We need to realize what is going on here. We finally have a public
spirited FDA Commissioner and he is under attack from those who want to remove health
claims that do not meet pharmaceutical standards. It is this kind of thinking
that caused 1000 babies to be born each year with neural tube defects including
Down's Syndrome for 15 years longer than needed. There was concern that
there was not enough evidence that folic acid prevented half of these defects.
Now the evidence has been developed to the point where it is generally accepted,
Demanding ironclad proof on a harmless nutritional supplement caused the defect
for half of those affected. I wonder if those that were responsible for withholding
this information can look at a Down's Syndrome youngster and realize that this
might be the one out of two that they helped cause. We need to support
Commissioner Mark McClellan to prevent further tragedies like this.
Sincerely,
Elwood Richard, President
Now Foods
Public Citizen Press Releases
Providing the latest information about Public Citizen activities
Sept. 23, 2003
Groups Sue FDA Over Weakening of Health Claims Rule
Change Permits Misleading Claims About Health Benefits of Food
WASHINGTON, D.C. - The Center for Science in the Public Interest (CSPI)
and Public Citizen today filed suit against the U.S. Food and Drug
Administration (FDA) to challenge the FDA's recently announced scheme to
permit food companies to make health claims based on weak or
inconclusive evidence.
Prior to 1990, food companies were not permitted to make claims that
their products helped to prevent, treat or cure any disease. Under the
Food, Drug and Cosmetic Act, such claims were limited to drugs, and if a
company wanted to make such a claim, it first had to apply for
permission through the statutory process for approval of new drugs.
In 1990, Congress enacted the Nutrition Labeling and Education Act,
which allows food companies to petition the FDA for approval of health
claims. The statute authorizes the FDA to approve a health claim for a
food only if the FDA determines that the claim is supported by
"significant scientific agreement." The law further requires that
before approving a health claim for food, the FDA solicit public comment
on a proposed regulation authorizing the claim. Only after the FDA
reviews the comments and issues a final regulation authorizing the claim
may companies make that health claim. Until this year, the FDA followed
these statutory requirements.
However, the FDA announced in July that it will now allow food
companies to make health claims even when the evidence is too weak or
inconclusive to meet the statutory standard. The FDA has announced that
it will even permit claims where the weight of the evidence suggests
that the claim is likely false, as long a disclaimer accompanies the
claim. The FDA calls food claims that do not meet the statutory
standard and are accompanied by a disclaimer "qualified claims."
Moreover, the FDA has stated that it will not follow the
notice-and-comment rulemaking procedure that Congress required as a
prerequisite for allowing a health claim for food. The FDA will post on
its Web site a food company's petition asking for permission to make a
qualified claim and will allow people to submit comments on the
petition. However, the agency will not issue a proposed rule and notice
informing the public of its preliminary thinking on the petition, as
required by the law; it will not respond to any comments received, as
required by the law; and it will not issue a regulation to authorize the
claim, as required by the law.
"The FDA's new plan is a dereliction of its duty to enforce the law
that Congress enacted," said Peter Lurie, deputy director of Public
Citizen's Health Research Group. "The FDA is essentially saying that
unproven or misleading claims are okay, as long as the food label also
says that the claims might not be true. The agency's scheme is another
in a growing list of Bush administration actions that put business's
financial interests ahead of consumer health."
In the lawsuit, the groups say that the agency is violating the
substantive and procedural requirements of the food labeling statute and
the regulations issued to implement that law. The groups also say that
the agency is violating the Administrative Procedure Act by initiating
the new regulatory scheme without going through notice-and-comment
rulemaking.
Congress enacted the high standard and procedural requirements of the
law to protect consumers from false and misleading claims and from
claims based on evidence still too preliminary to be trusted. The
groups allege that by announcing its intent blatantly to violate the
statute, the FDA threatens to injure consumers' health, as many will
make decisions regarding their health based on the specious claims that
the FDA is choosing to permit.
"The FDA is illegally putting consumers' health at risk and allowing
food companies to turn the supermarket aisle into a Tower of Babble,"
said Bruce Silverglade, director of legal affairs for CSPI.
The complaint was filed in federal district court in the District of
Columbia. Public Citizen Litigation Group attorneys Allison Zieve and
Scott Nelson represent CSPI and Public Citizen.
The complaint is available at
www.citizen.org/documents/compl-3.8xx.pdf.
Public Citizen is a national, nonprofit consumer advocacy organization
based in Washington, D.C. For more information, please visit
www.citizen.org.
The Center for Science in the Public Interest is a
Washington, D.C.- based nonprofit consumer advocacy organization
specializing in food and nutrition issues. For more information,
please visit www.cspinet.org.
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