The American Herbal Products Association (AHPA) and NPIcenter have collaborated to create a database to access all notifications the Food and Drug Administration (FDA) has received for new dietary ingredients (NDIs). The AHPA NDI Database launches on Monday, December 5, 2005, with a one-day-only open access trial period, before the subscription period begins.
The database can be searched by numerous relevant fields, including the generic or brand name of every 75-day notice (botanical and non-botanical), the Latin binomial of herbs, and the name of the company that made the submission. The database also provides a concise “outcome statement” for each file that quickly summarize how FDA has responded to every notification, and the problems, if any, that the agency identified for each.
“New ingredients are key to the supplement industry’s future and the AHPA NDI Database will be a valuable resource for firms that are filing the required notification prior to marketing an NDI, said Michael McGuffin, president of AHPA. “By accessing and reviewing other relevant NDI notifications, companies will be better prepared to file complete submissions and thereby prevent delays to market entry.”
The Dietary Supplement Health and Education Act (DSHEA) requires manufacturers or distributors of an NDI — an ingredient not sold before DSHEA went into effect in 1994 — to provide information to FDA that is the basis for a conclusion that the ingredient is reasonably expected to be safe (New dietary ingredients that are articles used as food in a form in which the food has not been chemically altered are exempt form the notification requirement described here.).
Since DSHEA passed, FDA has posted almost 300 NDI notifications on its dockets website. However, the only organization provided is by the FDA-assigned report numbers, which makes individual reports very difficult to locate. Even when found, it is impossible to know without opening and examining the entire file (which can run to hundreds of pages) whether a filing was successful or whether (and why) FDA objected to the notification. The AHPA NDI Database was specifically designed to provide faster and more informative access to filed notifications.
The database will be maintained on an ongoing basis; future NDI filings and FDA responses will be promptly added to the system. Special introductory access fees for AHPA members are $125 per year per site / $40 per day per site, and for non-members are $495 per year per site / $125 per day per site. The open-access trial period runs 9 a.m.–6 p.m. Eastern, Monday, December 5, only.