Landmark Decision
Pearson v. FDA

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued December 1, 1998 Decided January 15, 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

Appeals from the United States District Court

for the District of Columbia

(95cv01865)

Jonathan W. Emord argued the cause for appellants.

With him on the briefs were James S. Turner and Betsy E.

Lehrfeld.

Christine N. Kohl, Attorney, United States Department of

Justice, argued the cause for appellees. With her on the

brief were Frank W. Hunger, Assistant Attorney General,

Wilma A. Lewis, United States Attorney, and Douglas N.

Letter, Attorney, United States Department of Justice.

Nancy T. Lord-Johnson was on the brief for amici curiae

Direct Aids Alternative Information Resources, et al.

David C. Vladeck, Allison M. Zieve, and Bruce Silverglade

were on the brief for amici curiae American Cancer Society,

et al.

Before: Wald, Silberman, and Garland, Circuit Judges.

Opinion for the Court filed by Circuit Judge Silberman.

Silberman, Circuit Judge: Marketers of dietary supple-

ments must, before including on their labels a claim charac-

terizing the relationship of the supplement to a disease or

health-related condition, submit the claim to the Food and

Drug Administration for preapproval. The FDA authorizes a

claim only if it finds "significant scientific agreement" among

experts that the claim is supported by the available evidence.

Appellants failed to persuade the FDA to authorize four such

claims and sought relief in the district court, where their

various constitutional and statutory challenges were rejected.

We reverse.

I.

Dietary supplement marketers Durk Pearson and Sandy

Shaw, presumably hoping to bolster sales by increasing the

allure of their supplements' labels, asked the FDA to autho-

rize four separate health claims. (Pearson and Shaw are

supported by two other appellants, the American Preventive

Medical Association, a health care advocacy organization

whose members are health care practitioners, and Citizens

for Health, a health care advocacy organization whose mem-

bers are consumers of dietary supplements.) A "health

claim" is a "claim made on the label or in labeling of ... a

dietary supplement that expressly or by implication ... char-

acterizes the relationship of any substance to a disease or

health-related condition." 21 C.F.R. 101.14(a)(1) (1998).

Each of appellants' four claims links the consumption of a

particular supplement to the reduction in risk of a particular

disease:

(1) "Consumption of antioxidant vitamins may reduce the

risk of certain kinds of cancers."

(2) "Consumption of fiber may reduce the risk of colorec-

tal cancer."

(3) "Consumption of omega-3 fatty acids may reduce the

risk of coronary heart disease."

(4) ".8 mg of folic acid in a dietary supplement is more

effective in reducing the risk of neural tube defects than

a lower amount in foods in common form."

Understanding the preapproval requirement for health

claims on dietary supplements requires a brief excursus on

the broader regulatory framework applicable to dietary sup-

plements, foods, and drugs. A "dietary supplement" is a

"product (other than tobacco) intended to supplement the

diet" that contains one or more of certain dietary ingredients,

including a vitamin, a mineral, an herb or other botanical, or

an amino acid, 21 U.S.C.A. 321(ff)(1)(A)-(D) (Supp. 1998)

(emphasis added), "is not represented for use as a convention-

al food or as a sole item of a meal or the diet," id.

321(ff)(2)(B), and "is labeled as a dietary supplement," id.

321(ff)(2)(C). A "drug" includes, inter alia, "articles in-

tended for use in the diagnosis, cure, mitigation, treatment, or

prevention of disease." 21 U.S.C.A. 321(g)(1)(B) (Supp.

1998). If the product is a "new drug," the product must

survive the arduous drug approval process, see 21 U.S.C.A.

355 (Supp. 1998), before the manufacturer may introduce it

into interstate commerce, id. 355(a); see also 21 U.S.C.A.

343(r)(1)(B) (Supp. 1998) (deeming "misbranded" a dietary

supplement whose label includes a health claim); 21 U.S.C.

331 (1994) (prohibiting the introduction of a misbranded

product into interstate commerce); 21 U.S.C.A. 333 (Supp.

1998) (prescribing penalties for violations of 331).

Although there is apparently some definitional overlap

between drugs and dietary supplements under the statute, it

creates a safe harbor from designation as a "drug" for certain

dietary supplements whose labels or labeling1 advertise a

beneficial relationship to a disease or health-related condition:

If the FDA authorizes a label claim under 21 U.S.C.A.

343(r), the product is not considered a drug under 21

U.S.C.A. 321(g)(1). The FDA authorizes a claim only

when it determines, based on the totality of publicly

available scientific evidence (including evidence from

well-designed studies conducted in a manner which is

consistent with generally recognized scientific procedures

and principles), that there is significant scientific agree-

ment among experts qualified by scientific training and

experience to evaluate such claims, that the claim is

supported by such evidence.

21 C.F.R. 101.14(c) (1998). The FDA's authorization comes

by an informal rulemaking under the Administrative Proce-

dure Act. See 21 C.F.R. 101.70 (1998); 5 U.S.C. 553

(1994). This choice of a rulemaking rather than an adjudica-

tion--which would seem a more natural fit for this individual-

ized determination--was mandated by Congress for the regu-

lation of health claims on food labels, see 21 U.S.C.A.

343(r)(3)(B)(i), and then adopted by the FDA as well for the

regulation of health claims on dietary supplement labels, see

id. 343(5)(D) (authorizing but not specifying regulatory

procedure); 21 C.F.R. 101.70.

The requirement that health claims be approved before

being added to the label of a dietary supplement constitutes

__________

1 "Label" is defined as "a display of written, printed, or graphic

matter upon the immediate container of any article." 21 U.S.C.

