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FDA's ounce of prevention costs a pound of free speech

By Douglas Lee
Lawyer, Ehrmann Gehlbach Badger & Lee

A grocery store may be many things these days, but a marketplace of ideas it's not.

For every new banking or video rental service your grocer provides, there seems to be an accompanying regulation from the Food and Drug Administration to further restrict what manufacturers, distributors and sellers of food and medicines can say about their products.

Currently at issue is a proposed regulation under which the FDA would allow "truthful and non-misleading statements of effects on a body system, organ or function, provided that the context in which the claim appears does not suggest that the product treats, prevents or mitigates a disease."

Only in Washington would such impenetrable language be praised as a "clarification." To the rest of us, it only further confuses an already complex maze of labeling regulations that, contrary to the FDA's intent, makes the consumption of many health foods a leap of faith.

At one level, of course, the regulation and others like it make sense. If Twinkies don't prevent cancer, Hostess shouldn't claim that they do. On the other hand, the increasing reliance on herbs, vitamins and home remedies suggests that nutrition and medicine are not as black and white as the FDA would like to believe. As frequently happens when government attempts to regulate in uncertain terrain, one of the first victims is free speech.

Twenty years of First Amendment law establishes that the government can regulate speech about products and services if the government has a substantial interest in doing so and if the regulation is not more extensive than necessary. Courts usually presume that the government has a substantial interest in preventing misleading or false commercial speech, so restrictions aimed at advertising claims typically withstand constitutional scrutiny.

No one questions the government's substantial interest in regulating the way that manufacturers label potentially dangerous products. Many of the FDA's more recent efforts, however, are directed at allegedly bogus claims about apparently harmless products. In one case, for example, the FDA ordered a distributor of a dietary supplement called stevia to destroy approximately 2,500 cookbooks because the books contained information about the supplement, which its proponents claim is sweeter and healthier than sugar. Stevia, however, is not a banned substance, as the FDA readily acknowledged. The FDA instead based its action on the fact that stevia, while a permitted dietary supplement, is not approved as a food additive.

While there may be thousands of FDA employees who know the difference between a dietary supplement and a food additive, most Americans do not. The FDA's interest in regulating speech based upon these types of distinctions therefore is questionable at best. If a product does not cause harm, the government has little interest in regulating how it is advertised, particularly because such policing infringes upon the manufacturer's free-speech rights.

The efficacy of these paternalistic advertising regulations is also questionable. One of two things is true about the American consumer. Either the consumer is battle-tested and savvy enough to see through a claim that Twinkies prevent cancer or the consumer is so gullible that he will believe that water bottled in a Canadian factory is somehow better than that available from local faucets. In either case, governmental attempts to control advertising about safe products are unnecessary. While all of us probably would be better served if every product came with a warning that it didn't actually look, work or taste as advertised, an important part of our freedom is the opportunity to learn these things for ourselves.

Allowing free speech does not mean that the FDA must abandon its role as a consumer watchdog. Instead, the FDA should adopt an approach more consistent with free-speech principles, one that encourages speech about dubious products.

One approach would be for the FDA to put its stamp of approval on particular products. This approach would promote good products but not censor speech about products the FDA was unwilling to endorse. The American public then would have more information at its disposal and be able to better evaluate the products. While this approach undoubtedly would result in many outlandish advertisements and unsupported claims, the actual harm to the buying public would be minimal, especially if an FDA-approved alternative were available.

A similar approach is being forced on the FDA in drug marketing. Although physicians are free to prescribe drugs for whatever purpose they desire, the FDA traditionally has barred drug companies from urging doctors to prescribe drugs for purposes that have not been approved by the agency. A District of Columbia federal court recently overturned that ban, holding that drug companies have a First Amendment right to communicate this information to physicians. While doctors may rightfully be skeptical of drug uses that are not FDA-approved, they will now be able to fully evaluate the manufacturers' claims.

Without such a change in approach, the FDA likely will continue to overregulate safe food and nutrition products, stifling a fair amount of harmless speech as it does so. What will result will be marketing and labeling efforts that are neither understandable nor meaningful, and that will leave us wondering why a small bottle of harmless herbs contains more warnings than a two-pound bag of M&Ms.;

Douglas Lee is a partner in the Dixon, Ill., law firm of Ehrmann Gehlbach Beckman Badger & Lee and a legal correspondent for the First Amendment Center.


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