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The American Herbal Products Association (AHPA), the national trade association of the herbal products industry, and NPIcenter, a company offering e-based information, services and resources for natural and nutritional products companies, have collaborated to create a database to access all notifications the Food and Drug Administration (FDA) has received for new dietary ingredients (NDIs).1
The AHPA NDI Database is a resource for industry, regulatory attorneys and others who seek a convenient and comprehensive way to check the outcome of submissions by industry documenting the safety of new dietary ingredients. Section 8 of the Dietary Supplement Health and Education Act (DSHEA) requires manufacturers or distributors of an NDI - a dietary supplement ingredient not sold in the United States before DSHEA went into effect in October, 1994 - to provide information to FDA within 75 days prior to the date of the initial introduction of a new ingredient to the market. The submission is the basis for a conclusion by the FDA 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 from the notification requirement.
The AHPA NDI Database can be searched by numerous relevant fields: the generic or brand name of every 75-day notice (for both botanical and non-botanical ingredients), 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 summarizes how the FDA has responded to every notification, and the problems, if any, that the FDA 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.”
Since Congress passed DSHEA, manufacturers and marketers have submitted almost 300 NDI notifications, which FDA has posted on its dockets website (http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s0316.htm). However, the only access to an individual notification, or multiple notifications on the same ingredient, provided on this site is by the FDA-assigned report number. This makes individual reports 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 and the FDA’s responses.
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 AHPA NDI Database is located at http://ndi.npicenter.com/. For more on the NDI process, see the article on NDIs in HerbalGram 63 2 or the article by Michael McGuffin and Tony Young in the Journal of the Food and Drug Law Institute. 3
References
1. Database for New Dietary Ingredient Notifications Launching December 5. Searchable AHPA NDI Database Developed by AHPA and NPIcenter. [press release]. Silver Spring, MD: American Herbal Products Assn., Dec. 2, 2005.
2. Noonan C, Noonan WP. New Dietary Ingredients: DSHEA Provides Protection from Potentially Unsafe New Ingredients with no Prior Market History in the U.S. HerbalGram. 2004;63:70-74.
3. McGuffin M, Young AL. Premarket Notifications of New Dietary Ingredients: A Ten-year Review. Food Drug Law J. 2004;59(1):229-244.
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