In an initiative that some might place under the “about time” category, the FDA yesterday reported launch of a Nanotechnology Task Force, charged with determining regulatory approaches that encourage the development of FDA-regulated products that use nanotechnology materials.

In a statement, the agency said that the tasks force “will identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials.” It said it will address these “product-specific . . . issues on an ongoing basis.”

The statement provided no information concerning the membership of this group.

The task force will:

  • Chair a public meeting on Oct. 10 to help FDA further its understanding of developments in nanotechnology materials, including issues pertaining to biological interactions that may lead to either beneficial or adverse health effects.
  • Assess the current scientific knowledge concerning nanotechnology materials for carrying out FDA's mission.
  • Evaluate the effectiveness of the agency's regulatory approaches to meet any challenge presented by the use of nanotechnology materials in FDA-regulated products.
  • Explore opportunities to foster innovation using nanotechnology materials to develop drugs, biologics and devices, and to develop safe foods, feeds, and cosmetics.
  • Strengthen FDA's relationships with other federal agencies, and international regulatory bodies, professionals and other stakeholders to gather information regarding nanotechnology materials.
  • Consider vehicles for communicating to the public concerning issues in nanotechnology.

The Task Force is being asked to submit its initial findings and recommendations to Andrew von Eschenbach, MD, acting commissioner of the agency, within nine months after the Oct. 10 meeting.

“As this exciting new area of science develops, FDA must be positioned to address both health promotion and protection challenges that it may present,” von Eschenbach, MD, said. “Through this task force, we are leveraging our expertise and resources to guide the science and technology in the development of nanotechnology-based applications.”

PET identifies 'few puffs' addiction

The newest advanced imaging systems have been used to look at all sorts of mental processes, and so it is not particularly surprising that these systems are being used to consider the problems of addition.

The National Institute on Drug Abuse (NIDA) of the NIH (Bethesda) has just reported findings concerning the use of positron emission tomography, which it said demonstrated the addictive quality of nicotine.

It said the study showed that the nicotine received in just a few puffs of a cigarette appears to “exert a force powerful enough” to drive continued smoking – and thus the addiction.

The researchers found that the amount of nicotine contained in just one puff of a cigarette can occupy about 30% of the brain's most common type of nicotine receptors, while three puffs of a cigarette can occupy about 70% of these receptors.

“When nearly all of the receptors are occupied (as a result of smoking at least 2 and one-half cigarettes), the smoker becomes satiated, or satisfied, for a time. Soon, however, this level of satiation wears off, driving the smoker to continue smoking throughout the day to satisfy cigarette cravings,” according to a NIDA statement.

Arthur Brody, MD, of the David Geffen School of Medicine at UCLA (Los Angeles) and his team used PET to scan the brains of 11 smokers and assess nicotine distribution there. During the scanning sessions, the participants smoked one of five amounts — none, one puff, three puffs, one full cigarette, or until their craving was satisfied (2-1/2 to three cigarettes). Craving was measured with the “Urge to Smoke” scale, which assesses responses to 10 craving-related questions. The scientists also conducted MRI to help localize regions on the PET scans.

“This study illustrates the powerfully addictive impact of even small amounts of nicotine. Every time a smoker draws a puff from a cigarette, they inhale numerous toxic chemicals that promote the formation of lung cancer, and contribute in a significant way to death and disability worldwide,” said NIDA Director Dr. Nora Volkow.

“We saw on our PET scans that the radiotracer 'disappeared' over time as the nicotine receptors became occupied by nicotine from cigarettes,” said Brody.

The scientists found that the highest levels of nicotine binding occurred in the thalamus (a portion of the brain that acts as a conduit for all sensory information that reaches the brain's cerebral cortex, and which contains the highest concentration of these nicotine receptors), the brainstem (which controls various automatic functions, such as respiration, heart rate, and arousal), and the cerebellum (the portion of the brain responsible for the coordination of movement and balance).

Results of another recently published NIDA-supported study suggest that a portion of the cerebellum called the vermis may be a key factor in modulating the brain's dopamine and reward systems, and may be more involved in drug abuse and addiction than previously thought.

“Although craving was only reduced with near total occupancy of these receptors, there remains the question of whether other, less common types of nicotine receptors are equally important in tobacco dependence,” said Brody. “This is an important area of focus for future research.”

The study appears in the August 2006 issue of the Archives of General Psychiatry.