Fundamental Flaws of Tobacco Control Act—and FDA’s Implementation

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When Congress passed the the Tobacco Control Act in 2009, it amended the federal Food, Drug, and Cosmetic Act to give the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products for the first time.

This was seen as an important step to protect public health from the serious detrimental consequences of smoking combustible tobacco products.

But unfortunately, there are several fundamental flaws in both the statute and the FDA’s subsequent implementation of it. These have directly contributed to today’s chaotic marketplace and have had a detrimental impact on public health—particularly on the lives of adults who are unable or unwilling to quit smoking.

The primary flaw in the statute lies with the premarket authorization process for new tobacco products, a term used to include nicotine vapes. The Tobacco Control Act’s one-size-fits-all premarket review requirement is based entirely on a product’s market availability at a particular point in time. Only a “new” tobacco product—considered anything introduced to the US market or modified after February 15, 2007—is subject to premarket review.

Read full article here.

Azim Chowdhury – Filter – 2022-11-14.

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