LTE 2004723 letter to the editor
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Chemical & Engineering News:
To the editor:
Your issue of June 21, 2004 has an article about "Reining In Dietary
Supplements". That article has several errors that I would like to point
out.
The Dietary Supplement Health & Education Act of 1994 (DSHEA) was passed
unanimously by Congress because of consumer demands to prevent the FDA
from
over-regulating dietary supplements. The FDA had been repeatedly thrown
out
of federal courts for attempting legal stunts such as attempting to label
vegetable oil caps as "unapproved food additives", along with other
heavy-handed tactics that the courts often felt were unlawful. Because of
this consumer pressure (one observer called it the greatest letter writing
campaign since the Vietnam era), Congress worked out a Grand Compromise to
satisfy both the supplement industry and government regulators. Many of
the
lawmakers who normally opposed the industry signed off on this
legislation.
DSHEA did NOT reclassify dietary supplements as food, rather than food
additives, as the article states. It did prevent the FDA from
re-classifying
food supplements as "unapproved food additives". The FDA has been saying
that DSHEA actually enhanced its ability to regulate supplements by
allowing
them to restrict label claims lacking adequate proof and by allowing FDA
to
set up mandatory Good Manufacturing Practices (GMP) that would govern the
industry. Unfortunately, a lack of funds and a low priority delayed full
implementation of DSHEA for the past ten years. Still, dietary supplements
are one of the most tightly regulated categories of food products.
Another error: the FDA did not wait ten years to collect enough evidence
to
ban the supplement ephedra. The FDA instead created a novel legal theory
allowing them to ban it without needing any real evidence that it caused
serious harm. Citing the absence of pre-market approval for most
supplements
(new ingredients actually do need pre-market notification to FDA, allowing
them to review the safety data), FDA decided that they can ban any
supplement if they believe that it may cause harm. However, no actual harm
needs to be proved to invoke this ban, and any length of historic safe use
is not even a consideration. In fact, ephedra has been studied by science
for 120 years with no evidence of serious adverse effects, when used as
directed. A study of the literature by the Rand Corporation is widely
cited
for figures showing about 150 deaths from ephedra. In fact, this number
was
actually listed by Rand as unproven anecdotal figures that they cautioned
should not be cited as "evidence" of ephedra's dangers, but the consumer
advocates, medical experts and politicians wrongfully did cite it as if
that
number of deaths from ephedra was a proven fact.
The testimony of many experts that the FDA needs more power to ban
supplements without having to first prove that they cause harm is moot,
and
has been effectively answered by the ban on ephedra. By the way, the same
ephedrine alkaloids are readily available in over-the-counter allergy
medicines, making the ban even more bizarre. Ephedra was banned only if it
had a supplement label, not if it has a drug label. The FDA was trying to
implement a label standard for the supplements, but got shut down by
intense
political pressure. The ephedra ban is essentially a political decision,
rejecting the consensus of FDA scientific panels on ephedra safety.
The real science in the Rand report was the lack of serious side effects
in
any of the 52 well-designed studies that they reviewed. That lack of harm
was again demonstrated in recent studies published by Harvard and Columbia
scientists. No association between the use of ephedra-containing products
and increased risk of stroke was demonstrated in the Hemorrhagic Stroke
project, published in the journal Neurology. Ephedra has proven to be
'safer
than aspirin', as the saying goes.
While supplement manufacturers can indeed make label claims without FDA
approval, the FDA does vigorously contest claims that it feels go too far.
There are dozens of such enforcement actions each month. In fact, FDA has
sometimes denied truthful label claims, demanding almost complete
scientific
consensus before allowing them. Items with disease claims or mislabeled
products are routinely seized and destroyed. The FDA is far from
powerless,
and they have defended DSHEA as giving them adequate enforcement powers.
The
ban on ephedra proves that they have the power, if not always the wisdom
to
use it fairly.
Of course medical experts want supplements to be regulated as drugs.
That's
their paradigm. They are concerned about foods and supplements interfering
with drug therapies, and prefer to restrict or ban the food, not label the
drug. Many times they believe that all pills should be treated the same.
But
why?
Dietary supplements are safer than food by several degrees of magnitude.
Food allergies kill far more people, hundreds a year. Food poisoning kills
and sickens thousands. Drugs that are used as directed by physicians kill
about 100,000 people a year, and medical errors with drugs may kill an
equal
number. Vitamins have an average of zero deaths per year over a ten year
period, while plants kill typically about 10 people a year (mostly
poisonous
mushrooms), according to the American Association of Poison Control
Centers.
The Rand body count is speculative and unproven, contradicted by every
study
they looked at. So why should supplements be treated like drugs, which are
dangerous by definition?
There is already a bill going though Congress that is another compromise
between supplement freedom advocates and those normally pushing for
draconian regulations. That bill will restrict steroid hormone precursors.
This proves that the supplement industry is quite willing to preserve its
enviable safety record and to deal fairly with reasonable regulations. The
demand for adverse event reporting needs such a compromise, but the
industry
is not willing to have supplements treated as if they were far more
dangerous than drugs. Senator Durbin is attempting to pass a bill that
would
allow unproven safety concerns to generate more supplement bans by the
FDA,
when such anecdotal reports are not even allowed to be used as evidence
against over-the-counter drugs. Considering the high death rates from OTC
drugs, that is ridiculously disproportionate!
One doctor is cited as saying that the herb kava is toxic to the liver.
That
is news to noted toxicologists who have looked at the flimsy evidence and
concluded the opposite. This doctor wants vitamins and herbs to be
regulated
like drugs. But the medical establishment's lack of understanding of such
alternative therapies (and their massive safety record) makes them biased
against supplements and ignorant of their real safety record, in my
opinion.
Another bill is trying to fully fund DSHEA in order to mandate adequate
FDA
oversight of supplements. Adverse event reporting is only a reasonable
compromise away. Good Manufacturing Practices are already being
voluntarily
implemented by the supplement industry, while the FDA is still working on
its own final GMP rules. There's no need to ban or slander dietary
supplements. Just give them a fair hearing, based only on the published
science, and the supplement industry and consumers will be satisfied. When
regulators support a medical monopoly that is seemingly determined to
place
severe restrictions on competing natural health products in spite of their
safety record, truth is the surest casualty.
Neil E. Levin
Certified Clinical Nutritionist
Now Foods
Bloomingdale, IL
(630) 942-8094 ext. 215
