Modified-risk tobacco products like e-cigarettes and tobacco lozenges, products that may reduce health risks of using tobacco, need to go through a rigorous scientific evaluation before being approved to be marketed as low-risk by the Food and Drug Administration, according to a report issued on Wednesday by the Institute of Medicine.
Furthermore, to ensure that the results submitted to the FDA are reliable and credible, the IOM specifically states that the FDA should not rely on research from tobacco companies, but instead use an FDA-approved independent third party to oversee the health and safety research of the products to ensure that the results submitted to the FDA are reliable and credible.
“The industry’s history of improper manipulation of data undermined the credibility of its research and left it isolated from the mainstream scientific community,” the IOM said in a release.
"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. “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 IOM reported that only about 6 percent of smokers are able to successfully quit tobacco use, and because quitting is so difficult, many smokers will probably want products that allow them to continue smoking with less health risks, and because there is no research that proves that modified-risks tobacco products to be safer than traditional cigarettes, these new products can ultimately be just as risky as regular cigarettes.
The Family Smoking Prevention and Tobacco Control Act of 2009 require that modified risk tobacco products go through an approval process comparable to medical drugs and devices.
The act states that the FDA must be presented with scientific proof to show that not only will the product reduce harm to individual users, but it also benefits the health of the general population in order for it to be marketed. The act also directed FDA to consult with IOM on how studies should be designed and conducted.
The American Lund Association also released a statement on Wednesday and praised the IOM recommendations.
“The American Lung Association commends the IOM for its recognition that if a tobacco product is allowed to be marketed as ‘safer’ that the product must actually be safer,” said Charles D. Connor, President and CEO of the American Lung Association in a statement.
“Decades ago the tobacco industry developed light and low tobacco products that were no less harmful than those already on the market. Millions of Americans, who switched to those so-called ‘light’ and ‘low-tar’ products instead of quitting, died as a result of these claims,” he said.
The scientific standards recommended by this expert panel are designed to prevent a repeat of similar attempts to deceive the American public. We encourage the FDA to heed these lessons and never lose sight of the deception and fraud perpetrated for decades by Big Tobacco,” Connor added.