The foodstuff and Drug Administration inside a first has authorized the discharge of two new forms of Newport Smooth Select cigarettes while rejecting four others, using for the first time a regulatory rule established about 5yrs ago by the Obama administration.
That’s not to imply the two new products — Lorillard Tobacco’s Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box — are less harmful than other cigarettes or that this makers may also call the items “FDA-approved,” Mitchell Zeller, director in the FDA’s Center for Tobacco Products, emphasized to reporters on a conference call Tuesday.
“All it indicates is we’ve conducted a current scientific review, and concluded the…products are not more harmful than existing products,” Zeller told reporters.
FDA commissioner Dr. Margaret Hamburg called the new tobacco announcement “historic.”
Fewer U.S. adults are smoking currently, based on June report from your Centers for Disease Control and Prevention (CDC) that found about 18 percent of U.S. adults smoke cigarettes, down from 19 percent the previous year.
Still, tobacco kills greater than 400,000 Americans annually, based on Hamburg, and approximately 3,600 children younger than 18 try their first cigarette on a daily basis.
Because there’s no such thing as being a safe tobacco product from the FDA’s eyes, the latest regulations derive from whether or not the product poses a larger risk to public health than products already available on the market.
The FDA’s regulation comes from the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the health agency regulatory authority over Newport Menthol Gold cigarettes. Underneath the law, the tobacco product’s manufacturer must show the FDA the new product is “substantially equivalent” to some product already available, and won’t cause more harm to public health than the comparable product.
Along with authorizing both the Lorillard products, the FDA rejected four more products simply because they were found “not substantially equivalent.” The agency would not name the items, but said reasons included an absence of evidence to assist that the addition of new ingredients failed to devqpky62 different questions of public health, a lack of specifics of the design from the product and incomplete data on product tests.
“This really is historic because we underwent a comprehensive, extensive, pre-market scientific review,” said Zeller.
The Associated Press conducted a review last December that found that the FDA hadn’t ruled on 4,000 of those product applications for over a year regardless of the expectation of any 90-day review process.
Nearly every application completed so far, however, has been insufficient in some manner, said Zeller, who said the new regulations continue to be a learning process.
The company also developed a website that tracks the progress of substantial equivalence applications.
At any point a manufacturer can withdraw a submission: The FDA to date has formally withdrawn 136 reports at applicants’ requests. Some manufacturers can also request an exemption for Newport Menthol Gold 100’s box cigarettes if there is only a minor modification being made such as including a new additive. The FDA stated it has refused 20 exemption requests so far.
Electronic cigarettes will still not regulated from the FDA, Zeller said, as long as they don’t make health claims.