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FDA’s Draft Guidance Threatens Vitamins – Stop The Bully Now!

Written by Wellness Club on November 29, 2011 – 12:52 pm -

The FDA is continuing to behave like a bureaucracy Out-Of-Control

 

Dear HealthBeat News Readers

 

The FDA is proposing certain regulations to impede, restrict, and ban dietary supplements. They intend to do this by regulation, not by laws – this is an end-run around Congress.

Remember, laws are made by Congress – not by bureaucracies!

 

Your local policeman doesn’t make the laws – he just enforces them – and the FDA is the policeman for foods an drugs. The job of the FDA is to enforce the laws that Congress makes – not to make up laws all on it’s own!

We have written about this Draft Guidance issue in previous HealthBeat Newsletters: FDA Says: We’re Baaaack! No Vitamin Is Safe! and Dr. Myatt’s Wellness Club Forced Out Of Business? 

Many of you have already written your representatives: Sen. Durbin Is Still After Your Vitamins – In ‘Stealth-Mode’ and have received encouraging replies from some – but the FDA is taking little notice of the wishes of the House and of Congress, instead choosing to behave like a schoolyard bully – determined to get it’s way no matter what.

This issue is coming to a head now, with the “Comment Period” set to end on December 2nd. After that time your letters and comments will have all the effect of (as we country-folk say) “spittin’ into the wind.”

The letter below was received recently by Dr. Myatt from a laboratory service. We encourage our subscribers to read the letter and to follow the advice to make one final push to contact all elected representatives and to object strenuously to this blatant, bullying power-grab by the FDA – the paid lap-dog of the Pharmaceutical industry.

Sincerely,
Nurse Mark

 

Dear PCS Members,

The FDA has presented a troubling issue regarding nutritional supplements.

A GUIDANCE issued by the FDA calls for such incredible constraint on the supplement industry that, if enacted, could truly have a profound effect on the availability of a vast array of products.

Since virtually all of us, including myself, use dietary supplements, I urge you to take immediate action by sending the attached letters to your representatives. A text version is also at the end of this email – you may cut and paste it into an email to your elected representatives in Washington, but you will need to fill out a brief contact form first.  I believe faxing is the best way to be heard. Feel free to change the letters and personalize them.

Follow this link to a Website for government contact information including mailing addresses and fax numbers for your Senators and Representatives.

THE DEADLINE IS DECEMBER 2, 2011 FOR COMMENTS – The FDA is proposing certain regulations to impede, restrict, and ban dietary supplements. This has happened in Europe and other countries.  Please help to stop it from happening in America!

Below is more information if you care to read up on this topic.  We wish to thank Biotics Research Corp. for supplying the letters and information to us and virtually every company and organization attending the Florida Chiropractic Association conference last weekend in Naples, FL.

Sincerely,
J. William Beakey, D.O.M.
Director
Professional Co-op Services, Inc.
866-999-4041
866-999-9175 – fax
www.professionalco-op.com

The following are a few highlights of the Guidance document:

The FDA’s draft Guidance requires companies to possess exorbitant amounts of information concerning their existing dietary supplements to prove that New Dietary Ingredient (NDI) notifications are not required for the products they are currently marketing. In many cases, it will be impossible to gather such information, thereby threatening the future availability of numerous dietary supplement products on the market today.

In order to market a product that contains a new dietary ingredient, manufacturers will be required to submit a tremendous amount of information concerning historical use of the ingredient or conduct a multitude of animal and human studies which are overly burdensome and costly. Establishing such excessive requirements is both contrary to Congressional intent and unnecessary given the safety record of dietary supplements over the past few decades.

Any change in the manufacturing process of a dietary ingredient that results in chemical alteration of such ingredient or a change in specifications of the ingredient, regardless of how insignificant the alteration or change is, will require the submission of a NDI notification. This will discourage manufacturers from using the most advanced and efficient manufacturing technologies and pursuing methods that can improve the safety and effectiveness of dietary supplement products.

Any increase of the amount of a dietary ingredient in a dietary supplement or any change in formula of a dietary supplement, regardless of how minute or insignificant, will require the submission of a NDI notification. This will discourage the innovation of new products.

 

SAMPLE LETTER BELOW  

November          , 2011

To My Elected Representative:

My name is                                                                         , and I am a constituent in your District.  I am deeply concerned about the Food and Drug Administration’s (FDA) recently issued Draft Guidance document entitled New Dietary Ingredient Notifications and Related Issues.

Dietary supplements are an important part of my and my family’s health-maintenance routine.  We consider access to affordable supplements to be a crucial part of our healthy lifestyle to mitigate the need for expensive medical procedures and promote good health to improve and extend our lives.

The FDA’s issuance of its draft Guidance is very troubling because it signals a dramatic shift in its policy towards dietary supplements, and I believe the FDA is attempting to establish a system of pre-market approval for these products.

It has been nearly two decades since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA).  Back then the industry was in a fight for its life because of the FDA’s insistence on using the vague standards in the food additive provisions as a means of removing from the marketplace ingredients it disapproved of even for reasons unrelated to safety.  The FDA abused its authority, and through a lot of hard work, we won the battle.

Now we find ourselves having to defend the very existence of this industry once again.  While DSHEA purposely had drafted in it a sensible and reasonable system by which the agency must be notified of the marketing of a new dietary ingredient and the basis for which the manufacturer believes that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe the FDA has taken positions in its draft Guidance that indicate that it intends to treat dietary ingredients as food additives once again. 

Even more disturbing is the FDA’s insistence that any change in the formula of a dietary supplement that contains a new dietary ingredient will require the submission of a NDI notification.  The agency has announced its intention that all dietary supplements containing new dietary ingredients be pre-cleared by the FDA.  This is contrary to Congressional intent in passing DSHEA. 

If the FDA deems it necessary to make such drastic changes in the way dietary supplements are regulated, I think it should have to go through Congress.  This is a bureaucracy that is out-of-control. It would needlessly restrict access to safe dietary supplement products, and is a job killer for the dietary supplement industry.

As a concerned constituent in your District, I am requesting that you do everything in your power to stop the FDA from enforcing DSHEA in a manner that is contrary to Congressional intent and in a manner that has the potential to destroy an industry that has brought so much good to so many people.

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