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United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued November 10, 2003 Decided January 9, 2004
No. 03-5020
JULIAN M. WHITAKER, ET AL.,
APPELLANTS
v.
TOMMY G. THOMPSON, SECRETARY,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 99cv03247)
Jonathan W. Emord argued the cause and filed the briefs
for appellants.
Anthony L. Young was on the brief for amicus curiae
American Herbal Products Association in support of appel-
lants.
Bills of costs must be filed within 14 days after entry of judgment.
The court looks with disfavor upon motions to file bills of costs out
of time.
2
Howard S. Scher, Attorney, U.S. Department of Justice,
argued the cause for appellees. With him on the brief were
Roscoe C. Howard, Jr., U.S. Attorney, Scott R. McIntosh,
Attorney, U.S. Department of Justice, Alex M. Azar II,
General Counsel, U.S. Department of Health & Human Ser-
vices, and Daniel E. Troy, Chief Counsel.
Before: RANDOLPH and ROBERTS, Circuit Judges, and
WILLIAMS, Senior Circuit Judge.
Opinion for the Court filed by Senior Circuit Judge
WILLIAMS.
WILLIAMS, Senior Circuit Judge: When substances aimed
at the treatment or prevention of disease are marketed, their
regulation by the Food and Drug Administration (‘‘FDA’’)
commonly turns on the nature of the claims made about the
substance. Items to be sold with ‘‘drug claims,’’ including
foods and dietary supplements, are subject to extensive test-
ing; foods or dietary supplements that merely make ‘‘health
claims’’ pass muster far more easily. This case turns primar-
ily on whether the FDA faithfully applied the Federal Food,
Drug and Cosmetic Act (‘‘FFDCA’’), 21 U.S.C. § 301 et seq.,
in its analysis of a petition by Dr. Julian Whitaker and others
(for simplicity’s sake, ‘‘Whitaker’’) to approve their intended
marketing of ‘‘saw palmetto,’’ an extract from the pulp and
seed of the dwarf American palm, Serenoa repens, under a
label that they argued was a ‘‘health claim.’’
Whitaker proposed a label stating: ‘‘Consumption of 320
mg daily of Saw Palmetto extract may improve urine flow,
reduce nocturia and reduce voiding urgency associated with
mild benign prostatic hyperplasia (BPH).’’ Petition, May 25,
1999, p. 18. BPH is a non-cancerous enlargement of the
prostate that affects almost half of men over 50. The FDA
denied the petition. In explaining the decision, it drew a
distinction between claims regarding use of a product to
maintain health and to ‘‘prevent’’ disease, on the one hand,
and claims that a product could ‘‘treat’’ a disease, on the
other. The former could qualify as ‘‘health claims,’’ but the
latter would always be considered ‘‘drug claims.’’ May 26,
2000 FDA Letter (‘‘FDA Letter’’) at 2, 7–10. As BPH is
3
classified as a disease despite its comparative ubiquity, and
the proposed label indicated an intent to treat it, the FDA
decided that saw palmetto could not be marketed under that
label without approval as a drug. Whitaker challenged the
FDA’s decision in district court on statutory and First
Amendment grounds. The district court granted the FDA’s
motion to dismiss, Whitaker v. Thompson, 239 F. Supp. 2d 43
(D.D.C. 2003), and Whitaker appealed. We affirm.
* * *
The statutory claim
The FFDCA definition of ‘‘drug’’ includes ‘‘articles intended
for use in the diagnosis, cure, mitigation, treatment, or pre-
vention of disease,’’ 21 U.S.C. § 321(g)(1)(B), which would
seem by its plain terms to cover the marketing of a substance
intended to mitigate the symptoms associated with BPH.
But that apparent simplicity is undermined by language
added in 1990 by the Nutrition Labeling and Education Act
(‘‘NLEA’’), Pub. L. No. 101–535, 104 Stat. 2353, which created
a separate procedure authorizing ‘‘health claims’’ for food (or
for dietary supplements classified as food). The general
purpose of the NLEA appears to have been to allow the
dissemination—subject to a regulatory approval process—of
certain dietary and health information on food products with-
out requiring that those products be regulated as drugs.
Specifically, the NLEA amended the FFDCA to authorize the
sale of dietary supplements pursuant to ‘‘health claims’’ that
‘‘characterize[ ] the relationship of any nutrient TTT to a
disease or health-related condition,’’ id. § 343(r)(1)(B), so long
as the dietary supplement is ‘‘subject to a procedure and
standard, respecting the validity of such claim, established by
regulation of the Secretary,’’ id. § 343(r)(5)(D). Whitaker
insists, with some justification, that the label he proposed fits
within the plain terms of the ‘‘health claim’’ definition.
