(May 4, 2007, Silver Spring, MD) -- The American Herbal Products Association (AHPA) has updated the AHPA NDI Database by adding seventeen notifications submitted by manufacturers or distributors of new dietary ingredients (NDIs), along with the Food and Drug Administration's responses to these. The AHPA NDI Database is the most complete listing and analysis resource for NDI filings. It now contains 376 notifications.
Included in the newly added documents are just three NDI notifications that were filed by FDA to "acknowledge its receipt of a notification for a new dietary ingredient." FDA expressed one or more objection to each of the other fourteen notifications. These include seven new notices and seven revised submissions that provided additional information to try to address earlier objections by FDA. The two most common objections identified by FDA are a lack of sufficient information to clearly and specifically identify the new ingredient and a tendency for companies to submit safety information derived from an ingredient that is similar to but not the same as the NDI.
AHPA staff obtained the records of these notifications from the Rockville, MD office of FDA's Division of Dockets Management or directly from the submitting company. Only seven of these seventeen are currently posted at the FDA Docket's website, so the ten others can only be readily accessed at the AHPA NDI Database. In addition, the database is searchable and contains other features, such as links to associated submissions and an "outcome statement" for each notice to provide a succinct record of every FDA response.
The three notifications most recently acknowledged by FDA have thereby satisfied the requirement, as established by the Dietary Supplement Health and Education Act, for submission to FDA of the information that is the basis for the submitting companies' conclusion that a dietary supplement containing the NDI "will reasonably be expected to be safe." These are:
- Pom Wonderful's POMX(tm). In a letter to Pom Wonderful, LLC dated February 28, 2007, FDA acknowledged receipt of a notification for the company's POMX brand of pomegranate polyphenol extract at a level of 1,000 mg/day. Pom Wonderful is the only marketer of a new pomegranate polyphenol extract to submit an NDI notification to FDA.
- P&G's Psyllium hemicellulose. On November 21, 2006, FDA acknowledged receipt of a notification from The Proctor & Gamble Company for an NDI identified as psyllium hemicellulose at a level of 2.5 grams 3x daily (7.5 grams/day). The company described the ingredient as "a soluble polysaccharide fiber extracted from psyllium seed husk" which "comprises 80% of currently marketed psyllium fiber" in the company’s Metamucil(r) brand dietary supplements.
- Exquim's Diosvein(tm). On September 19, 2006, FDA acknowledged receipt of a notification from the Spanish manufacturer, Exquim, S.A., for their Diosvein brand of diosmin at a level of 500 mg/day for up to 3 months. This submission was the first for Exquim, who was represented by the Law Offices of Irving L. Wiesen, Esq., of counsel to Ullman, Shapiro & Ullman, LLP. This notification was the third submission for a diosmin ingredient to be acknowledged by FDA.
"The AHPA NDI Database is a truly valuable asset for any company interested in ensuring the safety of their new ingredients in the dietary supplement market," commented Mark Dreher, vice president of Scientific and Regulatory Affairs for Pom Wonderful. "Its organization of all of the NDI notifications that FDA has received allows access to records that are essential to understanding how to succeed in this regulatory process," he added.
"The successful completion of these three notifications shows that FDA's review process does work, especially for those who understand how to navigate the system," noted AHPA President, Michael McGuffin. "AHPA maintains this resource so that companies that have invested in new dietary ingredients can increase their knowledge of the mechanisms involved in submitting NDI notifications and speed their time to market."
The AHPA NDI Database is a joint project of the American Herbal Products Association, which is responsible for its content, and NPIcenter, which provides technical support. You may subscribe to and access the database at http://ndi.npicenter.com/.
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- our 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 herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.
Karen Robin, Director of Communications
American Herbal Products Association
Telephone: (301) 588-1171, x-107
Email: [email protected]