U.S. Smokeless Tobacco Company said on Friday that the Food and Drug Administration had accepted and filed for substantive scientific review a Modified Risk Tobacco Product application for its moist smokeless tobacco product Copenhagen® Snuff Fine Cut.
The application requests FDA authorization to make one claim: ‘IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer’.
“It’s critical that smokers have accurate, non-misleading health information about different tobacco products,” said Joe Murillo, senior vice president, regulatory affairs at Altria Client Services.
“We filed this application because we think adult smokers looking for potential reduced risk alternatives to cigarettes should have accurate information about the relative risks of Copenhagen Snuff.”
The Agency is due to begin a substantive scientific review process, which includes opportunities for public comment.
FDA to review risk claim
