comments were submitted by PETA today 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Administration (FDA) regarding the agency's Draft Guidance for Industry: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. Along with hundreds of consumers, PETA 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.