Thus, although the consequences of classification as a ‘‘drug
claim’’ or a ‘‘health claim’’ are quite substantial, Congress has
given definitions that at least partially overlap. And it has
given little guidance as to how the FDA should sort out
4
claims that seem to fit both definitions. On the one hand, as
the FDA points out, the statutory definition of ‘‘dietary
supplement’’ plainly contemplates that dietary supplements
may fall under the § 321(g) definition of ‘‘drugs’’: it says that
a dietary supplement shall be deemed to be a ‘‘food’’ ‘‘[e]xcept
for purposes of [§ 321(g)],’’ which defines ‘‘drugs’’ and ‘‘coun-
terfeit drugs.’’ 21 U.S.C. § 321(ff). On the other hand, the
last sentence of § 321(g)(1), which defines drugs, explicitly
states that a ‘‘dietary supplement for which a [health claim
under § 343(r)] is made TTT is not a drug TTT solely because
the label or the labeling contains such a statement.’’ Id.
§ 321(g)(1). This is the statutory provision most directly
relevant to the relationship between health claims and drug
claims, but there are at least three ways it might be read, all
of them problematic.
First, the last sentence of § 321(g)(1) might mean that a
§ 343(r) health claim cannot by itself establish that a product
is ‘‘intended’’ to cure, mitigate, prevent, or treat disease, but
such a statement may be used in conjunction with other
evidence to establish such intent. Under this view, a health
claim would be relevant but not sufficient to establish that a
product is a drug. Though this construction provides a
grammatically plausible reading of ‘‘solely,’’ it is not pressed
by any of the parties; in practice it might not make sense, as
a product’s label may often be the only readily available
evidence of the product’s intended use.
Second, the sentence in question might mean that a product
for which a ‘‘drug claim’’ is made under § 321(g)(1) is not
automatically exempt from drug regulation just because the
product label also makes a separate health claim under
§ 343(r). This view, urged by amicus American Herbal Prod-
ucts Association, founders on the broad definition of health
claims advanced by Whitaker. Such claims appear coexten-
sive with—or perhaps even broader than—§ 321(g) drug
claims. The amicus’s own brief demonstrates the problem.
The amicus seeks to illustrate its reading of the ‘‘solely’’
language, saying that it means only that ‘‘use of an authorized
health claim on the label of a dietary supplement (e.g., folate
reduces the risk of neural tube defects) does not give a
5
manufacturer blanket immunity to include other claims for
the product that would otherwise be classified as drug claims
(e.g., folate cures cancer).’’ But if § 343(r) covers anything
that characterizes the ‘‘relationship’’ between a nutrient and a
disease, then ‘‘folate cures cancer’’ is just as much a health
claim as ‘‘folate reduces the risk of neural tube defects.’’
Amicus’s interpretation of ‘‘solely’’ is sensible only if there are
‘‘drug claims’’ for foods or dietary supplements that are not
also ‘‘health claims,’’ but Whitaker’s broad interpretation of
health claims, and indeed the literal wording of § 343(r)(1)(B)
itself, foreclose that possibility.
Finally, the ‘‘solely’’ language in § 321(g) might mean that
while a claim that would qualify as a health claim may be
considered a drug claim, such a claim is not necessarily a
drug claim. Under this reading, in other words, the statute
allows some health claims to be exempted from the drug
claim definition; but as this class is not defined, it implicitly
leaves the choice to the FDA. This interpretation, urged by
the FDA, is plausible, but it too is problematic. The statute
on its face supplies no guiding principle for determining
which health claims should be exempt, and nowhere else
evinces an intent to give the FDA unfettered discretion to
make so drastic a choice.
Because we are reviewing an agency’s interpretation of the
statute it is entrusted to administer, and the agency reached
its interpretation after a relatively formal process with public
notice and comment, cf. United States v. Mead Corp., 533
U.S. 218, 230–31 (2001) (expressing assumption that Congress
‘‘contemplates administrative action with the effect of law
when it provides for a relatively formal administrative proce-
dure’’), we review under the familiar framework established
by Chevron, U.S.A., Inc. v. Natural Resources Defense Coun-
cil, Inc., 467 U.S. 837 (1984). We first ask whether, applying
the ‘‘traditional tools of statutory construction,’’ id. at 843 n.9,
we can discern ‘‘the unambiguously expressed intent of Con-
gress,’’ id. at 843. If the statute is ambiguous, then we defer
to the agency’s interpretation so long as it is reasonable. Id.
at 843–45.
6
As the discussion above suggests, we see no basis for
finding any ‘‘unambiguously expressed intent of Congress.’’
We thus turn to the FDA’s rationale for classifying certain
types of health claims as drug claims in order to decide
whether the FDA’s approach is reasonable in light of the
statute’s structure, history, and purposes.
