WASHINGTON, D.C. (November 15, 2004) – David Seckman, executive director and CEO of the National Nutritional Foods Association (NNFA), was among those testifying at a public meeting on pre-market notification of new dietary ingredients (NDI) held today by the Food and Drug Administration (FDA). According to the agency, it is seeking public comment on several issues to help clarify the requirements of NDI submissions as contained in section 413 (a) (2) of the Food, Drug and Cosmetic Act. A new dietary ingredient is defined as one that was not marketed prior to the passage of the Dietary Supplement Health and Education Act of 1994. Before such ingredients can be marketed, safety data must be reviewed and accepted by the FDA.
“What everyone in the industry needs is clear guidance,” Seckman testified. “Specifically, NNFA believes that as written, section 413 is unclear both as to when a new dietary ingredient notification is required and the type of information to be included if a premarket notification is filed.”
In fact, NNFA had previously voiced its thoughts in comments to FDA dated May 9, 2002, suggesting ways for FDA to enhance the quality, utility and clarity of the premarket notification requirement for NDIs.
“We continue to believe that FDA can use public comments on section 413 to provide the industry with much needed guidance on NDI submissions,” Seckman stated in his testimony. “Of course, any guidance will apply to any company putting dietary ingredients on the market – whether they be the manufacturers of finished products or raw ingredient suppliers who need to guarantee safety to their customers.”
(Complete testimony is available for download at: http://www.nnfa.org/services/government/comments/11-15-04_testimonyNDIs.htm)
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NNFA (www.nnfa.org) is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. NNFA represents more than 8,000 retailers, manufacturers, wholesalers and distributors of natural products including foods, dietary supplements, and health and beauty aids. In addition to offices in Washington D.C., and Newport Beach, Calif., NNFA also has seven regional offices throughout the United States and is governed by a 22-member board of directors representing all segments of industry.
Tracy Taylor, Vice President of Public Affairs and Communications