Protect your Health Freedom ~~ Health Freedom Protection Act

Protect your health freedom: Put an end to Codex and support the
Health Freedom Protection Act
March 15 2006

http://capwiz.com/liberty/issues/alert/%3Cbr%20/%3Ehttp://capwiz.com/liberty/issues/alert/?alertid=8240751&type=CO

The United States has come to a decision point on nutritional
supplements. Choice A is to continue participating in the Codex
Alimentarius Commission (Codex), which could be hazardous to public
health by setting limitations on supplements, and Choice B is to pass
the Health Freedom Protection Act (HFPA), which could revolutionize
the health supplement industry and greatly benefit public health, in
part by no longer allowing the FDA to prohibit disease treatment
claims for foods and supplements.

U.S. Rep. Ron Paul (R-Texas) said in his Nov. 10, 2005 speech before
the U.S. House of Representatives, "Because of the FDA's censorship
of truthful health claims, millions of Americans may suffer with
diseases and other healthcare problems they may have avoided by using
dietary supplements." Paul cited the FDA's four-year prohibition of
telling consumers that folic acid reduces birth defects, which
resulted in an estimated 10,000 cases of preventable birth defects,
as evidence that the FDA's current policy obstructs good public
health.

We're at a fork in the road, so to speak. If the United States'
participation in Codex continues, things could get much worse than
they are already. However, if Congress passes the HFPA, the U.S.
could be entering a new era in health care, when consumers will be
allowed to make informed decisions about which nutritional
supplements they want to use to support good health.

The Health Freedom Protection Act is relatively simple, yet it could
mean so much, not only to proponents of alternative medicine, but to
public health care in general. In Paul's words, the HFPA merely
allows consumers to have access to information about nutritional
supplements: "Specifically, the Health Freedom Protection Act stops
the FDA from censoring truthful claims about the curative, mitigative
or preventable effects of dietary supplements, and adopts the federal
court's suggested use of disclaimers as an alternative to
censorship."

Dietary Supplement Health and Education Act (DSHEA)
This topic of disclaimers first came up in the Dietary Supplement
Health and Education Act of 1994 (DSHEA), which first decreed which
statements nutritional supplement companies could and could not make
about their products. The law reads, "Under DSHEA, firms can make
statements about classical nutrient deficiency diseases -- as long as
these statements disclose the prevalence of the disease in the United
States. In addition, manufacturers may describe the supplement's
effects on 'structure or function' of the body or the 'well-being'
achieved by consuming the dietary ingredient. To use these claims,
manufacturers must have substantiation that the statements are
truthful and not misleading and the product label must bear the
statement: 'This statement has not been evaluated by the Food and
Drug Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.'"

As any trip down the supplement aisle of your local grocery store or
health food store will tell you, nutritional companies are following
the DSHEA's disclaimer guidelines to the tee, yet the FDA still
insists on censoring these products' proposed health benefits --
statements that definitely fall under the category of "the
supplement's effects on 'structure or function' of the body," such as
the DSHEA allows.

In his Nov. 10 speech, Paul went on to say, "The Health Freedom
Protection Act also stops the FDA from prohibiting the distribution
of scientific articles and publications regarding the role of
nutrients in protecting against disease."

One of the DSHEA's main goals is for the public to have access to
scientific information on nutritional supplements, stating, "The
DSHEA provides that retail outlets may make available 'third-party'
materials to help inform consumers about any health-related benefits
of dietary supplements. These materials include articles, book
chapters, scientific abstracts, or other third-party publications."

FDA suppression of health information and free speech
Now, 12 years after Congress' passage of the DSHEA, the FDA continues
to limit the public's access to the very information that the 1994
act prescribes. Paul addressed this issue in his speech, accusing the
FDA of violating First Amendment free speech rights. "FDA bureaucrats
are so determined to frustrate consumer access to truthful
information that they are even evading their duty to comply with four
federal court decisions [such as the 1999 case Pearson v. Shalala]
vindicating consumers' First Amendment rights to discover the health
benefits of foods and dietary supplements."

