We Win Our First Amendment Suit Against FDA!!
Freedom of Speech Lives!!
By Durk Pearson and Sandy
Shaw
On Jan. 15, 1999, in a landmark decision, a panel of the
U.S. Court of Appeals for the District of Columbia Circuit,
ruled 3-0 in favor of plaintiffs (that's us!), deciding that
the FDA's health claim approval process was unconstitutional
under the First Amendment and "arbitrary and capricious" under
the Administrative Procedure Act. Winners of this case include
us, our co-plaintiff the American Preventive Medical
Association, and (added to our case from a separate appeal)
Citizens for Health. Additional winners (who filed an amicus
brief in support of our First Amendment challenge of FDA
regulations) were: Direct AIDS Alternative Information
Resources, People Against Cancer, and the Foundation for
Advancement of Innovative Medicine. In addition to the
Department of Health and Human Services, Food & Drug
Administration, and the United States, other losers (who filed
an amicus brief supporting the FDA information restrictions)
were: American Cancer Society, American Heart Association,
Center for Science in the Public Interest, Public Citizen, and
Consumer Federation of America.
Special Thanks
We met constitutional attorney Jonathan Emord as a result
of publishing our 1993 book, Freedom of Informed Choice: FDA
vs. Nutrient Supplements (still available from Common Sense
Press for $6.95, (800)542-3230) and of our reading his
excellent paper, "The Doctrine of Commercial Speech in First
Amendment Jurisprudence," Cato Institute Policy Analysis
(Sept. 23, 1991). Jonathan has skillfully argued our FDA suit
from its initial filing in 1994 through the legal mazes to
this long-awaited victory. (The FDA may appeal, but we do not
expect they will be able to reverse this decision.) We spent a
lot of our own money in this case, but also got major help
along the way in paying the legal bills from Julian Whitaker,
M.D., and the American Preventive Medical Association. Some
additional financial help came from the National Health
Federation, Life Enhancement Products, Life Extension
Foundation, Greg and Michelle Pryor of Life Priority, Inc.,
and a few others who wish to remain anonymous. An analysis of
the decision, as well as our briefs and oral arguments, may be
downloaded from www.emord.com.
Those of you who have followed our work know that we have
been publicly critical of the FDA for many years, including a
long section (Appendix E) in our #1 bestseller Life Extension, a
Practical Scientific Approach. In Freedom of Informed
Choice, we specifically focused on the deleterious
consequences of FDA's regulations of "health claims" and why
we thought these regulations violated the First Amendment's
protections of speech and press. If you want to improve human
performance and extend human lifespan, it is not enough to do
research. You have to be able to turn research findings into
practical products people can buy and use, and you have to be
able to inform people of what those products do; the FDA has
long stood as the major barrier to these ends.
Suiting Up
The suit started for us in 1993, when we began filing
Public Comments in response to the FDA's proposed rules
regulating what health claims they would permit for dietary
supplements.2 As far as we were (and are) concerned, the
Constitution's First Amendment makes it clear that the federal
government has no authority to regulate truthful speech at
all. It seemed to us that the idea that "commercial speech"
(what you say when it accompanies a commercial transaction) is
somehow less deserving of constitutional protection than other
kinds of speech (though the First Amendment says nothing of
the kind) makes those of us involved in commercial
transactions -- either as buyers or sellers -- into second
class citizens. We had already become aware of this
"commercial speech" doctrine by 1986 and realized that it was
allowing government agencies, such as the FDA, unprecedented
control over the communication of truthful scientific
information when it accompanied a product.
