AHPA draws NDI distinction over herb processing
with the FDA over its new dietary ingredients (NDI) program,
drawing 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) - the industry association maintains that it has the same composition in each instance. Once an initial NDI notification has been made, there is no need for each distributor to submit one of its own.
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.
"The information that serves as a basis for a conclusion that data and information establishing that one semi-purified extract of a new herb will reasonably be expected to be safe may not be relevant to another," said AHPA president Michael McGuffin.
"Each manufacturer of such extracts should submit an NDI notification with the requisite safety information."
Last year the FDA requested comments on the NDI notification process, which is required 75 days before a product containing a new ingredient comes to market under the 1994 Dietary Supplement Health and Education Act.
Notification is only required for ingredients that were not used in products marketed in the United States prior to October 15 1994. But it has emerged that there has been some confusion in the industry over when it is necessary to make a filing, and exactly what information should be submitted.
A large proportion of the NDI notification reports posted on the FDA's website were incomplete or related to old ingredients that did not actually require review.
The new comments follow two earlier sets submitted in February, whereby AHPA suggests that its Herbs of Commerce publication may be a useful source document to cut down on the number of unnecessary filings.
AHPA also maintains that an ingredient's "chemical composition" or "active components" should be disclosed in its notification, and that a botanical's Latin binomial, author, and part be identified.
Moreover, once a manufacturer has made a filing for an ingredient covering a certain range of doses, there should be no need for a separate filing to be made by every dietary supplement maker using the ingredient within that range.
Despite having become law more than a decade ago, DSHEA has still not been fully implemented. One of the most eagerly-awaited outstanding issues is the finalization of the good manufacturing guidelines for the supplements industry.
It had been hoped that the GMPs would be sped along when Lester Crawford was appointed to the permanent position of FDA commissioner earlier this summer.
But his resignation last week could mean that the industry will have to be patient for a while longer. Certainly, the news has been met with dismay from some sectors of the food industry.
The Center for Science in the Public Interest said in a statement that the agency has had so much turnover in the top spot, and turmoil throughout, that it "could have benefited from a period of steady leadership".
Crawford was first appointed as acting commissioner in February 2002, and has since served in that role for all but 16 months.
Press reports have suggested that Dr Andrew von Eschenbach, chief of the National Cancer Institute, has been tapped for the agency's top job on a temporary basis.
