Bureaucrats and Politicians Seem Determined To Cripple a Lifesaving Alternative to Smoking
Electronic cigarettes, which deliver nicotine without tobacco or combustion, are the most important harm-reducing alternative to smoking ever developed, one that could prevent millions of premature deaths in the United States alone. Yet bureaucrats and politicians seem determined to negate that historic opportunity through regulations and taxes that threaten to cripple the industry.
When a court-set deadline for “premarket” approval of vaping products came and went on September 9, the Food and Drug Administration (FDA) had received millions of applications but had not approved any. As a result, the agency says, every vaping device and nicotine liquid sold in the U.S. is “marketed unlawfully” and “subject to enforcement action at the FDA’s discretion.”
Seven years after the FDA officially declared its intention to regulate “electronic nicotine delivery systems” (ENDS) as “tobacco products,” the industry remains in legal limbo, existing only thanks to the agency’s enforcement discretion and limited resources. Despite the FDA’s promises of regulatory flexibility, it is perpetuating a situation in which manufacturers don’t know whether they will still be in business next week, next month, or next year.
The FDA has rejected millions of applications for nicotine liquids in flavors other than tobacco, which are the products that former smokers overwhelmingly prefer. Because those flavors also appeal to teenagers, the agency says, they will be approved only if manufacturers present “robust,” “reliable,” and “product-specific” evidence that their benefits in helping smokers quit outweigh the risk that they will encourage underage vaping.
No one really knows what that means, although the FDA says “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” Such research is beyond the means of all but the largest companies, and even they may have trouble persuading the FDA that approval of their products is “appropriate for the protection of public health,” taking into account “the risks and benefits to the population as a whole.”
Under that highly
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