AHPA suggests ways to clear up NDI confusion
with the FDA aimed at helping it to tighten up the new dietary
ingredient (NDI) notification process required by the 1994 Dietary
Supplement Health and Education Act (DSHEA).
The association would like to see fewer dietary ingredients that are not new put forward for pre-market notification and suggest that its Herbs of Commerce publication may be a useful source document for companies.
Contrary to the FDA's stance, AHPA maintains that an ingredient's "chemical composition" or "active components" should be disclosed in its notification. It would also like to see a botanical's Latin binomial, author, and part identified.
AHPA's comments follow an open meeting held by the FDA in November 2004 to discuss the type, quantity, and quality of evidence that manufacturers should provide to the FDA in a new dietary ingredient notification.
While new dietary supplements do not have to be approved by the FDA before they are brought to market, DSHEA does require that pre-market safety notification is made for any NDI not marketed in the US before 15 October 1994.
Since 1994 a total of 260 NDI notification reports have been posted on the FDA's website, however some of the notifications were incomplete or related to old ingredients that did not actually require review, notes the AHPA.
In such cases the FDA has posted reports containing no comments and, when amended notifications are made by companies, these are assigned new references and posted as separate reports.
Furthermore, where companies erroneously submit notifications on new dietary supplements which are nothing more than new combinations of old ingredients, the FDA's lack of comment could be interpreted as indicating that these old ingredients are unsafe - whereas, in fact, their health benefits may be well documented and have been used for many years.
While the notification process is not complicated, it is causing confusion amongst industry members and consumers.
To rectify the situation, AHPA is urging FDA to reject filings for new dietary supplements, foods, and old, or already known, ingredients in the first instance and to allow companies to withdraw a notification if necessary.
AHPA also outlined key factors to define the standard for "reasonably expected to be safe".
"Bringing new products to market is important in every industry, including this one," said AHPA president Michael McGuffin. "We are pleased that FDA is taking steps to implement DSHEA fully, including the NDI safety review process."
The FDA said in November that it will thoroughly review comments received from the public meeting before taking any further steps on the matter. In January the AHPA submitted comments to the FDA on its draft guidance on dietary supplement claims in which it asked the agency to take into account relevant information on the traditional and historical use of herbs.
