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Townsend
Letter Editorial On Vitamin Cartel: A Swiftian Proposal By Any Other
Name
3 January 2000
by Ed Fry
Reading the Townsend Letter editorial "Vitamins Inc. Cartel"
was like reading Jonathan Swift's "modest proposal" to eat our young
as a means of resolving human population pressures. The editorial,
however, lacked Swift's irony and wit, and certainly didn't read
like satire.
[Read
Collin's editorial now or at
end of this editorial.]
In
lieu of a trip to Lilliput, the Townsend editor might consider
traveling to Germany to observe the kind of regulatory environment
he seems to invite: one shaped to the needs of huge pharmaceutical
interests. Since shortly after World War II, big drug companies
there have functioned as self-serving virtual monopolies, turning
what otherwise might be an open, cost-efficient marketplace beneficial
to consumers into a virtual monopoly with attendant high prices.
In
Germany, the enormous profits and political might of the large pharmaceutical
corporations has enabled them to shape the regulation of dietary
supplements. The coziness of pharmaceutical producers with legislators
and regulatory agencies has driven the near exclusive use of allopathic,
chemical drugs as medical therapies. The identification of novel
chemicals as "medicine" is today almost the exclusive basis for
drug manufacturing worldwide.
Such
is the influence of drug companies abroad that consumer access to
a whole array of nutrients that Americans can buy directly off the
shelf is highly restricted in Germany and most of the Common Market
countries. Point of example: Vitamin C, a basic nutrient we in the
US take for granted is available without prescription only in very
restricted doses. Ditto the B vitamins.
Most
of Europe has followed the example of its most powerful economy
and created similar regulations. This, of course, has all been done
in the interest of "public safety," with Norway even trumping the
"cautious" Germans by forbidding vitamin C in any dosage form without
a prescription (although C powder is still permitted as a food preservative).
Impact
on US
Such
regulation means that big drug companies have complete control of
the nutrient market, from production of basic raw materials to the
marketing of finished consumer goods. The net effect is a limited
supply of products and drug-like prices. Consumer outrage is muted
by the presence of socialized medicine, with government-subsidized
dietary supplements becoming a cash cow for the big drug companies.
The
profit potential in such a model is not lost on some American supplement
producers, but the loss of personal freedom and product quality
implicit in a manufacturer-HMO model predicated on prescribed supplements
and high prices should give us all pause.
Reflecting
the sentiments of former FDA officer Gary Dykstra, drug companies
abroad have assured that dietary supplements do not act as a "disincentive
for the development of new drugs." (New drug development is where
the serious profits are.)
"What's
that got to do with us?" you might ask, perhaps thinking such restrictions
couldn't happen here in the US given the passage of the Dietary
Supplement Health & Education Act (DSHEA) and the powerful voice
of grassroots consumers who stand behind it.
Legislative
and regulatory environments are not static. For example, read the
risk assessment proposal for nutrients developed by the National
Academy of Sciences www.nas.edu
for the FDA, which in turn has presented the document at Codex Alimentarius
meetings -- with the assent of members of the US vitamin industry.
The Codex Alimentarius negotiations, under the auspices of the UN's
World Health Organization (WHO) and Food and Agriculture Organization
(FAO), are intended to set international standards for food and
supplements in order to facilitate global "free trade."
Open
to interpretation
This
poses a potentially serious threat to US law and regulations. Codex
decisions are overseen, interpreted, and enforced by the World Trade
Organization (WTO), with its Dispute Settlement Body (DSB) acting
as a final arbiter. The short history of the WTO and DSB demonstrates
that domestic laws intended to protect a nation's people (in this
case, the American people) are not inviolable, being open to international
interpretation and the threat of trade sanctions.
And
who influences WTO and DSB policy? No one in the public knows for
sure, but based on past decisions, it would appear large corporate
interests wield disproportionate weight. Ordinary citizens, the
public interest, as it were, seem to count for little.
The
NAS Risk Assessment proposal presented at Codex and supported by
vitamin industry representatives would limit the prescriptionless
dosage level of supplements to the "Lowest Observable Adverse Event
Level" [LOAEL]. For niacin, this is 35 mg, thereby averting "skin
flushing," hardly a sufficient rationale for such stringency.
While
35 mg is 175% of the Daily Value [DV], and is adequate to prevent
clinical deficiency states, much higher amounts are commonly and
safely used by individuals for supporting healthy blood lipid levels
and enhanced neurological function.
