CSPI Calls on FDA to Prohibit Sale of Ginkgo in Wake of Cancer Study

4 June 2013 --- Following a government report that the herbal ingredient Ginkgo biloba causes cancer in lab animals, the nonprofit Center for Science in the Public Interest is urging the Food and Drug Administration to prohibit its use in foods and dietary supplements.

The watchdog organization says the FDA should give the industry a reasonable time to comply with such a directive and then seize whatever products remain on shelves to protect consumers.

A March report from the National Toxicology Program found "clear evidence" that Ginkgo caused liver cancer in mice and "some evidence" that Ginkgo caused thyroid cancer in rats. Researchers from NTP told the New York Times that the number of cancers found in the mice exceeded the numbers ever seen before in their lab. While the supplement industry argued that the NTP used an extract of Ginkgo not used in supplements sold in the United States, the NTP says the composition of the extract it tested falls within the range of what is sold.

"It used to be the case that the only problems associated with Ginkgo were the unfounded and deceptive claims by manufacturers that it helped memory," said CSPI executive director Michael F. Jacobson. "Now we know these make-believe benefits are far outweighed by a real risk of cancer."

Citing the NTP report, the FDA has already told one beverage maker, Stewart Brothers, Inc., that Ginkgo is not generally recognized as safe in food. It is harder for the agency to remove supplement ingredients from the market, but it may if it finds that an ingredient poses an unreasonable risk of illness or injury.

Ginkgo is found in single-ingredient supplement pills made by Natrol, GNC, Solaray, Now, and Nature's Way, as well as in multi-ingredient products such as Bayer One A Day Women's 50 Plus Advantage. It is used in some energy drinks, such as several varieties of Rockstar and Hansen's Energy Pro, Guru, and Steven Segal's Lightning Bolt, and in Redco Foods' Salada "Brain Boost" green tea and Yogi Tea's Ginkgo Clarity.

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.’”

Source: CSPI/CRN