FDA, NIH Create 14 Centers For Tobacco Research

The Food and Drug Administration and the National Institutes of Health are awarding millions in funding to create 14 centers to conduct research on tobacco products.

Officials said Thursday that the agencies have awarded up to $53 million for fiscal 2013 for the Tobacco Centers of Regulatory Science, mostly at universities around the country. The centers can eventually receive more than $273 million over the next five years for research on marketing of tobacco products, adverse health consequences, ways to reduce addiction and toxicity, economics, policies and communications, as well as so-called modified risk tobacco products and electronic cigarettes — battery-powered devices made of plastic or metal that heat a liquid nicotine solution, creating vapor that users inhale.

The federal agencies said the centers will help shape regulations on tobacco products with the aim of protecting the public health and reducing the death and disease caused by tobacco use. “The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation,” FDA Commissioner Margaret Hamburg said in a statement.

Among the multi-year grants is more than $18 million for researchers at Virginia Commonwealth University in Richmond to study methods for evaluating modified risk tobacco products and other tobacco products. VCU’s work will include research in engineering, clinical behavior and randomized control trials to study the effects of tobacco products. “It’s not always clear how best to regulate the vast array of tobacco products that are out there, especially the newer ones like electronic cigarettes,” said Thomas Eissenberg, professor of psychology and director of VCU’s Clinical Behavioral Pharmacology Laboratory. “We at VCU have absolutely no preconceived notions about these products. The whole basis behind science-based regulation is that we need to let the data guide us when it comes to regulating novel tobacco products.”

The 2009 Family Smoking Prevention and Tobacco Control Act gave the federal government authority, for the first time, to regulate tobacco products, including the ability to ban certain products, regulate marketing, reduce nicotine in tobacco products and block labels such “low tar” and “light.” The law also gives the FDA authority to evaluate tobacco products for their health risks and lets the agency approve ones that could be marketed as less harmful than what’s currently for sale. In addition to VCU, the network includes the American Heart Association, the University of Maryland, Georgia State, the University of California-San Francisco, the University of Vermont, the University of Pennsylvania, Yale, Penn State, the University of Southern California, the University of Texas, Ohio State and two centers at the University of North Carolina at Chapel Hill.

Source: http://washington.cbslocal.com/2013/09/19/fda-nih-create-14-centers-for-tobacco-research/

FDA: Tobacco companies must report chemical

Tobacco companies are required to report the level of hazardous substances contained in cigarettes, chew, and other products according to the latest rules aimed at tightening regulation of the tobacco industry.

Preliminary guidance on Friday by the Food and Drug Administration will be the first tobacco manufacturers will be required to report on the number of 20 chemicals linked to cancer, lung disease and other health problems. FDA will publish information in a consumer-friendly format in the following April.

"Cigarettes are only a mass product is consumed in this country, for which consumers are not aware that they are still," said Dr. Lawrence Deyton, director of the FDA tobacco center, in an interview with Associated Press.

Ammonia, carbon monoxide and formaldehyde is a component or by-products of tobacco, which are subject to new rules.
Regulators have identified more than 93 harmful or potentially harmful chemicals in tobacco products, although the agency account for only 20 for the coming year. The Agency will accept comments until June 4 manual. There is no date when the documents will be final.

The law, passed in 2009 gave the FDA power to regulate some aspects of tobacco marketing and production, although the agency can not prevent nicotine. FDA has also granted the right to set standards for levels of harmful ingredients in tobacco products, although the agency does not use that power.

The same law allows the agency to adopt new tobacco products that can be marketed as safer than what is currently for sale.
In separate guidance on Friday, FDA presented research this will require, before any company can sell the so-called change-risk tobacco products. Companies must provide a comprehensive test data on health risks for users and not users, changing consumer behavior and understanding of marketing materials for new products.
"The law sets a high standard to ensure that tobacco products are sold to reduce the risk actually reduces the risk," said Deyton.

Processing of the FDA-modified risk products was highly anticipated by both public health and the big tobacco companies who are looking for new products to sell, as they face declining demand due to an increase in cigarette taxes, health problems, smoking bans and social stigma.

Some tobacco companies have alternatives like snus - little bags, like tea bags that users stick between the cheek and gum - and dissolving tobacco - finely ground tobacco in the form of spheres, rods and strips. But they obviously are not positioned as a less risky as cigarettes.
FDA requires responding to the statement by the company within one year after its introduction and adoption. FDA officials would not comment on how many applications were filed to date.