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Action required! The Supplement Threat is Real & Imminent

Posted by Jackie 
Action required! The Supplement Threat is Real & Imminent
November 08, 2011 07:22AM
The alarm is sounding. The threat is very real and critically important if you rely on supplements to support good health. I’m posting here and in the General Health forum to be sure this isn’t missed. 2012 is just around the corner.

I just received the following urgent and well-done message and I want to pass it along to you. Please do your part.

Jackie

American consumers and voters have no idea about their inherent power to create change or stop oppression. If they only knew the tremendous power they could wield by organizing a little bit. If only takes a little faith and a little time to unify. If each concerned individual took radical political action to stop this travesty and power grab by Big Government, it would end.

Everyone needs to call their senators and congressmen once a day (it only takes 5 to 10 minutes, I have done it). They also need to send faxes two to three times a week. They can send letters and emails everyday or every other day to their representatives’ offices threatening them with the loss of their re-election if they don’t take action now to reign in the bullies at the FDA.

The following information was issued by Jarrow Formulas to their distributors… it applies to us as well.

Don't let the FDA take away your access to dietary supplements! Here is what you can do:

1. Read Jarrow's letter [www.jarrow.com] and then send your support of Jarrow's letter to Dr. Hamburg: Margaret.hamburg@fda.hhs.gov.

2. Write your elected officials and let them know you are opposed to the new NDI Draft Guidance:
* Write your Congressperson:
[writerep.house.gov]
* Write your Senator:
[www.senate.gov]

3. Let FDA know you completely oppose the NDI Draft Guidance by submitting your comments to the docket with this model comment letter.
<[www.regulations.gov]>

4. Get your friends and customers mobilized to fight to keep access to the dietary supplements they depend on for their health and well-being. (Bag-stuff this information, e-mail it, post it on facebook and twitter!)

Don't let the FDA take away your access to supplements. Let your voice be heard today!

Read on:

Re: FDA's "New Dietary Ingredient Guidance" DECIMATES New Dietary Ingredients–and most products on your shelf

Dear Retailer,
On July 1st, the FDA issued Draft Guidance for New Dietary Ingredients (NDIs). The FDA's new policy must be commented on by December 2, 2011; and we at Jarrow Formulas urge you to submit your comments. Here's why: should this NDI policy become the Final Guidance, the entire natural products industry is facing a scenario, in which:

1. Companies would have a difficult time even showing that a dietary ingredient was a pre-DSHEA ingredient, grandfathered in, and thus not needing an NDI Notification at all.

2. Every new (post-DSHEA) ingredient and formula would require an NDIN (New Dietary Ingredient Notification), creating longer lead times for product release.

3. For every new ingredient or new formula, a company would need to file a successful NDI Notification prior to marketing the product. Yet so far, the FDA has rejected 75 – 83% of all NDI Notifications—and the future safety testing requirements would be even tougher.

4. Every NDI Notification would require a significant amount of research—including toxicology studies for perfectly safe ingredients—that could cost millions of dollars and potentially limiting the product from ever being sold. Tests would also have to be performed on formulas that contain ingredients that have been in use for 50 years, potentially robbing consumers of the supplements they rely upon.

5. Each company would have to file its own NDI Notification for the same new ingredient that some other company tested as safe, and already got FDA clearance for, with a successful NDI Notification.

6. Contrary to Section 8 of DSHEA, each "new" formulation using old, pre-DSHEA ingredients, but perhaps formulated in a different way, will require an NDI Notification.

7. he FDA's decision on an NDI Notification takes at least 75 days, but a much longer time is needed for all the additional lab tests and safety studies now required for the Notification.

8. The Draft Guidance questions whether Probiotics are even dietary ingredients—that is, whether they can be sold as supplements at all.

9. New dietary ingredients that do manage to jump through several new hoops, and get FDA- "acknowledged" to go on the market, may take years as well as lots of money—thus putting a damper on innovative, beneficial products for the American consumer.

10. The FDA's over-reaching scheme will drive most products off the shelf and most companies out of business.

The FDA, which was never in favor of DSHEA, finally hopes it will get its way and destroy the supplement industry.
The current NDI Draft Guidance is such a regulatory nightmare that if it had been in place 30 or 50 years ago, there would not even be vitamin B complex, or vitamins C, D, or A unless the FDA wrote an "exception." And Co-Q10 would never have been allowed.

It gets worse. Did you know that Daniel Fabricant, Ph.D., the former #2 and #1 executive at the Natural Products Association (NPA, formerly NNFA) was hired by the FDA and is now their Director of Supplement Programs. This once industry advocate is now working for the FDA, to regulate dietary supplements out of existence. Does that sound ethical to you? Please read the attached letter written by Jarrow L. Rogovin, Founder and President of Jarrow Formulas to the Commissioner of the FDA, Dr. Margaret Hamburg. Jarrow does not think it is at all ethical, and he is letting the FDA and your elected officials know.
Marian from Miami
Re: Action required! The Supplement Threat is Real & Imminent
November 08, 2011 12:54PM

Sample documents and further information can be found here:


[operationpushback.com]

"The FDA is about ready to turn dietary supplements into drugs. This is a long-standing battle with the FDA, a repeat of what took place with the Sen. Proxmire hearings in the 1970s and passage of the Dietary Supplement Health & Education Act in 1994. You can read all about it at a website I started: www.operationpushback.com Believe me when I say ALL dietary supplements, save those with watered-down amounts of essential vitamins and minerals, will be declared drugs. You will be instructed what to do about this at the Operation Pushback site. There is no appeal for money at that site, and your name and info will be held in confidence. -Bill Sardi, Knowledge of Health, Inc."

Marian

Contact your local health food stores. Most of them haven't heard of it.
By phone,email what ever. Have the phone no.s and documents for them
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