The FDA gave several reasons for classifying claims re-
garding cure, mitigation, or treatment of an existing disease
(‘‘treatment claims’’) as drug claims and for exempting only
health claims that concern reducing the risk of contracting a
disease (‘‘prevention claims’’). First, the agency reasoned
that the legislative history of the NLEA demonstrated an
understanding that the health claim provision was intended
for claims of prevention rather than ones of treatment. The
agency noted statements in the legislative history indicating
that the purpose of the health claims provision was to pro-
mote long-term health maintenance and prevention of disease,
but found nothing suggesting that legislators enacting this
provision contemplated treatment of a person’s existing dis-
ease with dietary supplements. See FDA Letter at 5–6,
citing 136 Cong. Rec. H5843 (statement of Rep. Moakley);
136 Cong. Rec. H12,954 (statement of Rep. Moakley); 136
Cong. Rec. H5843 (statement of Rep. Madigan); 136 Cong.
Rec. S16,609 (statement of Sen. Metzenbaum); 136 Cong.
Rec. S16,610–11 (statement of Sen. Hatch). Indeed, all the
specific examples of ‘‘health claims’’ mentioned in the NLEA’s
legislative history involved prevention rather than treatment.
See id. at 5, citing H.R. Rep. No. 101–538 at 8, 20, reprinted
in 1990 U.S.C.C.A.N. at 3337, 3350; 136 Cong. Rec. H5841
(statement of intent of changes since bill was reported out of
committee); 136 Cong. Rec. H12,953 (statement of House
floor managers); 136 Cong. Rec. H5841 (statement of Rep.
Waxman); 136 Cong. Rec. H12,954 (statement of Rep. Madi-
gan); 136 Cong. Rec. S16,609 (statement of Sen. Mitchell).
Second, the FDA looked to research mandated by Congress
when it adopted the NLEA. At that time Congress instruct-
ed the FDA, in adopting regulations to implement § 343(r), to
investigate ten specific possible health claims, all of which
7
involved prevention—‘‘reduction of the risk of a chronic dis-
ease’’—rather than treatment. FDA Letter at 5, citing Pub.
L. No. 101–535, § 3(b)(1)(A)(vi),(x), 104 Stat. 2353, 2361 (1990)
(see 21 U.S.C. § 343 note).
Third, the FDA noted that the health claims provision was
enacted against a backdrop of longstanding application of
drug regulation to foods and dietary supplements that made
treatment claims—an assertion Whitaker does not dispute.
The agency inferred that Congress meant the ‘‘solely’’ sen-
tence of § 321(g)(1) to preserve this practice. FDA Letter at
6.
Finally, the FDA invoked policy concerns to support a
distinction between treatment and prevention claims. It ar-
gued that, because the health of diseased populations is
particularly vulnerable, greater regulation may be justified
for products intended for their consumption. Moreover, it
argued that treatment claims for symptoms of a disease
might lull people with those symptoms into a ‘‘false sense of
security,’’ leading them to delay a visit to a doctor that might
result, for example, in a diagnosis of prostate cancer rather
than BPH. Id. at 9. Finally, in a statement looking only at
possible benefits of its classification decision (and not any of
the possible drawbacks), the FDA said that if products could
escape regulation as drugs by qualifying as ‘‘dietary supple-
ments’’ that make treatment claims, the protections of the
drug approval system could be undermined and incentives to
research a substance’s health effects would be diminished.
Id. at 10.
None of these is a knock-down argument, and we doubt
that any of them would be sufficient to overcome a strong
textual or structural inference in favor of a different interpre-
tation. Certainly there is nothing in the two statutory defini-
tions that would obviously equate claims of ‘‘treatment’’ with
drug claims and of ‘‘prevention’’ with health claims. But
given our finding that the statute is ambiguous on the critical
question of how to classify a claim that meets the statutory
definitions both of a drug claim and of a health claim, the
8
legislative history and statutory context invoked by FDA are
enough to render its interpretation reasonable.
Whitaker also attacks the FDA’s distinction between pre-
vention and treatment claims as arbitrary and capricious.
First, he argues that there is no sharp distinction between
‘‘prevention’’ and ‘‘treatment’’; the two categories may often
overlap. They may, of course, but that does not render the
distinction either unworkable or irrational. The existence of
dawn and dusk, as has often been said, doesn’t make it absurd
to distinguish between day and night. Second, Whitaker
claims that the FDA failed to explain adequately how it could
square its decision not to allow Whitaker’s claim that saw
palmetto extract alleviates symptoms of BPH with the agen-
cy’s prior approval of a ‘‘health claim’’ that low-fat diets lower
cholesterol. See 21 C.F.R. § 101.75(e)(3). But here the FDA
plausibly explains that the reference to the lower cholesterol
consequences of low-fat diets merely clarifies the mechanism
by which heart disease is prevented; the FDA did not
authorize a claim that a low-fat diet could treat hypercholest-
erolemia. So the cholesterol example doesn’t show an irra-
tionality in the FDA’s attempted distinction.
