While modified risk tobacco products could be one part of a comprehensive strategy to lower tobacco-related death and disease in the U.S., especially among tobacco users who are unable or unwilling to quit entirely, little is currently known about the products' health effects and whether they pose less risk than traditional tobacco products. Examples of modified risk tobacco products may include e-cigarettes and tobacco lozenges.
Companies and other sponsors developing modified risk tobacco products should consider using FDA-approved independent third parties to oversee health and safety research on their products, adds the report, which was completed to fulfill a congressional mandate. Independent oversight would ensure that the data submitted to FDA are reliable and credible, and it could help re-engage the mainstream scientific community in research. Because of the tobacco industry's well-documented history of improper conduct, many institutions and scientists currently refuse to conduct or publish research supported by the tobacco industry.
"Right now there's a shortage of scientific evidence on the health effects of modified risk tobacco products, and the tobacco industry currently lacks the trustworthiness, expertise, and infrastructure to produce it," said Jane Henney, chair of the committee that wrote the report, and professor of medicine and public health sciences at the University of Cincinnati. "Having trusted third parties oversee the conduct of research could help re-engage scientists and enable generation of credible research data on the health effects of these products."
The Family Smoking Prevention and Tobacco Control Act of 2009 requires that modified-risk tobacco products undergo a pre-market approval process similar to drugs and devices. According to the act, a company that wants to market a lower risk tobacco product in the U.S. must offer scientific proof to FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole. The act also directed FDA to consult with IOM on how scientific studies of modified risk tobacco products should be designed and conducted.
The IOM's report says that the studies should examine all of the areas needed to forecast and monitor a proposed product's impact on public health, including its composition and addiction potential; the amount of human exposure to harmful components; perceptions about the product's effects and likelihood of addiction; and effects on human health. Studies should be generalizable to the whole population and should also include populations of special relevance, including current and former smokers, beginning smokers, adolescents, and populations at high risk for tobacco use.
While studies submitted to FDA to demonstrate products' safety are usually conducted or sponsored by the companies themselves, the tobacco industry at present lacks the capacity and expertise to conduct such research, the report says. The industry's history of improper manipulation of data undermined the credibility of its research and left it isolated from the mainstream scientific community. Many major universities have policies against acceptance of tobacco funding, for example, and many high-impact scientific and medical journals will not accept manuscripts supported by the tobacco industry.
Using independent, FDA-approved third parties to conduct, provide oversight of, and distribute funding for research could distance the influence and reputation of the tobacco industry from the scientists who are researching their products. Examples of third-party partnerships between industry and government include the Health Effects Institute and the Reagan-Udall Foundation. No similar organization currently exists for the tobacco industry.
Making data publicly available will also build public trust and will allow for independent analysis of data and methods, the report says. FDA should require sponsors of modified risk tobacco products to place all data generated during a product's development and marketing in a public repository selected by the agency.
FDA should also require that studies offered in support of an application to market modified risk tobacco products conform to established standards of good research governance, including appropriately qualified investigators, transparency, independent institutional review board or ethical review, and adherence to federal regulations that ensure the protection of human participants in biomedical research.
The study was sponsored by the Food and Drug Administration. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. For more information, visit http://national-academies.org or http://iom.edu. A committee roster follows.Date: Dec. 14, 2011
[ This news release and report are available at http://national-academies.org ]INSTITUTE OF MEDICINE
Bill Kearney | EurekAlert!
Using fragment-based approaches to discover new antibiotics
21.06.2018 | SLAS (Society for Laboratory Automation and Screening)
Scientists learn more about how gene linked to autism affects brain
19.06.2018 | Cincinnati Children's Hospital Medical Center
Russian researchers together with their French colleagues discovered that a genuine feature of superconductors -- quantum Abrikosov vortices of supercurrent -- can also exist in an ordinary nonsuperconducting metal put into contact with a superconductor. The observation of these vortices provides direct evidence of induced quantum coherence. The pioneering experimental observation was supported by a first-ever numerical model that describes the induced vortices in finer detail.
These fundamental results, published in the journal Nature Communications, enable a better understanding and description of the processes occurring at the...
In a recent publication in the renowned journal Optica, scientists of Leibniz-Institute of Photonic Technology (Leibniz IPHT) in Jena showed that they can accurately control the optical properties of liquid-core fiber lasers and therefore their spectral band width by temperature and pressure tuning.
Already last year, the researchers provided experimental proof of a new dynamic of hybrid solitons– temporally and spectrally stationary light waves resulting...
Scientists from the University of Freiburg and the University of Basel identified a master regulator for bone regeneration. Prasad Shastri, Professor of...
Moving into its fourth decade, AchemAsia is setting out for new horizons: The International Expo and Innovation Forum for Sustainable Chemical Production will take place from 21-23 May 2019 in Shanghai, China. With an updated event profile, the eleventh edition focusses on topics that are especially relevant for the Chinese process industry, putting a strong emphasis on sustainability and innovation.
Founded in 1989 as a spin-off of ACHEMA to cater to the needs of China’s then developing industry, AchemAsia has since grown into a platform where the latest...
The BMBF-funded OWICELLS project was successfully completed with a final presentation at the BMW plant in Munich. The presentation demonstrated a Li-Fi communication with a mobile robot, while the robot carried out usual production processes (welding, moving and testing parts) in a 5x5m² production cell. The robust, optical wireless transmission is based on spatial diversity; in other words, data is sent and received simultaneously by several LEDs and several photodiodes. The system can transmit data at more than 100 Mbit/s and five milliseconds latency.
Modern production technologies in the automobile industry must become more flexible in order to fulfil individual customer requirements.
13.06.2018 | Event News
08.06.2018 | Event News
05.06.2018 | Event News
25.06.2018 | Physics and Astronomy
25.06.2018 | Earth Sciences
25.06.2018 | Power and Electrical Engineering