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New Dietary Ingredients (NDIs)

NEJM Editorial: DSHEA too Lenient

Pieter A. Cohen, M.D., took a jab at the dietary supplement industry, saying FDA has not enforced the new dietary ingredient (NDI) provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA), in a recent New England Journal of Medicine perspective (DOI ...More
January 26, 2012
Posted in News
Support Growing for NDI Draft Guidance Retraction

In the flood of comments submitted to FDA, many called for a retraction of its NDI guidance, but some high-profile politicians have since added their voices. ...More
January 12, 2012
Posted in Blog
2012: A Year of Promise and Peril

The natural products industry faces big challenges in 2012. How it reacts to FDA's new era of preventative control, potential adulteration of products used by Olympic athletes and the U.S. November election could change the market for years to come. ...More
January 9, 2012
Posted in Articles, Sports Nutrition
Senators Hatch, Harkin Call for NDI Guidance Redo

Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) urged FDA to withdraw its New Dietary Ingredient (NDI) Draft Guidance in a letter to FDA Commissioner Margaret Hamburg, M.D. Senators Hatch and Harkin, the principal authors of the Dietary Supplement Health and Education ...More
January 5, 2012
Posted in News
Additional Thoughts on FDA's Reaction to NDI Comments

FDA's Daniel Fabricant, Ph.D., questioned the industry's reputation, noted some comments requested more restrictions and offered case examples of objectionable new dietary ingredient notifications (NDIs). ...More
December 27, 2011 By Sandy Almendarez
Posted in Blog
NDIs—OK, Really. What Now?

Waiting for FDA to make the next new dietary ingredient (NDI) move can be agonizing, but without further direction from the agency, what's a natural product company to do? ...More
December 23, 2011 By Sandy Almendarez
Posted in Blog
FDA Reacts to NDI Draft Guidance Comments

FDA has more than 146,000 pages of New Dietary Ingredient (NDI) Draft Guidance comments from around 7,000 unique entries to review, according to Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, during a post comment webinar hosted by the ...More
December 22, 2011
Posted in Articles
Premium Series—Dietary Supplement GMPs: What Can Industry Do Better?

This Webinar will examine key elements of GMPs for dietary supplements and what industry can do to improve its record of successful inspections. The first four years of GMP inspections have been a steep learning curve for industry and FDA. Inspection reports and warning ...More
December 16, 2011
Posted in Webinars
Congressman Tells Regulators NDI Guidance Needs Redo

A Republican Congressman from Illinois took a minute of floor time to support dietary supplement access and urge FDA to overhaul its NDI guidance. ...More
December 15, 2011
Posted in Blog
NDI Draft Guidance Comments—Industry Has its Say

Comments from different sectors of the industry—from trade organizations to ingredient suppliers, finished product manufacturers to lawyers—reflect the overwhelming opinion that FDA failed in its attempt to provide a workable new dietary ingredient (NDI) guidance. ...More
December 15, 2011 By Sandy Almendarez
Posted in Articles