GAO Questioning Status of "Grandfathered" Ingredients

The U.S. Government Accountability Office (GAO) has sent letters to a selection of dietary supplement marketers, requesting evidence to support their products' "grandfathered ingredient" status. The letters target herbs such as chamomile flower tincture, echinacea root 4:1 powdered extract, and oils of peppermint leaf, ginger root, and fennel seed, according to the American Herbal Products Association (AHPA).

In communication to its members, AHPA said that the letters' recipients were instructed to provide one of the following:

* Evidence that the dietary supplement product was marketed in the United States prior to the enactment of the Dietary Supplement Health and Education Act (DSHEA; 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 that has not been chemically altered.
* A copy of documented evidence sent to FDA that shows a history of use or other evidence of safety when used as recommended.
* Details of any extraction methods used.

Industry members are questioning GAO's motives for issuing such letters. Many believe that the congressional watchdog is looking to investigate DSHEA's new dietary ingredient (NDI) provision, which allows "grandfathered" ingredients to legally be sold as old dietary ingredients (ODIs).

In its letters, GAO states that it is reviewing the marketing of "selected herbal supplements" on behalf of the Senate Select Committee on Aging. An AHPA spokesperson informed Nutritional Outlook that GAO has declined to make the Senate committee's request available to the letters' recipients. The association said it is currently investigating why the Senate committee may have made the request to GAO.

Meanwhile, according to some, dietary supplement marketers and their ingredient suppliers may have some difficulty providing some of the evidence GAO is requesting, such as documented evidence that an ingredient was marketed prior to DSHEA's passage.

"The proof GAO may be requiring could include bills of lading, invoices, advertisements, etc., to show that the product was in commercial use prior to 1994," said Cal Bewicke, president of botanicals supplier Ethical Naturals (San Anselmo, CA), in an interview with Nutritional Outlook. "In some cases, a company might not have records going back to 1994. That's 16 years ago, and after all, even tax records only need to be saved for seven years."

Also complicating the matter is the fact that FDA has so far not issued any guidance on establishing NDIs. Last January, GAO issued a report recommending that FDA "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," according to AHPA. Meanwhile, the fact that extraction and testing technologies have advanced since 1994 may further add to the problem of defining a "grandfathered" ingredient passed under DSHEA versus an NDI.

AHPA points out that based on its review of the letters GAO has sent so far, it suspects that GAO "is not entirely clear on the way DSHEA addresses dietary supplements, dietary ingredients, and NDIs." The association suggests that companies that have received a letter from GAO seek legal counsel before responding, and, if needed, request more time before answering.

Read AHPA's notification to its members, as well as its advice on what steps to take, at http://www.ahpa.org/Default.aspx?tabid=69&aId=572&zId=1