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ADA ‘concerned’ tobacco companies introducing products without proper review

March 04, 2016

By Jennifer Garvin

Silver Spring, Md. — The ADA and 35 other health organizations have asked the Food and Drug Administration to be more diligent about requiring tobacco companies to obtain approval before introducing new tobacco products to market.

In a Feb. 26 letter to Mitchell Zeller, director, Center for Tobacco Products, the organizations shared that they are "increasingly concerned" that tobacco companies are introducing new tobacco products into the marketplace without proper regulatory review.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA unprecedented authority to regulate the manufacturing, distribution and marketing of tobacco products. It also requires tobacco companies to seek FDA approval before introducing new tobacco products to the market.

"The premarket review provisions of the Tobacco Control Act are intended to prevent the tobacco industry from continuing to introduce new tobacco products that are more harmful, more addictive and more appealing, particularly to young people," stated the letter.

The letter also points out that the Tobacco Control Act prohibits commercial marketing of a new tobacco product unless FDA has issued an order finding the product "appropriate for the protection of the public health." It singles out several new products it claims are non-compliant with the act. These products include:

  • Marlboro Midnight, a menthol cigarette;
  • Grizzly Wintergreen, a new snuff;
  • Three new brands of snus from Kretek International Inc: Thunder Xtreme, Offroad and Oden's Extreme;
  • Marlboro Black NXT, a crushable menthol capsule.
"FDA's failure to take the actions necessary to remove these products from the market represents a serious failure to protect the public health," the letter stated.

"Given that the avoidance of premarket review seriously undercuts the public health protections of the Tobacco Control Act, please explain why no enforcement actions have been taken by FDA against these products and indicate what the agency plans to do to prevent additional products from entering the market without the required regulatory review."

Read the entire letter here.