Over at the LA Times Health Blog, Rosie Mestel updates on a new lawsuit targeting the FDA, demanding less stringent standards for placing health claims on foods and supplements.
An example is selenium, which manufacturers would like to embellish to the effect of:
“Selenium may reduce the risk of prostate cancer.”
Here is the disclaimer that the FDA requires on the product package:
“Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”
What you need to know:
The above is an example of a Qualified Health Claim. It is different from an Authorized Health Claim, for which there is a substantial body of scientific evidence.
The first appearance of qualified health claims was in the late nineties on dietary supplement packages, as a result of a legal battle between the FDA and manufacturers. In 2003, through the Consumer Health Information for Better Nutrition Initiative, qualified health claims were allowed on foods as well. A petition process was put in place, and ever since manufacturers can file for claims.
The petition process does not automatically guarantee a health claim, and even if approved there are three levels of qualified health claims:
1. Strongest: “Although there is scientific evidence supporting the claim, the evidence is not conclusive.”
2. Medium: “Some scientific evidence suggests …However, FDA has determined that this evidence is limited and not conclusive.”
3. Weakest: “Very limited and preliminary scientific research suggests…. FDA concludes that there is little scientific evidence supporting this claim.”
Obviously manufacturers would like the strongest claims, but can’t cough up the requisite studies, despite many shelling out millions to sponsor research in universities and “independent” labs.
Thus we get funny disclaimers such as:
tomatoes/tomato sauce and prostate cancer: “Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.”
for green tea: “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.”
If history is an indicator, the new lawsuit will once again result in concessions to manufacturers in the name of First Amendment right of free speech. Our right as consumers not to be BSed by food and supplement producers are unfortunately absent from the Constitution.
What to do at the supermarket:
Ignore any marketing information you see on a product package that is not on the nutrition facts panel. Better yet, buy foods that don’t need a nutrition information panel – fresh vegetables, fruits, grains and legumes in bulk. Tap water needs no nutrition information either.
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