FDA’s Crackdown On Nutritional Supplements 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their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.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helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.”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
I understand that on the face of it, this seems as if the FDA would like to ban all supplements and create widespread disease. Think about this critically. Does that even make sense? Consider trendy things like laetrile (NOT a B vitamin, B17 doesn’t exist) and cansema. This “supplements” cause death and disfigurement constantly because people buy into all the bs claims and stories COMPLETELY MADE UP BY THOSE WHO ONLY SEEK TO CURE YOU OF EXCESS CASH. Stupid people (that’s you) really do need protection from Big Brother lest you ignorantly ruin your life.
Right, let’s let government make our health decisions for us.
You really need to get some facts straight here. The US Poison Control Center reported, in 2010, there were 187,000 known DEATHS from pharmaceutical drugs side effects and ZERO DEATHS from all nutritional supplements combined.
What does make sense is allowing us to make our own decisions. Doesn’t BIG Pharma control enough of our lives already?
Yeah that’s all fine and dandy. Let’s just get a cohort of patients suffering from the same cancer. Say 150. 50 get no treatment. 50 get traditional medicine in groups of 10 (10 chemo, 10 radiation, etc). 50 get bs scams like 10 will snort curry powder, 10 will take laetrile, 10 will rub cansema on their skin, 10 will eat baking soda, etc. And to make things interesting, I propose a side bet on which group of 50 has the best outcomes. Deal?
Hi Danser, Nice article.
I wouldn’t bother starting a discussion with the ‘anonymous’ troll if I where you…a pointless waste of energy
(& I think that figure of 187,000 deaths is GROSSLY less than the real number. I’d suggest the true premature deaths figures from psychiatric drugs alone would be much more than this) scandalous scandalous scandalous
Alan
Yes, education and knowledge are such a waste of energy. Moron. Throw some more made-up numbers out while you “waste energy.”
“It ain’t what you know, it’s what you know that ain’t so.”