This
"risk" approach to evaluating nutrient safety is modeled on the
way that the EPA evaluates toxins, having been developed by John
Hathcock, a former FDA employee who now works for the Council for
Responsible Nutrition. CRN was founded in the 1970s by long-time
members of the vitamin industry like Bill Thompson, who felt good
science should be the foundation for the vitamin business. But CRN's
membership today is dominated by large corporate drug producers
whose impulse to gain competitive advantage and its attendant profits
may exert undue influence on regulatory and quality concerns.
Why
are key representatives of the vitamin industry supporting such
a restrictive measure as the NAS Risk Assessment? Several industry
trade group officials say "it's the best science we have," yet top
scientists in the field of nutrition say this interpretation is
based on a false premise. A model for determining the "risk" of
essential nutrients (life-giving molecules) based on the EPA's methodology
for evaluating the dangers of toxins (killer molecules) is far-fetched
at best.
Point
of fact: the safety record of dietary supplements surpasses that
of common foods. Will the FDA next seek to establish risks and "safe
upper limits" for apples or water? Wouldn't a better and more accurate
definition of the "best nutritional science" be one that includes
an attempt to identify optimal nutrient intake levels, instead of
levels that, by arcane and tortuous means, merely identify "risk"?
"Representing"
the trade
Vitamin
company personnel who "represent" the trade at Codex negotiations
have no voting power. As sole US government representative, only
the FDA votes. Members of industry are present only to offer perspective.
The prevailing view is that the NAS/FDA Risk Assessment document,
its imperfections already noted, has the best chance of mollifying
the "international community," as influenced and exemplified by
the German position.
Surely
an American advocate for the benefits of dietary supplements would
oppose a focus on risk and instead offer an affirmative agenda.
Indeed, why should the United States representative be willing to
negotiate a lowest common denominator approach? As a representative
of a free, vigorous and health-affirming sector of the world's leading
economy, wouldn't it make more sense to lobby for research and standards
that seek to identify optimal nutrient intake levels? And where
is the arms-length relationship that should exist between industry
and the FDA?
As
someone who has worked in the vitamin industry for 30 years (but
not as an owner or corporate executive), I have observed the common
phenomenon of smaller producers selling their businesses to larger
drug companies. In itself, of course, there is nothing wrong with
business owners taking profits.
But
when such profits are earned at the expense of a free market, especially
given the tendency of acquiring companies to come from the drug
sector which is scrambling after consumers of vitamins and other
natural products, then such notions as "natural," "cost competitive,"
"and "quality based on personal integrity" are brought into question
-- all at the expense of the consumer.
What
interest, for example, would a drug company have in promoting St.
John's wort which might directly threaten a proprietary position
in hugely profitable serotonin re-uptake inhibitors? In such a scenario,
would the company, at the risk of its own market position, bear
the expense of educating health providers as to the relative and
comparative benefits of its proprietary prescriptive and a commonly
occurring herbal?
Big
corporate money
A
commitment to optimizing human nutrition may seem fanciful or naive
to cynics. The fact is, although the vitamin industry was once the
target of big money-inspired regulatory assaults, it now faces the
danger of being overwhelmed by big corporate money.
"If
you can't beat 'em, buy 'em up," may be useful business school strategy,
but intelligent consumers of dietary supplements must exercise special
vigilance if the freedoms of DSHEA are to be retained -- and giant
drug manufacturers stopped from overwhelming the marketplace with
self-serving regulations created by their friends in the FDA.
If
big business interests think they're going to win competitive advantage
by imposing needless regulations on how dietary supplements are
produced and regulated, they are mistaken. Transportation, communications
and banking have all gained substantially from deregulation. The
computer industry has become the colossus of global industry in
a largely self-regulated environment.
If
the current trend continues, we must prepare to witness a rapid
decline of products available without prescription, along with sky-high
price inflation for whole constellations of supplement products
we now take for granted as inexpensive and widely available. Such
a Lilliputian outcome is unacceptable and should be met with vigorous
resistance. Health freedom must not only be protected, it must be
reaffirmed through action. Excessive dietary supplement regulation
is a good place to draw the line.
And
in addition
- No
one is "running to Congress to ask that labeling requirements
on vitamin products should be given free reign [sic]". Virtually
every reputable vitamin company is complying with the latest FDA
regulations. Those who believe otherwise need only speak with
companies spending millions of dollars to comply with FDA regulations
governing what can be stated on labels and how.
