From Health & Healing
(Tomorrow's Medicine Today) ~ March, 1999
Health & Healing readers
are unique because you actively seek solutions and reliable directions for using them. One
source of help should be supplement labels, and for as long as I can remember, I've argued
for having useful and nonmisleading information there But it's been illegal. The Food and
Drug Administration (FDA) has suppressed virtually all scientific information on
supplement labels that would explain how to use them to prevent and treat disease. You
deserve to have this information right on the product you want to purchase. And now the
In a titanic struggle with the
FDA that started eight years ago, attorney Jonathan Emord prevailed, driving a wooden
stake through the agency's black heart. On January 15, 1999, the Circuit Court of Appeals
ruled that the FDA's suppression of health claims for nutritional supplement was unlawful
and unconstitutional. And it's about time.
To understand the impact of this
landmark decision and what it means for you, let's take the example of saw palmetto.
Numerous studies have shown that the extract of the saw palmetto berry will reduce the
symptoms of an enlarged prostate, such as nighttime urination and poor urinary stream.
However, if the label states, "This product can be used to relieve the symptoms of
prostate enlargement," the FDA would seize the product and arrest the manufacturer.
Folks, the claim is truthful, but according to the FDA's perverse regulations, placing it
on the label is criminal. The manufacturer was not given permission by the FDA to tell the
Why Are Scientific Claims
Marching under the banner of
consumer protectionism, the FDA has stated that, yes, they would "permit" health
claims for supplements, if the claim meets their standard of "significant scientific
agreement." On the surface, this appears to be in the public interest. No one wants
to be hoodwinked by unscrupulous vitamin manufacturers and marketers withoutlandish,
The problem is that the FDA has
refused to define what constitutes "significant scientific agreement." A
standard not defined is no standard at all. The FDA has denied thousands of truthful
claims about the healing power of certain natural products by "decree"~and this,
my friends, is arbitrary and capricious and against federal law.
The FDA Muzzles Our Freedom of
It is also unconstitutional, in
violation of the First Amendment's guarantee of freedom of speech. So it was challenged.
Eight years ago, Durk Pearson and
Sandy Shaw, who have a line of high-quality nutritional supplements, petitioned the FDA
for permission to put truthful, nonmisleading claims on their products. The claims were
that supplemental antioxidant nutrients may reduce the risk of some forms of cancer, fiber
may reduce the risk of colorectal cancer, omega-3 essential fatty acids may reduce the
risk of heart disease, and folic acid in supplement form is superior to folic acid from
food in preventing neural tube defects. They submitted substantial amounts of scientific
evidence validating these claims.
In addition, Pearson and Shaw
suggested that if the FDA did not agree that their claims met the FDA's standard of
significant scientific agreement, the FDA could allow the claims but require a disclaimer
on the bottle, such as "This claim has not been approved by the FDA."
As expected, the FDA disallowed
the claim and disclaimer option, so on behalf of Pearson and Shaw, attorney Jonathan Emord
filed suit. The American Preventive Medical Association joined the suit six years ago and,
as a founder and president of this newly formed organization, I guaranteed their financial
participation. Citizens for Health was added to the suit as they had filed a similar one.
The suit was argued in District Court in the District of Columbia, where we lost. So we
appealed to the Court of Appeals for the D.C. Circuit, where we won, and won big.
...And Blocks the Truth From
The court agreed with our
arguments that the FDA's posture of "you can't say boo until we can you can
say boo" was a clear violation of the First Amendment of the Constitution,
which guarantees free speech. Imagine, the First Amendment protects our rights to produce
and dispense pornography, to burn the American flag, and to wear t-shirts broadcasting
offensive languae~yet supplement manufacturers must seek government permission to tell the
truth about their products! And if that permission is not granted and they tell the truth
anyway, they could go to jail!
