A Year Later, No Progress in FDA Tobacco Plan

The FDA is being criticized for its seemingly null progress on revised tobacco and nicotine regulations announced a year ago.

In a scathing editorial by the Competitive Enterprise Institute, Michelle Minton called out “the agency’s own cumbersome product approval process” as the biggest reason their regulatory efforts have failed.

When the Problem Began

The agency acknowledged in their announcement last year that “nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes” (emphasis mine). Continuum notwithstanding, vape products and other smoking alternatives are classified as tobacco products in the US, and are subject to the same regulations, warnings, and stigma of cigarettes.

Even though a number of smoking alternatives are factually and markedly less harmful than cigarettes, smokers who are not given proper information about the differences between the two are less likely to switch on their own.

It is this reductive approach to smoking cessation tools with which Minton, and others, take issue. Of the 367 premarket tobacco applications and the 35 modified risk tobacco product applications the FDA has received since they announced regulatory changes, they have not approved a single one. Some of the unapproved or pending applications include products that have been successful in other markets.

J. Reynolds’ moist tobacco powder, Snus, for example, contributed to the decline of Sweden’s smoking rates all the way to 5%. Sweden, thus, also enjoys the lowest rates of lung and oral cancers in the EU. Snus is available in the US, but has not been approved for modified risk status, regardless of the fact that by virtue of not being a cigarette, it is a modified (lower) risk.

What’s Being Done Instead

As Minton puts it: “Instead of making sure these innovative reduced-risk products make it market and can advertise the fact that they are reduced-risk, the FDA has put its energies on a fear-campaign intended to scare teens away from e-cigs.” The agency’s concerted efforts to insist teen vaping is an epidemic are absurd. CDC data reflects teen vaping has dropped a remarkable 30% since 2015.

Instead of focusing on an impossible zero-sum effort, the FDA needs to take the concerns of adult smokers and former smokers into equal consideration. Minton challenges current FDA commissioner, Scott Gottlieb, to “balance enforcement aimed at stopping teen initiation of nicotine use against actions aimed at encouraging adult smokers to quit.” Without alternatives on the market for smokers to turn to, and zero currently approved PMTA or MRTP applications, tobacco harm reduction seems a far cry from a priority for the agency.

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