This is my response to the operational review of the performance of the FDA’s Center for Tobacco Products by the Reagan-Udall foundation.
The heart of the problem is the lack of a coherent regulatory strategy, grounded in real-world understanding
The Reagan-Udall foundation is conducting an “operational review” of the FDA’s handling of its tobacco and nicotine brief. The review was commissioned by Robert Califf, the FDA’s Commissioner. I have submitted comments through the stakeholder portal. Please consider making your own submission – it’s easy.
My contribution is available below, in a formatted PDF version and via the stakeholder portal.
The stakeholder portal requested comments on a range of themes, with a box for no more than 2,000 characters of text. I will set out the headings and my responses under each.
The Reagan-Udall foundation is conducting an “operational review” of the FDA’s handling of its tobacco and nicotine brief. The review was commissioned by Robert Califf, the FDA’s Commissioner. I have submitted comments through the stakeholder portal. Please consider making your own submission – it’s easy.
My contribution is available below, in a formatted PDF version and via the stakeholder portal.
The stakeholder portal requested comments on a range of themes, with a box for no more than 2,000 characters of text. I will set out the headings and my responses under each.
What recommendations do you have to improve FDA’s tobacco program operations? Please specify for categories listed.
Regulations and guidance
Whatever the intent, FDA’s regulation of tobacco and nicotine products functions in practice as a protection of the incumbent and highly damaging cigarette trade. There are about 3,000 cigarette variants on the US market, largely undisturbed by FDA.
The PMTA process for new products (vaping, heated tobacco, nicotine pouches etc.) is exceptionally burdensome, the rules are opaque, the process inefficient, and the outcomes unpredictable. The extreme compliance burdens, together with the unpredictability of the process, favor large companies. Tobacco companies are especially advantaged – first through the barriers to entry that protect the cigarette trade, second through the advantage to large companies in the vape market, and third through their ability to cross-subsidize vaping compliance costs from their cigarette business. Few vape companies have the balance sheet or patient investors to withstand the pressure FDA piles onto them.
First Last – Outlet – 2022-11-03.
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