The supplements industry is responding heartily to the U.S. Food and Drug Administration?s recent request for comments on the new dietary ingredient notification process.
When the Dietary Supplement Health and Education Act went into effect in 1994, it instructed FDA to establish regulations to receive notifications about the safety of new supplement ingredients. FDA increased its attention to NDIs last October due to industry-wide confusion over the process.
One of the primary concerns is whether 75-day notices must be filed by each supplier that sells a dietary supplement containing an NDI if the manufacturer of that ingredient has already filed. Another question is whether chemical alteration of an ingredient makes it ?new.? Similar concerns have been raised regarding extracts from old ingredients.
?The point behind all of this is safety—that with any new ingredient introduced, you can reasonably expect that it?ll be safe,? said Karen Robin, director of communications for the American Herbal Products Association.
Some also question what information FDA requires during the NDI notification process. In the more than 10 years since DSHEA was passed, FDA has received 145 unique notices of proposed new ingredients and objected to nearly half of these notifications, either because the submissions were incomplete, or because the ingredient itself or the product that would contain it did not fall within existing legal definitions.
The cost of the NDI notification process is low and shouldn?t cause product prices to rise.
AHPA's NDI Database, a searchable database of existing NDI notifications at http://NDI.npicenter.com, will be available soon.
Natural Foods Merchandiser volume XXVI/number 5/p. 7