Save Your Supplements: Write the FDA Now – Here’s Why & How

By Scott Tipps
National Health Federation

Everyone with even an ounce of common sense has grave concerns about the U.S. Food and Drug Administration’s recently released “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”  This Agency sprang this trap on both industry and consumers without seeking any prior input from us at all.  It had almost 17 years to seek our opinion before coming out with this document, and now they are giving us a miserly 90 days to respond with our comments.

Please mail, fax, or e-mail your protest letter (Click Here for Sample Letter) to the FDA, and watch Kevin Miller’s “Shadows of the Future,” a 10-minute film on market control of the food and medicine supply. And listen to this Power Hour interview of Scott Tipps July 25, 2011 (hour 3).

Why is this issue so important?

The Erosion of Our Health Rights

When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed, contrary to what the mainstream media falsely reports, the law did not remove dietary supplements from the regulatory oversight of the FDA.  What it did do is to remove the FDA’s arbitrary powers of life and death over supplements so that they could be treated more like foods rather than as drugs.  The innovative tidal wave that was unleashed as a result of this breakout from regulatory prison resulted in some 1,000 new products a year in this market.  What an incredible difference DSHEA made, and we all benefited from the prison break.  Oh, wait, the FDA’s drug-industry bosom-buddies did not benefit.  And that is something they have never forgotten and have been fuming over ever since.

Not without their cohorts in U.S. Congress, the drug industry’s lobbyists have been pushing for years to hamstring DSHEA and its freedoms.  For more than a decade, they have failed.  But for the last several years, they have succeeded with sausage-slicing tactics that have gradually eroded DSHEA.  First, there was the Adverse Event Reporting law, then the law mandating “Good Manufacturing Practices,” and after that came the so-called FDA “Modernization” Act – each one designed to ratchet up the pressure on supplements, to drive out the smaller supplement manufacturers who could not keep up with the increasing regulatory costs demanded of them by these laws that were touted as making already-safe supplements “safe,” and to gradually eliminate individual supplements.  Were these laws ever truly designed to protect consumers?  No, these laws had only one purpose in mind: To make supplements more expensive, less available, and to drive the consumer back into the filthy arms of the drug pushers.

This latest nonsense is straight out of the warped minds of the FDA’s Berchtesgaden nest of anti-health thugs.  They could care less about good health, certainly care less about you or me.  This has been proven so many, countless times over the decades of the Agency’s existence that there can no longer be even a shred of doubt.  The revolving door between the drug industry and the FDA is a never-stopping one.  Just witness its recent hiring of Johnson & Johnson’s executive Spielberg who was tapped by FDA Commissioner Margaret Hamburg, as the latest deputy commissioner within the Office of the Commissioner to oversee the Agency’s drug and device centers.  This is not an exception, this is the rule.

The Compromise

Unfortunately, when DSHEA was passed, a compromise was reached in order to get unanimous passage.  The parties agreed that all dietary supplements not marketed as of the date of DSHEA’s passage (October 15, 1994) would be “new dietary ingredients” (NDIs) for which notification would be sent to the FDA.  At the time, some did not think much was wrong with this compromise.  After all, most supplements had already been discovered.  But, now, almost 17 years later, the health-food market is awash with these new dietary ingredients, such as resveratrol, ubiquinol, GABA, curcumin, and bioperine.  Notifications to the FDA have been made for many, but what is to happen to them now, with the FDA changing the law, all on its own?

Fantasy Land

This draft Guidance is a step into fantasy land.  One night the FDA went to sleep and had a wonderful dream, a dream about a land where bureaucrats reigned supreme and the common citizen answered to every edict that flowed from the lovely bureaucrats’ mouths.  If the bureaucrat said jump, then the citizen would jump; if the bureaucrat said roll over, then the citizen would roll over.  It was a wonderful place, this bureau-paradise.  But then the FDA woke up, and the non-dream reality was not nearly that perfect, yet the urge to make it bureau-perfect remained.  Hence, these constant bureaucratic attempts to whittle down our freedoms until we can only jump to the tune of some unknown functionary sitting in some unknown office thinking that he or she knows better for us than we do.

This draft Guidance is just such an attempt.  It turns the law on its head by changing a very basic notification system into an approval system subject to the arbitrary whims of the FDA.  It requires very safe NDIs to go through unnecessary, expensive tests so that they can meet drug-like safety requirements.  In essence, this Guidance ignores the incredible,proven safety record of supplements, both new and old.  The FDA can produce no dead bodies whatsoever coming from the use of these new dietary ingredients.

