Health Supreme by Sepp Hasslberger

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September 30, 2003

FDA sued - consumers bamboozled?

September 23, 2003 - Washington, D.C. - Public Citizen and the Center for Science in the Public Interest - CSPI - have sued the US Food and Drug Administration over its announced intent of relaxing the severity of the rules by which descriptions of a food's health properties must be judged.

What Public Citizen and CSPI are saying sounds like "consumers must not be told anything with relation to food and health unless there is clinical evidence to prove it". This, in the end, comes down to "consumers must be kept completely in the dark that there may be a connection between certain nutritional factors and their health".

Do they think we are so stupid we must not be trusted with information?

For years no one could tell women that with a supplement of Folic Acid they could markedly reduce the chances of their babies being born with malformations. Why? There was not enough "clinical evidence"!

Here is a pertinent comment from someone in the US:

"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..."

I am confused: why would two organizations that say they represent consumers do such a thing? Who might profit if the public were to be kept in the dark about the possible health benefits of foods?

Being a regular reader of this site, you might have guessed correctly: There is only one agenda which fits: the Pharmaceutical Business with Disease.

Why "consumer groups" such as Public Citizen and the CSPI would push a pharmaceutical agenda is of course anyone's guess.

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 here as a download (pdf).

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit 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

See also related articles:

The Role of the FDA
The Claim There is "No Scientific Evidence" for Alternative Treatments...

FDA muffed chance to reduce birth defects

Aspartame - a real public health threat the CSPI is strangely silent about

Supplement regulation - who is pushing for what

Folate supplementation - a phony attempt to "prove" it useless

CSPI: 100% litigious - it seems that the CSPI is not new to this kind of exploit


posted by Sepp Hasslberger on Tuesday September 30 2003
updated on Monday November 29 2010

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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.



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