Our Blog
11
Jan
FDA Denies Snus Claims for Safer Tobacco Label
Currently, all tobacco products are required to carry warning labels that describe the serious health risks related to their use. This includes both cigarettes and smokeless tobacco. Recently, Swedish Match attempted to use the Modified Risk Tobacco Product (MRTP) process to get these labels changed for eight different varieties of its smokeless tobacco, pre-portioned into small packets known as “snus.”
Swedish Match hoped to get modified warnings for oral cancer risks, oral health risks, and other labeled risks. However, the FDA decided to reject all claims, although it did allow some claims may be reviewed again with a modified application.
Cancer Risks Remain
The current application asked for permission to remove the label: “WARNING: This product causes mouth cancer.” Obviously, this warning label is seen as a sales killer (which is part of the reason it was created). The FDA said that a request to remove this label could only be granted if the evidence showed that this tobacco product, unlike other tobacco products, cannot cause mouth cancer.
However, the FDA pointed out that snus, like other smokeless tobacco products, still contains several carcinogenic agents. They pointed out that there’s no known lower threshold for exposure to these carcinogens, so, even if they’re reduced in snus, they are still potentially carcinogenic. The FDA pointed to a recent epidemiological study that showed an association between snus and oral cancer as evidence that the risk of cancer still existed with snus.
Usage Habits Crucial
Other aspects of the new label request were denied not so much on the basis of biology but on the basis of psychology. Swedish Match wanted a label that said their product represented a safer alternative to cigarettes, but the FDA was unsure that was true because of the way that US consumers might use snus.
People in Sweden and Norway who use snus instead of smoke do experience fewer health effects–although some parts of the risk profile are unchanged–the FDA was unsure US consumers would use it the same way. The FDA wanted evidence showing, for example, that US consumers wouldn’t use the product in a more concentrated pattern, or that they wouldn’t use the product while smoking.
The FDA did, however, say that the claims of reduced risk could be included on the label, just someplace other than the warning label area.
Have You Suffered as a Result of Oral Tobacco Use?
If you’re an oral tobacco user, you may know the seriousness of these risks firsthand. Gum disease, oral cancer, and receding gums can all have a lasting impact on your overall health as well as your oral health.
Some of these effects can be treated. Nicolas A. Ravon, DDS, MSD can correct receding gums with gum graft surgery, which provides attractive long-term results.
To learn how gum graft surgery in Beverly Hills can improve the appearance and health of your smile, please call (310) 275-5325 today for an appointment at Nicolas A. Ravon, DDS, MSD.