GAO investigating NDI herbs status

By Shane Starling

- Last updated on GMT

Related tags: Food and drug administration, Dietary supplement

GAO investigating NDI herbs status
Several American Herbal Products Association (AHPA) and American Botanical Council (ABC) members have been contacted by the Government Accountability Office (GAO) seeking information about the marketing of herbal products with an emphasis on new dietary ingredient (NDI) status.

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, click here​ .

Related topics: Regulation, GMPs, QA & QC, Polyphenols

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Evidence Herb available before October 15, 1994

Posted by steve,

There is only one reason they want to know if Herb was marketed before October 15, 1994. Lately they have been many applications by companys to make certain vitamins drugs such as B6. This is what they want to do take everything that has research that was not on the market by October 15, 1994 and make it into a drug.

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Posted by Stephen Jared,

The idea that herbs are inert or worthless, as the AMA and big pharma/FDA believe, is based on a rigged experiment (1892). An electrode was hooked up to a dry herb and produced no reaction. Any 8th grader would know that herbs must be ionized before they can work. Traditional people did this by heating in water.
The FDA regulation, which became law, that medicinal quality may not be attributed to any plant is an insult to everyone's intelligence.

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