California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of intent to list clomiphene citrate as a chemical known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). According to the agency, the chemical, a prescription drug used to treat infertility in women, has a Food and Drug Administration (FDA)-approved label which cautions users that prolonged use “may increase the risk of borderline or invasive ovarian tumor” and that “Ovarian cancer has been infrequently reported in patients who have received fertility drugs.”
Noting that this is a “ministerial” listing, OEHHA says that it cannot “consider scientific arguments concerning the weight or quality of the evidence considered by FDA when it established the labeling requirement.” Comments are requested by May 6, 2013, “limited to whether FDA requires that clomiphene citrate be labeled to communicate a risk of cancer or tumors.” If the chemical is added to the Prop. 65 list, California consumers must be informed that it is a substance known to the state to cause cancer. See OEHHA News Release, April 5, 2013.