Pending Regs

FDA moves to limit cancer-causing chemicals in chewing tobacco


The Obama administration is pushing ahead with a new tobacco regulation in its final hours.

The Food and Drug Administration (FDA) is proposing a rule to require lower levels of a well-known carcinogen in chewing tobacco and other finished smokeless products that use cut, ground, powdered or leaf tobacco. 

Under the proposed rule, the average amount of N-nitrosonornicotine in a product batch can’t exceed 1.0 microgram per gram of tobacco before the product expires.

The rule would require all products to have an expiration date, and manufacturers would have to prove that the product’s level of N-nitrosonornicotine meets the new standard up to that date when kept at room temperature or in the refrigerator.

{mosads}Industry is expected to spend anywhere from $17.91 million to $42.72 million a year over the next 20 years complying with the rule.

The FDA, meanwhile, expects the rule to generate anywhere from $228.6 million to $2.46 billion in benefits by preventing an estimated 12,700 new cases of oral cancer and approximately 2,200 oral cancer deaths.

Public comments will be accepted for 75 days after the proposed rule is published in the Federal Register, which is scheduled for Monday.

The Campaign for Tobacco Free Kids said this is the first time the FDA has exercised authority under the 2009 Family Smoking Prevention and Tobacco Control Act to establish product standards for the design and content of a tobacco product.

“The FDA and the new Administration should move quickly to finalize the proposed rule, and this rule should provide the foundation for additional product standards that can reduce the addictiveness, toxicity and/or appeal of tobacco products – and the death and disease they cause,” campaign president Matthew Myers said in a statement.

Tags Chewing tobacco Family Smoking Prevention and Tobacco Control Act Food and Drug Administration N-Nitrosonornicotine Regulation of tobacco by the U.S. Food and Drug Administration Tobacco

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