Yet the FDA, ignoring the many tens of thousands of actual dead bodies coming from its expensive drug-approval regulatory regime, wants to imprint that badly flawed drug-approval regime upon the dietary-supplement market.  In doing so, it ignores the clear 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” and that “the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”

Flood Them with Letters

The Guidance document is not law, but it is a clear expression of how the FDA intends to enforce its interpretation of the law.  This interpretation is badly flawed.  And its implementation will result in unnecessary high costs, arbitrary discrimination against small- and medium-sized businesses that will put thousands of people out of work by destroying jobs in a time of economic decline, and the loss of many useful and healthful supplements.

The FDA must withdraw this Guidance document at once, consult with industry and consumers on a longer-term basis than this miserly 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 NDIs.  The FDA’s proposed document is unauthorized under Law and will guarantee a backlash of legislative action the likes of which have not been seen in this legislative arena since the passage of DSHEA in 1994.

The NHF suggests that the cut-off date for NDIs either be eliminated entirely or else pushed forward to a date 15 years after 1994.

Please mail, fax, or e-mail your protest letter (Click Here for Sample Letter) to the FDA as soon as possible, but no later than October 1st of this year.  They need to be awakened from dreamland.

3 responses to “Save Your Supplements: Write the FDA Now – Here’s Why & How

  1. There is nothing that can be done about CORPORATE ALIMENTARIUS until the WAR is over between Mankind and this filthy NOT-SEE NWO.

  2. Please also make comments to the Federal Register – where regulations are posted and the public given an opportunity to comment. (If they know about it and the bureaucrats consider what they public is saying, that is.) Although the deadline for comments is October 3, 2011, the sooner the comments are made, the better. Please make your comments ASAP! A massive outcry, in an official government publication, may be our best hope for stopping this tyranny! The regulation and instructions on how to comment can be found in the Federal Register at: http://www.federalregister.gov/articles/2011/07/05/2011-16711/draft-guidance-for-industry-dietary-supplements-new-dietary-ingredient-notifications-and-related
    I do not think that we should ask for new guidelines as none are needed (then again, I also think we don’t need an FDA, or even a government; but, that’s just me.) Thank you and also please spread the word among interested consumers, businesses and the media!

  3. They will not post the comments for weeks. It might be good to post them everywhere, to reach more people. The way to stop the NWO is to get out of their controlling agencies – the UN and WTO – both responsible for Codex (and so many other horrors), both run by the Rockefellers (Bankers/pharma) and corporations. Phyllis Schlafly at Eagle Forum is calling for us to get out of the WTO. Forget all other differences and form alliances across all groups, to get out.

    Excellent lecture by Ian Crane on Codex (and the UN “net” over everyone). http://www.youtube.com/watch?v=O2D4-noTiCg

    Comment:

    Pharma controls the FDA, one of the most corrupt US agencies and responsible for millions of deaths.

    The attack on supplements has do with safety only of Pharrma’s deadly monopoly. There is zero risk from supplements. The risk is that Pharma is threatened by increasing evidence that supplements are CURING diseases.

    http://www.thenhf.com/fda_90.htm

    The Hazardous-Nutritional-Supplements-Target of FDA Police Raids:
    Annual Deaths From:
    FDA-Approved Drugs (1)…….60,000 – 140,000
    Food Contamination (2)………………………9,100
    Aspirin (3)………………………………………………90
    All vitamins (4). …………………………………….. 0
    Uncontaminated amino acids (4)………………0
    Commercial herbs (4)……………………………… 0

    1. Classen, et al., “Surveillance of Adverse Drug Events,” JAMA, 1991
    2. Centers for Disease Control
    3. FDA Fact Sheet, July 1971
    4. American Association of Poison Control Centers (data for years 1983-1990 as published in _American Journal of Emergency Medicine_)

    From the Laws of the Pharmaeutical Industry:

    It is not in the financial interests of the pharmaceutical industry to prevent common diseases – the maintenance and expansion of diseases is a precondition for the financial growth of this industry. …

    The marketplace for the pharmaceutical industry is the human body – but only for as long as the body hosts diseases. Thus, maintaining and expanding diseases is a precondition for the growth of the pharmaceutical industry.

    The pharmaceutical “business with disease” is the largest deception and fraud business in human history.

    The survival of the pharmaceutical industry is dependent on the elimination by any means of effective natural health therapies. These natural and non-patentable therapies have become the treatment of choice for millions of people despite the combined economic, political and media opposition of the world’s largest investment industry.

    See SHADOWS OF THE FUTURE

What do YOU think?

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s