January 26, 2010 – The American Herbal Products Association (AHPA) has become aware that the Government Accountability Office (GAO) has contacted several dietary supplement marketers to request information related to the marketing of dietary supplements containing one or more herbal extracts.

Each GAO letter AHPA has seen identifies one dietary supplement product marketed by the company and then states:

The term “dietary supplement” is defined in 21 U.S.C. 321(ff) [section 210(ff) of the Federal Food, Drug, and Cosmetic Act (the Act)]. Given that you have labeled your product as a dietary supplement, we assume you have a basis to conclude that [e.g., Horsemint (Horsemint Oil Extract – Monarda punctata)] is a “dietary ingredient” under 21 U.S.C. 31 (ff)(1).

The letter next requests that addressees provide one of the following:

• Evidence that the addressees’ specifically identified dietary supplement product was marketed in the U.S. prior to the Dietary Supplement Health and Education Act (DSHEA) (i.e., 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, or
• 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.

All of the letters AHPA has seen have been addressed to marketers of supplements containing herbal extracts, and GAO requests “the details of the extraction method, if any, used to create” the identified herbal extract.

The products that have been identified to AHPA as the subject of these letters are 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,” noted AHPA president Michael McGuffin. (See AHPA’s Feb. 1, 2005 comments to FDA on its premarket notification program for new dietary ingredients, as well as additional comments on the program made Feb. 25, 2005 and Sept. 23, 2005.)

The GAO letter states it is conducting a review of the marketing of “selected herbal dietary supplements” at the request of the Senate Select Committee on Aging. AHPA is working to learn more about the reason for the committee’s request. It is evident from these questions, however, that GAO has an interest in DSHEA’s new dietary ingredient (NDI) provision. In this regard, GAO issued a report in January 2009 recommending the Secretary of the Department of Health and Human Services (HHS) direct the Commissioner of FDA 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.”

However, the questions posed in these letters indicate that GAO is not entirely clear on the way DSHEA addresses dietary supplements, dietary ingredients and NDIs. 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).) 

Companies that receive these letters may wish to consult with their legal counsel before responding. Companies requiring more time to respond to a GAO letter should not hesitate to request more time and to document that request in an e-mail to GAO.

Before contacting AHPA with any questions, companies receiving letters of this kind should gather relevant information regarding the questions asked in the letter:   

• 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

Documents:

The January 2009 GAO report, ”Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding,” is available online at http://www.gao.gov/products/GAO-09-250.

AHPA’s Feb. 1, 2005 comments are here: http://www.ahpa.org/Portals/0/pdfs/05_0201_ahpa_ndi_comments.pdf.

AHPA’s Feb. 25, 2005 and Sept. 23, 2005 comments are, respectively, here http://www.ahpa.org/Portals/0/pdfs/05_0224_AHPA_NDIAddendum_Final.pdf and here http://www.ahpa.org/Portals/0/pdfs/05_0923_AHPA_NDIAddendum_2.pdf.