NUTRACEUTICAL NONSENSE:
The FDA's Hidden Agenda
 Background Briefing
In the USA, foods and drugs are policed by the FDA (Food and Drug Administration).
Over the years, the FDA has sought to extend its tentacles to include nutrition products,
without success. At one point, around 1993, Congress effectively told the FDA "hands
off!" and passed legislation that placed nutrition firmly outside the control
of the FDA.
Never an organisation to take a rebuff lying down, the FDA created a new hybrid classification
called "nutraceuticals"... a cross between foods and drugs that meant any
company wanting to patent genetically-modified or synthesized products, etc that
fell into this category could now register with the FDA.
nutraceutical |ˌn(y)oōtrəˈsoōtikəl|
noun
a food containing health-giving additives and having medicinal benefit.
ORIGIN 1990s: from Latin nutrire ‘nourish’ + pharmaceutical.
Smart strategy. Build the empire by stealth.
Hi-tech MLM nutrition companies fell over themselves in the rush to gain the putative
"respectability" and competitive marketing advantage offered by 'climbing on the
tiger's back' and seeking registration with the FDA.
Of course, when you look closely at the FDA's history of falling into line with whatever
the major pharmaceutical companies want it to do, and the disinterest of those companies
in any product that can't be synthesized or patented (hence their interest in genetically-modifed crops), this development was heaven-sent for the Big Pharma. So much so, in fact, that one can only wonder where the idea really originated?
These multi-national drug giants could now branch into the highly lucrative nutrition
market with patented products.
Of course, their long history of anti-competitive activities in concert with the
FDA do NOT augur well for MLM nutraceutical companies, but that's another story.
These MLM nutraceutical companies and their distributors have been quick to capitalise
on the perceived competitive marketing advantage of being registered with the FDA:
- Quality, quantity and efficacy of ingredients must be pharmaceutical grade.
- Manufacturing and packaging plants must comply with Good Manufacturing Practice (international standard).
This means that consumers can rely on the quality and efficacy and safety of their
products.
All well and good.
But they've become very adept at implying — without actually stating, let alone PROVING — that any nutrition products not approved by the FDA are automatically
suspect.
The Australian Scene
In Australia, food and drugs are administered by separate authorities:
- The Australian
and New Zealand Food Authority, and
- the Therapeutic Goods Administration.
Nutrition products fall within the jurisdiction of the TGA, which requires all manufacturers
to comply with Certificate of Good Manufacturing Practice, and all products to comply
with stringent pharmaceutical manufacturing standards.
Compared to TGA requirements, the FDA's standards just don't cut it. Products that the
FDA routinely approves can't get a look-in here. The FDA comes in well below Australian
benchmarks, including its Certificate of Good Manufacturing Practice.
In fact, nutraceutical manufacturers in the USA who want to market their products
in Australia have to have their manufacturing facilities audited every year by TGA
inspectors to ensure compliance with the higher standards.
Interestingly, some well-known nutraceutical manufacturers can't get approval for
their products in Australia, while other, non-nutraceutical manufacturers from the
USA can.
At the time of writing this article, one low-profile, US-owned nutritional supplements manufacturer, renowned for its
innovative approach, even in network marketing, was manufacturing products in Australia
for many of its markets outside the USA, because it's easier to get those products
approved in those countries using this approach. And it refuses to risk its future by getting into bed
with the FDA!
Smart. No wonder it was growing at a rapid rate, with retention
in the 70%-80% range.
So much for the so-called competitive advantage and higher manufacturing standards
of nutraceutical manufacturers over unregistered manufacturers.
No doubt about it... some companies' claims and stories appear to have more in common
with emotionally-charged marketing propaganda than with objective FACT.
The Two-fold Risk for MLM nutraceutical Companies
The first risk is the obvious one... the FDA and the drug companies that effectively
control it can shut them down with little or no effort, once the drug companies decide
the time is right for them to move into nutritional supplementation with patented,
genetically-modified nutrients.
It won't be too blatant. It will follow the classic scenario:
- Registration of the patented, genetically-modified or synthesized products by the drug companies with the FDA as "nutraceuticals".
- A series of carefully-timed, well-publicized complaints by those companies to the FDA about the safety, quality and efficacy of the natural ingredients used by MLM nutraceutical
manufacturers.
- The FDA issues orders that prevent the sale of these products — or requires hideously-expensive research, testing, plant audits, etc etc etc over
a prolonged period so that the viability of the MLM companies concerned is placed
at serious risk, or forces their closure.
Don't believe this scenario?
Try researching the history of stevia (steviocide, rebaudiocide) in the USA. Especially after the release of aspartame — the artificial sweetener marketed under a variety of brand names, including Nutrasweet™. That's just ONE blatant example from recent
history that demonstrates the reality of this scenario.
The second risk is a consequence of the increasingly heated debate over genetically-modified
foods and the risks they present to human and animal health, especially their impact
on the human immune system.
(View two articles here... Article 1 and Article 2.)
As this debate heats up, and many more people become alarmed by the threat posed
by genetically-modified (GM) foods — and the highly deceptive way in which the issue
is being controlled, including refusal by some governments** to identify GM ingredients
on food labelling and packaging — even "Blind Freddy" can foresee a HUGE
consumer backlash against companies that include GM ingredients in their products, including NUTRITIONAL SUPPLEMENTS.
A major part of this backlash will be that ANY nutritional supplement that includes
PATENTED ingredients or processes will become suspect simply because of the murkiness of
the 'debate'.