The FDA's 20-year repression of
the nutritional supplement industry is surreal and that is exactly how the judges viewed
it. Judge Laurence Silberman wrote:
As best we understand the
government, its first argument runs along the following lines: that health claims lacking
"significant scientific agreement"[which is no more than FDA
"opinion"] are inherently misleading because they have such an awesome impact on
consumers as to make it virtually impossible for hem to exercise any judgment at the point
of sale. It would be as if the consumers were asked to buy something while hypnotized, and
therefore they are bound to be misled. We think this contention is almost frivolous. We
From my experience, you aren't
hypnotized, just in search of reliable information about your supplements.
FDA Protects Drug Companies, Not
Do you really believe that the
FDA's blackout of truthful information about the benefits of supplements was needed to
protect the public from fraud? Well, Judge Silberman did not and addressed it in his
[The] First Amendment directs
us to be especially skeptical of regulations that seek to help people in the dark for what
the government perceives to be their own good.
The FDA's obvious motive was to
protect pharmaceutical interests. If the truth about the power of certain nutrients were
allowed, millions would give these items a try, and millions would find relief.
Consequently, they would neither need nor desire expensive and far more dangerous
prescription drugs. In fact, this is precisely the concern the FDA addressed in its
Dietary Supplement Task Force report, when it stated that "the agency should insure
that the existence of dietary supplements on the market does not act as a disincentive for
This is a Landmark Case
I cannot overemphasize to you the
significance of this case. For decades, the FDA leadership has used its power to mislead
the public, denying millions the chance to find relief from debilitating disease. Now the
FDA's illegal censorship has been shut down because the court defended constitutional
principle. As a result of this case, you will soon begin to see a torrent of useful
information flow onto the labels of nutritional supplements telling you how to use them.
This decision is one of the most
significant events in FDA history, but you are not likely to read about it in the lay
press for two reasons. First, it will take at least a year to see any real changes.
Second, and more discouraging, is that we are no longer governed by the Constitution and
laws that uphold it. We are ruled instead by federal decrees written by isolated
bureaucrats. We've become too accepting and complacent, and no entity is more complacent
about the replacement of laws with rules than the lay press.
Reporters who claim expertise in the FDA
act like the town criers of old who yelled out the decrees of the king. Like town criers,
modern-day reporters would be frightened or embarrassed to disclose that their king had
been stripped naked. You see, past actions of the FDA were obviously unlawful and
unconstitutional. That means that those town criers failed to note that the decrees themselves
were criminal. They just don't "get it," or they would have "gotten
it" years ago.
A Small Group Turned the Tide
Guess how many people it took to
undress King FDA? Three: Duck Pearson, Sandy Shaw, and Jonathan Emord. Yes, they had
supporters, and all of us who stood by them are proud of that, but imagine~only three
people actually did the work. They submitted the initial claims. They filed the complaint,
written arguments, motions, and oral arguments. And they appealed the loss in the district
court, which meant that they had to do it all over again~until we won. Pearson and Shaw
This decision has made us
feel great (as one friend put it, we feel "like the minutemen did!"). It is
possible, with enough conviction, careful choices of case, court and attorney, plus time
and money, to bind the federal government down with the chains of the Constitution.
So, what's next? The FDA could
appeal to the Supreme Court, but this is not likely. The decision of the Circuit of
Appeals was unanimous, and cut through the FDA's nonsense argument like a hot knife
through butter. What the FDA is likely to do is what it does best~issue a whole bunch of
"new rules" that pervert the court's mandate.
Well, folks, Pearson, Shaw,
Emord, the American Preventive Medical Association~and yours truly~are committed and
standing at the ready, swords drawn, prepared for the next battle of our freedom in a war
that will never end. If you would like to stand at the ready with us you can make a
tax-deductible donation to the APMA's Legal and Education Foundation, P.O. Box 1002, Great
Falls, VA 22066. Donors of $25 or more receive a gift of the Court of Appeals decision;
and $100 or more, a gift of The Citizen's Guide to Fighting Government, by
Senator Steve Symms.