FDA Censorship of Truthful Information
Kills
In our Freedom of Informed Choice: FDA vs. Nutrient
Supplements, we discussed the constitutional and scientific
issues of FDA's regulation of the dissemination of scientific
information. We explained what a disastrous effect upon the
public health the FDA was having by drastically slowing the
flow of truthful health information concerning dietary
supplements, such as antioxidant vitamins. (We also included
several diabolically nasty cartoons aimed at the FDA.) One of
our examples was low-dose aspirin. In the "Physician's Health
Study" published in 1989 1, it was reported that in previously
healthy men over 50, an aspirin every other day reduced the
risk of a first heart attack by about 44%. Ten years later,
the FDA still unconstitutionally prohibits aspirin companies
from communicating this information to the general public. (It
only decided a few months ago to allow the information to be
communicated to doctors!) During this period, hundreds of
thousands of people have died from heart attacks unnecessarily
because they did not know about and were not taking low-dose
aspirin (the latest evidence places the most protective dose
for most people over 50 in the range of 1/4 to 1/2 aspirin a
day -- we take 1/4).
"Commercial Speech" in the Courts
We began reading the entire text of U.S. Supreme Court
decisions in "commercial speech" cases in 1993 to learn how
the Court and how individual Justices viewed the
constitutional limits on government regulation of
advertisements and of product labels. We found a well
developed jurisprudence that provided for an awkward (and, to
our minds, unsatisfactory) "balancing test" (of free speech
vs. government interests in regulating speech) that attempted
to allow yet provide limits to government regulations of
truthful speech accompanying the sale of a product. We
considered FDA's regulations on truthful health claims to have
gone beyond the bounds set by the Court and by Congressional
statutes and far beyond the bounds set by the clear language
of the First Amendment ("Congress shall make no law ...
abridging the freedom of speech or of the press") and filed
suit against the FDA in 1994. We thought, in doing so, we
might push the envelope on freedom of speech to help restore
constitutional restraints on government regulation of
"commercial speech."
The D.C. Appeals Court in our case logically developed the
consequences of prior U.S. Supreme Court decisions concerning
First Amendment limitations on governmental censorship, with
particular focus on the communication of scientific
information as part of "commercial speech." As we had hoped,
this decision has enlarged the boundaries of freedom of speech
recognized by the Courts as being clearly beyond
constitutional federal government regulatory power.
Courts Do Not Usually Consider Constitutional
Arguments
In fact, the Court did something very unusual. Courts
generally examine constitutional challenges to laws after they
have considered procedural challenges. If a law can be thrown
out on a procedural basis, a Court will almost always do that
in preference to taking on a constitutional challenge. Rarely
do the constitutional questions get a review. In our case,
however, the Court stated, "Normally we would discuss the non-
constitutional argument first, particularly because we believe
it [that an undefined standard is no standard] has merit. We
invert the normal order here to discuss first appellants' most
powerful constitutional claim, that the government has
violated the First Amendment by declining to employ a less
draconian method--the use of disclaimers--to serve the
government's interests [of protecting the public from
misleading information]" Thus, the Court said, "even if
'significant scientific agreement' were given a more concrete
meaning, appellants might be entitled to make health claims
that do not meet that standard -- with proper disclaimers."
(The Court decided this, though it was not one of the issues
we raised in this case because we didn't think the courts were
ready for it! it looks to us as if they are pointing the way
for the FDA -- how, if they take the decision seriously, they
can thereby avoid both violating the First Amendment's
constitutional prohibitions and the otherwise inevitable next
FDA First Amendment suit!)
The Court's discussion of the First Amendment implications
of the FDA's not permitting disclaimers was a response to our
complaint that the FDA refused to permit four claims that we
wished to make. They prohibited all four proposed claims (such
as "antioxidant vitamins may reduce the risk of certain
cancers" and "omega-3 fatty acids may reduce the risk of
cardiovascular disease") by claiming that there was not
"significant scientific agreement" (which they would not
define) and would not permit us to qualify the claim by
including, for example, information about the limits of the
current evidence of cancer risk reduction by antioxidant
vitamins and what types of evidence exist (cell cultures,
animal, clinical studies, epidemiological studies, etc.). The
Court established that there is a clear First Amendment
preference for more information rather than less, and the use
of disclaimers to correct potentially (but not inherently)
misleading information must be considered by the agency.
