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URGENT! Emergency Notice! FDA 60 days left.

August 2011 - Print | Index

Dear Customers,

I urge you to read through this letter and act. It is through government action that we can affect the FDA.

The FDA has issued its process for destroying the food supplement industry.  The FDA states their goal is to protect the pharmaceutical industry from all competition. The FDA is the rotating door between the pharmaceutical industry and government.

Food supplement use has increased to a multi-billion dollar industry that competes in the open market where consumers have access to nutrients that provide great health benefits. 

As this use increases, certain sales of pharmaceutical drugs have decreased, for example, Lipitor sales have gone from 10 billion dollars in 2007 to 6.9 billion in 2010. Other lucrative drugs are losing their patents and competition is great.

Late last year Congress passed a food safety bill (S.510) that slipped in a renewed call to mandate the FDA to take action on NDI rules first mandated 17 years ago under DSHEA but never acted upon by the FDA.

NDI stands for “new dietary ingredient”. 

In 1994 after years of censorship, court decisions decrying FDA harassment, and actual armed raids on doctor’s offices, the US Congress passed the Dietary Supplement Health and Education Act, (DSHEA).  The law forced the Food and Drug Administration to stop regulating the dietary supplement industry out of existence. It did give the FDA full power to remove any dangerous products and set up good manufacturing practices (GMP).

DSHEA also required supplement manufacturers to notify the FDA any time they used a new dietary ingredient in their formulations, NDI.

However, since 1994, no guidelines were issued by the FDA telling the supplement industry the rules to report NDI’s. Even with repeated requests from the Health Food industry nothing came forward. 

Now, 17 years later, the FDA has issued new NDI rules with a vengeance, bearing their full set of teeth with a short 90-day comment period, beginning the process during the long 4th of July weekend creating little time for comment and analysis.

These new draconian rules can be adopted as active regulations threatening the entire supplement industry after the 90 day period.  They spell out the eventual death of most health supplement manufacturers. It creates a future with denial of health promoting and life saving nutrients in the marketplace for the general public and citizens of this country.

The FDA’s new NDI rules go far beyond notification to requiring actual approval from the FDA through a similar process as used for drug approval.  In other words, a supplement with pomegranate juice or acai would require similar drug approval processing, though the nutrients are harmless and never required approval in the past.

No one except drug companies can afford this process because natural substances can not be patented in order to ensure enough profits to pay for the lengthy expensive process.

Also, drug companies go through the FDA process in order to prove safety because their products can result in death or great harm. Often, with harm reported they continue to be prescribed longer than they should.

Amazing as it may seem - - under the new NDI rules of the FDA, “synthetic copies” of natural molecules are exempted from any new reporting requirements.  Pharmaceutical giants can take molecules from nature and turn them into chemical drugs to offer for sale as a replacement product and patent them.

Meanwhile natural product manufacturers offering full spectrum natural nutrients are put out of business by the NDI reporting process.

Clearly the FDA’s mission will be accomplished in protecting the pharmaceutical industry from competition. The new NDI Rules will provide an unattainable platform for gaining permission, resulting in prohibition of dietary supplement ingredients introduced since 1994.

This means nearly all superfoods, detox products, numerous probiotics, many multi-vitamin formulas, a multitude of herbal products, and other newer nutrients such as resveratrol, plant sterols and an extensive list  that goes on and on will be prohibited from sale.  These products will disappear.  These products aid our immunity, brain function, digestion, circulation, strength, longevity, beauty and attitudes. These products have special uses for men, women, children and the elderly.

Our store shelves would be stripped bare and your choice of products would be as if you were on a deserted island.

Please act now and sign this letter and mail it to the FDA and contact your Congressperson. 

The FDA should no longer be the governmental organization regulating food supplements. This treatment has gone on long before the day we first started business in 1982. Its results are rules that go against US Congressional intent, legal harassment suits, denial of the curative abilities of nutrition, and a road to health bankruptcy. We desperately need a new direction, one that promotes dietary food supplements as safe and economical health alternatives. We need a Department Of Health.

Thank you.

Michael

Letter to send

Emergency - the FDA moves to limit access to natural food supplement products. Here is another source to check out.

Please read the following article: http://www.newswithviews.com/Richards/byron210.htm

The latest FDA actions can be changed through your actions. Please read the following letter, and forward it to your legislative representative and to the FDA. Thank you.

 

 

Name___________________________________________________Date______________

Address___________________________________________________________________

Food and Drug Administration

Division of Dockets Management (HFA-305)

5630 Fishers Lane, Room 1061

Rockville, Maryland  20852

                        Re:  Draft FDA Guidance Document for NDIs; Docket # 2011-D-0376-001

Dear Sir or Madam,

            I am writing you to express my grave concerns about your Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient (NDI) Notifications and Related Issues, which was issued for industry and other comment in early July 2011.  Your Agency sprung this on both industry and consumers without seeking any prior input from either and your draft Guidance is badly flawed as a result.  Therefore, I ask that you withdraw this document at once, consult with industry and consumers on a longer-term basis than the 90-day period, and come out with a new Guidance that better reflects the realities of the marketplace and the safe track record of supplements, including those with new dietary ingredients (NDIs).

            In particular, this draft Guidance causes me concern because it:

  1. Requires NDIs to meet drug-like safety tests
  2. Requires NDIs to be proven through unnecessary, expensive tests
  3. Elevates NDI submissions to food-additive or GRAS levels
  4. Ignores the incredible, proven safety record of supplements, both new and old
  5. Ignores the intent of Congress when passing DSHEA that “the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers”
  6. Through its imposition of unnecessary high costs, arbitrarily discriminates against small- and medium-sized businesses
  7. Will put thousands of people out of work by destroying jobs in a time of economic decline
  8. Turns a basic notification system for new supplements into an arbitrary approval system.
  9. Is overly burdensome and destructive of Congress’ express intent in DSHEA that “the right of access of consumers to safe dietary supplements is necessary in order to promote wellness”
  10. Reveals the true agenda of your Agency to ignore the intent of Congress and suppress consumer access to safe dietary supplements while promoting dangerous drugs. 

Sincerely yours,

____________________________________________

 

 

These statements have not been evaluated by the Food and Drug Administration. The products listed in this newsletter are not intended to diagnose, treat, cure, or prevent any disease. Consult with your physician before taking any of these products.