Thursday, March 13, 2008

Kenendy -Waxman "Gang of Four" attack health claims

This report just in from NutraIngredients .com -

Qualified health claims draw more heat
By Shane Starling

"13-Mar-2008 - Four Capitol Hill parliamentarians are calling on the FDA to abandon funding for the qualified health claims system it launched to much industry fanfare in 2003. The four - Senators Richard J. Durbin and Edward M. Kennedy as well as House of Representatives' members Rosa L. DeLauro and Henry A. Waxman - have written a letter to the Food and Drug Administration commissioner, Dr Andrew C. von Eschenbach seeking clarity on a number of issues.

It asks the FDA to make explicit its plans regarding a December 17 appropriations bill in which Congress "urged the FDA not to use funds provided in this bill to review requests for qualified health claims for conventional foods or to issue letters permitting such claims through exercises of enforcement discretion".

They state: "We wish to inquire how the FDA plans to change its policy regarding qualified health claims in response to this statement."

The parliamentarians ask the FDA to:

* Clarify how it planned to deal with any pending or new petitions for health claims
* Publish a statement advising food and supplements companies of Congress's December 17 position regarding qualified health claims
* Reallocate qualified health claims staff to reviewing food labelling violations
* Release results of a survey that investigated consumer reactions to a range of qualified health claims

An FDA spokesperson said there had been no change to the system and all health claim petitions would be dealt with as per normal. "


My comments:

Qualified Health Claims are not a creation of FDA that can be abandoned at the whim of the Kennedy - Waxman Axis of Control. The highest federal courts have supported consumer access to qualified health claims in the lead Federal Circuit case of Pearson v Shalala, which first forced FDA to allow qualified health claims where there was no "significant scientific agreement" on the benefit, but where there was "reliable and competent scientific evidence..." with appropriate qualifying language.

This basic concept was further supported by the US Supreme Court in Thompson v Western States Medical Centers 535 U.S. 357, where Justice Sandra Day O'Connor wrote for the majority,

"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort."

"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

"Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring ... a warning that the [substance] had not undergone FDA testing and that its risks were unknown."

Say "No" to the Gang of Four and their machinations!

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