Undefined Standard is No Standard At
All
One specific rule the new decision throws out is the FDA's
purported "significant scientific agreement" standard for
health claims. The Court agreed with our argument that the FDA
has established no standard since the FDA has refused to
define what "significant scientific agreement" means. This is
a statutory violation because Congress required in the DSHEA
that the FDA establish a procedure and standard for accepting
health claims.3 The FDA will now have to proceed with new
rulemakings in which it attempts to decide what "significant
scientific agreement" might mean when they cannot define it
simply as whatever the FDA says it is on a case by case basis.
We think it likely that the FDA will first attempt to propose
the same old unconstitutional rules dressed up in new
verbiage. You can be sure we will be filing Public
Comments!
The Court appears to have found some of the government's
arguments a bit ridiculous. For example, on page 10 of the
decision, the Court notes, "As best we understand the
government, its first argument runs along the following lines:
that health claims lacking 'significant scientific agreement'
are inherently misleading because they have such an awesome
impact on consumers as to make it virtually impossible for
them to exercise any judgment at the point of sale. (emphasis
in original) 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." Both of
us got a good laugh out of that. See the excerpts from the
oral arguments below (ADDENDUM) for even more laughs.
The FDA Does Not Approve This Claim
The Court also said, "The government's general concern
that, given the extensiveness of government regulation of the
sale of drugs, consumers might assume that a claim or a
supplement's label is approved by the government, suggests an
obvious answer. The agency could require the label to state
that 'The FDA does not approve this claim.'" We had suggested
such an approach, which we called a "split label," in our
early Public Comments to the FDA, but the FDA rejected it.
Perhaps they were concerned that people might see 'The FDA
does not approve this claim' everywhere and wonder why they
needed the FDA in the first place. In fact, the FDA has
approved only two health claims for dietary supplements during
the entire eight year period since the Nutrition Labeling and
Education Act required the FDA to review and approve health
claims for dietary supplements and foods.
Consequences of this Court Decision
This decision has made us feel great (as a friend of ours
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. The result of this
decision is going to be immense, though there seems to be
almost no notice yet in the mainstream press. Greater freedom
of speech is going to dramatically increase the market
potential of the dietary supplement industry, with much more
information about products being supplied to consumers. As
consumers learn more about the effects of dietary supplements,
they will become more sophisticated in evaluating available
products and far less likely to believe lies (whether from
private or government sources). As with any new technology, it
will take consumers a while to sort things out and locate and
stick with reliable sources of information. Fly by night
outfits may do well in the short run but suppliers of truthful
and nonmisleading information about dietary supplements, as
well as those who receive the information, will come out the
long-term winners.
Because of extensive and burdensome government regulations
of medicine and medical insurance, alternative medicine (for
example, dietary supplements) is one of the few areas of
medical practice that is still in a free market in which
consumers pay with their own money and get what they pay for.
We hope that those alternative medical practitioners and their
patients who want to require taxpayer coverage of alternative
medicine under Medicare and other government programs are not
successful in getting their wish because the result would be
to help the government take over and destroy the freedom we
currently enjoy in alternative medicine. He who pays the piper
calls the tune....
Speaking of Government Takeover of Medical
Practice: The Federal Government Has No Constitutional
Authority to Regulate Intrastate Use of Medical
Marijuana
We also have a suit filed with the U.S. District Court for
the District of Columbia (97CV00462(WBB)) challenging the
federal government's authority under the Constitution to take
action against the intrastate prescription and use of medical
marijuana in states where that is legal, on the basis of the
First, Ninth, and Tenth Amendments, and the limits of the
Commerce Clause4. This case is not about whether medical
marijuana is a good medication or not; it is about whether the
federal government has constitutional authority to regulate
the intrastate practice of medicine and whether Congress and
the "drug czar" can grant the federal government general
police powers (which the constitution does not do) over
medicine or anything else by the simple expedient of decreeing
all commerce to be interstate.
