California Proposition 65 requires manufacturers to provide clear and reasonable warnings to consumers before exposing them to over 950 listed carcinogens, including acrylamide.  As reported in this blog yesterday, California’s regulations for reporting the presence of the carcinogens have changed.  Also as previously reported in this blog, producers of roasted coffee have been sued under Proposition 65 for failing to declare the presence of acrylamide in coffee.  In June, California’s Office of Environmental Health Hazard Assessment (OEHAA) proposed a regulation that would exempt coffee from required Proposition 65 warnings, based on an extensive scientific review of coffee’s health effects.

On August 29, FDA issued a statement supporting California’s decision to exempt coffee from the required Proposition 65 warning for acrylamide.  In the statement, FDA Commissioner Scott Gottlieb, M.D., noted that FDA has the authority to regulate the labeling of food to prevent statements that are false or misleading in any particular.  Of particular note, the statement reads, “if a state law purports to require food labeling to include a false or misleading statement, the FDA may decide to step in.”

FDA’s position is that state labeling requirements for products regulated by FDA can be preempted by FDA regulation if the labeling requirement is inconsistent with FDA requirements.  Inportantly, FDA extends this argument to labeling statements that, upon scientific scrutiny, are determined to be false or misleading.  Dr. Gottlieb’s statement is consistent with the Accurate Labels Act, which many believe would eviscerate Proposition 65.  Manufacturers of FDA regulated products may now have more success raising FDA labeling requirements as a defense against state mandated warnings that are not supported by the weight of scientific evidence.