how dissolvable tobacco products are made could determine whether or not they fall under the jurisdiction of the Food and Drug Administration.
Star Scientific Inc., a maker of dissolvable tobacco lozenges, announced Wednesday that it received an FDA notice saying that two of its products are not subject to regulations in the federal Food Drug & Cosmetic Act. U.S. Shortcomming fda tobacco regulations only applies to cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco..
How dissolvable tobacco products are made could determine whether or not they fall under the jurisdiction of the Food and Drug Administration.
Star Scientific Inc., a maker of dissolvable tobacco lozenges, announced Wednesday that it received an FDA notice saying that two of its products are not subject to regulations in the federal Food Drug & Cosmetic Act.
The determination could open the door for other dissolvable tobacco products, such as R.J. Reynolds Tobacco Co.’s Camel orbs, sticks and filmlike strips for the tongue, to also not be subject to FDA regulation.
The industry, led by Reynolds, has put more focus on smokeless tobacco as a revenue source in recent years as the number of U.S. adults who smoke has dropped to about 20 percent.
According to the federal act, smokeless tobacco is defined as “any tobacco product that consists of cut, ground, powdered or leaf tobacco, and that is intended to be placed in the oral or nasal cavity.”
he FDA verified Deyton’s statement that “not all tobacco products are currently subject” to the act. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject.
Jeffery Ventura, a spokesman for the FDA, said that the agency “recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products.
“The FDA is considering its legal and regulatory options regarding these products.”
Refwerence: Two tobacco products free of FDA oversightt, smokersinfo.net, 3/24/2011.
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