This notice is brought to you by the OEHHA.
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical identified in the table below as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.1 This action is being proposed under the “formally required to be labeled or identified” listing mechanism.2
OEHHA’s determination: Clomiphene citrate has been identified or labeled to communicate a risk of cancer in accordance with formal requirements by the U.S. Food and Drug Administration (FDA).
clomiphene citrate
Cancer Endpoint (Under PRECAUTIONS and Adverse Reactions)
Under PRECAUTIONS: “Prolonged use of clomiphene citrate tablets USP may increase the risk of borderline or invasive ovarian tumor (see ADVERSE REACTIONS).”
Under ADVERSE REACTIONS: “Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiphene may increase the risk of a borderline or invasive ovarian tumor.”
Request for comments: OEHHA is requesting comments as to whether this chemical meets the criteria set forth in the Proposition 65 regulations for listings via the formally required to be labeled or identified mechanism (Section 25902).
For more information and the full notice please refer to the link above.
Nexreg Compliance