MD Anderson welcomes FDA proposed rule to limit carcinogen levels in smokeless tobacco

The University of Texas MD Anderson Cancer Center fully supports the proposed rule released today by the U.S. Food and Drug Administration (FDA), which would limit a known carcinogen in finished smokeless tobacco products.

“We applaud the FDA for taking this unprecedented step toward improving public health by exercising their authority over the contents of tobacco products,” says Ronald DePinho, M.D., president of MD Anderson. “As tobacco remains the leading preventable cause of cancer deaths in the U.S., it is imperative that we take action to limit the devastating health impacts of these products.”

The proposed rule is the first-ever product standard for tobacco issued by the FDA and would establish a maximum amount of N-nitrosonornicotine (NNN) content in any batch of finished smokeless tobacco products sold in the U.S. It would further establish testing requirements to ensure products adhere to the new limit and require smokeless tobacco products to have an expiration date, as NNN can build up over time.

According to evidence presented in the proposed rule, the FDA expects implementation of this product standard would prevent approximately 12,700 new cases of oral cancer and 2,200 oral cancer deaths over the following 20-year period, and would lower the risk for a number of other cancers.

“While the proposed rule would not eliminate cancer risk from smokeless tobacco products, the data clearly supports this as a means of saving lives in the future,” says DePinho. “However, we must continue to consider additional evidence-based actions to regulate the incredibly harmful and addictive nature of tobacco products in order to protect the public health.”