FDA’s Crackdown on Nutritional Suppliments Thwarted by Voter Outrage

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 heals 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their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.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helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.”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.

While the FDA has not yet agreed to a specific timeline for revising the guidance, nor indicated what exactly will be revised, they did commit to collaborating with the dietary supplement industry to create a list of agreed-upon “grandfathered” dietary ingredients (ie. supplements). A “grandfathered” dietary ingredient is an ingredient marketed before 1994 and therefore not considered an NDI (new). Grandfathered dietary ingredients are therefore not subject to the NDI guidance. Currently, there is no authoritative list of “grandfathered” dietary ingredients, leaving the legal status of many dietary supplements in limbo.

Although an authoritative list of “grandfathered” dietary ingredients could be useful to the supplement industry, we fear that the FDA will use this as an opportunity to knock out supplements that were indeed on the market before 1994 but may not meet the FDA’s idea of proof. This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. Although we know that pyridoxamine was on the market before 1994, the FDA determined that there was not enough of the right kind of evidence to conclusively prove so, and removed the ingredient from the market.

ANH-USA will participate in this process to try to ensure that the list of “grandfathered” dietary ingredients is inclusive in order to maintain your access to as many supplements as possible. We will also try to prevent the FDA from using the list as an excuse to delay indefinitely their promise to revise the draft guidance.

Your Health Freedoms Are at Risk

Write to your Senator or Congressman and let them know that you want to enjoy the freedom to choose when it comes to making informed health decisions.  Protect your health freedoms by screaming at the top of your lungs until the government finally understands that we are determined to maintain our health freedoms. www.nutrasilver.com

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About CareMan
I am the CareMan, have been for 7 years now. I really do care about YOU and getting YOU back to great, natural health, so long as you have an open mind.

2 Responses to FDA’s Crackdown on Nutritional Suppliments Thwarted by Voter Outrage

  1. Pingback: FDA’s Crackdown on Nutritional Suppliments Thwarted by Voter Outrage « Fda « CareMan

  2. Pingback: Breaking News: We Win Major Concession on New Supplement Guidance | Progressive Radio Network

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