CFH Campaigns Against NDI Draft Guidance

WASHINGTONCitizens for Health (CFH) launched a campaign against FDAs New Dietary Ingredient (NDI) Draft Guidance. CFH said the Draft Guidance is attempting to drastically change existing law and goes beyond clarifying existing requirements. The biggest issues CFH contends are FDAs request for NDI notifications for every finished product that contains an NDI and the need for notification when a formula is changed.

Quite simply, FDA is ignoring Section 413 [21 USC §350b] of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which says an NDI submission is not required if there is a history of use or other evidence of safety supporting its inclusion, use and marketing prior to 1994," said James Gormley, vice president and senior policy advisor for CFH. Essentially, FDA is making NDI submissions product-specific rather than ingredient-specific, which contravenes the spirit and the letter of DSHEA."

CFH is calling for the comment period to be extended to July, 2012; the current deadline is Dec. 2, 2011, which FDA extended from Oct. 3, 2011. CFH an extension of one year since FDA released the Draft Guidance will give industry, policy experts and the public sufficient time to be heard on the issue.

CFH also offers a form letter consumers can send to Congress urging it to pressure FDA to withdraw the guidance.

CFH said it will be conferring with consumer advocates and health-food industry leaders on Friday, Sept. 23, at the Natural Products Expo East trade show in a meeting sponsored by Jarrow Formulas Inc. Jarrow also requested FDA extend the deadline one year.