Tobacco

FDA Reviewing Tobacco, Food Programs

Commissions external experts to evaluate Center for Tobacco Products, citing ‘increasing number of novel products’
fda food and drug administration califf
Image/FDA; Photograph courtesy of the U.S. Food and Drug Administration

SILVER SPRING, Md. — U.S. Food and Drug Administration Commissioner Robert Califf said the FDA is evaluating the Center for Tobacco Products (CTP) as part of a broader review of the agency that also includes the Human Foods Program. He cited the increasing number of new products as the reason for looking at the tobacco program.

“In February 2022, I rejoined the [FDA] as commissioner of food and drugs, having served in the role five years earlier,” Califf said. “Since my return, the agency has taken many significant actions that benefit the public health. Yet at the same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.”

He has commissioned external experts to conduct a comprehensive evaluation of the two “key programs.”

“Just over 13 years ago, Congress tasked the FDA with regulating tobacco products,” said Califf. “In the ensuing years, we have made important progress and reached regulatory decisions on a broad array of millions of products. But even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.”

The CTP is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law gives the agency broad authority to regulate the manufacturing, distribution and marketing of tobacco products. It develops policy, issues regulations, conducts research, educates Americans on tobacco products and makes decisions on whether new tobacco products and claims can be marketed—including the review and evaluation of applications and claims before the new products are allowed on the market.

The FDA, an agency within the U.S. Department of Health and Human Services (HHS), protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products and medical devices for human use. The agency also is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

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