- The
Townsend Letter editor's comments notwithstanding,
such is the scope of FDA authority that it absolutely does have
the power to keep even safe products off the market. Free form,
synthesized l-tryptophan is daily administered in significant
doses to infants and the infirm in the form of infant formulas
and parenteral feeding preparations. Yet tryptophan is deemed
dangerous and is forbidden as a supplement for healthy adults.
In a widely-publicized incident over a decade ago, batches of
improperly made trypotophan circulated in the US, causing death
and injury. It is arguable that the FDA might have intercepted
the foreign-made substance at its port of entry. Less arguable
is tryptophan's utility as a serotonin precursor and its relatively
low cost and safety when properly used.
By coincidence, Prozac¨, a serotonin reuptake inhibitor, was introduced
concurrent with the permanent removal of tryptophan from the US
market, thus eliminating a potential drug "competitor" that had
been selling at an estimated value of $150 million annually. Prozac
sales are reckoned in the billions!
- The
Townsend Letter editor, instead of directing allegations
at "proprietary vitamin manufacturers," might venture a clear
expression of outrage for admitted drug corporation perpetration
of conspiracy and price fixing. The conspiracy to raise, fix,
and control prices of vitamin raw materials compromised the health
of countless people, particularly those requiring, but least able
to afford, vitamin enriched foods and supplements. For nine years,
consumers and consumer product manufacturers were defrauded and
overcharged, yet the Townsend editorial somehow uses the fact
of price fixing of raw material production by huge drug conglomerates
as a basis for more stringently regulating smaller consumer product
companies.
- Should
mislabeled, fraudulent, and potentially harmful products be
removed from the market? Absolutely. Are regulations in place
that would sanction such enforcement? Yes, indeed. Yet the FDA
too often behaves like a traffic cop at an intersection, tallying
instead of ticketing red light runners in order to build a case
for more bureaucratic powers.
The FDA continues to lament its lack of authority over dietary
supplements rather than sponsoring initiatives for developing
quality programs at the producer level. It has sponsored studies
by the private National Academy of Sciences and traveled abroad
to Codex meetings as the sole voting representative of the US
for the establishment of trade standards and policies. In this
latter role, the FDA should be present only in an advisory capacity
to assure no weakening of its mission to protect the nation's
food and drug supply. Its mission is not to facilitate "harmonization"
of US regulations to international trade standards.
- If
the editorial seeks to seriously discuss the corrupting influence
of profit, it might better begin with a careful analysis of pharmaceutical
drug development costs (Is it possible they are inflated?) and
various attempts to "patent" natural substances. It might note
that drug corporations are large enough to manipulate the crafting
of the very regulations that govern their operation, the very
laws that affect their ability to cross international boundaries
with minimal regulatory interference (just enough to keep small,
upstart competitors from emerging).
It might mention that drugs have historically generated the greatest
profits of any industry. It might also note the dietary supplement
margins are modest by comparison, as are industry profits. Yet
without the means to do business in a minimally regulated market,
the obvious social benefit of such a circumstance -- low prices
-- might evaporate.
- Would
it be better to regulate supplements as drugs? Better for
whom? By publicly televised Congressional testimony, over 100,000
Americans die annually from appropriately prescribed and properly
administered drugs (drugs that ostensibly have been determined
to be safe and efficacious).
This is the equivalent of a fully loaded 747 crashing every day,
or of the US troop casualties from two Vietnams every year. This
figure does not include errors in prescription or administration
leading to death. How would such a system assure greater integrity
and safety of supplements, which today, with the exception of
accidental overdosage of iron, harm virtually no one?
- No
rational or honest purveyor of vitamins argues for freedom
from regulation on the basis that nutrients are "natural". Someone
with but a modest knowledge of the value of dietary supplements
would argue instead that supplements, and the physiological molecules
they contain, are safer by orders of magnitude than xenomolecular,
pharmaceutical agents. Because supplements are also safer than
the US food supply, they therefore require less stringent regulations.
- The
remark that "ascorbic acid supplements are synthetic" could
readily be interpreted by uninformed readers to mean that such
supplements are made from petrochemicals or contain the kind of
artificial (xeno-) molecules found in patent pharmaceuticals.
