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FDA opens 'historic' era on tobacco regulation

By Melissa Healy

6:14 PM CDT, June 25, 2013

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Four years after Congress granted it the power to regulate tobacco products to protect the nation's health, the Food and Drug Administration has issued a first slate of decisions affecting the market for tobacco products, approving two new products and rejecting four.

The agency on Tuesday gave Lorillard Tobacco Co. the green light to market two new cigarette offerings - both unmentholated versions of its Newport brand - finding that Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box "do not raise different questions of public health" than similar brands already on the market.

The FDA's blessing is a far cry from a safety endorsement by the agency. With more than 400,000 American deaths yearly from tobacco-related illnesses and about 20% of American adults still smoking, the FDA's regulatory powers over tobacco are limited to ensuring that new tobacco-related products do not increase existing levels of harm.

The FDA also turned away four proposed new tobacco products that had been submitted for review. Those products, which the FDA is legally forbidden to identify, raised questions of public health that have not been substantially answered by studies of existing products.

Among the justifications it cited in blocking the sale of the four proposed new products were incomplete test data and a lack of information about a product's design provided by the sponsoring company.

In a third reason, the FDA found that one or more of the companies seeking approval for a new product had added specific ingredients without demonstrating that the resulting product raised no new public health questions.

None of the four rejected products had reached the U.S. market, so Tuesday's decision does not require stores to stop selling products already on shelves.

"This is historic," said Mitch Zeller, director of the FDA's Center for Tobacco Products. The FDA is the first regulatory agency in the world to regulate tobacco products with an eye to protecting the public's health, said Zeller, and the decisions represent its first bid to determine what products can enter the market.

Others will follow, and more quickly than the first six decisions. Zeller said companies seeking to sell tobacco products on the U.S. market had submitted 4,000 requests to have a product designated as "substantially equivalent" to tobacco products already for sale in the United States. Though 3,500 of those are "provisional" - meaning the designation is sought for a product already on the market - the remaining 500 are for new tobacco products, which must pass FDA muster before they can appear in stores or kiosks.

If recent history is any guide, the FDA's decisions will not go unchallenged by companies seeking access to the U.S. market. The agency's claim to have regulatory power over electronic cigarettes, which deliver tobacco-derived nicotine to consumers in the form of vapor, has been challenged - and for now, blocked - in court.

Zeller said the agency continued its efforts to "create a regulatory framework" that would allow it to oversee the burgeoning e-cigarette market.

Similarly, in 2011, tobacco companies went to court and successfully blocked the FDA's opening regulatory gambit - a requirement that cigarette manufacturers use half of their products' packaging to display graphic warning labels. Those labels remain on hold.