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FDA reverses itself- for now.

We have pointed out for months that the FDA’s NDI (new supplement) guidance threatens our access to supplements and indeed could destroy the industry, leaving drugs with a total monopoly.

After adamantly digging in its heels and refusing to reconsider, FDA has now at last agreed that the draft NDI guidance requires substantial revision. This follows a meeting between FDA Commissioner Margaret Hamburg and Mike Taylor, Deputy Commissioner of Foods, with Senators Harkin and Hatch, longtime champions of natural health.

According to our sources, the FDA stated in the meeting that the guidance would be revised to account for the numerous comments and concerns, and released in draft form once again, which will then be open for public comment. This is exactly what we asked for!

The FDA’s decision is a dramatic reversal of the position taken in an earlier meeting with the Senators’ representatives, in which they adamantly refused this very same request. While we may never know how or why the FDA changed their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.

ANH-USA has also been working closely with the Appropriations Committee that controls the FDA’s purse strings. We recently helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.” This appears to be another reason the FDA is finally listening.