Sunday, December 07, 2014

Required Reading: Michael Marlow's Commentary on the FDA's Proposed Deeming Regulations

Everyone involved in the debate over electronic cigarettes must read Dr. Michael Marlow's commentary on the FDA's proposed deeming regulations. According to his Mercatus Center biography, Dr. Marlow is "an affiliated senior scholar at the Mercatus Center at George Mason University and professor of economics and distinguished scholar at California Polytechnic State University, San Luis Obispo."

(See: Marlow ML. Regulating a less unhealthy cigarette: The FDA's treatment of e-cigarettes jeopardizes public health. Regulation. Fall 2014.)

In his commentary, Dr. Marlow argues that in its proposed deeming regulations, the FDA has completely skewed its cost-benefit analysis by failing to recognize the dramatic negative effect its burdensome regulatory requirements for electronic cigarettes will have on the public's health by virtue of the suppression of the e-cigarette market that these regulations will cause.

Dr. Marlow writes: "This article argues that the FDA jeopardizes public health by not developing an appropriate benefit-cost analysis of the proposed rule. The FDA “anticipates,” without quantifying, substantial benefits from reducing harm by regulating e-cigarettes and non-cigarette tobacco products. The FDA also does not adequately assess costs that appear likely from its suppression of the e-cigarette market. The evolving literature on e-cigarettes strongly suggests they help smokers to quit smoking. The proposed rule endangers public health by pushing e-cigarette manufacturers to focus efforts toward developing attributes unrelated to improved public health, thereby promoting combustible tobacco use and reducing the number of smokers who would use e-cigarettes to quit or reduce cigarette consumption. Public health would worsen because e-cigarettes are a safer alternative to tobacco cigarettes."

Dr. Marlow carefully articulates the adverse consequences to the public's health that would occur if the FDA's proposed deeming regulations are adopted. These regulations, he argues, would result in the suppression of the e-cigarette market, a stifling of product innovation, a contraction of the overall e-cigarette market with limitation of consumer choices and increased product costs, and an increase in youth e-cigarette use due to the prohibition of honest claims that e-cigarettes are safer than combustible tobacco products.

Dr. Marlow concludes that: "The FDA needs to develop a regulatory strategy that fully considers the potential benefits that smokers receive from e-cigarettes and the many unintended adverse effects on public health associated with how this proposed regulation slows the evolution of a promising harm reduction tool."

The Rest of the Story

This commentary very nicely summarizes many of the major points that I have tried to make here at the Rest of the Story over the past months. Like Dr. Marlow, I have argued that the proposed deeming regulations would suppress the e-cigarette market, stifle innovation, and contract the overall market by reducing the number of players as well as consumer choices. The burdensome requirement for a new product application for virtually every e-cigarette product on the market will almost certainly drive most e-cigarette companies and shops out of business. The net effect of this disruption of the industry will be a reduction in the rate at which smokers switch from combustible cigarettes to the much safer electronic ones. Thus, the net effect of the proposed regulations would be a strongly negative impact on public health.

In addition, Dr. Marlow nicely articulates the argument I have previously made that by disallowing companies from truthfully informing their customers that these products are safer than tobacco cigarettes and may be helpful in smoking cessation, the result will be that companies have no option other than marketing these products as having benefits unrelated to health, such as looking cool and sexy and allowing smokers to inhale nicotine in places where smoking is not allowed. The net effect of this suppression of the truth will be an increase in youth e-cigarette use, as honest marketing of e-cigarettes based on their health benefits would have far less appeal to youth.

Instead of the burdensome requirements that the FDA is proposing, I believe that the agency should take a different approach which recognizes the vast difference in risk between tobacco and electronic cigarettes, which embraces the harm reduction potential of e-cigarettes, and which enhances the progression of the nicotine market away from combustible products.

Specifically, the FDA should:
  1. Scrap the requirement that e-cigarette products must submit new product applications.
  2. Instead, simply promulgate uniform safety standards that all products must meet.
  3. These standards should include:
    • child-proof packaging;
    • quality assurance of nicotine levels;
    • battery and charging safety;
    • voltage and/or temperature regulation to avoid the formation of carbonyl compounds like formaldehyde;
    • manufacturing standards such as those set out by AEMSA;
    • banning the use of diacetyl as a flavoring; and
    • soldering restrictions to prevent the presence of metals in e-liquid.
       4. Explicitly allow companies to truthfully inform their customers that these products are intended to aid   in smoking cessation and that these products are much safer than tobacco cigarettes.
The last thing we need is the creation of a monstrous bureaucracy in which the FDA will have to review literally thousands of new product applications, including hundreds of applications - in some cases - from a single company. The FDA has not demonstrated how such a process, which is unduly burdensome, which actually benefit the public's health. Instead, the agency should simply mandate the safety standards that all companies must follow. This minimizes the bureuacracy, limits the economic and time burden on small companies, allows the market to continue to expand rather than contract, encourages innovation, and directly regulates the factors that will most affect product safety.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.


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