Furthermore, free speech (or the lack thereof) is a major factor in
both the FDA's and the Federal Trade Commission's (FTC) restriction
of the nutritional supplement industry. By Paul's reasoning, the
FTC's censorship on supplements' health claims completely reverses
the U.S. government's notion of free speech, a concept that has been
essential to the United States since its birth as a nation. Paul
explains, "Under traditional First Amendment jurisprudence, the
federal government bears the burden of proving an advertising
statement false before censoring that statement. However, the FTC has
reversed the standard in the case of dietary supplements by requiring
supplement manufacturers to satisfy an unobtainable standard of proof
that their statement is true."

Paul isn't alone in his belief that the FDA's standards for
nutritional supplement companies are unrealistic. In fact, in the
1999 case of Pearson v. Shalala, the United States Court of Appeals
for the DC Circuit Court decided that, in the case of nutritional
supplements, "the mere absence of significant evidence in support of
a particular claim does not translate into negative evidence against
it."

Even after the 1994 DSHEA and the 1999 case of Pearson v. Shalala,
the FDA regularly suppresses health benefit information on
nutritional supplements and sometimes even the distribution of the
supplements themselves. Though the FDA often overlooks the DSHEA's
goal of making scientific information on nutritional supplements more
available to the public, it readily exercises the Federal Food, Drug
and Cosmetic Act (FD & C), most specifically its definition of drugs.
The FD & C, which is best-known for making it mandatory to list food
coloring additives in 1938, states that, "the term 'drug' means ...
articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals." In
other words, whenever a nutritional supplement claims to prevent
disease, the FDA can, based on the FD & C, term it a "drug" and apply
the same standards demanded of a new pharmaceutical before allowing
the nutritional supplement to enter the consumer market.

This is where the problem arises. Because products of nature cannot
be patented, it is simply not economically feasible for companies to
run millions of dollars of tests on a nutritional supplement, which
is a natural substance. This is why pharmaceutical companies take
natural substances and break them apart at a molecular level to make
the isolated active ingredients patentable.
FDA suppression in action: Optimal Nutrients
The FDA's Feb. 2, 2005 letter to Tim Lally of Optimal Nutrients
offers a sad but remarkable picture of this "unobtainable standard of
proof" in action. Dr. Susan J. Walker, the director of the FDA's
Division of Dietary Supplement Programs, begins a letter to Lally by
listing the "offending" products listed on his website and
referencing the FD & C's definition of drugs:

"This is to advise you that the Food and Drug Administration
(FDA) has reviewed your website ... and has determined that the
products Borage, EPA (Fish Lipid Concentrate), Flax (100% Organic
Flax Seed Oil), Evening Primrose Oil, Attention Support, Barley
(Barley Juice Powder), Cat’s Claw, CoQ10 (Co-Enzyme Q10), DHEA
(Dehydroepiandrosterone), St. John’s wort and Valerian Root are
promoted for conditions that cause these products to be drugs under
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the
Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website
establish that these products are drugs because they are intended for
use in the cure, mitigation, treatment or prevention of diseases."

Flax seed is a drug? Of course not, but according to Dr. Walker,
Optimal Nutrients' following statement makes it a drug under FD & C:
"Flax Seed Oil is an important source of alpha-linolenic acid (ALA),
an Omega 3 series of essential fatty acids. ALA is the precursor to
EPA and the Series 3 prostaglandins ... 3PGEs protect the body
against the deleterious effects of high blood pressure."

It's interesting that, throughout the entire letter, Dr. Walker never
references the much more recent DSHEA, especially considering that,
again, the 1994 act specifically states that "manufacturers may
describe the supplement's effects on 'structure or function' of the
body or the 'well-being' achieved by consuming the dietary
ingredient." In its claim about flax seed oil, the company simply
describes ALA's "effects on 'structure or function' of the body"
("ALA is the precursor to EPA and the Series 3 prostaglandins ...
3PGEs protect the body against the deleterious effects of high blood
pressure"), which is of course permissible by DSHEA standards.

Then, later on in the letter, Dr. Walker takes the second step in the
FDA's classification of nutritional supplements as drugs by requiring
Optimal Nutrients' natural products to go through the same approval
process as new pharmaceuticals. She writes:

"Furthermore, your products are not generally recognized as safe
and effective for the above referenced conditions and therefore,
these products are ... 'new drugs' under section 201(p) of the Act
[21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the
U.S. without prior approval from FDA as described in section 505(a)
of the Act [21 U.S.C. § 355(a)]. FDA approves new drugs on the basis
of scientific data submitted by a drug sponsor to demonstrate that
the drugs are safe and effective."