While it is demonstrably true that co-nutrients found with vitamin
C in nature contribute to ascorbate's value, only an uninformed
person would argue that the vitamin C in oranges is chemically
superior to the identical compound synthesized from sugar (food),
the same means by which organisms biosynthesize the substance.
- The
editorial confused and failed to distinguish commonly marketed
forms of natural (food) source beta carotene and vitamin E from
the chemical versions of those nutrients manufactured by big drug
companies. Natural beta carotene is always derived (commonly from
micro-algae) amidst an array of other, natural, physiologically
useful carotenoids.
Natural source, vegetable-oil derived, d- form vitamin E is chemically
distinct from the synthetic dl- form, which does not exist in
nature. There is ample evidence that chemically derived and isolated
b-carotene and synthesized dl- vitamin E act differently in the
body and are inferior to natural (food) source forms.
- The
muddled syntax and logic at the end of the editorial make
it difficult to determine just how the editor justifies his intent
that supplements be further policed. It's suggested that makers
of pricey and profitable faux drugs (i.e., "so-called immune supporting
agents") should be reined in for insisting that their products
are natural. It is never made clear why natural molecules that
are derived or processed from various sources by large concerns,
and then "peddled as natural" require more regulation.
The
author's final admonition is that vitamins, if found to be adulterated,
would seem to be in need of regulation. Again, the FDA can remove
an adulterated product from the market in a heartbeat. However,
the implication that inexpensive readily translates to adulterated
is not borne out by studies. Several independent trials have demonstrated
that inexpensive supplements are no more likely to be deficient
or adulterated than higher priced brands.
It's
not difficult to identify dietary supplement makers who mimic the
profit strategies of drug makers, wherever possible patenting ingredients,
processing methods, or uses. To maximize profits, many have adopted
the practice of developing formulations with suggestive, trademarked
names -- and have thereby grabbed a share of the kind of proprietary
advantage and profits for which drug companies are famous. Is this
praiseworthy? No, but if fraud or malfeasance is alleged, regulatory
remedies presently exist. The FDA (or FTC) has but to enforce, instead
of stumping for expanded powers.
Finally,
a tip from a long-time vitamin industry employee: the fifty-year
standard in the industry has been the 100% mark-up. A manufacturer
sells a product that costs $10 to produce to a retailer for $20.
The retailer sells it for $40. A review of consumer websites shows
that many name-brand vitamin manufacturers are sticking with this
profit structure.
Some
manufacturing companies and retailers, however, have determined
that the market is now large enough to rely on velocity and volume
of sales for bottom line growth. These companies are satisfied with
quick nickels in place of slow dimes, i.e., food profit margins.
There are reputable brands and retailers today selling vitamins
at a 30 to 35% profit margin, not the traditional 50 to 70%. This
is of enormous benefit to consumers on one hand, while on the other
showing that price alone is not a test of quality.
If
one buys a clearly labeled product from a company recognizable as
being large enough to have a stake in doing things correctly and
avoiding litigation (look for published quality standards, clear,
easy-to-read materials and recommendations from knowledgeable health
providers, retailers and consumers as well as passing grades from
such new testing web sites as Consumerlab.com) one might conclude
that a low-priced product is what it purports to be. Quality as
an abstraction is indeterminate. The determination and measurement
of ingredients as claimed on the label of a supplement product is
definitely achievable.
Companies
that need a reminder about how to keep the substantive elements
of product quality consistent with their advertising claims would
do well to consider the work of the Dietary Supplement Quality Initiative,
the organization that sponsors the website on which this article
originally appeared (www.SupplementQuality.com). DSQI's approach
offers a standards-based framework for providing safety and quality
assurance in a self-regulating environment, while preserving consumer
access -- a proposition that large drug producers and the government
agencies that serve them would do well to observe.
About
Ed Fry, our SupplementQuality.com columnist
Edward Fry has worked in virtually every phase of the dietary supplement
business, ranging from the importation and procurement of raw materials,
through formulation and marketing of consumer products, to the wholesale
and retail distribution of supplements. Ed believes that the free
flow of coherent, truthful, and empowering information is as essential
to the well-being of consumers as the products themselves.
Vitamin Inc. Cartel: In the last ten days of May the US Justice
Department disclosed and fined a European vitamin cartel . . .
Collin's reply to Fry editorial: I feel honored to be compared,
if only derisively, to the English author Swift. And I do regret
that I don't have wit. The points made in Mr. Fry's commentary are
certainly meritorious. However . . .
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