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Member Research & Reports

Member Research & Reports

Ohio State: FDA Not Flexing Muscle to Regulate Tobacco Products

A recent study released in Tobacco Control by authors at The Ohio State University and the Public Health Law Center and found that the U.S. Food and Drug Administration (FDA) is not properly exercising its authority to regulate the sale of new tobacco products.

Berman FDA
[Photo: Mr. Micah Berman]

In 2009, the U.S. Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), establishing federal authority to regulate tobacco products for the first time. As part of that authority, Congress determined that no new tobacco products could enter the market without first undergoing review by the FDA. After conducting a thorough review of FDA regulatory actions, the authors found that despite this requirement, tobacco companies are still introducing new products that have not undergone the required review process.

Products that were commercially available at the time the law was introduced and have not been changed in any meaningful way do not require FDA authorization to stay on the market. 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. The authors 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.

Specifically, the paper outlines three misplaced priorities that are detrimental to public health:

  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. In one case documented by the authors, 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.

“Though our investigation, we found that the FDA has significant opportunities to improve the premarket review process to better protect public health,” said Mr. Micah Berman, co-author and assistant professor of Public Health and Law at The Ohio State University. “The FDA should look first at products that are already on the market, and it should act quickly to remove products that clearly do meet the legal requirements for sale under the Tobacco Control Act.”

Additional recommendations for the FDA to better protect public health include:

The full paper, “The FDA’s Misplaced Priorities: Premarket Review Under the Family Smoking Prevention and Tobacco Control Act” is available through the journal Tobacco Control. (