PCRM Asks U.S. Food and Drug Administration to End Tobacco Tests on Animals

The Physicians Committee

PCRM Asks U.S. Food and Drug Administration to End Tobacco Tests on Animals

Millions of primates, dogs, rats, and mice have been used to test the hazards of tobacco products, including cigarettes. The results of these animal tests are not predictive of human addiction, behavior, or health outcomes. But the U.S. Food and Drug Administration recently recommended that tobacco companies use animal tests to prove certain tobacco products are safer than others. PCRM has collected nearly 15,000 petitions asking FDA commissioner Margaret Hamburg to revise this guidance to remove recommendations for animal experiments.

For decades animals have been forced to “smoke” in contrived laboratory experiments, yet thousands of people still die due to tobacco-related illnesses. Tobacco kills more than 1,200 Americans each day. Congress recently passed a law that would prevent the labeling of tobacco products as “light” or “mild” unless a tobacco company can prove that its product significantly reduces the risk of tobacco-related disease to tobacco users and benefits the health of the population as a whole. The FDA, charged by the law to regulate tobacco products, has now offered Modified Risk Tobacco Product Applications: Draft Guidance for Industry that includes the use of animal tests.

The Institute of Medicine’s recent report Scientific Standards for Studies on Modified Risk Tobacco Products says “it is not possible to make laboratory animals use tobacco products the way humans do, and there are inherent interspecies differences that prevent meaningful extrapolation of human effects.” Even tobacco industry scientists have stated that that “in vitro toxicology tests can be successfully used both for better understanding the biological activity of cigarette smoke...and for guiding the development of cigarettes with reduced toxicity.”

Tobacco products should only be tested using the best methods and strategies. Tobacco companies can and should rely on human-relevant in vitro studies and clinical investigations to develop lower risk products—not animal models.

The FDA must ensure that industry does not conduct ineffective and wasteful animal tests with tobacco products.