UNITED STATES COURT OF APPEALS FOR THE D.C. CIRCUIT


PEARSON, DURK

v.

FDA


98-5043b

D.C. Cir. 1999


*	*	*


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:


Mark J. Langer, Clerk


BY:


Robert A. Bonner  Deputy Clerk


A statement by Circuit Judge Silberman is attached.


Silberman, Circuit Judge, concurring in the denial of re- hearing en
banc: The government, in its petition for rehear- ing and suggestion
for rehearing en banc, advances an argu- ment 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 Edu-
cation 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 claim- bearing 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


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 non- jurisdictional 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, 


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); School- er 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.


Apart from this argument, the government has misrepre- sented 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 safe- ty." To the contrary, we stated
that "[i]t is important to  recognize that the government does not
assert that appel- lants' dietary supplements in any fashion threaten
[a] con- sumer'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 appel- lants' dietary
supplements, as opposed to other dietary sup- plements 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-by- case development of the
"significant scientific agreement"  standard is consistent with the