Green tea qualified health claim ruling: ‘Once again FDA is taken to task…’

By Elaine Watson

- Last updated on GMT

Related tags: Green tea, Cancer, Fda

Green tea qualified health claim ruling: ‘Once again FDA is taken to task…’
A Food and Drug Administration (FDA) qualified health claim about green tea and the risk of breast and prostate cancer is so strongly worded that it “effectively negates” the claim it is designed to qualify and violates the first amendment, a judge has ruled.

The ruling marks a victory for Fleminger, which sells green tea at www.teaforhealth.com​ and has been engaged in a nine-year battle with the FDA over the wording of a claim.

Judge: There are less burdensome ways in which the FDA could get its point across

The latest version of the claim proposed by the FDA reads: “Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” 

However, the US District Court for the Northern District of Connecticut said the disclaimer went too far and has told the FDA to go back to the drawing board.

In the ruling, dated February 23, judge Vanessa L Bryant said: “The FDA’s language burdens substantially more speech than is necessary to further that interest since the language effectively negates the substance-disease relationship claim altogether.”

This violates the first amendment​ 

She added: “The portion of the disclaimer stating that the ‘FDA does not agree that green tea may reduce that risk’ does not strike a reasonable fit between the government’s ends and the means chosen to accomplish those ends, and therefore violates the First Amendment.

“There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”

Emord: An important decision

Virginia-based attorney Jonathan Emord told NutraIngredients-USA the ruling was significant: “This is an important decision that adds to the landmark precedent of the Alliance for Natural Health USA v Sebelius concerning the limits on FDA discretion in drafting health claim qualifications.

“Once again FDA is taken to task for using the disclaimer to promote its own agenda rather than constraining itself to a succinct and accurate qualification of the inconclusiveness of supporting science.”

Welch: Court made the right decision…Qualified health claims like this are next to impossible to use

Natural Products Association (NPA) vice president of scientific and regulatory affairs Dr Cara Welch agreed the ruling was good news for the industry.

She added: “We appreciate the FDA's need to be cautious with qualified health claims but, in this case, we feel the court made the right decision.

“Qualified health claims like this are next to impossible to use and I'm looking forward to the next version FDA will draft. Hopefully this decision puts QHCs in the spotlight and when the science is actually there, we can have a strong claim to use.”

Carvajal: Not all bad news for the FDA

However, writing in the FDA blog, Ricardo Carvajal, a director at law firm Hyman, Phelps & McNamara, said: “Although the FDA’s qualified health claim was found unconstitutional, the news is not all bad for FDA."

He added:“Applying the framework established by the Supreme Court in Central Hudson, the court reached the following conclusions:

“It is beyond doubt that the FDA’s interest in preventing consumer confusion and protecting public health is a substantial interest which justifies the FDA’s imposition of appropriate disclaimers in connection with qualified health claims.

“FDA has a substantial interest in preventing consumers from assuming the FDA has approved the qualified health claim… Absent the FDA’s express agreement, a proposed health claim cannot include specific reference to the FDA in its marketing.”  

Nine year legal battle

Fleminger first submitted a health claim petition to FDA in 2004. A year later, the FDA proposed two heavily qualified claims:

Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.

One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.

Fleminger then (unsuccessfully) petitioned for administrative review and proposed a new claim (which the FDA did not formally consider): ‘Green tea may reduce the risk of breast and prostate cancers.  The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.’

In 2010, FDA sent a warning letter to Fleminger threatening to seize its products and insisting it use the exact language set forth in its qualified health claims.

But shortly afterwards it proposed a revised claim: “Green tea may reduce the risk of breast or prostate cancer.  FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.”​ 

Fleminger then filed a complaint in the US District Court for the District of Connecticut, asserting that FDA essentially required it to “choose between speaking exactly as [FDA] wishes, remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment.” 

What are qualified health claims?

Qualified health claims have been permitted in the US since the 1999 Pearson v. Shalala case (brought against the FDA by Jonathan Emord on behalf of Durk Pearson and Sandy Shaw), which validated them as a First Amendment freedom of speech right.

The claims enable firms to talk about a relationship between a substance and disease where the supporting science fails to meet the FDA’s ‘significant scientific agreement’ standard, but is ‘qualified’ in such a way as to not mislead consumers.

While the qualification comes in the form of a far-from-consumer-friendly disclaimer, many observers believe the claims are still better than nothing.

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4 comments

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Is the FDA really protecting the public?

Posted by K Trinkle,

And you know everything about the "many diseases that formulate even a tumour"? So you feel qualified to discredit the claim simply because the FDA has determined there's not enough evidence to make a claim.

I have been the "victim" of the FDA. A drug that was prescribed for tens of thousands of migraine sufferers has been made unavailable because the almighty FDA decided that because it hasn't been tested specifically for use in migraines, it may not be effective or safe. If you do just a little research, you will discover 1000s of patients affected by this decision disagree, as do most most neurologists and primary care physicians.

The FDA decided the drug (which had already become readily available as a generic from multiple labs) needed to go through new trials. Given the expiration of the patent and that many labs were making the drug available to patients at a relatively affordable price, there was simply no economic incentive for the pharmaceutical companies to invest in new studies. Therefore, the medication that many found to be their only reasonable source of relief has been made unavailable.

The industry is touting triptans (which many, many migraine sufferers complain are ineffective and have VERY negative side effects) and ergotamines (only minimally effective). Triptans are all very expensive. They are patent-protected, ensuring the drug companies can make more money. They are good for the companies, but not for the patients.

As one afflicted by migraines for thirty years now, I can not begin to tell you how much damage the FDA did to my trust in their guidance or credibility with this ruling. Like many others, I've been put through the ringer trying the newly approved drugs only to find little, if any, relief and bad side effects. The warnings on the new medications include far more serious risks than those presented (and time-tested/proven) by Midrin.

The point of all of this...do not assume the FDA is doing what is in the best interest of the public. And never blind yourself to the possibility a supplement may have a legitimate right to claim health benefits. Require them to state whether tested & provide the public with the results if sought, maybe.

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These claims flip flop with every other study

Posted by Frank42,

If the evidence of the claim is weak then the FDA is correct in toning down the claim.

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green tea for cancer?

Posted by harry,

Very very foolish to make such a proposal. Obviously they no nothing about the many diseases that formulate even a tumour. A very useful product, yet such a claim is not the thing to do.

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