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Senators Urge FDA to Withdraw NDI Draft Guidance: Encouraging News for the Supplement Industry

Dietary Supplements,FDA,Regulatory,Sports Nutrition

In what may be considered highly encouraging and promising news for the supplement industry, Senators Orrin Hatch (R-UT) and Tom Harkin (D-Iowa) have asked FDA Commissioner Dr. Margaret Hamburg to withdraw the controversial NDI Draft Guidance — and replace it with a new draft that, according to the Senators, “will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”

As reported in yesterday’s American Herbal Products Association Update, Senators Hatch and Harkin — who were the principal authors of the Dietary Supplement Health and Education Act (DSHEA) and are in a unique position to comment on this controversial new draft guidance and whether it is consistent with DSHEA — wrote a letter to the FDA to formally ask them to withdraw the document.  In their letter, the Senators pointed out that the draft guidance “serves to undermine DSHEA in a number of important aspects” — and went on to note their many concerns with the draft guidance (which many experts in the supplement industry have been noting since this controversial draft guidance for NDIs was introduced.)

With the support of these two powerful Senators, who are both long-time supporters of the natural health industry, there may be a glimmer of hope that this highly contested NDI draft guidance document may not be finalized in its current state, if at all.  According to reports, a meeting will take place in early January to discuss the issue — and the many concerns with this draft guidance — in more detail.

Although nothing is set in stone yet and it’s not clear what the final draft guidance will look like, this recent development is certainly welcome news for the supplement industry — and is an important step in helping to illustrate to the FDA that there is a tremendous opposition to this draft guidance.  We’ll keep you posted as to further developments after the parties convene sometime over the next few weeks — and hopefully will bring you word of a new, “improved”  policy concerning NDIs that is far more acceptable to everyone involved in the supplement industry.

To read the AHPA Update report, click here.

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