Untitled Document
If you take vitamin supplements, as I do, you'll want to pay attention to an emerging
debate over how closely vitamins might be regulated in this country.
The outcome could be as severe as the Food and Drug Administration regulating
vitamins like prescription drugs or as simple as more detailed labeling about
vitamin supplements and their effects.
Whichever way it goes, the controversy is gathering momentum.
Every day I get several e-mails warning that a shadowy international body,
Codex Alimentarius, is on the verge of cutting off availability of vitamins
and other nutritional supplements to American consumers, restricting our health
freedom, or dictating formulas so large dosages just won't be available.
Most of the vitamin consumers worried about Codex are also concerned with the
recently passed Central American Free Trade Agreement. As Texas Republican Rep.
Ron Paul put it, CAFTA "increases the possibility that Codex regulations
will be imposed on the American public."
How real are these threats? In brief, the threats exist but are not yet cataclysmic.
But it could take mobilizing vitamin and supplement consumers to neutralize
them.
Where does the main threat come from? Codex Alimentarius, Latin for
"food code" or "food law," is a United Nations-affiliated
international organization formed in 1963 under the aegis of the Food and Agriculture
Organization and World Health Organization. It promulgates international regulatory
guidelines on a range of food-related issues. At its July 4-9 meeting in Rome
it dealt mostly with uncontroversial minutiae like "proposed draft maximum
level for total aflatoxins in unprocessed almonds, hazelnuts and pistachios"
and "maximum residue levels in/on dried chili peppers" and a lot of
organizational detail.
It spent about five minutes on July 4 passing a proposal to promulgate guidelines
for regulating vitamins and mineral food supplements. As the FAO/WHO reported,
"The guidelines recommend labeling that contains information on maximum
consumption levels of vitamins and mineral food supplements, assisting countries
to increase consumer information, which will help consumers use them in a safe
and effective way...
"The guidelines say that people should be encouraged to select
a balanced diet to get the sufficient amount of vitamins and minerals. Only
in cases where food does not provide sufficient vitamins and minerals should
supplements be used."
That wording is a red flag to many users of vitamins and other supplements.
There are two distinct approaches to vitamins, both with nuances. One approach
sees the main purpose of supplements as preventing diseases caused by deficiencies,
like scurvy, beriberi and pellagra. The early quasi-official "recommended
daily allowances," which have been revised only slightly, are based loosely,
without allowance for individual biochemical or environmental differences, on
the amounts of nutrients needed to prevent deficiencies that lead to deadly
diseases.
Other researchers, including Linus Pauling (who developed the concept of "molecular
disease" after DNA was discovered), Denham Harman (the free-radical theory
of aging) and Roger Williams (biochemical and nutritional individuality) began
to develop and test the idea that there might be levels of nutrients that not
only prevented deadly diseases but improved health and ameliorated the aging
process. Since the late 1950s studies have suggested strongly that the intake
of certain vitamins can reduce the risk of numerous diseases, including heart
disease and cancer.
Europe acts with caution
As there are different approaches to the usefulness of vitamins, there are
different approaches to the most desirable way to regulate vitamins (assuming
there's a need to regulate; the fact that the American Association of Poison
Control Centers has reported no deaths due to vitamins for the last 8 years
suggests the putative dangers of "overdose" are somewhat overblown).
One faction believes that vitamins are useful only to prevent deficiency diseases,
that there must be potential dangers to doses markedly higher than deficiency-prevention
doses, that claims about disease prevention are mainly the work of charlatans,
and that vitamins should, by and large, be used only under medical supervision.
This is a variation on the "precautionary principle," which suggests
that substances should not be allowed on the market until they are proven safe
and effective beyond doubt, though how that can apply to natural substances
that occur in food and are already readily available is a question.
Most European countries and Australia regulate vitamins similarly to the way
the United States regulates prescription drugs. A set of EU guidelines, the
Food Supplements Directive, based on 1998 German regulations that emphasize
"maximum upper limits" and would have taken as many as 5,000 products
off the European market, went into effect August 1, but its impact might be
mitigated by litigation.
U.S. treats vitamins as food
The United States, on the other hand, at least since the 1994 Dietary Supplement
Health and Education Act, treats vitamins as food, not drugs. The act was passed
in one of the more remarkable instances of grassroots politicking - vitamin
manufacturers mobilized many of their customers - in response to efforts by
the FDA to assume more control over vitamins and supplements, which would probably
have led to pharmaceutical-like restrictions if the FDA had had its druthers.
