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Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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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 appellants.

 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.

USCA Case #03-5020 Document #795805 Filed: 01/09/2004 Page 1 of 10
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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 Services, 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 testing; foods or dietary supplements that merely make ‘‘health

claims’’ pass muster far more easily. This case turns primarily 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

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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 prevention 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 without 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

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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 ‘‘counterfeit 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 Products Association, founders on the broad definition of health

claims advanced by Whitaker. Such claims appear coextensive 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

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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 procedure’’), we review under the familiar framework established

by Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 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 Congress,’’ 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.

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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 regarding 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 promote long-term health maintenance and prevention of disease,

but found nothing suggesting that legislators enacting this

provision contemplated treatment of a person’s existing disease 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. Madigan); 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 instructed the FDA, in adopting regulations to implement § 343(r), to

investigate ten specific possible health claims, all of which

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involved prevention—‘‘reduction of the risk of a chronic disease’’—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’’ sentence 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 argued 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 supplements’’ 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 interpretation. Certainly there is nothing in the two statutory definitions 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

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legislative history and statutory context invoked by FDA are

enough to render its interpretation reasonable.

Whitaker also attacks the FDA’s distinction between prevention 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 agency’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 hypercholesterolemia. So the cholesterol example doesn’t show an irrationality 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 constitutional prohibitions. Thus in practice the canon’s application

requires a comparatively high likelihood of unconstitutionality, 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.

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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 interpretation would ‘‘preclude[ ] appellants from communicating on political subjects with thousands of persons, heretofore

regarded by the Commission as members’’). As the discussion 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 Amendment’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 treatment, 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 unlawful 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

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testing that the statute requires (an assumption that Whitaker 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 consumers will purchase and use the product for a particular purpose—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 constitutionally valid. In fact, the First Amendment allows ‘‘the evidentiary 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 defendant selected battery victim because of his race, for purposes

of statutory sentence enhancement). Thus it is constitutionally 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.

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