Less Risky Tobacco Product? Only if the Science Says So

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• Preventing a Repeat of History
• Providing an Accurate Sense of Risk

No tobacco product is safe.

But some could be more dangerous than others.

The Tobacco Control Act, which was signed into law in 2009, created a path that companies may use to bring to the market products that are less harmful or reduce the risk of tobacco-related disease. FDA is asking for public comment on draft guidelines for the tobacco industry regarding scientific evidence the industry must submit to FDA to be able to sell and market such products, which are defined as Modified Risk Tobacco Products (MRTP).

"We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers," said FDA Commissioner Margaret Hamburg, M.D. "We are committed to stopping practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death."

FDA is particularly concerned about the impact of misleading marketing on kids because an estimated 4,000 youths start smoking every day and 1,000 of them become regular smokers. According to the Centers for Disease Control and Prevention, tobacco-related illness is the leading, preventable cause of death in the United States—causing more than 440,000 deaths each year. More than 8.6 million Americans have chronic illnesses attributable to smoking.

FDA's goal is to reduce the number of tobacco-related deaths and chronic illnesses, says Lawrence Deyton, M.S.P.H., M.D., director of FDA's Center for Tobacco Products (CTP). "Today, FDA is taking a big step toward implementing this requirement by explaining these standards and providing its thinking about the scientific evidence required for the sale of a modified risk product."

Preventing a Repeat of History

FDA wants to make sure that consumers do not repeat their experience with light and low-tar cigarettes, Deyton explains.

Cigarette makers started using the light, low-tar and similar labels after a 1964 Surgeon General's report linking smoking to cancer. As rates of American adults who smoked began to decline, tobacco companies changed the design of cigarettes and used adjectives like "light," "mild," or "low," to imply that these new brands were less harmful. This marketing persuaded many smokers to keep smoking instead of quitting. But experts found that they were no safer than regular cigarettes.

Congress ultimately determined that prohibiting the use of these and similar descriptions is necessary to protect the public health and to ensure that tobacco product labeling and advertising are not misleading, except where it is shown that a product with any of those descriptions can actually be expected to reduce harm or risk and consumers will understand the claim. The law now prohibits the use of such descriptions in tobacco product labeling or advertising unless an FDA order allows them.

Deyton says that tobacco companies now have to demonstrate to FDA with scientific evidence why a specific product may be marketed to reduce the risk or harm associated with the use of tobacco products—a label that will actually mean what "light," "mild," or "low" tried to imply.

Providing an Accurate Sense of Risk

The Family Smoking Prevention and Tobacco Control Act that was passed by Congress and signed by President Obama in 2009 gives FDA the authority to allow marketing of modified-risk products only if a company meets the criteria established in the law.

FDA must make sure that modified-risk claims are backed by sound scientific evidence and that advertising and labeling enable the public to understand these claims in relation to total health, and all of the diseases and health-related conditions associated with the use of tobacco products.

These criteria also require that the product, as actually used by consumers, will benefit or is expected to benefit, the health of the population as a whole, taking into account both users and non-users of tobacco products.

Even if FDA issues an order to permit the sale of a modified-risk product, the order is not permanent. Under the Tobacco Control Act, FDA may only issue a modified-risk order for a limited period of time. Before a company is able to renew an order, it will have to submit data demonstrating that the modified risk tobacco product still meets all the criteria in the Tobacco Control Act.

Because FDA has not yet issued an order permitting the sale of an MRTP, FDA can't yet say what kinds of modified risk products might be permitted under this authority. An order permitting the marketing of an MRTP may only refer to a single specific product; it may not apply to an entire class of tobacco products.

CTP has more information on FDA's draft guidance document.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

March 30, 2012