AAFP Demands Answers From FDA About New Tobacco Products

March 14, 2016 01:45 pm Jill Sederstrom

Concerned that new types of cigarettes, snuff and other tobacco products are filling store shelves despite a law meant to prevent the introduction of new tobacco products, the AAFP joined with 35 other organizations to demand that the FDA explain what it will do about this serious public health concern.

[Cigars, cigarettes, matches stacked together]

A Feb. 26 letter(4 page PDF) to Mitchell Zeller, J.D., director of the FDA's Center for Tobacco Products, voiced concern that new tobacco products are being marketed to the American public apparently without going through the regulatory review required by the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009.

The organizations that joined the AAFP in signing the letter -- including the American Heart Association, American Cancer Society Cancer Action Network and the American Public Health Association -- urged the FDA to remove the products from the market if they do not meet the requirements of the law.

The letter questioned whether multiple new tobacco products have met the premarket review provisions outlined by the TCA to prevent "more harmful, more addictive and more appealing" products from being introduced into the marketplace.

"It appears that major tobacco companies continue to market new products without an order from FDA that they have met the public health standard for new products or that they have been found substantially equivalent to a predicate product," the letter states.

Under the law, a new tobacco product cannot legally be marketed in the United States unless the FDA has issued an order that it is "appropriate for the protection of the public health" or it is "substantially equivalent" to a predicate tobacco product -- defined as a product that either was marketed before Feb. 15, 2007, or was itself previously found to be substantially equivalent to another predicate product. New products also can be deemed substantially equivalent if they have different characteristics than a predicate tobacco product but can be shown not to raise any different public health concerns.

The letter names several new products that appear to have been introduced without the necessary premarket review. For instance, Philip Morris recently announced a new menthol cigarette called Marlboro Midnight, which one analyst said was designed to appeal to younger consumers. The letter also highlighted a new cigarette with a crushable menthol capsule as well as new forms of snuff that have been released in recent years.

New tobacco products can be exempt from premarket review if they were first commercially marketed between Feb. 15, 2007, and March 22, 2011, and submitted a substantial equivalence report by that later date.

However, the letter states it appears unlikely that all 12 of the new tobacco products mentioned could have met these standards.

"Because FDA has provided so little information in response, it is difficult to determine the reasons why such products remain on the market. However, given the circumstances in which these products were introduced, it is implausible that all of them were the subject of substantial equivalence applications filed by March 22, 2011, and that they were marketed before that date," says the letter.

The three dozen organizations demand a response from the FDA.

"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," the letter states.

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