Obviously it would not be economically feasible for Optimal Nutrients
to run millions of dollars worth of tests on substances that, as
products of nature, are not patentable. Today, the Optimal Nutrients
web site has no products listed on it and reads that it is "under
construction." Unfortunately, this is just one of many nutritional
supplement companies oppressed by the "unobtainable standard of
proof" that Paul spoke of in his speech before Congress.

Don't put your health freedom in the hands of the government
As if this present war against nutritional supplements was not
enough, the situation could get worse. In their Congressional
Oversight Letter, Paul and fellow U.S. Rep. Peter DeFazio (D-Ore.)
express concern about the United States' participation in the Codex
Alimentarius Commission (Codex), which is part of the Food and
Agriculture Organization (FAO) of the United Nations and the World
Health Organization (WHO) Food Standard Program. Through Codex, the
WTO hopes to "harmonize" food and other safety regulations of all WTO
countries; however, it also serves to put power in the hands of
national and international agencies and out of the hands of
consumers. For example, Codex's 2005 Guidelines for Vitamin and
Mineral Supplements reads, "Vitamin and mineral food supplements
should contain vitamins/provitamins and minerals whose nutritional
value for human beings has been proven by scientific data and whose
status as vitamins and minerals is recognized by FAO and WHO."

The field of nutrition is constantly growing with new and remarkable
products. With this in mind, putting the sole right to judge a
product's worth on FAO and WHO severely limits consumers' rights to
choose groundbreaking products that FAO and WHO may simply not be
aware of yet.

Codex's use of the term "harmonization" gives the illusion that the
WTO is working to better the world, bringing diverse nations into a
state of harmony, but that is not the reality. Codex is little more
than an attempt by Big Business to further control the global economy
and put more money in pockets that are already deep. In fact, in
their Congressional Oversight Letter, Paul and Defazio give this
warning: "Harmonization may be beneficial for the large corporations
and international businesses that control the WTO, but it would be a
disaster for American consumers of dietary supplements!" In other
words, don't let the choice words fool you. As is all too often the
case with public policy, money talks louder than the public good.

If the United States' participation in Codex continues, Paul and
DeFazio worry that the WTO will pressure the United States to enforce
draconian policies on nutritional supplements. They write, "We are
concerned that the end result of this process will force the United
States to adopt the same strict regulations of dietary supplements
common in European countries such as Germany, where consumers cannot
even examine a bottle of dietary supplements without a pharmacist's
permission."

Can you imagine living in a society like that? Most consumers would
not want to live in such a society and, according to Paul and
DeFazio's interpretation of past legislation, neither would Congress.
"By participating in this process, the FDA is ignoring the will of
Congress as expressed in DSHEA and in the FDA Modernization Act of
1997, which expressively forbid the FDA from participating in the
harmonization process, as well as the will of the American people,"
they explain.

Paul and DeFazio end their Congressional Oversight Letter with the
following wish: "We also express our hope that Congress will act to
protect the freedom of American consumers from overregulation of
dietary supplements whether imposed by the FDA or through the back
door by an international organization such as the WTO."

Paul's proposed Health Freedom Protection Act is a step toward making
that simple yet profound hope a reality. Currently, 10 congressmen
co-sponsor the HFPA. They include Paul, DeFazio, Dan Burton (R-Ind.),
Walter Jones (R-N.C.), Rob Bishop (R-Utah), John J. Duncan (R-Tenn.),
Roscoe Bartlett (R-Md.), Jeff Miller (R-Fla.), Butch Otter (R-Idaho)
and Tom Tancredo (R-Colo.). Hopefully, this number will grow. You can
do your part by visiting the Health Action Center web site and
sending the online letter to your U.S. representative. It will take
only one or two minutes to do, and it won't even cost you a postage
stamp. Remember, you don't want to live in a nation in which you need
a pharmacist's permission to look at a bottle of vitamins.

Another resource to visit is http://www.stopfdacensorship.org/