AHPA plans centralized ODI database

By staff reporter

- Last updated on GMT

Related tags: Dietary supplement

The American Herbal Products Association is planning to compile a
database of dietary ingredients marketed in the United States
before October 1994, and is calling on companies to send records of
the products they sold.

Under DSHEA (the 1994 Dietary Supplement Health and Education Act) any dietary ingredient not marketed in the US before October 15 1994 must be notified as a new dietary ingredient (NDI) 75 days before entering the market - a process that involves submission of scientific data to the FDA.

However last year debate raged in the industry about how streamlined the process is, since a large proportion of the NDI notification reports posted on the FDA's website were incomplete or related to old dietary ingredients that did not actually require review. Thus, a centralized database listing ODIs could prove a useful reference tool.

The ODI database is not the first initiative AHPA has come up with to help ease the process, however. In January it launched a database of NDIs in collaboration with NPI Center.

Whilst this will be a working tool for the future, the ODI database, by contrast, could become a historical record.

"As we approach DSHEA's 12th anniversary, we need to preserve the records that substantiate which ingredients were already in the market,"​ said AHPA President Michael McGuffin.

"This will become even more important as more years pass, so now is the time to consolidate the records of the industry's historical uses."

McGuffin has spoken out in the past about the NDI procedures, particularly when FDA has requested feedback.

For instance, last September he draw attention to possible differences in composition between unprocessed herbs and those that have been semi-processed.

When an herb is unprocessed - that is, simply cleaned, dehydrated and reduced into smaller matter (such as through milling) - he maintains that it has the same composition in each instance and no separate NDI notification is needed.

When herbs are semi-purified for a high concentration of active constituents, however, this is often done using a unique proprietary process. The end result may be significantly different both from the original herb and from any other semi-purified versions, thus NDI notification is needed.

Related topics: R&D

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