Finally, Whitaker urges us to adopt his reading of the
statute on the ground that this will enable us to avoid the
‘‘grave and doubtful constitutional questions’’ that the FDA’s
understanding would entail. United States ex rel. Attorney
General v. Del. & Hudson Co., 213 U.S. 366, 408 (1909). It is
true that the canon of constitutional avoidance can trump
Chevron. See Edward J. DeBartolo Corp. v. Florida Gulf
Coast Bldg. & Const. Trades Council, 485 U.S. 568, 575
(1988); Chamber of Commerce of the United States v. Federal
Election Comm’n, 69 F.3d 600, 604–05 (D.C. Cir. 1995). But
if the avoidance canon were extravagantly applied it would
tend, in effect, to expand unnecessarily the scope of constitu-
tional prohibitions. Thus in practice the canon’s application
requires a comparatively high likelihood of unconstitutionali-
ty, or at least some exceptional intricacy of constitutional
doctrine. Compare, e.g., Rust v. Sullivan, 500 U.S. 173, 191
(1991) (finding the constitutional question not so ‘‘grave and
doubtful’’ as to justify avoidance doctrine); Republican Nat.
9
Committee v. Federal Election Comm’n, 76 F.3d 400, 409
(D.C. Cir. 1996) (same), with Chamber of Commerce, 69 F.3d
at 604–05 (applying avoidance doctrine because agency’s in-
terpretation would ‘‘preclude[ ] appellants from communicat-
ing on political subjects with thousands of persons, heretofore
regarded by the Commission as members’’). As the discus-
sion below should make clear, here we do not find Whitaker’s
First Amendment objection so powerful as to require us to
abandon or qualify Chevron deference.
The constitutional claim
Whitaker argues that the FDA’s refusal to allow marketing
of saw palmetto extract under the proposed label, which he
describes as a true and non-misleading statement about its
salutary effects on BPH symptoms, violates the First Amend-
ment’s limits on restrictions of commercial speech. Under
Central Hudson Gas & Electric Corp. v. Public Service
Commission, 447 U.S. 557 (1980), commercial speech enjoys
First Amendment protection only if it concerns a lawful
activity and is not misleading. If the speech in question
passes those screens, the government may impose restrictions
that advance a ‘‘substantial’’ government interest and are no
‘‘more extensive than is necessary to serve that interest.’’ Id.
at 566.
The district court upheld the FDA’s decision under the first
step of Central Hudson. ‘‘Because the FDA determined that
the saw palmetto claim was a drug claim for disease treat-
ment, it concluded that the claim was an unlawful health
claimTTTT’’ Whitaker v. Thompson, 239 F. Supp. 2d at 54.
Accordingly, the proposed label constituted speech about
unlawful activities. Id.
So worded, the analysis appears, as Whitaker points out,
completely circular. Because sale pursuant to the claim was
‘‘unlawful’’ under the statute, the speech related to an unlaw-
ful activity and enjoyed no First Amendment protection.
But one may recharacterize the analysis in a way that
avoids the circularity. Assuming that the government may
condition the sale of drugs on passage through the elaborate
10
testing that the statute requires (an assumption that Whit-
aker doesn’t question), the key step is the FFDCA principle
that classification of a substance as a ‘‘drug’’ turns on the
nature of the claims advanced on its behalf.
That principle, in turn, rests on the idea that claims about a
product by its manufacturer and vendors, including product
labeling, serve as evidence of the sellers’ intent that consum-
ers will purchase and use the product for a particular pur-
pose—and, therefore, as evidence whether the product is or is
not a drug. See, e.g., Action on Smoking and Health v.
Harris, 655 F.2d 236, 239 (D.C. Cir. 1980). The question is
whether this use of speech to infer intent, which in turn
renders an otherwise permissible act unlawful, is constitution-
ally valid. In fact, the First Amendment allows ‘‘the eviden-
tiary use of speech to establish the elements of a crime or to
prove motive or intent.’’ Wisconsin v. Mitchell, 508 U.S. 476,
489 (1993) (upholding use of speech to determine that defen-
dant selected battery victim because of his race, for purposes
of statutory sentence enhancement). Thus it is constitution-
ally permissible for the FDA to use speech, in the form of
labeling, to infer intent for purposes of determining that
Whitaker’s proposed sale of saw palmetto extract would
constitute the forbidden sale of an unapproved drug.
* * *
The judgment of the district court dismissing plaintiffs’
claim is
Affirmed.