It is, of course, impossible to predict how this will come
out. We believe our constitutional arguments are very strong
and there has been some movement in recent U.S. Supreme Court
and lower court decisions to limit the intrastate reach of the
Commerce Clause (eg., U.S. vs. Lopez, 1995; U.S. vs.
Pappadopoulos, 1995). Still, there are those in the judiciary
who care much more about maintaining the federal government's
usurped powers than of restoring constitutional limits to
federal actions. (This is called "outcome based"
jurisprudence.) It will demand considerably more courage on
the part of the courts to decide in our favor than the FDA
First Amendment suit did. If we win, it will vastly increase
freedom of choice in medical practice by jettisoning the "one
size fits all" federal government approach (the whole point of
the constitutional design of federalism) to allow 50 different
competing intrastate regulatory approaches. We will, however,
have to raise more money for the appeal (whether it is the
government or ourselves who file it) after the District Court
decision on our medical marijuana/federalism suit comes down.
You can download the briefs and oral arguments for our medical
marijuana suit from www.emord.com.
Is this fun or what? Yes, but only when you
win. © 1999 by Sandy Shaw & Durk Pearson
- "Final Report on the Aspirin Component of the Ongoing
Physicians' Health Study," New England Journal of Medicine
321(3):131-135 (July 20, 1989)
- The reason for filing comments during the Public Comment
period after an agency has published a proposed rule in the
Federal Register is not because you expect the agency to care
what you have to say, but because it gives you standing to
sue. If you do not file comments on a proposed rule and are
later injured by it, you cannot go directly to the federal
courts to challenge the rule; you have to first "exhaust your
Administrative remedies," which means spending a lot of money
in the agency's internal Administrative court where you
cannot hope to win.
- It is also unconstitutional because the Constitution
authorizes only one federal institution to make laws, the
Congress. See U.S. Constitution, Article I, Section 1. The
federal agencies can carry out the will of Congress pursuant
to Congressionally created law, but cannot make rules in the
absence of statutory authorization. This is a constitutional
principle that is widely flouted by federal agencies. (For
one thing, why limit your rulemaking to that authorized by
Congressional statute when nobody in a regulatory agency has
ever been thrown in jail or lost their job or even been
disciplined by the Congress for making law that went beyond
or even defied the explicit will of Congress as expressed in
statute?) A time is rapidly approaching when a properly
chosen regulatory agency rule or rules should be challenged
on the basis of Article I, Section 1 of the constitution;
however, we didn't judge that this case was the right one for
such a challenge or that the courts were ready for it.
- Our co-plaintiffs include Julian M. Whitaker, M.D.,
Jeffrey A. Singer, M.D., Richard D. Fisher, M.D., Henry N.
Blansfield, M.D., William Regelson, M.D., American Preventive
Medical Association, and Life Extension Foundation. Our
thanks to these brave people!
ADDENDUM: Oral Arguments in Pearson & Shaw et
al v. Shalala et al.
You can learn a lot about a court and its judges by
listening to oral arguments, in which there is usually a
lively interaction between each side's attorney and the
judges, who interrupt frequently to ask questions and make
comments, sometimes pointed and humorous. Unfortunately, we
were not able to travel to Washington, D.C. to hear oral
arguments, so we did the next best thing by getting and
reading the transcript of the oral arguments. The following
short excerpt shows how dubious the judges were of the FDA's
position that unapproved health claims are inherently
misleading.
THE COURT: ... Do you seriously argue that
these statements are inherently misleading?
MS KOHL [Christine N. Kohl, representing the
FDA]: In the FDA's judgment, Your Honor, yes, they are. There
is such power over the consumer in the market place at the
point of sale...
