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Home/DSHEA Under Fire/The FDA Goes Back To The Drawing Board On NDI Draft Guidance!

The FDA Goes Back To The Drawing Board On NDI Draft Guidance!

Over 30,000 of you – Citizen for Health supporters, all – responded to the call to urge the FDA to revise or scrap the supplement-killing New Dietary Ingredient (NDI) Draft Guidance after we launched our multi-pronged campaign in September 2011.

Together with the outreach efforts of fellow health-freedom groups and the natural products industry, we were able to force the FDA to go back to the drawing board on the NDI Draft Guidance!

According to Natural Products INSIDER, “After close to a year of industry outcry, FDA apparently will issue a revised draft guidance on the topic of new dietary ingredients (NDIs).”

According to news reports, FDA’s Commissioner Margaret Hamburg, Deputy Commissioner Mike Taylor, and Assistant Commissioner Jeanne Ireland met with Sens. Orrin Hatch [R-UT] and Tom Harkin [D-IL] on June 19.

Word on the street is that, as a result of that meeting and the overwhelming outcry from the natural health and wellness community, the FDA will be releasing a revised draft guidance that the agency hopes will provide greater clarity and address concerns that the document is not in line with the intent of the original statute. However, industry observers do not expect a revised draft guidance will be released until after the election.

As mentioned, we began our campaign in September 2011, and shortly thereafter, on October 6th, Citizens for Health submitted its own organizational comments to the FDA in opposition to the NDI Draft Guidance.

In November, we launched a viral petition campaign accompanied by a video re-mastered by Australian truth rapper Jody Lloyd a.k.a. Trillion, electrifying American consumers and setting a new benchmark in grassroots advocacy: 10,000 petition signatures in 10 days!

In fact, over 12,000 of you initially made a commitment to health freedom and Citizens for Health (CFH) by signing your name to that critical petition to stop what would have been a dangerous extension of the FDA’s reach!!! We at CFH (Jim Turner and James Gormley) honored that commitment by meeting with top aides from 11 key U.S. House of Representatives and U.S. Senate offices, providing copies of the petition strengthned by 12,686 citizen activist signatures!

Here is a Thank You video tweaked by Trillion:

And we didn’t stop there.

Not only did you help us reach past our original goal and amass 25,000 signatures by February 25th – today we have 30,215 petition signatures calling on the FDA to do what is right.

While the FDA has to be watched very carefully as this process unfolds, it is certain that consumers successfully sent the agency a clear, irrefutable message. To borrow some jargon from the world of boxing, we made them “retreat to a neutral corner” for the time being.

While we still maintain the position that a complete withdrawal of the petition is what is needed, mothballing it and massively overhauling may hold some promise.

But only time will tell. In the meantime, you can (very briefly) sit on your high horse AND rest on your laurels! How many people get to do that?!

Stay tuned for updates as we move forward with this historic effort.

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6 Responses to “The FDA Goes Back To The Drawing Board On NDI Draft Guidance!”

By michele mohr - 23 June 2012 Reply

fda needs to do what is right!!!!! scrap the supplement killing NDI for good!!!

By Georgia - 23 June 2012 Reply

The greed for money can not fill an empty stomach

By Diane - 24 June 2012 Reply

I live in New Zealand – is it worth my voting as per your emails?

By James Gormley - 24 June 2012 Reply

H Diane,
Thanks for writing in…..feel free to sign the petition and note you are from New Zealand and don’t want to see TGA-like restrictions on U.S. products! Please sign up to receive our regular alerts and please let us know about what is going on in NZ supplements-wise!
Many thanks.
James

By Victoria - 24 June 2012 Reply

Thank you for initiating and facilitating this effort! We are alertly standing by.

By giuseppe nacci - 3 August 2012 Reply

Rome: GMOs and Hydrogenated Fats Cause Diabetes, due to “American Obesity”

Rome, July 2012

In the presence of the Italian Health Monitoring Centre, with the support of the Senate of the Italian Republic, the Italian Ministry for Health, the Regional Council of Lazio, the Municipal Authority of Rome and the Provincial Authority of Rome, the ten short-listed authors of medicine books deemed to be of particular interest were rewarded. The event was filmed by Raiuno, the Italian public broadcaster.

The awarding ceremony was held at Terrazza Caffarelli, on the Capitoline Hill, which was also visited by President Obama and his wife on their state visit to Rome.

While introducing one of the competitors, Trieste-based Dr. Nacci, special attention was given to a study led by American scientists in the Eighties. The results of that study pointed to a possible correlation between Type-2 Diabetes Mellitus (which is related to Obesity) and cell wall damage deriving from Non-Natural Fats.

In his book “Come affrontare il Diabete” (How to Tackle Diabetes), Dr. Nacci linked this great American discovery from the 80s to a previous paper published by Dr. Mosenthal in 1933, also in the USA. The paper indicated very low numbers of diabetes cases in the United States in the 1920s.

The first observation made by Dr. Nacci was to consider hydrogenated fats (which are artificial, non-natural fats invented in 1912) as a possible cause for Diabetes, as the disease was virtually unknown in the 1920s and subsequently affected 6-10% of the US population in the years between 1950 and 1990. The development was concomitant with the diffusion of hydrogenated fats in the US food chain after the Second World War. At the same time, the percentage of overweight people in the USA increased, reaching a proportion of between 20 and 30% of the total.

The second observation made by Dr. Nacci was to relate the introduction into the US food chain of Genetically Modified Organisms with the sudden appearance, after the Nineties, of so-called “American Obesity”, which led to an unexpected increase in the number of overweight Americans from 20-30% (1950-1988) to about 70% (1990-2010) and to a similarly sharp increase in the number of people affected by Type-2 Diabetes (which is linked to obesity).

The book “Come affrontare il Diabete” (“How to Tackle Diabetes”) http://www.procaduceo.org/dottnacci/NACCI%20Abstract%20italian%20Book%20on%20Diabete1.pdf

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