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GAO Trolls for NDIs in Herbal Market
January 27, 2010
3 Min Read
SILVER SPRING, MDThe American Herbal Products Association (AHPA) has reported the Government Accountability Office (GAO) has requested several dietary supplement marketers submit information on dietary supplements containing one or more herbal extracts. It appears GAO is interested in the legal dietary supplement status of various herbal ingredients, asking companies for proof the ingredient:
was marketed before the passage of DSHEA (1992);
was present in the food supply as an article used for food in a form in which the food has not been chemically altered; or,
is supported by documents filed with FDA showing a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in its labeling, will reasonably be expected to be safe.
AHPA further noted the letters it has seen have been addressed to marketers of supplements containing herbal extracts, and have asked for details about any extraction method used to create the extract in question. Also, the products covered in these letters tend to be primary long-established ingredients, such as chamomile flower tincture, echinacea root 4:1 powdered extract, and oils of peppermint leaf, ginger root, and fennel seed.
AHPA has communicated its position to FDA that any of the over 2,000 plant species included in the second edition of Herbs of Commerce, as well as extracts of these plants made by long-established extraction processes, should be assumed to be old dietary ingredients, said AHPA president Michael McGuffin.
In these letters, GAO noted it is acting at the request of the Senate Select Committee on Aging, although AHPA contends this action indicates GAOs growing interest in New Dietary Ingredient (NDI) regulation of the supplement industry, especially herbals. In fact, AHPA noted GAO previously recommended the Secretary of the Department of Health and Human Services (HHS) direct the FDA Commissioner to issue guidance to clarify when an ingredient is considered a new dietary ingredient, what evidence is needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.
In the end, AHPA thinks GAO has a deficient grasp ofDSHEA, dietary supplement regulation, dietary ingredients and NDIs. The trade group reminded: No notification to FDA is required for a new dietary ingredient which has been present in the food supply as an article used for food in a form in which the food has not been chemically altered (see 21 USC 350b(a)(1)). Additionally, dietary ingredients are not NDIs if they were marketed in the United States before October 15, 1994 (see 21 USC 350b(c)).
AHPA suggested companies receiving such letters should consult their legal counsel. Before contacting AHPA, the association asked these companies to gather several bits of information, including:
The product name and when it was first marketed by the company in its current form
The list of ingredient(s) specified in the GAO letter
When each of the ingredient(s) was first marketed by the company, and, if this was not pre DSHEA, find out when the ingredient was first marketed by the supplier
A Supplier Certificate of Analysis or other information regarding ingredient(s) called out in GAO letter
The form of extract and extraction method used for each ingredient
Any other information the company believes is relevant
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