| FOR IMMEDIATE RELEASE
CONTACT: Robert S. McCaleb
Regulation of Dietary Supplements Misrepresented
by New England Journal of Medicine
September 21, 1998: In a Letter to the Editor submitted
today to the New England Journal of Medicine, Herb Research
Foundation president Rob McCaleb pointed out the disservice done
to the public and to Congress through the Journal's "misrepresentation
of the legal facts on supplements." In the September 17 editorial
"Alternative Medicine: The Risks of Untested and Unregulated
Remedies," Executive Editor Marcia Angell, MD incorrectly
states that Congress "exempted" herbs and supplements
from regulation in 1994 because of lobbying by the "multibillion
dollar dietary supplement industry." This is a serious and
unfounded accusation of wrongdoing directed at both Congress and
the industry. Incidentally, the entire herbal dietary supplement
industry is substantially smaller than a single mid-sized drug
The Dietary Supplement Health and Education Act of 1994 did not
deregulate supplements. In fact, dietary supplements are subject
to a safety definition stricter than that required for conventional
foods and far stronger than for all classes of drugs. A supplement
is considered unsafe if it "presents a significant or unreasonable
risk of illness or injury." In contrast, drugs are allowed
to present significant risks, as long as these risks are
outweighed by benefits. True, preapproval of old supplement ingredients
is not required, but neither is preapproval of old foods, food
chemicals or over-the-counter drugs. Only new drugs need
be rigorously tested prior to marketing (a process which misses
"serious adverse effects" over 50% of the time, according
to the government's General Accounting Office). Adequate safety
evidence must exist for new supplement ingredients as well. The
FDA can also remove from the market any product, including supplements,
which contain harmful levels of heavy metals or other toxins.
And the FDA can - and should - take action against any product
whose contents are not exactly as labeled, which is just as illegal
for supplements as for drugs, again contrary to statements made
in the NEJM editorial. These important and surprising errors
of fact in the editorial should be corrected.
Dr. Angell also displays her confusion about supplement research
when she states that advocates of alternative medicine rely on
"anecdotes and theories" instead of rigorous scientific
testing. The editorial unfairly links ethical manufacturers with
unnamed persons who are "reverting to irrational approaches,"
ignoring biologic mechanisms and disparaging modern science. It
also overlooks the hundreds of clinical trials and in vitro
and in vivo laboratory studies that have been conducted
on supplement ingredients. Some botanical supplements have already
been found comparable to conventional drugs in efficacy and superior
in safety, including St. John's wort for depression and saw palmetto
for prostate enlargement. Supplement makers, which now include
Bayer, Warner Lambert and other multinational drug companies as
well as herbal product pioneers such as Nature's Way and Celestial
Seasonings, are serious about research and quality. Corporate
sponsorship of research on botanicals is on the rise and, in fact,
publication of quality supplement research in peer-reviewed journals
is at an all-time high.
The Herb Research Foundation mission is to educate the public,
health practitioners, pharmacists and the media about the latest
scientific research on herbs. Safe and responsible use of herbs
is the prime concern of the Foundation. HRF has tracked the reports
of poison centers, the CDC, World Health Organization mortality
data, and other safety monitoring systems for more than 15 years
and has found the overall record of safety for herbs to be exemplary.
The HRF library, containing over 200,000 scientific articles and
books, provides scientific support for the safety and effectiveness
The use of botanicals has been at the heart of health care in
every culture at every time throughout history. Many herbs are
approved drugs in other modern nations, including Germany, Australia,
and Canada, but FDA regulations make drug approval too expensive
for nonpatentable herbs in the US. Under DSHEA, herbal product
supplements can be labeled with limited claims, providing consumers
useful information about the intended use and effects of these
products in maintaining health and well-being.
Here is an itemized response to the errors and misguided opinions
of the New England Journal of Medicine Editor Marcia Angell,
What most sets alternative medicine apart, in our view, is that
it has not been scientifically tested and its advocates largely
deny the need for such testing
We don't know which "advocates" of alternative medicine
Angell is talking about. Harvard's David Eisenberg, MD who is
named in the article, is a strong advocate of scientific research,
as is the Office of Alternative Medicine's Wayne Jonas MD, the
Executive Directors of all the industry trade associations, most
manufacturers and of course, the Herb Research Foundation.
Many advocates of alternative medicine, in contrast, believe the
scientific method is simply not applicable to their remedies.
They rely instead on anecdotes and theories.
