The FDA gets sued — this time, for nixing or watering down supplement health claims *

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The Food and Drug Administration is being sued. (Not for the first time.) This time, it’s by supplement companies who don’t like the way the agency denies or waters down the ‘qualified health claims’ they can put on their wares. The proximate reason for their ire: Four claims linking selenium to reduced risk of certain cancers were denied. Another had language added that weakened the claim. Thirteen claims for antioxidants vitamin C and E were also denied and four others were weakened.

You can see why the companies don’t like the way the FDA alters the qualified claims they allow. One claim cited in the lawsuit started out as ‘Vitamin E may reduce the risk of bladder cancer. The scientific evidence supporting this claim is convincing, but not conclusive.’

It was changed to: ‘One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, the FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.’

True, you really have to wonder what some of these claims on foods and supplements are doing there, so flabby do they seem.

Take this one, for 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.’

Or this one — 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.’

Whoo hoo! I’m going to run out and get me some green tea and I’m going to tell all my male friends to hurry up and chow down on tomatoes.

In the past, the only health claims that were allowed on foods and supplements were full-fledged ‘health claims’ — ones where the FDA felt a significant body of evidence supported the link between some food or supplement and a reduced risk for a health condition.

Then, following court cases in 1999 and 2002, the FDA was forced to allow more qualified health claims based on a judgment that to do otherwise was a suppression of First Amendment rights to free speech.

In the new lawsuits it’s argued that the FDA is way too picky in selecting the studies it will consider when assessing a health claim — rejecting ones in animals or cells in dishes, or ones in people that fall short of what it deems as sufficiently rigorous, thus ‘erecting a straw man to either deny or saddle claims with misleadingly negative disclaimers,’ the law firm Emord & Associates states in a press release referring to the antioxidant suit.

‘FDA has reinstated a regime of censorship, demanding near conclusive proof before it allows any nutrition science to enter the market,’ the statement continues. ‘That move violates four First Amendment cases that have repeatedly demanded that FDA favor disclosure of nutrition science over its suppression as the operative rule. Rather than permit public access to accurate representations of science, FDA refuses to allow any science to reach the market unless it thinks scientific proof established to a near conclusive degree, an extremely rare happenstance.’

What do consumers make of these qualified health claims anyway? In a rather long 2005 study, two FDA researchers reported that despite all those ‘nope, nothing going on here, folks’ caveats they really didn’t help people assess the scientific standing of claims very well.

-- Rosie Mestel

* P.S. For more on what qualified health claims are, go to the Fooducate blog.