The Law And Vitamin Freedom In The United States
This presentation was given by Kevin Grimes to
the Hague Tribunal, 15th June 2003
To be perfectly honest, I think that listening to a lawyer talk about
anything is about as exciting as watching grass grow and as pleasant
as getting a cavity in your tooth filled.
It is my privilege to have the opportunity to talk with you about the
state of the law and vitamin freedom in the United States.
The good news is that vitamin freedom has increased dramatically in
the U.S. during the last 20 years and that the current state of the law
regarding nutritional or “dietary” supplements is better
than it has ever been. While the pharmaceutical industry still retains
a vast stronghold in the U.S., it is losing ground.
The bad news is that this is not a trend that is mirrored elsewhere
in the world, and there are, even in the U.S., serious threats to vitamin
With your indulgence, I would like to share with you an overview of
the history of dietary supplement freedom in the U.S. My problem is that
I have got several hours of information that I have to compress into
15 minutes. So if my remarks are not particularly coherent, I hope you
will forgive me. In the time I have, I will briefly discuss.
Two federal governmental or regulatory bodies have jurisdiction over
dietary supplements – the FDA and FTC.
Definition – A “dietary supplement” is
- A “product intended to supplement the diet” that contains
one or more of certain dietary ingredients, including a vitamin, a
mineral, an herb or other botanical, or an amino acid,”
- “ Is not represented for use as a conventional food or as
a sole item of a meal or the diet,” and
- “ is labeled as a dietary supplement,”
Products regulated — FDA is the federal agency responsible
for foods, human and veterinary drugs, biological products, medical devices,
cosmetics and electronic products that emit radiation. The FDA has jurisdiction
over product approvals (for drugs and medical devices), product safety,
manufacturing, and labeling, which includes product claims.
The bottom line is that the FDA tells the world that it is all about
protecting consumers and promoting public health. With respect to dietary
supplements, this has historically meant the suppression of the truth.
One of the most frustrating things that I have to tell clients is, “Just
because it is true, doesn’t mean you can say it.” Thus, the
truth can sometimes be hard to find.
Mission — To ensure the smooth operation of our free
market system, the FTC enforces federal consumer protection laws that
prevent fraud, deception and unfair business practices. The FTC’s
primary mission is to protect consumers.
The FTC is the Nation’s enforcer of federal truth-in-advertising
laws. Among other things, its law enforcement activities focus on claims
for foods, drugs, dietary supplements, and other products promising health
The History of Dietary Supplement Law in the U.S.
Two very significant laws enacted in the last 15 years. In order to
understand the current state of the law regarding dietary supplements
in the U.S., you must have the backdrop of
(1) The Nutrition Labeling and Education Act or NLEA; and
(2) The Dietary Supplement Health and Education Act, or DSHEA.
The Dietary Supplement Health and Education Act
DSHEA is the biggest legal victory for the consumer and the nutrition
industry in the history of the U.S.
Congressional Intent – This is fantastic! You have got
to hear this. In Section 2 of DSHEA, Congress wrote
Congress finds that –
(1) Improving the health status of United States citizens ranks at
the top of the national priorities of the Federal Government;
(2) The importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have
been documented increasingly in scientific studies;
(3) (A) there is a link between the ingestion
of certain nutrients or dietary supplements and the prevention of chronic
diseases such as cancer, heart disease, and osteoporosis; and
(B) clinical research has shown that several chronic diseases can
be prevented simply with a healthful diet, such as a
diet that is low in fat, saturated fat, cholesterol, and sodium, with
a high proportion of plant-based foods;
(4) Healthful diets may mitigate the need for expensive medical procedures,
such as coronary bypass surgery or angioplasty;
(5) Preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements will
limit the incidence of chronic diseases, and reduce long-term health
(6) (A) promotion of good health and healthy lifestyles improves and
extends lives while reducing health care expenditures; and
(B) reduction in health care expenditures is of paramount importance
to the future of the country and the economic well-being of the country;
(7) There is a growing need for emphasis on the dissemination
of information linking nutrition and long-term good health;
(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific studies
of health benefits related to particular dietary supplements;
(9) National surveys have revealed that almost 50 percent of 260,000,000
Americans regularly consume dietary supplements of vitamins, minerals,
or herbs as a means of improving their nutrition;
(10) Studies indicate that consumers are placing increased reliance
on the use of non-traditional health care providers to avoid the excessive
costs of traditional medical services and to obtain more holistic consideration
of their needs;
(11) The United States will spend over $1,000,000,000,000 on health
care in 1994, which is about 12 percent of the Gross National Product
of the United States, and this amount and percentage will continue
to increase unless significant efforts are undertaken to reverse the
(12) Although the Federal Government should take swift action against
products that are unsafe or adulterated, the Federal Government
should not take any actions to impose unreasonable regulatory barriers
limiting or slowing the flow of safe products and accurate information
(13) Dietary supplements are safe within a broad range of intake, and
safety problems with the supplements are relatively rare; and
(14) Legislative action that protects the right of access
of consumers to safe dietary supplements is necessary in order to promote
(15) A rational Federal framework must be established to supersede
the current ad hoc, patchwork regulatory policy on dietary supplements.
