ADDENDUM JUNE 3, 2010 NEWS FLASH

GAO Report Finds Heavy Metals in Herbal Supplements at Levels That Do Not Raise Safety Concerns for FDA


May 26, 2010 – The U.S. Government Accountability Office is providing testimony today during a hearing of the Senate Special Committee on Aging entitled, “Dietary Supplements: What Seniors Need to Know.” The testimony focuses on herbal dietary supplements and GAO’s investigative findings with regards to marketing claims and “harmful substance contamination.”

GAO reports that none of the 40 herbal products tested were found to contain heavy metals in amounts exceeding either Food and Drug Administration (FDA) or Environmental Protection Agency (EPA) regulations governing dietary supplements or raw ingredients used in supplements. Additionally, the report states, “FDA and EPA officials did not express concern regarding any immediate health consequences from consuming these 40 supplements.” This sentiment is reiterated in a May 25 article in New York Times, which quotes FDA Deputy Commissioner Dr. Joshua Sharfstein as saying he “was not concerned about the safety of the supplements tested by the G.A.O. investigators.”

“The area of trace elements in dietary supplements is one to which AHPA has dedicated time and attention,” said American Herbal Products Association (AHPA) President Michael McGuffin. “AHPA is pleased to see that manufacturers of all tested products appear to be aware of the ways good agriculture and manufacturing practice can minimize the level of trace amounts of these naturally-occurring metals in their products.”

GAO reports that investigators posing as elderly customers received potentially harmful medical advice from retail sales staff. Upon review, FDA and FTC informed GAO many of the claims were “largely improper". GAO also reports “in several cases, written sales materials for products sold through online retailers claimed that herbal dietary supplements could treat, prevent or cure conditions such as diabetes, cancer or cardiovascular disease.” Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), claims that a dietary supplement can treat, prevent or cure a disease are illegal.

In one example provided by GAO, a ginseng product bears labeling stating the product possesses “Powerful Anti-cancer Function". An Internet search conducted by AHPA finds this claim and other illegal disease claims being made by China-based Internet-marketer KunMing LingCao-Dali Industry and Trade Company.

“In the past, FDA has taken enforcement action against companies making the kinds of claims noted in the GAO report,” McGuffin said. “AHPA has long supported active enforcement of DSHEA and is always pleased to see FDA exercise its enforcement authority when warranted.”

A press release from the Special Committee on Aging is available here: http://aging.senate.gov/hearing_detail.cfm?id=325240&.http://

A Webcast of the hearing is now available on the committee’s Web site: http://aging.senate.gov/.