HerbalEGram: Volume 3

The American Herbal Products Association (AHPA), the leading trade association in the United States dealing with herbal products, announced in August that it will be compiling a database of all “old dietary ingredients” (ODIs), which consist of all dietary ingredients marketed prior to the passage of the Dietary Supplement Health & Education Act (DSHEA) of 1994. AHPA has asked that companies submit printed materials that document their marketing and sales of ODIs, for use in creating this “ODI Substantiation Database.”¹

Under DSHEA, all dietary ingredients introduced to the market after October 15, 1994, are considered “new dietary ingredients” (NDIs). Manufacturers are required to provide evidence of safety of NDIs to the U.S. Food and Drug Administration (FDA) before such ingredients can enter the market. (For more information on NDIs, see the article by Chris and W. Patrick Noonan in HerbalGram 63 and/or ABC’s HerbClip on Michael McGuffin and Tony Young’s article in the Food & Drug Law Journal.^2,3) On the other hand, dietary ingredients that were lawfully sold before the passage of DSHEA, referred to within the herbal industry as ODIs (this term is not found in DSHEA), do not require such FDA approval. They are presumed safe unless evidence suggests otherwise.

“As we approach DSHEA’s 12^th anniversary, we need to preserve the records that substantiate which ingredients were already in the market,” AHPA President Michael McGuffin explained in an AHPA press release.¹ “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.”

Although AHPA claims to already be in possession of numerous dated herb catalogues from 1994 and earlier, the organization is also enlisting the help of the supplement industry to ensure a more complete list of ingredients. AHPA is specifically soliciting records that clearly identify ingredients included in products marketed pre-1994 that would today be recognized as dietary supplements. Such records could include product catalogues, labels, invoices, packing lists, certificates of analysis, product specification sheets, product or packaging records, or any other information that clearly establishes the marketing of the ingredients in as much detail as possible. Companies may redact the information they submit by removing confidential or proprietary information (pricing, customer names, etc) or request that AHPA redact such information. Companies that submit new information to AHPA will receive a discount for accessing the AHPA ODI Substantiation Database, the price of which has not yet been determined.

AHPA conducted a similar project in 1995 and used its collected list of ODIs as a basis for the 2^nd edition of AHPA’s Herbs of Commerce.⁴ In its press release, AHPA encouraged even those companies that provided information for the 1995 call for ODIs to submit information that would substantiate their original submissions.¹ All records can be sent to: AHPA, ODI Substantiation Database, 8484 Georgia Ave., #370, Silver Spring, MD 20910.

-Courtney Cavaliere

References

1. AHPA to create “ODI substantiation database” [press release]. Silver Spring, MD: American Herbal Products Association; August 9, 2006.
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. Milot B. Review of the premarketed notification procedures for new dietary ingredients. HerbClip. October 14, 2005. (No. 100141-290). Austin, TX: American Botanical Council. Review of Premarket notifications of new dietary ingredients-a ten-year review by McGuffin M, Young A. Food & Drug Law Journal. 2004;59:229-244.
4. McGuffin M, Kartesz JT, Leung AY, Tucker AO. American Herbal Products Association’s Herbs of Commerce, 2^nd ed. Silver Spring, MD: American Herbal Products Association, 2000.