THE COURT: ... what if the proposed
statement were exactly what your FDA's parent Agency [HHS]
said, quote, "Fatty acid omega-3 is under study because of a
possible association with a reduced risk of heart disease in
certain people." That was the only thing they wanted to put on
the label, and it was word for word what HHS put out. Is your
position that is inherently deceptive?
MS. KOHL: Yes, Your Honor, that's the
scientific judgement of the FDA that there is not --
THE COURT: So HHS, FDA's position is that
HHS is making inherently deceptive statements.
MS. KOHL: ...These regulations that are
being challenged apply only to labeling on the dietary
supplement.
THE COURT: But why does that matter? ... Why
is it inherently deceptive in the label, and not in the
brochure.
THE COURT: Is this [that the statements are
inherently misleading in a label] some impression the FDA has?
Or maybe they have some study in the back. But I mean, I've
got to tell you, I walk to the grocery store all the time. ...
I just don't get the impression that people are absolutely
terrorized when they approach a dietary supplement.
THE COURT: It's not like approaching a
lawyer.
THE COURT: Yes. Label, as opposed to reading
an article in a magazine. I mean, is this something that you
think it really rises to the, you have to have a qualitatively
different standard when they go into the grocery store?
THE COURT (a few lines later): ...But I find
the argument that this is inherently misleading is
absurd....
MS. KOHL: Well, Your Honor, again, it is the
Agency's scientific judgment based on their --
THE COURT: Well, that's not a scientific
judgment. That's a legal judgment, isn't it?
THE COURT: ... in order to win your case,
you have to establish that this is inherently misleading.
That's basically what you are arguing, isn't it?
MS KOHL: ...If the Court doesn't agree with
the FDA's conclusion that these claims have so much potential
for abuse that they are inherently misleading --
THE COURT: Potential? Wait a minute counsel.
You are switching between inherent and potential. I'm trying
to take out of the case, obviously, and I think Judge Garland
is too, this inherently misleading notion.
MS. KOHL: And my response to that is, if you
--
THE COURT: Is, you hate like hell to give it
up, but --
THE COURT: You can't legally. They're in
trouble if they give it up.
THE COURT: I know, because the Agency said
inherently misleading.
Too Early to Recommend Vitamin E Supplements Says
American Heart Association
One of the losing amici in the above case was the American
Heart Association, which supported the FDA's information-
restricting policies. In the Feb. 1, 1999 "Yahoo! News," there
was a report on the AHA's view (from Circulation 1999;99) on
the possible health benefits of taking antioxidant
supplements. The AHA says, according to the report, that,
although there is some evidence suggesting that diets rich in
antioxidants such as vitamins A, C, and E can reduce heart
disease risk, it is still too early to recommend the use of
antioxidant supplements to the general public. Moreover,
"[a]lthough diets alone may not provide the levels of vitamin
E intake that have been associated with the lowest risk in a
few observational studies," we should wait for more studies
before making public recommendations to take vitamin E
supplements.
Why would the AHA make "wait and see" recommendations about
vitamin E supplements in the face of the astronomically high
medical and human costs of heart disease (the #1 killer in
industrialized countries and already the #2 killer in most
Third World countries), the large and growing body of evidence
supporting the protective effects of vitamin E (including both
large epidemiological and intervention studies, such as
CHAOS), as well as the low potential risk of supplemental
vitamin E at the dose levels found to be protective in
prospective and intervention studies? We don't know, but we
have to wonder if someone in the AHA fears that, if people
think they can substantially reduce their own risk of heart
disease by taking vitamin E, they may be less likely to donate
money to the AHA. As Nobel Prize winning James Buchanan's
"Public Choice" theory has shown, those running large
bureaucratic organizations tend to do whatever will keep money
flowing into their organization.
Balloon Payment
Government is the ultimate "fly by night" organization.
Current officeholders benefit from what they do today (such as
lying and spending a lot of other people's money) and then
somebody else has to fix the resulting disaster later. This is
particularly bad for life extenders, as we intend to (or at
least we are trying to) be around later.
-Sandy Shaw
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