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How the FDA Defeated 21 USC 343(r)(3)(C)

By Jonathan W. Emord

Emord Blog at


In the FDA Modernization Act of 1997 Congress enacted an amendment that would permit health claims to appear on the labels of foods and dietary supplements if those claims were an accurate representation of an authoritative statement made by a scientific body of the United States Government or by the National Academy of Sciences.  Congress created the provision out of frustration with the FDA’s refusal to implement the plain and intended meaning of the health claim section in the Nutrition Labeling and Education Act of 1990, 21 USC 342(r)(5)(D).  In particular, Congress reacted to FDA’s refusal to adhere to the First Amendment mandate in Pearson v. Shalala which, inter alia, required FDA to favor disclosure over suppression in its treatment of nutrient-disease association claims.

In particular, the FDAMA amendment was designed to provide a means for claim entry into the market that was an alternative to the health claim provision in the NLEA, an alternative that would escape FDA’s ambiguous and largely impenetrable “significant scientific agreement” standard of health claim review.

Under the terms of the FDAMA provision, a party wishing to make a nutrient-disease relationship claim based on an authoritative statement of a federal health agency or the NAS could serve notice to FDA of the statement along with proof that the statement was in fact one, inter alia, made by a government agency and based upon a “balanced representation of the scientific literature” (whatever that means).  If FDA failed to deny the statement within 120 days of receipt, the statement would be allowed into the market until such time, if ever, as the FDA promulgated a regulation denying it.

Congress meant for the section to create an avenue permitting greater ease of entry into the market than the health claims review process for claims representative of authoritative government statements.  FDA effectively defeated that intent, however, through a draconian interpretation of the terms “authoritative statement” and “balanced representation of the scientific literature.”

In denying the first set of notices submitted to the agency for authorization of authoritative statements, the FDA took the position that it was not enough that a federal health agency published a statement.  Rather, the agency had to have formally adopted it as an authoritative statement or position.  Consequently, if the statement appeared in an official government publication disseminated to the American public and, within context, was a direct representation of scientific findings, that would not suffice.  Rather, FDA had to determine, additionally, if the agency agreed that the statement represented its official position.  Moreover, FDA presumed nothing could be considered a balanced representation of the scientific literature unless it was fully vetted under its health claims approval process standard of review.  Consequently, even if the statement was deemed authoritative by a sister agency, FDA said that it would always have the last word by making a determination, even then, of whether the statement satisfied FDA’s “significant scientific agreement” (SSA) standard.

In short, through construction, FDA took a statutory provision meant to provide an alternative to SSA health claim review and transformed it into one directly subject to the SSA health claim review standard, defeating the utility of the section in all but the rarest of circumstances.

That position is, however, at odds with the First Amendment.  As the D.C. Circuit intimated during oral argument in Pearson v. Shalala, FDA lacks power under the First Amendment to prohibit the republication by a dietary supplement company of nutrient-disease information that the government itself publishes.  In the oral argument for that case, government counsel and I addressed the court’s hypothetical involving a government publication of an association between antioxidants and cancer risk reduction.  The court pointedly asked Department of Justice counsel (and I paraphrase), you mean to say that if I lift a statement from a government publication on health and put that very same statement on the label of a dietary supplement, it goes from the status of protected speech under the First Amendment to unprotected?  And, with difficulty, the Department of Justice counsel said that it did.  She said that it was unquestionably accurate and protected speech when in the government publication but potentially misleading when appearing on the label.  The Court was found that incongruity unpersuasive, even nonsensical.

It remains, therefore, a sound First Amendment argument (one to which the FDA no doubt vigorously objects) that regardless of how FDA interprets the FDAMA provision on authoritative statements, FDA is barred by the First Amendment from preventing a dietary supplement company from republishing an accurate quotation of a federal health agency’s statement on labels and in labeling of dietary supplements and foods.  I suspect that sooner or later that issue will be joined in federal court, and I would hope, for the sake of the First Amendment and individual liberty, FDA loses the contest.

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