Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-98-05043/USCOURTS-caDC-98-05043-1/pdf.json

Nature of Suit Code: 620
Nature of Suit: Forfeiture and Penalty - Food and Drug Acts
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Filed April 2, 1999

No. 98-5043

Durk Pearson and Sandy Shaw,

American Preventive Medical Association and

Citizens for Health,

Appellants

v.

Donna E. Shalala, Secretary,

United States Department of Health and

Human Services, et al.,

Appellees

Consolidated with

98-5084

On Appellees' Suggestion for 

Rehearing En Banc

Before: Edwards, Chief Judge, Wald, Silberman, Williams,

Ginsburg, Sentelle, Henderson, Randolph, Rogers, Tatel, and

Garland, Circuit Judges.

O R D E R

Upon consideration of appellees' suggestion for rehearing

en banc, and the absence of a request by any member of the

court for a vote, it is

ORDERED that the suggestion be denied.

Per Curiam

FOR THE COURT:

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Mark J. Langer, Clerk

BY:

Robert A. Bonner

Deputy Clerk

A statement by Circuit Judge Silberman is attached.

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Silberman, Circuit Judge, concurring in the denial of rehearing en banc: The government, in its petition for rehearing and suggestion for rehearing en banc, advances an argument that it did not present at any stage in this appeal--the

government candidly concedes as much. We are told that the

panel's decision is anomalous in light of the regime that

governed the sale and labeling of dietary supplements prior

to Congress' enactment of the Nutrition Labeling and Education Act of 1990, 104 Stat. 2353. This Act created a safe

harbor from drug status (and the rigorous testing attendant

thereto) for certain dietary supplements whose labels include

health claims. Under the prior regime, putting a health claim

on a dietary supplement transformed the dietary supplement

into a "drug," thereby triggering the rigorous drug approval

process. The government asserts that neither employing a

health claim as a trigger to the drug approval process (which

was never tested in litigation), nor subjecting "drugs" to the

drug approval process, raises a First Amendment concern.

From this premise, the government now reasons that the

FDA's present approach of exempting from drug status only

those health-claim bearing dietary supplements whose claims

attain "significant scientific agreement" easily passes muster

because the greater power to subject a health-claim bearing

dietary supplement to the drug approval process must include

the lesser power to refuse to exempt some health claimbearing dietary supplements from the drug approval process.

(The government also seems to suggest that the statutory

provisions governing the labeling of drugs, which applied to

all health claim-bearing dietary supplements prior to 1990,

survive First Amendment scrutiny, and hence that today's

statutory and regulatory provisions governing the labeling of

dietary supplements should be upheld.)

While I am dubious of the force of such "greater includes

the lesser" logic in the commercial speech context, see 44

Liquormart, Inc. v. Rhode Island, 584 U.S. 484, 510-13 (1996)

(plurality), I do not think it appropriate for us to formally

consider and decide this argument. The government, like

any other litigant, cannot be heard to advance a major nonjurisdictional argument for the first time at the rehearing

stage. That would be palpably unfair to appellants and would

jeopardize our own ability to process cases efficiently. See,

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e.g., Benavides v. DEA, 976 F.2d 751, 753 (D.C. Cir. 1992);

Keating v. FERC, 927 F.2d 616, 625 (D.C. Cir. 1991); Schooler v. Schooler, 173 F.2d 299, 303 (D.C. Cir. 1949). Indeed, we

even refuse to consider arguments an appellant asserts for

the first time in a reply brief. See, e.g., Adams v. Hinchman,

154 F.3d 420, 424 n.7 (D.C. Cir. 1998).

Apart from this argument, the government has misrepresented the panel's opinion in several respects, two of which

deserve brief mention. The government claims that the panel

"mistakenly believed that FDA has no concern that the use of

dietary supplements may threaten consumer health and safety." To the contrary, we stated that "[i]t is important to

recognize that the government does not assert that appellants' dietary supplements in any fashion threaten [a] consumer's health and safety." Pearson v. Shalala, 164 F.3d

650, 656 (D.C. Cir. 1999) (footnote omitted) (first emphasis

added). The government has never contended that appellants' dietary supplements, as opposed to other dietary supplements not at issue in this litigation, threaten consumers'

health and safety.

Second, the government describes the panel as "concluding

that it was arbitrary under the APA for FDA not to specify in

advance precisely what evidence will establish 'significant

scientific agreement.' " This seems a careless interpretation

of the opinion. We took care to acknowledge that although

"the APA requires the agency ... [to] giv[e] some definitional

content to the phrase 'significant scientific agreement.' "

Pearson, 164 F.3d at 660, "[t]hat is not to say that the agency

was necessarily required to define the term in its initial

general regulation--or indeed that it is obliged to issue a

comprehensive definition all at once," id. at 661. To be sure,

we also observed in dicta that the First or Fifth Amendments

might, in some respects, bear on the agency's discretion. See

id. at 660 n.12. But the opinion is quite clear that case-bycase development of the "significant scientific agreement"

standard is consistent with the APA.

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