The decision by the Food and Drug Administration (FDA) allowing R.J. Reynolds Tobacco Co. to market e-cigarette products with high nicotine levels is wrong on multiple levels—but the agency’s gravest error is to frame its action as “appropriate for the protection of the public health.”

The Premarket Tobacco Product Application pathway requires applicants to provide scientific data that demonstrates a product is appropriate for the protection of public health.

In the case of Vuse, the agency found that tobacco-flavored products could benefit addicted adult smokers who switch to these products by reducing their exposure to harmful chemicals due to cigarette consumption.

However, the role that e-cigarettes may play in smoking cessation strategies is unclear. To date there has not been a rigorous independent study that supports e-cigarettes as a gateway to quitting smoking. In fact, a recent study published in JAMA Network Open suggests that smokers who turned to e-cigarettes as a cessation device had a higher relapse rate back to smoking than those who remained tobacco-free.

As the FDA acknowledges in allowing the marketing of Reynolds’ Vuse brand, “all tobacco products are harmful and addictive.” The AMA has specifically recognized the use of e-cigarettes and vaping as an urgent public health epidemic and has called for a total ban on all e-cigarette and vaping products that do not meet FDA approval standards as cessation tools.

Data has shown that using FDA-approved cessation medicine can double a persons chance of quitting smoking successfully. These products include over-the-counter options like skin patches, lozenges and gum, as well as prescription medicines.

Read full article here.

Gerald E. Harmon, MD – American Medical Association – 2021-11-19.

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