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How FDA and EFSA Prior Restraints Defeat Government Objectives and Foster Fraud and Deception

By Jonathan W. Emord

FDA and EFSA censorship regimes are based on an anti-fraud or anti-deception rationale.  In short, FDA presumes that deprivation of all information not officially sanctioned that expressly or impliedly links a nutrient with a disease helps prevent consumers from being misled.  Likewise, EFSA presumes that deprivation of all information not officially sanctioned that expressly or impliedly links a nutrient with any health benefit, including but not limited to an effect on disease, helps prevent consumers from being misled.  As I explain below, FDA and EFSA prior restraints on speech fail to advance in any direct or material way the stated objective.  Moreover, that censorship actually creates an environment conducive to fraud and deception in the market, an ironic twist that the regulators in the U.S. and Europe utterly fail to take into account.

FDA and EFSA depend on prior restraint as their principal speech regulatory tool.  Consequently, they censor ab initio every conceivable statement within broad categories.  FDA prohibits any claim that a nutrient treats a disease.  FDA requires prior agency authorization as a condition precedent to the lawful use in the market of claims that associate a nutrient with disease risk reduction or prevention.  FDA allows without prior approval claims that associate a nutrient with an effect on a body structure or function, provided that the effect is one that does not itself imply disease treatment.  EFSA, by contrast, bans outright all disease treatment claims (like FDA) but also prohibits all claims of every conceivable kind that associates a nutrient with a health benefit, including not only claims of disease prevention but also claims of an effect on a body structure or function, unless EFSA pre-approves the claims.

In the U.S., courtesy of the 1999 D.C. Circuit Pearson v. Shalala decision, FDA must rely on claim qualification as a less speech restrictive alternative to outright claim suppression.  Not so in Europe thus far in its evolution; Europe has no court mandated claim qualification regime.  In the context of commercial speech jurisprudence, Europe trails behind the United States by a few decades, because a body of distinct commercial speech jurisprudence first appeared in the United States decades before it did in Europe.  Moreover, Europe lacks a “no law” provision in the EU treaty comparable to the First Amendment to the United States Constitution.  Rather, the EU treaty’s human rights provisions germane to speech freedom call for a balancing between individual liberty and government interests that tips the scale in favor of regulation.

The primary reason why FDA and EFSA prior restraints are counterproductive lies in their practical impact.  FDA and EFSA prior restraints work well on the law-abiding, but they have no effect on law breakers.  Unlike prosecution after the fact, which is effective in attacking precisely those who have acted in ways that cause injury, a prior restraint endeavors to ban an entire category of action (here, speech about nutrient-disease and nutrient-health effects) on the supposition that some of those who will speak will do so fraudulently or deceptively.  Of course, not all who would speak will lie and some, indeed likely most, will exercise the speech freedom in ways profoundly helpful to others by informing them of precious emerging truths concerning the effects of nutrients on disease and health.

There is, of course, an enormous overlap between the universe of all those who would speak truthfully concerning the effects of nutrients on disease and health and the universe of all those who will abide by the FDA and EFSA’s prior restraints.  Consequently, the great bulk of speech prohibited by FDA and EFSA is speech that is truthful or, at worst, only potentially misleading, rather than speech that is inherently misleading.

Likewise, there is an enormous overlap between the universe of all those who would speak untruthfully concerning the effects of nutrients on disease and health and the universe of all those who have no scruples about honoring the FDA and EFSA prior restraints.  Consequently, the speech carrying with it the greatest likelihood of being false and deceptive is precisely the speech which remains largely unaffected by FDA and EFSA’s prior restraints.

The overall consequence of FDA and EFSA censorship is, therefore, to remove from the market all manner of actually and potentially helpful health information concerning nutrients while having little, if any, effect on all manner of inherently misleading claims.

In an environment artificially deficient in truthful nutrient disease and nutrient health information, charlatans thrive.  When present in the market, truthful nutrient disease and nutrient health information increases the ambient level of consumer sophistication, enabling consumers to make more informed decisions.  FDA and EFSA removal of that information from the market by prior restraint thus ensures that the ambient level of consumer sophistication is far lower than it otherwise would be.  With less sophistication concerning nutrient disease and nutrient health information, consumers are more vulnerable to exploitation from those who engage in intentional fraud and deception.  They are less able to discern the validity of claims because they are exposed to fewer of them overall and no truthful ones beyond officially sanctioned claims.

To illustrate, assume the following to be a statement backed by credible scientific evidence: Bioflavonoids have anti-inflammatory effects that may reduce the risk of cancer and cardiovascular disease.  Such a statement is forbidden by the FDA and EFSA prior restraints.  Consequently, the law abiding will not communicate them in the market; indeed, the law abiding will not communicate anything at all concerning the association between bioflavonoids and disease.  Assume, further, that a charlatan enters the market for bioflavonoids, one who acts in utter disregard of FDA and EFSA’s prior restraints.  That charlatan may choose to tell consumers a falsehood concerning bioflavonoids to induce purchase of the products.  He or she may tell consumers, “Bioflavonoids cure cancer and cardiovascular disease,” for example.  A certain percentage of consumers, denied access to information in the market concerning the risk reducing effects of bioflavonoids, may well find the false claim facially convincing and credible.  This kind of scenario no doubt occurs over and over again across the universe of products and across geographic borders, enhanced by the absence of truthful information on nutrient-disease and nutrient-health benefits.  In this way, FDA and EFSA prior restraints actually foster an environment hospitable to fraud and deception.

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