If you worked for a federal agency that was killing
people at the rate of 100,000 a year, every year, like clockwork, and if
you knew it, wouldn’t you feel compelled to say or do something about
At the FDA, which is, in fact, killing Americans at
that rate, no one has ever felt the need to step forward and speak up.
Let’s shift the venue and ask the same question. If
you were a
medical reporter for a major media outlet in the US, and you
knew the above fact, wouldn’t you make it a priority to say something,
write something, do something?
I’m talking about people like Sanjay Gupta (CNN, CBS),
Gina Kolata (NY Times), Tim Johnson (ABC News), and Thomas Maugh II (LA
Lenzer refers to a report by the Institute for Safe
Medication Practices: “It calculated that in 2011 prescription drugs
were associated with two to four million people in the US experiencing
‘serious, disabling, or fatal injuries, including 128,000 deaths.’”
The report called this “one of the most significant
perils to humans resulting from human activity.”
And here is the final dagger. The report was compiled
by outside researchers who went into the FDA’s own database of “serious
adverse [medical-drug] events.”
Therefore, to say the FDA isn’t aware of this finding
would be absurd. The FDA knows. The FDA knows and it isn’t saying
anything about it, because the FDA certifies, as safe and effective, all
the medical drugs that are routinely maiming and killing Americans.
Previously, I have documented that the FDA knows;
because the FDA has a page on its
own website that admits 100,000 people are killed every year
by medical drugs, and two million more people are severely injured by
the drugs. (Search engine “FDA Why Learn About Adverse Drug Reactions”
click here to be taken directly to the FDA page in question).
And for the past five years or so, I have been
writing about and citing a published report by the late Dr.
Barbara Starfield that indicates
106,000 people in the US are killed by medical drugs every year.
Until her death in 2011, Dr. Starfield worked at the Johns Hopkins
School of Public Health. Her report, “Is US health really the best in
the world?”, was published in the Journal of American Medical
Association on July 26, 2000.
Since the Department of
Homeland Security is working its way into every nook and
corner of American life, hyper-extending its mandate to protect all of
us from everything, why shouldn’t I go along with Janet Napolitano’s
advice: see something, say something.
This is what I see and this is what I’m saying. Maybe
DHS would like to investigate the FDA as a terrorist organization.
How many smoking guns do we need before a sitting
president shuts down the FDA buildings, fumigates the place, and
prosecutes very large numbers of FDA employees?
Do we need 100,000 smoking guns every year? Do we need
relatives of the people who’ve all died in the span of merely a year,
from the poisonous effects of FDA-approved medical drugs, to bring their
corpses to the doors of FDA headquarters?
And let me ask another question. If instead of drugs like
warfarin, dabigatran, levofloxacin, carboplatin, and lisinopril
(the five leading killers in the FDA database), the 100,000 deaths per year
were led by gingko, ginseng, vitamin D, niacin, and
raw milk, what do you think would happen?
I’ll tell you what would happen. SEALS, Delta Force, SWAT
teams, snipers, predator drones, tanks, and infantry would be attacking
every health-food store in America. The resulting fatalities would be
written off as necessary collateral damage in the fight to keep America safe
All those phony stories in the press, reported dutifully
by so-called medical reporters? The stories about
maybe-could-be-possible-miracle breakthroughs just over the horizon of
state-of-the-art medical research? Those stories are there to obscure the
very, very hard facts of medically-caused death on the ground.
The buck stops at the FDA.
Except in the real world, it doesn’t. Which tells you
something about the so-called real world and how much of it is composed of
Here is the situation. No medical drug in the US can be
released for public use unless and until the FDA says it is safe and
effective. That’s the rule. The FDA is spitting out drug approvals month
after month and year after year, and the drugs are routinely killing 100,000
people a year and maiming two million more, which adds up to a million
deaths per decade and 20 million maimings per decade. The FDA and the
federal government are doing nothing about it, even though they know what’s
going on. This is mass murder. Not accidental death. Murder. A holocaust.