However, Virginia-based attorney Jonathan Emord argues the redrafted claim is little better than the previous one because the FDA still includes a disclaimer that contradicts the claim it claim it is designed to qualify.
The new claim
In a letter to Connecticut-based firm Fleminger, which sells green tea atwww.teaforhealth.com the FDA proposes the following qualified health claims: Green tea may reduce the risk of breast or prostate cancer although the FDA has concluded that there is very little scientific evidence for this claim.
Green tea may reduce the risk of breast or prostate cancer. FDA has concluded that there is very little scientific evidence for this claim.The old claim
Previously the FDA had proposed the following 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.”
However, it was forced to revise the claim after judge Vanessa L Bryant at the US District Court for the Northern District of Connecticut told the FDA to go back to the drawing board in a high-profile ruling in February.
She said: “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: FDA is still using a forbidden qualitative qualifier: ‘very little scientific evidence’
However, Jonathan Emord told NutraIngredients-USA that the revised claim was not much better than the old one.
He added: “The FDA has once again violated its First Amendment obligation. It is using a forbidden qualitative qualifier: ‘very little scientific evidence’.
“Under the First Amendment, the fact that the science is inconclusive may be required but not the value laden subjective judgment that ‘very little’ science supports the claim. Experts disagree with FDA's biased view. Moreover, as ANH v. Sebelius taught, the qualification may not contradict the claim.”
NPA: At least new version is shorter…
Natural Products Association (NPA) vice president of scientific and regulatory affairs Dr Cara Welch said: “The one thing I can say about the revised claim is that it is shorter and contains fewer subjective statements.
“Whether it represents a violation of the first amendment I can’t say but we’ve certainly been arguing that very long qualified health claims are very difficult for companies to use.”
She added: “With its revised wording, the FDA seems to have been closely following what the judge said [In her ruling, Bryant said the following wording would be more reasonable, ‘Green tea may reduce the risk of breast or prostate cancer although the FDA has concluded that there is very little scientific evidence to support the claim’].”
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.
