Divining qualified health claims policy by reading the tea leaves
Divining qualified health claims policy by reading the tea leaves
FDA’s policy, announced in 2003, was forced by a court decision. Under the policy, FDA reviews company petitions asking for permission to make qualified health claims. FDA allows the claims whenever it’s possible to make the “qualified” claim and not end up misleading the public about the real state of the evidence. For example, to make a claim based on a single study that was contradicted by 25 other studies would probably be considered misleading.
So, qualified claims assert that some evidence shows the food may fight disease, together with qualifiers and disclaimers that make clear the limits of the claim or that it is uncertain or still-being-studied. As in, “One small study has shown that chicken soup cures the common cold, though other studies do not.”
Before the court decision, FDA’s traditional approach to foods making claims about diseases was not to allow any statements about a food-disease relationship until there was “significant scientific agreement” that the food had that beneficial effect. FDA’s approach was, Until the medical community agrees it is so, you are not to say it is so on the food label or in advertising, and no hinting, winking, signaling, passing notes under the desk, no fooling around.
Third, what does “somebody’s uncle” have to do with these issues? Just this: Don’t underestimate the power of individual belief, rather than science, in guiding behavior and also in adding pressure on regulators to allow more free flow of information. That’s because, whenever there’s a debate about whether a particular food can help prevent a particular disease, you will always find somebody whose uncle swears it’s true.
You’ll hear statements like, “My uncle eats blueberries soaked in beer every day and his bursitis is cured!” or “My uncle has been eating that dandelion leaf salad since he was 8 years old, and he’s never been in the hospital a day in his life.”
The point is not to doubt everyone’s uncle, with all due respect, but to realize these two things: First, there will always be large segments of the population who simply don’t care what the government thinks is true, and who will rely instead on their own beliefs or uncles. And second, so-called anecdotal reports like those from an uncle carry essentially no weight with FDA or the Federal Trade Commission or any other government agency trying to establish if something is scientifically true.
But those who listen to their uncles often don’t want FDA or other agencies “protecting” them from false or misleading claims or products. They’d rather make their own decisions about what’s good for them. And voices like theirs are a big part of the reason the FDA was challenged in court about its strict approach to allowing claims, and the reason it now has a regulatory scheme that permits some qualified health claims.
One’s attitude on these issues depends in large part on the degree to which you trust the FDA to play the role of neutral arbiter of scientific fact. If instead you think FDA wants simply to erect roadblocks to keep consumers from getting useful new health information about green tea and other natural products, then you don’t want them deciding whether sufficient information exists to support a label claim. You’d rather they just get out of the way and let the market decide which claims will survive and which won’t.
The philosophy of lightening up on government regulation of business gets a fair amount of attention these days, and maybe we’d all be better off if a freer flow of information on food labels was permitted.
On the other hand, agencies like FDA and FTC have traditionally been given the job of protecting the public from dangerous products (and false health claims can be actually dangerous if consumers forego proven treatments in favor of the false ones) and also to protect the public from phony, ineffective products that don’t do what they claim, even if they aren’t dangerous.
Are we moving to a world where these traditional functions of the government are going to be scrapped in the name of enhanced freedom of speech for companies and choice for consumers? It’s an interesting question. Discuss amongst yourselves, as they say.
But most people, I suspect, would tell you they believe FDA does indeed check out and clear every claim on a food or dietary supplement label before it’s made. (They don’t check them all out, by the way—and dietary supplement labels even make this point explicitly!). What’s more, I think most people want FDA to protect them from dangerous products, freedom and reduced-government philosophies notwithstanding. Companies do, too, because companies trying to market legitimate products would just as soon have FDA take action against their unscrupulous competitors.
As with so many things, balance is the key. The best approach balances freedom and protection. There is value of course in a free flow of information, but also in controls on false or misleading information.
The trick is to keep those controls from making companies, or consumers, want to cry “Uncle!”








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