Testimony Before the House Government Reform Committee
on Access to Dietary Supplements
Mr. Chairman, we appreciate the opportunity to submit comments regarding
the need to protect consumers from intrusive regulations which interfere
with the availability of dietary supplements. Today's hearing is just
the latest example of the leadership you have shown on this important
Over the past decade the American people have made it clear that they
do not want the federal government to interfere with their access to dietary
supplements. In 1994, Congress responded to the American people's desire
for greater access to the truth about the benefits of dietary supplements
by passing the Dietary Supplements and Health and Education Act of 1994
(DSHEA), which liberalised the rules regarding the regulation of dietary
supplements. Congressional offices received a record number of comments
in favour of DSHEA.
Despite DSHEA, officials of the Food and Drug Administration (FDA) continued
to attempt to enforce regulations aimed at keeping the American public
in the dark about the benefits of dietary supplements. However, in the
case of Pearson v. Shalala, 154 F.3d 650 (DC Cir. 1999), reh'g denied
en banc, 172 F.3d 72 (DC Cir. 1999), the United States Court of Appeals
for the DC Circuit Court reaffirmed consumers' first amendment right to
learn about how using dietary supplements can improve their health without
unnecessary interference from the FDA. The FDA has been forced to revise
its regulations in order to comply with Pearson. However, members of Congress
have had to intervene with the FDA on several occasions to ensure that
they followed the court's order. Clearly Congress must continue to monitor
the FDA's action in this area.
The freedom of consumers to use, or even obtain truthful information
about, dietary supplements could also be threatened by the United States
participation in the Codex Alimentarius Commission (Codex). Codex is a
part of the Food and Agriculture Organisation of the United Nations and
the World Health Organisation Food Standard Program operating under the
authority of the Sanitary Phytosanitary Agreement and the Technical Barriers
to Trade Agreement.
Codex is the vehicle through which the World Trade Organisation (WTO)
is working to "harmonise" (e.g. conform) food and safety regulations
of WTO member countries. Codex is currently creating a guideline on the
proper regulations for dietary supplements with the participation of the
Food and Drug Administration (FDA). 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. By participating in this process, the
FDA is ignoring the will of Congress as expressed in DSHEA and in the
FDA Modernisation Act of 1997, which expressly forbids the FDA from participating
in the harmonisation process, as well as the will of the American people.
While Codex has no direct authority to force Americans to adopt stringent
regulations of dietary supplements, we are concerned that the United States
may be forced to adopt Codex standards as a result of the United States'
status as a member of the WTO. According to an August 1999 report of the
Congressional Research Service, "As a member of the WTO, the United
States does commit to act in accordance with the rules of the multilateral
body. It [the US] is legally obligated to ensure national laws do not
conflict with WTO rules." Thus, Congress may have a legal obligation
to again change American laws and regulations to conform with WTO rules!
If Congress were to refuse to "harmonise" US laws according
to strict Codex/WTO guidelines, a WTO "dispute resolution panel"
could find that the United States is engaging in unfair trade because
of our failure to "harmonise" our regulations with the rest
of the world. In any such trade dispute, the scales are tipped in favour
of countries using the Codex standards because of WTO rules presuming
that a nation who has adopted Codex has not erected an unfair trade barrier.
Therefore, in a dispute with a country that has adopted the Codex standards
it is highly probable that America would lose and be subject to heavy
sanctions unless Congress harmonised our laws with the other WTO countries.
Harmonisation may be beneficial for the large corporations and international
bureaucrats that control the WTO but it would be a disaster for American
consumers of dietary supplements!
In conclusion, we once again thank Chairman Burton for holding this hearing
and for all his efforts to protect the freedom of American dietary supplement
customers and for the opportunity to express our concerns regarding the
threat to American consumers posed by the WTO and the Codex Alimentarius
process. 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
organisation such as the WTO.
Print Note: This page is excerpted from the web site
of U.S. Representative Peter DeFazio, Fourth District, Oregon.