These truths are not merely true for Americans! They are true for every
citizen of this planet!
Burden of Proof of Safety – DSHEA did several incredible
things for the cause of dietary supplement freedom. The first affected
the FDA’s ability to remove a product simply because it contended
that the product was not safe.
Prior to DSHEA, if the FDA wanted to take the position that a particular
supplement or ingredient was not safe, it could simply ban the product.
The burden of proof to establish safety was imposed upon the manufacturer
or marketer. As you can well understand, the compilation of safety data
is a very expensive undertaking. Consequently, many of the smaller companies
were not able to meet this burden, and thus, the public was deprived
of many dietary supplements and fair competition.
DSHEA dramatically alters the balance of power in that dietary supplements
are effectively presumed to be safe. The burden has shifted from the
industry to the government to establish that a particular product is NOT safe.
Unless the FDA can sustain this burden of proof, a product cannot be
Stevia is a great example of the FDA’s misuse of power. Prior
to 1994, the FDA banned its use in any food product. While it is still
banned for use in conventional foods, it is permissible for use in dietary
supplements as long as it is not used for a technical effect. Stevia
presents a very interesting window into the FDA. The FDA has not attempted
to ban stevia for use in dietary supplements. Clearly, if
the agency thought that the existing evidence was sufficient to sustain
its burden of proof, it would have done so already. The
fact that is has not, is indicative of the fact that even the FDA itself
does not believe sufficient evidence exists to assert that stevia is
not safe. Notwithstanding this lack of science-based evidence, the FDA
continues to maintain that it is not safe for conventional foods.
Exemption from Labeling – The second area in which the
cause of supplement freedom was advanced was in the use of books, articles,
and other publications regarding particular nutrients. Prior to DSHEA,
the FDA took the position, that anything that
was used to promote the sale of a product constituted “labeling.” For
example, a study by Harvard Medical School that discussed the relationship
between antioxidants and cancer. Consistent with its findings that what
we needed was more information about the relationship
between nutrition and health rather than less information, and that consumers
should be empowered to make choices based on information from scientific
studies, Congress expressly exempted certain materials from the definition
DSHEA provides that a publication, which is reprinted in its entirety,
shall not be defined as labeling when used in connection with the sale
of a dietary supplement to consumers when it
(1) Is not false or misleading;
(2) Does not promote a particular manufacturer or brand of a dietary
(3) Is displayed or presented, or is displayed or presented with other
such items on the same subject matter, so as to present a balanced
view of the available scientific information on a dietary supplement;
(4) If displayed in an establishment, is physically separate from the
dietary supplements; and
(5) Does not have appended to it any information by sticker or any
So, if a publication meets these five criteria, I encourage people to
make maximum use of it. Hand out copies to everyone. Use it for wall
Statements of Nutritional Support – Prior to DSHEA, if
a supplement manufacturer or marketer even hinted that there was a relationship
between a nutrient and a disease, the FDA would stop him. That changed
with DSHEA. DSHEA expressly authorized four types of claims.
- Claims related to a classical nutrient deficiency disease;
- General well-being claims;
- Claims that describe the role of a nutrient or dietary ingredient
intended to affect the structure or function in humans;
- Claims that characterize the documented mechanism by which a nutrient
or dietary ingredient acts to maintain such structure or function.
As you know, nutrients affect every structure and every function of
the body. The ability to explain this to consumers is another huge victory.
Moreover, many diseases are directly related to a degeneration of a structure,
or the malfunction of a function. So the ability to make such claims
allows supplement marketers to educate consumers about such diseases.
