The letters focus on the likes of St Johns wort, chamomile flower tincture, echinacea root 4:1 powdered extract, and oils of peppermint leaf, ginger root, and fennel seed and are signed by the GAO’s managing director of forensic audits and investigations, Gregory D. Kutz.
AHPA said the GAO letters had been issued as recently as January 18. Each company had received a similar letter that requested information such as:
- Details of extraction method.
- Evidence that the addressees’ specifically identified dietary supplement product was marketed in the US prior to the Dietary Supplement Health and Education Act (DSHEA) (before October 15, 1994).
- Evidence that the identified product contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
- A copy of such documentation as has been provided to the Food and Drug Administration (FDA) showing that there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe.
A GAO spokesperson said she was not aware of the letters but was investigating the matter.
The letters state that the GAO is investigating the area after a request from the Senate Select Committee on Aging. AHPA said it was looking into why such a request had been made by the Committee in the first place.
The founder and executive director of the ABC, Mark Blumenthal, said while many of the ingredients under review had been mandated as old dietary ingredients (ODIs) there was debate about newer extracts from the same plants – especially as the FDA was yet to issue guidance on the matter.
Such discrepancies may have motivated the GAO to move into an area that is typically the domain of the FDA. Blumenthal speculated about how such information may be used.
“There are some such as Congressman Henry Waxman who are vocal opponents of DSHEA and seeking to build a base of information that may be used to attack DSHEA,” he said, noting at least three ABC members that had contacted him with concerns about the letters. “The problem is that NDI is open and ambiguous.”
The GAO issued a report on dietary supplements and DSHEA in January, 2009, a report that sought counsel from the Council for Responsible Nutrition and the Natural Products Association (NPA).
“We are aware of these letters and CRN is investigating what may have prompted the Senate Committee on Aging to issue the request to GAO,” said Steve Mister, president and chief executive officer of CRN.
To access the full report, click here .
To read a summary of the report and recommendations from NutraIngredients-USA.com, click here .