Proposed FDA menthol rules sent to Biden OMB for approval before release for public comment

One February 24, 2022, the FDA submitted two proposed rules on menthol to the White House Office of Management and Budget for review before public release: “Tobacco Product Standard for Menthol in Cigarettes” and “Tobacco Product Standard for Characterizing Flavors in Cigars.” The OMB can approve the proposed rules as submitted, deny them, or approve with changes.

The last time OMB dealt with flavored tobacco products was under President Obama when it dropped menthol and other flavor restrictions from the “deeming rule” under which FDA took jurisdiction over e-cigarettes, cigars, and other non-cigarette tobacco products. Had the Obama OMB allowed FDA to move forward then, much of the damage that flavored tobacco products have done would have been avoided.

Given that President Biden has pledged to follow the science, hopefully OMB will not repeat its past behavior. Here is what he said:

An important detail to watch is whether FDA bans menthol (and menthol analogs) as “characterizing flavors” or “ingredients.” It is important that menthol be banned as an ingredient.

If OMB approves the proposed rules, FDA will put them out for public comment, the next step toward issuing final rules, a process likely to take a year or more.

Once the final rules are issued, the tobacco companies will almost certainly sue, which will further delay implementation, as they done successfully with the FDA’s well-conceived rule requiring graphic warning labels.

That’s why, in the meantime, states and localities should continue to press forward with laws ending the sale of all flavored tobacco products, including menthol.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

One thought on “Proposed FDA menthol rules sent to Biden OMB for approval before release for public comment

  1. E-cigarettes/Vaping NYT OP-ED

    Why do most people blindly accept the premise that vaping and secondhand vaping are less harmful than smoking and secondhand smoke? My experience tells me that in 20 years, we will learn of diseases caused by vaping and secondhand vaping that we don’t even know the names of today.

    EVALI, a new vaping lung disease, has already caused thousands of teen hospitalizations and dozens of teen deaths, a feat that pales in comparison to teen cigarette smoking. EVALI is the first heretofore unknown vaping disease. There will be others, including brain disease (according to preliminary date).

    Fifty years ago, people were told that smoking and secondhand smoke were harmless, even good for you. Now we are being told that vaping and secondhand vaping are less harmful. The truth won’t be known for another 20 years. In the meantime, should we believe the tobacco cartel again?

    E-cigarette and vaping dispensers that open to allow users to add flavors, chemicals, and other substances (some illegal) are particularly troublesome. Currently, there exists over 100 flavors/chemicals (such as cotton candy, popsicle, candy-cane, mint, etc.) easily available online as well as in the ever expanding number of e-cig/vape stores. The danger signs are flashing and government, as always, is hand-tied by tobacco cartel influence.

    Australia has shown us one solution to the problem. Require a doctor’s prescription to obtain any electronic nicotine delivery device. It makes sense since nicotine delivery devices are medical devices supposedly only intended to help people with a medical problem, nicotine addiction. E-cigarettes are not intended to create a new generation of addiction (wink, wink), which is unfortunately what is happening. Youth smoking is soaring for the first time in thirty years.


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