On February 1, 2005, the American Botanical Council (ABC) filed public comments with the Food and Drug Administration (FDA) on the subject of New Dietary Ingredients (NDIs) as defined by the Dietary Supplement Health and Education Act of 1994 (DSHEA).¹

ABC’s comments were prepared in response to a Notice filed by the FDA in the Federal Register on October 20, 2004, in which FDA announced a public meeting to be held on November 15 at which various parties were able to present their views on how the FDA should regulate NDIs.² The Agency allowed the public to file written comments on NDIs until February 1.

“Ten years after its passage FDA is now preparing to fully implement all the provisions of DSHEA,” said Mark Blumenthal, founder and executive director of the American Botanical Council. “For many years various herbal experts, researchers, industry groups, and others have expressed concern that some of the problems viewed in the herb and dietary supplement market were a result of inadequate enforcement of existing laws and regulations. ABC appreciates this opportunity to work with all interested parties for more rational regulation and self-regulation of the herb market,” he added.

Under the terms of DSHEA, dietary ingredients (vitamins, minerals, herbs, amino acids, and other similar substances) that were sold in the U.S. market prior to the passage of DSHEA on October 15, 1994, were considered “grandfathered” (i.e., they can be sold without any documentation of their safety as a precondition of their being offered for sale). These ingredients have been called by industry and regulators “old dietary ingredients” or ODIs, even though this term does not appear in the language of DSHEA.

To help protect the American public from potentially unsafe new ingredients that had never been sold previously in the U.S. food supply, Congress created Section 8 of DSHEA dealing with “new dietary ingredients.” The NDI provision requires that the seller of any dietary ingredient intended for initial introduction into the U.S. market after October 15, 1994, must notify the FDA at least 75 days in advance of marketing the ingredient. The 75-day notification must include documentation of the safety of the NDI.

To date, there has been little formal guidance from the FDA as to how much and what type of information should be submitted for FDA’s consideration, and what standard of evidence would be employed by FDA in determining whether the ingredient would be allowed to be sold. These topics and other related issues were the subject of testimony by various industry groups, companies, and individuals at the FDA’s meeting on November 15 as well as the public comments filed by ABC, various trade organizations, and presumably, other groups and individuals.

In order to help determine which ingredients were NDIs, shortly after DSHEA was passed several dietary supplement industry trade organizations began developing lists of ODIs (or “grandfather” lists as some were called). Even though these lists were used as reference points by industry and were not considered “authoritative” by the FDA (i.e., each ingredient on the lists had not been verified to have been sold prior to October 15, 1994, with formal evidence, e.g., an invoice, bill of lading, catalog listing, etc.), ABC’s comments suggest that FDA should officially recognize the lists developed by the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), and the Utah Natural Products Alliance (UNPA) as positive lists of ODIs. ABC stated that since ten years has lapsed since the passage of DSHEA, it does not believe that it should be necessary to create a new “authoritative” list in which all ingredients are confirmed as ODIs with such confirmatory evidence as FDA might have required previously, particularly since some of the records needed for such confirmation are probably no longer extant.

ABC also noted that FDA has recently stated in correspondence that an ingredient must have been “lawfully marketed” prior to October 15, 1994, for it to qualify as an ODI. In the comments filed with FDA, ABC objected to this stipulation, noting that this term does not appear in DSHEA and thus was not the intent of Congress. ABC noted that in the pre-DSHEA regulatory environment there was considerable confusion about the legal and regulatory status of most botanicals and FDA tried unsuccessfully to remove some herbs from the market by declaring them “unapproved food additives.” FDA was stopped by two highly publicized federal court decisions from doing so, and these cases, among other issues, became a primary impetus supporting the passage of DSHEA.

ABC has had a keen interest in the issue of NDIs. In 2004 ABC published an extensive article on this subject in HerbalGram (issue #63) in which the authors demonstrate that about 70 percent of the notifications for botanical NDIs were not accepted by FDA.³ This was usually due to the lack of adequate safety data being filed or other problems with the submissions—much of which was related to the lack of any formal guidance from FDA.

References

1. American Botanical Council. Comments to Food and Drug Administration on Premarket Notifications for New Dietary Ingredients [Docket No. 2004N-0454]. Austin, TX: American Botanical Council, February 1, 2005. Available at: http://www.herbalgram.org/default.asp?c=ndicomments.

2. Food and Drug Administration. Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting. [Notices] Federal Register 69;202: 61680-61684. October 20, 2004. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23439.pdf.

3. Noonan C, Noonan WP. New Dietary Ingredients: DSHEA Provides Protection from Potentially Unsafe New Ingredients with no Prior Market History in the U.S. HerbalGram. 2004;No. 63:70-74. Available at:  http://www.herbalgram.org/herbalgram/articleview.asp?a=2716.