Progress in the Cause of Supplement Freedom
Pearson v. Shalala was the first significant case to challenge the
FDA’s arbitrary and capricious denials of industry-proposed health
claims. The plaintiffs in the Pearson case were dietary supplement manufacturers
and trade associations representing manufacturers and retailers.
Under the NLEA, an interested party may petition the FDA to seek approval
of a particular health claim. The requirement that health claims be approved
before being added to the label of a dietary supplement constitutes the
primary regulatory hurdle faced by marketers of dietary supplements.
The plaintiffs submitted 4 health claims to the FDA for approval.
(1) “Consumption of antioxidant vitamins may reduce the risk
of certain kinds of cancers.”
(2) “Consumption of fiber may reduce the risk of colorectal cancer.”
(3) “Consumption of omega-3 fatty acids may reduce the risk of
coronary heart disease.”
(4) “0.8 mg of folic acid in a dietary supplement is more effective
in reducing the risk of neural tube defects than a lower amount in
foods in common form.”
Not surprisingly, the FDA denied all four claims.
The court found that the FDA’s concerns easily could be accommodated
by adding a prominent disclaimer to the label. The court specifically
stated that, “…more disclosure rather than less
is the preferred approach, it is clearly in the public interest to ensure
that governmental agencies, such as the FDA, fully comply with the law,
especially when that law concerns the parameters of a party’s First
Amendment rights to effectively communicate its health message.”
The court held the FDA’s denials in suppressing the Plaintiffs’ claims,
rather than proposing a clarifying disclaimer to accompany the claims,
violated the Constitution of the United States, specifically the First
Amendment that guarantees freedom of speech.
Under the Pearson decision, completely banning a health claim is reasonable
only if the FDA has found NO evidence that supports the claim, or if
the evidence in support of a health claim is weaker than the evidence
against the claim.
The FDA was also directed to relax its “significant scientific
agreement” standard in order to permit a broader range of health
claims, as long as they are accompanied by a disclaimer.
Whitaker v. Thompson
In May of 2001, the FDA rejected a claim which stated, “Consumption
of antioxidant vitamins may reduce the risk of certain kinds of cancer.” This
claim was almost identical to the claim in the Pearson case.
In December of last year, a federal court held that the FDA’s
rejection of an antioxidant/cancer risk reduction health claim failed
to satisfy the conditions that permit a ban of the claim because
evidence exists supporting the fact that antioxidants DO reduce the risk
After reviewing the studies the FDA used to reject the antioxidant claim,
the court pointed out that one-third of the 150 studies considered by
the FDA supported the antioxidant vitamin/cancer relationship. It was
undisputed that the FDA identified some evidence in support of the antioxidant
vitamin claim. Therefore, a complete ban of the claim could not be justified. The
court wrote, “The FDA has failed to recognize that its decision
to suppress the plaintiff’s antioxidant vitamin claim does not
comport with the First Amendment’s clear preference for disclosure
over suppression of commercial speech.”
As the Pearson and the Whitaker cases demonstrate, the FDA has a rich
history of animosity to dietary supplements and natural health. Notwithstanding
the FDA’s imperial agenda, Congress has made its intent clear,
and the courts are forcing the FDA to change its ways.
FDA Allowed Qualified Health Claims
The FDA is getting the message!
Selenium and Cancer Risk Reduction – Health claims linking
selenium supplements with reducing cancer risks are now permitted by
the FDA through its “enforcement discretion.” The agency
will allow products to state on labels and in labeling that “Selenium
may reduce the risk of certain cancers” or in the alternative, “Selenium
may produce anti-carcinogenic effects in the body.” The claim must
be accompanied by the qualifier “Some scientific evidence suggests
that consumption of selenium may reduce certain forms of cancer. However,
FDA has determined that this evidence is limited and not conclusive.”
Plant Sterol and Stanol Esters and Reduced Risk of Coronary Heart Disease – In
February of this year, the FDA indicated that it would allow health claims
regarding plant sterol or stanol esters and reduced risk of coronary
Attempts to Erode DSHEA
Enemies in Congress
Senator Richard Durbin (Democrat, Illinois):
- Was formerly the Chairman of the Government Affairs/Oversight of
Government Management Sub-committee. He presided over many hearings
on the dietary supplement industry. Fortunately, he lost his chairmanship
in last November’s elections.
- Is pushing for stricter labeling standards for dietary supplements.
- In October of last year, held hearings on ephedra and asked the
FDA to remove it from the market.
