On September 10, 2003, the Food and Drug Administration (FDA) advised consumers not to consume "teas" brewed from star anise. It has come to FDA’s attention that brewed "teas" containing star anise have been associated with illnesses affecting about 40 individuals, including approximately 15 infants. The illnesses, which occurred over the last two years, ranged from serious neurological effects, such as seizures, to vomiting, jitteriness and rapid eye movement.

Although the labeling of "teas" that contain star anise does not make claims for the product, FDA understands that these products are popularly believed to help against colic in infants. FDA is unaware of scientific evidence to support benefits from "teas" brewed from star anise. Given that fact, consumers should not use them or give them to infants and children.

FDA has not yet identified the specific type of star anise associated with the illnesses. For this reason, the agency is issuing this advisory as an interim measure while it continues to gather additional information, including that from some European countries that have reported similar outbreaks of seizures in individuals who have consumed tea brewed from star anise.

"One of FDA’s highest priorities is to make sure that consumers have accurate information about the products FDA regulates," said FDA Commissioner Mark B. McClellan. "This case illustrates that FDA will take action to protect consumers against products that may pose health risks."

FDA is concerned that commonly available Chinese star anise (Illicium verum), a product considered by FDA to be generally recognized as safe (GRAS), may contain Japanese star anise (Illicium anisatum), which has long been recognized as toxic in many countries and which should be used for decorative purposes only. At this time, FDA cannot determine if the star anise associated with the illnesses was associated with Japanese star anise or a mixture of Chinese and Japanese star anise.

Japanese star anise in its dried or processed form cannot be distinguished from Chinese star anise through visual examination. Therefore, FDA is evaluating chemical analytical methods that will differentiate between the two species of star anise. Until FDA is able to differentiate between Japanese and Chinese star anise, it is advising the public not to consume "tea" brewed from any star anise. As part of its ongoing efforts to protect consumers from unsafe products, FDA will monitor imports of star anise entering the United States from various countries to ensure that any imports of Japanese star anise are not labeled or otherwise indicated for use as a food.

FDA considers Chinese star anise to be GRAS when used as a spice or flavoring; Japanese star anise is not GRAS. GRAS status means that a food substance is considered by qualified experts to be safe for is intended use. Safety must be adequately shown through scientific procedures and/or experience based on a common history of use in food, depending on the substance.

The initial reported illnesses were identified retrospectively through a record review after a resident physician from Miami Children’s Hospital treating an infant with seizures associated with the ingestion of a star anise-containing tea reported his findings to the Florida Poison Information Center (FPIC). FPIC then reported the findings to the FDA.

All the affected individuals, including infants, involved in these reported cases recovered without complications.

FDA has since learned of similar reports from Florida, Illinois, New Jersey, Texas, and Washington as well as the Netherlands, France, and Spain.