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Waiting Game Continues for Revised NDI Draft GuidanceWaiting Game Continues for Revised NDI Draft Guidance

John Shaw

June 14, 2013

2 Min Read
Waiting Game Continues for Revised NDI Draft Guidance

The Natural Products Association and our industry partners have met several times with the Food and Drug Administration this year about requested revisions to the New Dietary Ingredients (NDI) Draft Guidance that was released in July 2011.

Weve been encouraged by the FDAs willingness to engage in this dialogue, and were hopeful the revised draft will address the concerns raised by both the industry and by Congress.

As you may know, the Dietary Supplement Health and Education Act (DSHEA) created a clear framework for the regulation of dietary supplements, including the regulatory structure for NDI Notifications as a pre-market review process, not pre-market approval.

A new dietary ingredient is defined as a dietary ingredient that was not marketed in the United States before October 15, 1994. Dietary supplements marketed before October 1994 are grandfathered if the company can establish that same form or dosage was on the market.And therein lays an important question: What demonstrates whether an ingredient should be grandfathered under the law?

NPA continues to work with the FDA on this and other issues to gain more clarity about the industrys responsibilities so we can achieve a balanced approach to these regulations.In May, NPA and the other trade associations urged the FDA to issue revised guidance on NDI notifications, with a specific focus on the information that should be included to identify the new dietary ingredient.

The FDAs rule on NDI notifications does not specifically state what information should be provided to the agency, yet the FDAs most common objection in its responses to NDI notifications is that the agency is unable to establish the identity of the dietary ingredient subject to the notification.

While we wait for the revised NDI draft guidance, the FDA has said the agency will not enforce under the principles of the current draft guidance. NPA will continue to lead the industrys outreach to the FDA and keep our members informed about developments with the NDI guidance while we await the revised draft, expected later this year.

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