How will the public KNOW which ones are suspect?
They can't trust their governments
to require any kind of labelling of GM ingredients, so they're going to seize on
ANY means, reliable or not, of identifying suspect products.
Well... it's not hard to predict that anything labeled as "nutraceutical"
will be immediately lumped in with all the GM products in the emotional landscape of most
consumers, if only because they're registered — along with all the GM foodstuffs — by the FDA, which will increasingly be seen as the lacky of the drug companies
that created the GM crops (a long-overdue realisation).
When this happens, MLM companies claiming to be nutraceutical manufacturers will bear
the brunt of public hostility. After all, MLM is an easy target for the media, and
for governments looking frantically to deflect political damage over their complicity
in the whole GM agenda, which benefits NOBODY but the drug companies and agribusiness.
Can YOU see the risk that's coming down the track?
That light at the end of the tunnel is NOT daylight!
(** These include the US and Australian governments, under intense pressure from
the drug companies and agribusiness... both countries are, after all, HUGE food exporters!)
Learn more: http://www.gmwatch.org
Management Ignorance, Inexperience or Ineptitude
Why Registration as a nutraceutical Manufacturer can be a Sign of Management Ignorance, Inexperience or Ineptitude in MLM Companies.
There's really only ONE reason why any MLM company would want to register with the
FDA as a nutraceutical manufacturer: to gain a perceived marketing advantage over
its competitors.
This can be cloaked in any number of specious arguments. Here are the main ones...
- "FDA approval of our manufacturing facilities ensures that our customers' health is protected."
- "Unapproved nutritional supplements may be inferior in quality, safety and efficacy... you just don't know what you're consuming."
Let's examine these plausible arguments a little more closely
1. "FDA approval of our manufacturing facilities ensures that our customers' health is protected."
The FDA can issue a Certificate of Good Manufacturing Practice. This is an international
standard used in pharmaceutical grade manufacturing. Or it's supposed to be.
If the FDA were serious about protecting public health, it would welcome requests
from manufacturers of nutrition products to certify their manufacturing plants.
But no... if you want the FDA to certify your nutritional supplements manufacturing
plant, you MUST register with the FDA as a nutraceuticals manufacturer — even if
you're not one!
This raises two important questions:
- Just how serious is the FDA about protecting public health? (Its record is appalling. FDA-approved products kill more Americans every
year than anything else except cars, alcohol and tobacco.)
- How reliable is the classification of any manufacturer as a "nutraceuticals" producer? If a consumer genuinely wants to buy nutraceutical products, there's no way they can be certain that the manufacturer didn't just register
in order to get its plant certified for GMP.
What's NOT in doubt is the FDA's REAL agenda in all this — MORE CONTROL for the FDA! (Beginning and end of story.)
[By the way, the FDA's Certificate of Good Manufacturing Practice is NOT accepted in all countries. Even US nutraceuticals manufacturers
exporting to Australia must have their plants audited and certified by the Australian
Therapeutic Goods Administration before their products can be approved for sale in
Australia.]
2. "Unapproved nutritional supplements may be inferior in quality, safety and efficacy... you just don't know what you're consuming."
In the light of what we've just seen, this argument is highly questionable... especially
the bit about not knowing what you're consuming. The reality is that, when you consume
FDA-approved nutrition products — especially those with GM ingredients — you really DON'T know what you're eating!
One US-owned MLM nutritional manufacturer I know of (because it was a professional
consulting client of mine) that refuses to have anything to do with the FDA or its
deceptive "nutraceuticals" classification, has gone a much more intelligent
and innovative route... it's now manufacturing its products for international distribution
in Australia, because the TGA's requirements (MUCH tougher than the FDA's) make it
much easier for it to gain approval for its world- class nutrition products in other
countries.
So much for any argument about nutraceutical products being safer or better or more
effective.
Like so many of these arguments, they don't let the FACTS get in the way of a highly-emotional
story.
But what does this all have to do with management ignorance, inexperience or ineptitude
in MLM nutrition companies?
Think it through.
It's like those MLM companies who plunge into public ownership so they can boast
a listing on the stock exchange.
The reality is that publicly-listed MLM companies tend to lose their true focus. Share prices and shareholder dividends become the primary focus of
management. Corporations and Securities regulators and paperwork become a major distraction
and a serious drain on company resources.
Several publicly-listed MLM companies — including Amway and Herbalife — changed
their minds and have been buying back their publicly-held shares to go private once
more.
Let me ask you this:
Would you trust ANY company management who "couldn't see the forest for the
trees" with YOUR hard-earned investment funds? How about your time, faith, energy, friendships, reputation and future financial
security?
The fact is that any MLM company management that opts for registration as a nutraceutical manufacturer — then compounds the folly by listing publicly — either doesn't know
what it's doing — or, even more alarming — knows EXACTLY what it's doing!
Either way, YOUR financial security (and a lot more) is at risk. You could end up
being a victim of incompetence or fraud. Both are fatal for your financial security.
As for nutrition companies that are NOT registered with the FDA, but claim to
manufacture or sell "nutraceuticals"... they're either naive, ignorant,
dishonest or just plain suicidal!
They take the dangerous sport of jumping on any passing bandwagons to new heights
of stupidity and risk. Would you REALLY want to ride that wagon?
Think about these issues carefully. Look beyond the warm, fuzzy appeals.
Seek the TRUTH.
Trust only the FACTS.
Dig deeper.
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