Since the 1994 act vitamins and supplements have grown from a $3.4 billion to
a $20 billion industry. And the FDA would still love to get its regulatory mitts
on vitamins and supplements.
The Codex Commission obviously leans toward the European model. Its guidelines
- still not written, and there's a chance, if minuscule, of influencing them
with a barrage of scientific evidence - are likely to recommend dosages similar
to current RDAs, with the strong suggestion that higher dosage formulas not
be allowed.
Even if such formulations are not mandated, they will come with a great deal
of "education" to the effect that the authorities have determined
that vitamins with higher dosages are a waste that leaves consumers literally
urinating away their money. Many vitamin consumers who pay little attention
will believe this, according to Bill Sardi, a nutrition journalist, author and
consumer advocate in San Dimas (www.knowledgeofhealth.com). If those who believe
there are therapeutic and disease-preventing dosages are right, a great deal
of unnecessary illness will ensue.
U.S. will be divided on Codex
The Codex guidelines will find a friendly reception in some quarters in the
United States. The FDA would certainly like to exercise more regulatory oversight
on supplements than is authorized by current law. This April the Department
of Health and Human Services wrote a report urging more power for the FDA. Most
big pharmaceutical companies, which are accustomed to dealing with the FDA in
pharmaceuticals, wouldn't mind this; they would probably increase their market
share as smaller vitamin companies found the regulations too onerous to deal
with and thus close up, find a partner, or sell out to a larger company.
The 1994 Dietary Supplement Health and Education Act would deter such efforts
to "harmonize" U.S. law with international guidelines, but laws can
be changed and determined bureaucrats can be skillful at following their own
agendas without quite going so far as to violate the law too obviously. The
FDA lost an appeals court decision in Pearson v. Shalala in 1999 that challenged
its practice of forbidding health claims on vitamin packages. The court said
the First Amendment applied even to FDA efforts to restrict such free speech.
But it responded by setting up a bureaucratic process to govern "qualified
health claims" and to date has approved only nine of them.
Those who dismiss concerns about Codex as alarmist note that Codex guidelines
would be voluntary, so health freedom in the U.S. would not be threatened. Skeptics
point out that the Codex guidelines, even prior to being formulated, were specifically
mentioned as the "gold standard" of desirable vitamin guidelines in
the CAFTA treaty.
International pressures
Is it out of the question to speculate that some other country might challenge
the "antiquated" and "dangerously permissive" U.S. law as
intruding on the freedom of trade that would be promoted by uniform standards?
Scott Tips, counsel for the National Health Federation (www.thenhf.com), a
50-year-old advocate for consumer choice in health care, who has attended Codex
meetings since 2000, thinks not. "Most European officials see the freedom
allowed under the [Dietary Supplement Health and Education Act]as dangerous,
and quite sincerely," he told me.
Might the World Trade Organization then authorize the complaining country to
impose countervailing duties as a punishment? If these were politically targeted
- as were the duties proposed by the EU when the WTO said it could impose trade
sanctions after the U.S. imposed steel tariffs - they might persuade Congress
to change U.S. law.
Even absent a WTO action, U.S. companies that sell in international markets
might find it convenient to adopt Codex's guidelines. If they started producing
mostly "upper limit" vitamins, that would make it inconvenient and
more expensive for consumers who believe "megadoses" are desirable.
Health choices in the balance
The threat to nutritional freedom posed by Codex is indirect but real. The
antagonism toward vitamins and supplements - partly explainable by the fact
that some vitamin advocates have displayed signs of quackery and some enthusiasms
or fads for certain supplements have turned out to be overblown after heavy
promotion - seen in some quarters of the regulatory bureaucracy, certain politicians
and most of the media, is an important factor. These elements will pounce on
the Codex guidelines eagerly and seek to make U.S. law conform.
Contrary to Internet articles with titles like "Kiss Your Vitamins Good
Bye," however, this fight is just beginning. Vitamin consumers may have
to mobilize again, as they did in 1994. But there are more of them now than
there were then, especially as the boomers age.
Whether its guidelines take root in the United States or not, the Codex influence
could make it more important than ever that consumers inform themselves independently
and not assume the duly constituted authorities know what they're talking about.
It could take some political acumen to maintain and expand health freedom, but
it's far from impossible.