents or construction. This contrasts starkly with heavy restrictions on traditional NRT, including physician prescription requirements for the e-cigarette's close cousin, the nicotine inhaler. Currently, e-cigarette manufacturers and distributers are taking venture capital to expand (e.g. Njoy [8]), seeking to establish market share during this unregulated period. For them, academic and political debate fosters delay in regulation, and delay gains time to grow while the tobacco and pharmaceutical industries are in limbo awaiting regulatory rule-making. While protagonists such as Professor Siegel [9, 10] may seek to portray the US debate as one lacking balance, we believe it is a snapshot of aggressive corporate jockeying within a capitalist system to determine who will gain a cut of a lucrative market for an addictive drug. Meanwhile, tobacco companies are preparing for their own entry, not least by investing heavily in intellectual property to create more efficient devices [11, 12]. The same companies that brought us decades of deception and manipulation will be the major beneficiaries of any limitation on regulation achieved by the current industry and its advocates.

Ultimately at issue is not the potential for refined nicotine products, including ‘e-cigarettes’, to be part of a comprehensive harm reduction strategy. Rather, the question is if this should occur under a regulatory framework such as the US FSPTCA—or whether harm reduction should evolve within the existing tobacco market-place unfettered by national regulatory agencies.

The authors present a limited view of the utility of regulation, comparing refined nicotine to flavored acetaminophen syrup (e.g. Tylenol): ‘… for consumer products that are hazardous to children, we simply warn adults to keep them out of their reach’ [3]. The reality is complex—multiple laws, codified as regulations, exist and are enforced to ensure safety before and after sale. Acetaminophen, like refined nicotine, can be lethal in commonly dispensed sizes [13], yet can be purchased over the counter even when sold with flavorings. Such a risk would be unacceptable to modern consumers without the guardrails of FDA regulation; for example, labeling standards, tamper-resistant caps, evidence of safety of the drug supply and traceable identification of each batch.

In the absence of modern regulatory controls is the chaos of the early 1900s, and rarely seen in the developed world today. Like ‘e-cigarette juice’, acetaminophen solutions are usually sold in propylene glycol or glycerol solutions susceptible to contamination by diethylene glycol. In the mid-1990s scores of Haitian children were poisoned by acetaminophen syrup, resulting in more than 80 deaths. Because of Haiti and a half-dozen similar events [14], the public health community was critically concerned by contamination in ‘only one of 18’ samples tested by the FDA. Drugs, chemicals and devices sold outside the bounds of traditional regulation and scrutiny carry risks that are unfamiliar to consumers who trust in FDA oversight.

The authors conclude by noting that ‘some e-cigarette manufacturers are attending to safety concerns by making their products safer, such as using distilled water and glycerin instead of propylene glycol’ [3]. Such a laissez-faire approach emphasizes the responsibility of the tobacco industry in producing safe products, assuming that safer products will flourish while unsafe ones falter (or even explode [15]). However, it is difficult to reconcile the continued strict regulation of pharmaceutical nicotine and its competing delivery systems (inhalers, sprays, gums, lozenges, etc.) with the unregulated sale of nicotine in ‘electronic’ form. The end result of the current US system is that safe and effective nicotine is expensive and difficult to obtain, while unmonitored and unregulated nicotine is cheaper and more easily purchased.

A balanced argument would call for opening the market by loosening regulation on existing products, allowing safe and effective nicotine replacement to be available more widely to smokers but still preserving measures to prevent pediatric use. In the United States the FDA has the authority to regulate nicotine products (including ‘e-cigarettes’) [4] provided that it exercises its jurisdiction under the FSPTCA. We believe it is unwise to waive or delay regulation based on corporate expediency, a vocal consumer base or even academic opinion, however well intentioned. It would be inappropriate to use the cited self-selected online survey data [16], small convenience samples of users [17] or industry-funded [18] pilot studies [19] to exempt oversight for one particular product among many. We agree with the authors that more rigorous research will be informative, but efforts to use the current evidence to support ongoing sale of ‘e-cigarettes’ without regulation could result in a subversion of the FDA and a century of progress in public health, and in our opinion is profoundly unwise.

Declarations of interest