ADA comments on ‘modified risk’ tobacco products

December 05, 2014

By Craig Palmer

Rockville, Md. – It is “virtually impossible” to justify claims that smokeless tobacco and such newer generation products as electronic cigarettes and hookah tobacco “are somehow less harmful to the oral cavity than combustible tobacco products or without other adverse effects,” the Association told the Food and Drug Administration Dec. 5.

“Unfortunately, there is a scarcity of published research on – and certainly no scientific consensus about – the immediate and long-term effects of these new products on oral health,” the Association said in preliminary comments on an FDA regulatory notice issued Aug. 27. The Association will offer supplemental comments by Feb 23, when the comment process closes.

“Preventing oral cancer and other tobacco-related disease has been a long-standing priority for the ADA,” said the letter signed by Association President Dr. Maxine Feinberg and Executive Director Dr. Kathleen T. O’Loughlin.” ‘We strongly support developing the published research on the latest generation of tobacco products and the immediate and long-term effects of those products on oral health.”

The Association urged the FDA to consult with the National Institute of Dental and Craniofacial Research “about the current state of published research in this area.” The ADA separately said it supports NIDCR-proposed research on the “Effects of E-cigarette Aerosol Mixtures on Oral and Periodontal Epithelia.”

The FDA opened a regulatory docket and called for comments on modified risk tobacco product applications submitted by Swedish Match North America Inc. for “snus” and other smokeless tobacco products. Modified risk tobacco products are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed products.

Federal law requires the FDA to make the applications available to the public and to request comments on label, labeling, advertising and other information in the application. Applicants must show that the products “will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and will benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products,” the FDA said.

Under current law, every package and advertisement for a smokeless tobacco product, including “snus,” moist snuff and chewing tobacco, must include one of the following WARNINGS:

  • This product can cause mouth cancer.
  • This product can cause gum disease and tooth loss.
  • This product is not a safe alternative to cigarettes.
  • Smokeless tobacco is addictive.

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