New report identifies research needed on 'modified risk' tobacco products

A new Institute of Medicine report specifies the types of research that the Food and Drug Administration should require before allowing tobacco companies to sell or advertise 'modified risk' tobacco products as being capable of reducing the health risks of tobacco use. 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 and 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 .

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 .

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 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.

add to favorites email to friend print save as pdf

Related Stories

FDA: Agency must review tobacco products

Jan 05, 2011

(AP) -- The Food and Drug Administration says it must review tobacco products that were introduced or changed over the last four years in order for companies to keep selling them.

Virginia tobacco maker seeks new FDA designation

Jan 04, 2011

(AP) -- Tobacco maker Star Scientific Inc. says it has developed a moist smokeless tobacco with lower levels of cancer-causing chemicals than any other tobacco product now on the market.

Researches link tobacco industry's marketing to youth smoking

Aug 21, 2008

The National Cancer Institute (NCI) released a report, co-edited by University of Minnesota professor Barbara Loken, that reaches the government's strongest conclusion to date that tobacco marketing and depictions of smoking ...

Recommended for you

Electronic health records tied to shorter time in ER

54 minutes ago

(HealthDay)—Length of emergency room stay for trauma patients is shorter with the use of electronic health records, according to a study published in the September issue of the Journal of Emergency Nursing.

CDC: Almost everyone needs a flu shot

5 hours ago

(HealthDay)—Less than half of all Americans got a flu shot last year, so U.S. health officials on Thursday urged that everyone 6 months and older get vaccinated for the coming flu season. "It's really unfortunate ...

User comments