Premarket Review of Tobacco Products: The FDA’s Misplaced Priorities

by Micah Berman — Wednesday, Apr. 13, 2016

Along with colleagues at the Public Health Law Center, I published an article this week in the journal Tobacco Control that critically reviews the FDA’s implementation of its authority to regulate the sale of new tobacco products.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), establishing federal authority to regulate tobacco products. As part of that authority, Congress determined that no new tobacco products could enter the market without first undergoing review by the FDA. To our amazement, we found that despite this requirement, tobacco companies are still introducing new products that have not undergone the required review process. And these are no small players; it’s the major cigarette companies that are engaging in this behavior. For example, Philip Morris USA publicly launched “Marlboro Midnight” in 2015, despite the fact that the FDA has not issued an order permitting its sale. The FDA has not yet taken any enforcement action against the company.

There is an exception to the premarket review requirement for products that were commercially available at the time the law was introduced and have not been changed in any meaningful way. In addition, if a company submitted an application to the FDA before March 22, 2011, establishing that one of its products was “substantially equivalent” to a product commercially available at the time the law was introduced, such a product is permitted to remain on the market until the FDA reviews the application. If the FDA concludes that the product does not meet the “substantial equivalence” requirement, it can no longer be sold. We found that more than five years after the deadline for submitting such applications, the FDA has failed to take action on more than 3,000 of them. I have previously blogged about this massive backlog here.

Although it is no surprise that the tobacco industry is trying to game the system, we believe the FDA shares much of the responsibility for failing to more effectively implement these product review provisions. Specifically, we identified three ways in which we think the FDA has demonstrated misplaced priorities:

1. The FDA has prioritized the review of premarket applications for new tobacco products over the review of potentially noncompliant products that are already on the market.

2. Rather than reject clearly deficient applications, the FDA has provided tobacco companies with an excessive number of opportunities to modify their applications. For example, in one case we documented, the FDA requested information from a company 16 different times over two and a half years before finally rejecting its substantial equivalence application.

3. Tobacco companies have introduced new products to the market that have completely ignored the premarket review requirements of the Tobacco Control Act, and the FDA has taken no enforcement action against them.

I spent a year working at the FDA Center for Tobacco Products and have great respect for the people who work there. But for reasons that are not clear to me, the implementation of the premarket review provisions of the Tobacco Control Act has been deeply, deeply problematic. We hope this article will spur discussion and reform.

The full paper is available here (subscription required). I will update this blog post when a free version of the paper is available.

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