Dispatches from the IPA World Congress

'Master Files' top list of NDI comments of note… so far

By Stephen Daniells in Universal City, CA

- Last updated on GMT

Related tags Dr fabricant Dietary supplement

Dr Fabricant addressed attendees at the IPA World Congress
Dr Fabricant addressed attendees at the IPA World Congress
The proposal to use Master Files for IP protection and to expedite the notification process is attracting attention within FDA, as the agency considers comments submitted in response to its controversial NDI draft guidance.

The period for comments on the FDA’s new dietary ingredient (NDI) draft guidance closed on December 2nd​, 2011 with the agency logging 7,000 unique entries totally 146,000 pages​ of comments.

FDA is still wading through this paper mountain, but Daniel Fabricant, PhD, Director of the Division of Dietary Supplement Programs at FDA presented several comments of note (so far) during last week’s International Probiotics Association’s World Congress in Universal City, California.

Both ‘Master Files’ and process proficiency were highlighted for mention by Dr Fabricant, with Master Files intended for IP protection and to expedite the notification process.

As reported by NutraIngredients-USA​, NDI Master Files were amongst Herbalife’s six steps to improve functionality of the NDI guidance submitted to FDA on October 13, 2011.

Expectation of safety

Another set of comments noted by Dr Fabricant stated: “Despite its strengths, the framework requires four key modifications to ensure the expectation of safety:

1) Historical use should rarely, if ever, be sufficient to replace experimental data;

2) Entirely novel ingredients should undergo, at a minimum, 90-day human testing;

3) Manufacturers should be required to submit to the FDA all available data regarding new ingredients, both favorable and unfavorable; and

4) Before assuming that consumers follow instructions on supplement labels, this assumption should be confirmed empirically. Absence significant modification, the FDA’s guidance may have the effect of providing a false sense of security to consumers seeking safe dietary supplements.”


Dr Fabricant added that, so far, a number of issues have also been conspicuous by their absence from comments, including nanoscale, safety margins, and recommended templates

Also absent so far has been any data supporting current number/level of submissions, he said.

“There were 4,000 products when DSHEA passed,”​ said Dr Fabricant. “At present, there are roughly 55,600 dietary supplement products on the market, and the Institute of Medicine has estimated that 1,000 new dietary supplements are introduced to the market each year, yet FDA has only received approximately 730 NDI notifications since we began reviewing NDI notifications some 16 years ago.”

The agency receives about 50 NDINs per year, he said.

The agency is continuing to review the comments and no timescale is set for any decisions.

Related topics Regulation NDI draft guidance

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