- His office has said, “We think we need to retool
- On March 26, Senator Durbin introduced the “Dietary Supplement
Safety Act.” The proposed Act requires supplement products that
contain any kind of a stimulant to by approved by the FDA. If the bill
passes, manufacturers would be required to submit data showing that
their ingredients do not cause serious side effects when taken as directed.
As you know, it costs a tremendous amount of money to conduct safety
studies, which means that small and medium-sized manufacturers would
not be able to comply.
Representatives John Sweeney (R-N.Y.) and Greg Walden (R-Ore.) announced
plans earlier in the year to challenge ephedra’s safety and address
restrictions on its sale following the death of professional baseball
player Steve Bechler.
Sweeney sent a letter to the FDA asking it to “suspend all sales
of ephedra until Congress has hearings and views evidence with regard
to the immediate safety risk involved with its use. Ephedra is a dangerous
substance and it shouldn’t be available over-the-counter. The Major
Leagues should ban its use in baseball and I’ll make sure Congress
ends its sale over-the-counter.”
On March 4, Sweeney and Walden introduced a bill called the “Ephedra
Public Protection Act,” which would ban the sale of all ephedrine
alkaloid-containing dietary supplements under most conditions.
On February 28, the House Energy and Commerce Committee launched an
investigation into the safety of ephedra. Letters have been sent to numerous
manufacturers and marketers of ephedra dietary supplements demanding
a variety of information. Hearings by the full committee will probably
be held in the next several months.
States and Ephedra
- New York – A bill to ban the sale of ephedra supplements except
for drugs under FDA supervision has been introduced in the New York
- Banned in a couple of states, and many are proposing to do the same.
The American Medical Association
Significant Scientific Agreement Standard – The FDA has
since promulgated 21 C.F.R. § 101.14 – the “significant
scientific agreement” “standard” (quoted above) – and
21 C.F.R. § 101.70 – a “procedure” (not particularly
relevant to this case) – for evaluating the validity of health
claims on dietary supplements.
A New Standard – “Weight of the evidence” v. “significant
The American Medical Association “strongly opposes” the
FDA’s decision to allow “weight of the evidence” standard.
The AMA contends that the new standard would allow the use of health
claims “that have a reasonable chance of being erroneous” and “actually
could confuse consumers” rather than help them to make informed
decision. The AMA says it is working with Congress to amend DSHEA.
We tend to think that the pharmaceutical industry is the only enemy
in this battle. It should come as no surprise that the very powerful
medical industry is a close ally to big pharma.
- There seems to be an increasing desire on the part of a very small
minority of the more liberal legislators in Congress to amend DSHEA.
- In DSHEA, Congress has made its intent clear. It has spoken. The
whims of a few radical legislators will not derail the progress that
has been made.
- The courts clearly like DSHEA and are intent on protecting freedom
of speech and the health of the people.
- The FDA has consistently lost court cases.
- The FDA’s decision to allow selenium and cancer risk reduction
claims is perhaps representative of a new level of cooperation between
the agency and the nutrition industry regarding health claims.
What we are seeing in the U.S.
There is a powerful movement in the U.S. away from drugs and conventional
health care to preventative natural health care.
There is an equally powerful desire on the parts of legislators and
courts to ensure that the public has free access to information about
dietary supplements are their abilities to prevent and treat diseases.
Similarly, there is a powerful momentum to ensure that the public has
increasing access to all types of dietary supplements.
The age-old problem still remains – Just because something
is true, doesn’t mean you can say it.
Nevertheless, the fight for vitamin freedom is going well in the U.S.,
and we are winning.
The pharmaceutical industry is losing ground in the U.S. However, it
did not gain power over night, and it will not lose power overnight.
A lot of dietary supplement freedom has been won in the U.S., but it
is constantly being threatened
Comparatively speaking, there is vastly less supplement freedom elsewhere
in the world. That needs to change.
By virtue of your participation in this Tribunal, you are privileged
to have knowledge that not many in the world have. Knowledge, however,
that is not applied is useless.
I want to challenge you to put that knowledge into action. There is
a war that is raging even now. It’s not a war of military might.
As Dr. Rath has pointed out, it’s a war between truth and deception.
Protecting our hard won freedoms means getting involved! I want to challenge
you to suit up, and get in the game. It’s time to play offense!
“Eternal vigilance and relentless action are the prices of freedom.”
If we are not vigilant, we could lose the tremendous freedoms we have
Thank you all for you vigilance, and thank you Dr. Rath for your vigilance,
your passion, and your relentless willingness to act.