Regulatory

[Guest guest]

NDIs extend to entire supplement says FDA during CRN/Virgo webinar, soon

available ‘on-demand’

FDA made clear in a Dec. 11th webinar that industry must file new dietary

ingredient (NDI) notifications for all combination products that include any

ingredients not marketed before Oct. 15, 1994. “The new ingredient notification

is really a notification that is addressing the dietary supplement that contains

the new dietary ingredient,” Bill os, Ph.D., director of the Division of

Dietary Supplement Programs at FDA stated. To the surprise of many Dr. os

added, “The notification has to address the safety of the whole dietary

supplement that has the dietary ingredient in it, not just the ingredient

itself.” Dr. os further observed that during a good manufacturing practices

(GMP) inspection, it would be reasonable for an inspector to ask if an

ingredient was marketed before Oct. 15, 1994 (the cut-off date for “new”

ingredients), and if not, whether a NDI notification has been submitted to FDA.

These statements were just some of many useful insights shared during the

webinar “Bringing New Ingredients to Market: FDA Guidance and Developments in

the New Dietary Ingredient (NDI) Notification Process,” presented by CRN and

Virgo Publishing this week. Close to 90 companies listened intently as FDA’s

Dr. os and Dan D. Levy, Ph.D., acting supervisor of the New Dietary

Ingredient Review Team, Division of Dietary Supplement Programs, presented

guidelines on what constitutes an appropriate NDIN and when one is needed. In

addition, details on the history of NDINs, meeting safety standards, and

practical approaches to bringing new ingredients to market were discussed by the

following industry experts: CRN’s Shao, Ph.D.; Debbie Trinker of Kemin

Health, L.C.; -Eng of Venable LLP; and Burdock, Ph.D.,

president of Burdock Group.

If you missed this valuable webinar, it will be available starting Wednesday,

Dec. 17 for “on-demand” viewing at a cost of $149 for CRN members. See the

Nutrilearn website for details.

S. Kalman PhD, RD, CCRC, FACN

Director, Nutrition & Applied Clinical Research

Miami Research Associates

6141 Sunset Drive #301

Miami, FL. 33143

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