Washington -- PETA today submitted official comments to the Food and Drug Administration (FDA) regarding the agency's Draft Guidance for Industry: Modified Risk Tobacco Product [MRTP] Applications, which, as currently written, will lead to animal studies being conducted in support of MRTP applications. PETA, along with hundreds of consumers who submitted comments to the FDA through an action alert on PETA's popular website, is calling on the FDA to amend its guidance to recommend using only modern, effective non-animal testing methods--including computer simulation, tests using human cells, and clinical studies with human smokers--that are widely available and are the required tests in Canada. Belgium, Germany, the U.K., and other countries have all banned the testing of tobacco products on animals.
"Everyone knows that tobacco products are inherently hazardous, addictive, and deadly and that decades of animal tests did not predict the link between smoking and cancer," says PETA Vice President of Laboratory Investigations Kathy Guillermo. "PETA is calling on the FDA to make it clear, once and for all, that no more animals should suffer and die in tests for new tobacco products, 'less harmful' or not."
PETA recommends evaluation of toxicity in vitro be completed and submitted and MRTP applications be made public prior to commencement of any further studies, since many products will be similar to other tobacco products currently on the market, perhaps differing only in the concentration of one or more constituents already known to be harmful or potentially harmful. Laboratory analyses and evaluation in vitro should suffice to identify products of this type that are particularly risky or lack potential to reduce risk and harm. Development of such products need proceed no further, since any additional studies would be unlikely to restore confidence. For products that are not particularly risky, it should be possible to select clinical exposures that are not more risky than those from study participants' current tobacco use without first conducting animal studies.
A copy of PETA's comments to the FDA is available upon request.