This is not true and represents outdated thinking and a lack
of dialog on the part of the author. Any phenomenon which is repeatable
is subject to research by the scientific method. The fact is,
regulations by the FDA have placed the cost of drug approval beyond
the reach of any potential medicines, natural or
synthetic, which are not patentable. DSHEA has provided more incentive
for supplement research than anything in the entire 50 year history
of FDA regulation.
[case studies published by NEJM are anecdotal but are "well-documented"
while] anecdotes about alternative remedies (usually published
in books and magazines for the public) have no such documentation
and are considered sufficient in themselves as support for therapeutic
This is patently false. By law, statements made about supplement
products must be truthful, not misleading, and supported by scientific
evidence. Dr. Angell has obviously not read the law.
Alternative medicine also distinguishes itself by an ideology
that largely ignores biologic mechanisms, often disparages modern
science, and relies on what are purported to be ancient practices
and natural remedies...
Again, who is the good doctor talking to? Obviously not a reader
of HerbalGram or Phytomedicine, Planta Medica, Journal
of Ethnopharmacology, or even the promotional literature of
the leading dozen herbal supplement manufacturers, all of whom
emphasize the support of modern scientific research on herbs.
Today, research on herbs appears in JAMA, The Lancet, Cancer,
The Prostate, and dozens of other peer-reviewed scientific
We have learned to ask for and expect statistically reliable evidence
before accepting conclusions about remedies.
Conventional synthetic medicines do not have nearly the positive
record Dr. Angell presents. Over half of approved drugs are discovered
to have "serious post-approval side-effects" requiring
them to be removed from sale or restricted from use by significant
groups in the population (General Accounting Office study of 10
years of FDA drug approvals). As for evidence of effectiveness,
the Office of Technology Assessment reports that only 10-20% of
procedures and drugs used in hospitals have been subjected to
the rigorous research described.
Now, with the increased interest in alternative medicine, we see
a reversion to irrational approaches to medical practice...
As one of the medical doctors on our advisory board quips, if
a substance is safe and there is evidence that it works, patients
should be allowed to try it. Often it works and can be recommended
to other patients. This approach is referred to as "outcome-based
medicine." The other approach, he says, is described as "income-based
And some people may embrace alternative medicine exclusively,
putting themselves in great danger.
Of course, those who embrace conventional medicine exclusively
may put themselves in greater danger. The Journal of the AMA
reported this year that over 100,000 Americans die each year from
conventional drugs, not counting those who overdose or abuse the
medications. Over 2 million are injured each year. No one has
suggested that even a fraction of these numbers of injuries and
fatalities result from supplement use.
In response to the lobbying efforts of the "multibillion-dollar
dietary supplement industry," Congress in 1994 exempted their
products from FDA regulation.
Someone in Congress should take NEJM to task for this accusation.
The law passed in 1994 (DSHEA) does not exempt supplements
from regulation. It requires a tougher safety standard than other
foods or drugs, requires scientific evidence of claims made, authorizes
new tougher manufacturing standards for supplements than for foods,
and established a new office within the National Institutes of
Health to study supplements.
They may contain the substances listed on the label in the amounts
claimed, but they need not, and there is no one to prevent their
sale if they don't.
It is just as illegal for supplements to contain lesser amounts
of a labeled substance as for drugs. Responding to statements
made by NEJM in this editorial FDA spokeswoman Judy Foulke
said "You hear there are no rules. That's not true."
Herbal remedies may also be sold without any knowledge of their
mechanism of action.
We have only theories of the mechanism of action of many conventional
drugs, too. We used aspirin for over 40 years without knowing
how it works. Pharmacologists agree that one need not know the
mechanism of action nor the active principles to prove safety
The only legal requirement in the sale of such products is that
they not be promoted as preventing or treating disease.
Wrong again. Supplement manufacturers must comply with hundreds
of specific regulations
To comply with that stipulation, their labeling has risen to an
art form of doublespeak (witness the name PC-SPES.)
The author takes the prize for silly examples. How many Americans,
seeing a product labeled "PC-SPES" would think "Aha,
prostate cancer 'hope!' From the Latin, right?"
The FDA can intervene only after the fact, when it is shown that
a product is harmful.
This statement was true of supplements before the passage
of DSHEA, but no longer. Conventional foods, the category in which
supplements were formerly regulated, are considered safe unless
the FDA can prove they are "ordinarily injurious to health"
(that is, always toxic, to everyone). Supplements must only be
proven to present a "significant or unreasonable risk of
causing illness or injury." That is, for all other foods
except supplements, the FDA can only intervene after the
fact (maybe we should toughen the standard on conventional food).
Supplements can be declared unsafe based on evidence that they
might be harmful.