Call for Records of Use of Old Dietary Ingredients
(August 9, 2006, Silver Spring, MD) -- The American Herbal Products Association (AHPA) is requesting that companies that have sold dietary supplements and dietary ingredients since at least 1994 submit information to AHPA that records which "old dietary ingredients" (ODIs) they marketed prior to October 15, 1994. AHPA is specifically soliciting pre-1994 printed records, such as labels, product catalogues, invoices, packing lists, certificates of analysis, product specification sheets, and production or packaging records, which document the marketing or sale of individual dietary ingredients or their presence in a company’s product line. AHPA intends to use this information to create a centralized “ODI Substantiation Database.”
When the Dietary Supplement Health & Education Act (DSHEA) became law, it defined the term "new dietary ingredient" (NDI) as "a dietary ingredient that was not marketed in the United States before October 15, 1994." DSHEA also stated that the term "does not include any dietary ingredient which was marketed in the United States before October 15, 1994," and the industry has come to refer to these prior-marketed ingredients as ODIs.
"As we approach DSHEA’s 12th anniversary, we need to preserve the records that substantiate which ingredients were already in the market," stated AHPA President Michael McGuffin, in announcing this new AHPA program. "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."
AHPA has already initiated the first stages of this program, as it is in possession of numerous dated herb catalogues from 1994 and earlier. Companies that provide additional information now will receive a discount for accessing the information that will be contained in the AHPA ODI Substantiation Database (note that pricing has not yet been set).
To participate in this "call for records," please send copies of any dated materials with a date earlier than October 15, 1994. The most useful records will be those that clearly identify the ingredients included in products that were marketed in the U.S. prior to that date, in a form that would today be recognized as a dietary supplement. As noted above, these may include product catalogues; production or packaging records; label printing records; invoices; packing lists; certificates of analysis; product specification sheets; or any other information that clearly establishes the marketing of the ingredients. Records should describe the ingredient(s) in as much detail as possible. Where appropriate, you may redact the information to remove confidential or proprietary information (pricing, customer names, etc.), or request AHPA to redact it for you. Send all records to:
ODI Substantiation Database
8484 Georgia Ave., #370
Silver Spring, MD 20910
AHPA engaged in a similar project in 1995, when the herb industry was asked to submit lists of the botanical ingredients that they were marketing before DSHEA was passed. The ingredients identified in this earlier process served as the basis for the 2nd edition of AHPA's Herbs of Commerce. Nevertheless, AHPA staff receives requests on an ongoing basis from members who want to create more robust records for their files. The AHPA ODI Substantiation Database will fill this ongoing need, and even those companies that participated in the 1995 call for ODIs should submit new information that substantiates their original submissions.
The American Herbal Products Association (AHPA) represents the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.