FDA opens the “historical” period to regulate tobacco

Four years after Congress gave him the authority to regulate tobacco products to protect the health of the nation, the Food and Drug Administration issued the first slate of decisions affecting the market for tobacco products, by adopting two new products and rejecting four.
The agency on Tuesday gave Lorillard Tobacco Co. the green light to market two new proposals cigarette offerings - and menthol version of its brand Newport - Newport finding Non-Menthol 100s gold box and Newport Non-Menthol Gold Box “do not raise different questions of public health,” than their counterparts that are already on the market.

360_tabacco_0609The FDA’s blessing is far from the safety agency approval. With more than 400,000 American deaths each year from tobacco-related diseases, and about 20% of American adults are still smoking, the FDA authority regulate over tobacco are limited to the fact that new tobacco products do not increase the existing levels of harm.

The FDA has also turned four proposed new tobacco products that were submitted for consideration. Those products, which the FDA is prohibited by law to determine, raised public health issues have not been substantially answered studies of existing products.
Among the studies he mentioned in blocking the proposed sale of four new products were incomplete test data and the lack of information about the design of the product provided by the sponsoring company.

The third reason, FDA found that one or more companies that are looking for permission for a new product has been added to specific ingredients, without demonstrating that the product was not put forward a new public health issues.
None of the four divert articles from them under the U.S. market; therefore, the solution does not require Tuesday stores to stop selling products already on the shelves.

“This is an historic,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. FDA is the first agency to regulate the world to regulate tobacco products for the purpose of protection of public health, said Zeller, and the solutions are your first bet in order to determine what products can enter the market.

Others will follow, and faster than the first six decisions. Zeller said companies seeking to sell tobacco products in the U.S. market provided 4,000 requests that the product labeled as “substantially equivalent” to tobacco products already on sale in the United States. Though 3500 of them are “temporary” - that is looking for a designation of product already on the market - the remaining 500 are for new tobacco products that must pass FDA muster, before they can be in the shops or kiosks.

If recent history is any guide, solutions FDA will not go unanswered companies seeking access to the U.S. market. Claims Agency has regulatory power over electronic cigarettes that deliver nicotine tobacco derivatives to customers in the form of steam, has been called into question - and at the moment, locked - in court.

Zeller said the agency continued its efforts to “create a legal framework” that would oversee the growing electronic cigarette market.
Similarly, in 2011, tobacco companies have sued and successfully blocked the opening of FDA regulatory gambit - a requirement that cigarette manufacturers use half the packaging of their products to display graphic health warnings.

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