FDA Releases Revised Draft of NDI Guidance

FDA Releases Revised Draft of NDI Guidance

Revised draft replaces FDA’s 2011 draft

Published: Thursday, August 11, 2016

The Food and Drug Administration (FDA) today released revised draft guidance for new dietary ingredients (NDIs) to be published in the Federal Register on Friday. The revised draft replaces FDA’s 2011 draft.

The draft guidance, "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” is subject to a 60-day comment period. AHPA will be convening a working group of the Government Relations Committee to prepare comments to the revised draft. AHPA will also be cooperating with other trade associations in addressing the revised draft.

According to FDA, the latest version clarifies several important points that were misunderstood or not fully explained and describes the public health significance of the recommendations.

AHPA identified several keys points of concern with FDA’s 2011 draft that AHPA requested be completely withdrawn. Key points of concern in the 2011 draft identified by AHPA, included:

  • The draft guidance improperly narrowed the range of “pre-DSHEA dietary ingredients”
  • The draft guidance placed a burden on companies that market only pre-DSHEA ingredients where the Act places no such burden
  • FDA failed to acknowledge the value of published and industry-submitted ingredient lists of pre-DSHEA dietary ingredients
  • The draft guidance was inaccurate in its discussion of when separate NDI notifications are needed, and did not clarify that a generally-described dietary supplement is acceptable in a NDI notification
  • FDA overstated the amount of data required by the law

AHPA staff is reviewing the revised draft guidance to assess FDA’s responsiveness to these issues and to determine the extent of changes and whether FDA has brought the revised draft into alignment with the law. AHPA will be providing members with additional analysis in the near future.

“The dietary supplement industry and FDA should have a shared goal to ensure that NDI notifications, when they are required, are clearly presented and thorough in providing to FDA the safety information that is required under the law,” said Michael McGuffin, AHPA’s president. “This system is in need of improvement, so it AHPA’s sincere hope that FDA has not missed another opportunity in this draft guidance to assist industry in meeting this goal.”

Background

Dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency help the agency identify safety concerns before products reach consumers.

Manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient (one that was not marketed in the United States before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.

Resources

AHPA has several resources to help the industry file NDI notifications, including:

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