These memos show that FDA regulation of e-cigarettes is driven by dubious value judgments rather than science

The agency is determined to ban the flavors that former smokers overwhelmingly prefer. For the children.

It has long been clear that the Food and Drug Administration (FDA) is leery of approving nicotine vaping products in flavors other than tobacco because the agency worries that they appeal to teenagers.

Two recently disclosed FDA memos not only confirm that impression; they indicate that the agency is determined to ban all other flavors, no matter how popular they are among former smokers and no matter what evidence a manufacturer presents in favor of a particular product.

The memos came to light thanks to a lawsuit that Logic Technology filed against the FDA after the agency approved the marketing of the company’s tobacco-flavored e-cigarettes but rejected applications for menthol-flavored versions. The documents show that higher-ups in the FDA overrode staff scientists who initially recommended approval of the latter applications.

Filter‘s Alex Norcia, who wrote about the memos yesterday, presents that episode as an example of how political considerations shape regulatory decisions that supposedly are driven by data. But the root of that problem in this context is a nebulous statutory standard that invites subjective judgments, allowing regulators to cloak preexisting policy preferences in the garb of science.

Last March, the FDA granted “marketing orders” for the Logic Pro and Logic Power vaping systems and the tobacco-flavored capsules and cartridges they use. In October, the FDA issued “marketing denial orders” for the menthol versions of those products, saying “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”

The memos show what was going on behind the scenes during that seven-month lag. Both are dated October 25, the day before the FDA told Logic Technology it had to stop selling menthol-flavored capsules and cartridges.

Read full article here.

Jacob Sullum – Reason – 2022-12-15.