The American Herbal Products Association (AHPA), Silver Spring, MD, filed comments in September related to FDA’s estimates of the costs and benefits associated with the agency’s proposed current good manufacturing practices (cGMPs) for dietary supplements. AHPA had submitted comments to the proposed rule in August to address most of the issues that AHPA member companies had identified as important. AHPA had also requested and obtained an additional 30 days to file comments on the economic factors as well. The document submitted to FDA expressed concerns that the agency may have, in analyzing the economic impact of the proposed rule, overstated the economic benefits and understated the costs. While FDA stated that the annual benefit of the proposed cGMP would be $218 million, AHPA suggested that the actual benefit may only be $21 million, or even less. Similarly, FDA calculated the annual industry cost to be $86 million, while AHPA’s evaluation estimated the actual cost to be at least $700 million if the agency failed to consider appropriate modifications to the rule.

In other developments, FDA issued an advisory to consumers to avoid the consumption of teas brewed from star anise. The agency stated that it has become aware of at least 40 reports of individuals, including about 15 infants, who became ill after consuming “brewed teas” that contained star anise. The agency also noted that all the affected individuals recovered without complications. The agency made no mention of dietary supplements containing star anise and AHPA said it has been informed that none of the reported cases have been associated with dietary supplement products. In addition, while FDA did not identify the part of the plant that was used in the “brewed teas,” AHPA understands that at least some of the reported cases were associated with the plant’s flowers. It is generally the dehydrated fruit of star anise that is found in commerce. The agency stated in its advisory that it has not identified the particular species of star anise that was used by the affected individuals. The true star anise (Illicium verum), identified by FDA as “Chinese star anise,” is generally recognized as safe (GRAS) for use in foods. On the other hand, species such as Japanese star anise or shikimi (I. anisatum) and native North American species such as Florida anise (I. floridanum) are known to be toxic. FDA stated that the cases have occurred over the past two years, primarily in southern Florida but also in Illinois, New Jersey, Texas and Washington. Symptoms have included serious neurological effects, such as seizures, as well as vomiting, jitteriness and rapid eye movement. The agency recommended that consumers refrain from using teas brewed from star anise as well as refrain from giving them to children or infants. According to AHPA, there are notable morphological differences between the fruit of true star anise and that of Japanese star anise when these articles are examined in whole form. In addition, the composition of the volatile compounds in these two species differs considerably. I. verum, for example, contains a significant amount of anethole, and safrole is either absent or is found in only trace amounts in this species. On the other hand, I. anisatum is high in safrole.