03-30-12 FDA Acts to Stop Tobacco Industry Deception About Health Risks
March 30, 2012
WASHINGTON, DC - For decades, the tobacco industry has deceived the public about the health risks of tobacco products, most prominently in its fraudulent marketing of light and low-tar cigarettes as a safer alternative. Today, the U.S. Food and Drug Administration has taken action to prevent a repeat of the industry's deception and ensure that any future health claims about tobacco products are supported by sound science and do in fact reduce the death and disease caused by tobacco use. For the first time, we have a policy that places protecting public health over promoting the tobacco industry's products and profits.
The message to tobacco companies is clear: If they want to make health claims about their products, those claims must be supported by the science, they have to benefit public health, and they must be marketed in a way that does not increase youth tobacco use or discourage quitting. This is the right approach given the tobacco industry's long history of deception and the magnitude of the health problems caused by tobacco use, the nation's number one cause of preventable death.
Under the 2009 law granting the FDA authority over tobacco products, tobacco companies are prohibited from claiming that a tobacco product is less harmful without first providing the FDA with extensive scientific evidence supporting the claim and demonstrating that it will benefit public health as a whole, and not just individual tobacco users. Today, the FDA told tobacco companies that it will rigorously enforce the strong public health standard set by the law and require an appropriately wide range of scientific evidence to support any claims the companies seek to make. For the first time, tobacco companies will have to conduct rigorous science before making health claims and prove to a government agency that they are telling the truth about their products.
Importantly, the FDA's directive recognizes the need to evaluate not only the contents and health effects of the products involved, but also whether the products' labeling and marketing would attract new tobacco users or discourage current users from quitting.
This approach is critical to properly enforcing the law. Before allowing any "modified risk" claim about a tobacco product, the law requires the FDA to determine based on the scientific evidence that the product "as it is actually used by consumers, will (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole," taking into account both users and non-users of tobacco products. In other words, the FDA must ensure that any reduction in harm to individual tobacco users is not offset by increasing the number of people, including kids, who start using tobacco or reducing the number of current tobacco users who quit. The FDA's directive follows closely the requirements set forth by Congress.
The FDA has taken seriously its responsibility to enforce the law and appropriately put the burden of proof on tobacco manufacturers to show that they telling the truth about their products and that they will market their products in a responsible way.