WASHINGTON, D.C., June 4, 2013—In response to a press release issued yesterday by the Center for Science in the Public Interest (CSPI) calling on FDA to prohibit the sale of Ginkgo biloba, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, today issued the following statement:
Statement by Steve Mister, President & CEO, CRN:
“Ginkgo biloba has literally been used for thousands of years, and this attempt by CSPI to discredit this safe and beneficial dietary supplement demonstrates an irresponsible misinterpretation of both the science and the intent of the National Toxicology Program (NTP) in reviewing ginkgo. This premature evaluation from CSPI reveals an abuse of its position, a lack of understanding about the regulation of food by FDA, and presents a true disservice to consumers.
CSPI’s request to FDA to ban ginkgo is based on an NTP report examining high doses of ginkgo force-fed to mice and rats. However, in the second paragraph of the report’s Foreword, NTP states: ‘Extrapolation of these results to other species, including characterization of hazards and risks to humans, requires analyses beyond the intent of these reports.’ NTP conducts toxicological tests on hundreds of thousands of substances, with thousands of similar conclusions, most of which are determined to be of no risk to humans after a risk assessment is complete, which is the standard scientific method employed by the toxicologists and the federal government to determine whether a substance increases cancer risk.
In response to CSPI’s request, FDA responded in part by saying, ‘…it is not scientifically valid to conclude with certainty that dietary supplement products containing Ginkgo biloba are unsafe based solely on data from the new NTP study. In the study, rats and mice were fed amounts of Ginkgo biloba extracts (by body weight) that may be considerably greater from those which a consumer would normally ingest from a dietary supplement product containing Ginkgo biloba. In addition, there may be differences in the extract used in these studies in contrast to what is available on the market for Ginkgo biloba dietary supplements.’”