321(k) (1994). "Labeling" is defined as "all labels and other

written, printed, or graphic matter (1) upon any article or any of its

containers or wrappers, or (2) accompanying such article." Id.

321(m).

the primary regulatory hurdle faced by marketers of dietary

supplements. The actual sale of dietary supplements is regu-

lated only when the supplement contains a "new dietary

ingredient," 21 U.S.C.A. 350b (Supp. 1998), or poses a

safety risk, id. 342(f). See also Food Labeling; General

Requirements for Health Claims for Dietary Supplements, 59

Fed. Reg. 395, 396 (1994) (explaining that "the availability of

dietary supplements will not be affected by these regulations

[of health claims]").

The safe harbor from "drug" status for dietary supple-

ments bearing FDA-approved health claims did not always

exist. Prior to 1984, the FDA took the position that a

statement that consumption of a food could prevent a particu-

lar disease was "tantamount to a claim that the food was a

drug ... and therefore that its sale was prohibited until a

new drug application had been approved." H.R. Rep. No. 538,

101st Cong., 2d Sess. 9 (1990), reprinted in 1990 U.S. Code

Cong. & Admin. News 3336, 3338. But during the mid-1980s,

companies began making health claims on foods without

seeking new drug approval, a practice that the FDA sup-

ported in regulations proposed in 1987. Id. at 3338-39.

Congress became concerned that health claims were increas-

ingly common in the marketplace, and that the FDA had not

issued clear, enforceable rules to regulate such claims. Id.

Against this background, and in light of the further concern

that the FDA might lack statutory authority to permit health

claims on foods without also requiring that the claim meet the

premarket approval requirements applicable to drugs, see id.,

Congress enacted the Nutrition Labeling and Education Act

of 1990 (NLEA), Pub. L. No. 101-535, 104 Stat 2353 (codified

as amended at 21 U.S.C.A. 301, 321, 337, 343, 371 (1972 &

Supp. 1998)). The NLEA addressed foods and dietary sup-

plements separately. Health claims on foods may be made

without FDA approval as a new drug, or the risk of sanctions

for issuing a "misbranded" product, if it has been certified by

the FDA as supported by "significant scientific agreement."

Id. 343(r)(3)(B)(i). Congress created a similar safe harbor

for health claims on dietary supplements, but delegated to the

FDA the task of establishing a "procedure and standard

respecting the validity of [the health] claim." Id.

343(r)(5)(D).

The FDA has since promulgated 21 C.F.R. 101.14--the

"significant scientific agreement" "standard" (quoted

above)--and 21 C.F.R. 101.70--a "procedure" (not particu-

larly relevant to this case)--for evaluating the validity of

health claims on dietary supplements.2 In doing so, the

agency rejected arguments asserted by commenters--includ-

ing appellants--that the "significant scientific agreement"

standard violates the First Amendment because it precludes

the approval of less-well supported claims accompanied by a

disclaimer and because it is impermissibly vague. See 59

Fed. Reg. 395, 405, 422-23 (1994). The FDA explained that,

in its view, the disclaimer approach would be ineffective

because "there would be a question as to whether consumers

would be able to ascertain which claims were preliminary

[and accompanied by a disclaimer] and which were not," id. at

405, and concluded that its prophylactic approach is consis-

tent with applicable commercial speech doctrine, see id. at 423

(discussing Central Hudson Gas & Elec. Corp. v. Public Serv.

Comm'n, 447 U.S. 557, 563-64 (1980)). The agency, respond-

ing to the comment that "significant scientific agreement" is

impermissibly vague, asserted that the standard is "based on

objective factors" and that its procedures for approving

health claims, including the notice and comment procedure,

sufficiently circumscribe its discretion.

Then the FDA rejected the four claims supported by

appellants. See 21 C.F.R. 101.71(a) (dietary fiber-cancer),

101.71(c) (antioxidant vitamins-cancer), 101.71(e) (omega-

3 fatty acids-coronary heart disease) (1998); id.

101.79(c)(2)(i)(G) (1998) (claim that 0.8 mg of folic acid in a

dietary supplement is more effective in reducing the risk of

__________

2 The FDA uses the same substantive standard and procedure

for the regulation of health claims on foods, see 21 C.F.R. 101.14,

101.70 (1998), even though the substantive standard and procedure

for foods, unlike dietary supplements, was prescribed by statute, see

21 U.S.C.A. 343(r)(3)(B)(i).

neural tube defects than a lower amount in foods in common

form). The problem with these claims, according to the FDA,

was not a dearth of supporting evidence; rather, the agency

concluded that the evidence was inconclusive for one reason

or another and thus failed to give rise to "significant scientific

agreement." But the FDA never explained just how it

measured "significant" or otherwise defined the phrase. The

agency refused to approve the dietary fiber-cancer claim

because "a supplement would contain only fiber, and there is

no evidence that any specific fiber itself caused the effects

that were seen in studies involving fiber-rich [foods]." 58

Fed. Reg. 53,296, 53,298 (1993) (emphasis added). The FDA

gave similar reasons for rejecting the antioxidant vitamins-

cancer claim, see id. at 53,302, and the omega-3 fatty acids-

coronary heart disease claim, see id. at 53,304. As for the

claim that 0.8 mg of folic acid in a dietary supplement is more

effective in reducing the risk of neural tube defects than a

lower amount in foods in common form, the FDA merely

stated that "the scientific literature does not support the

superiority of any one source over others." 61 Fed. Reg.

8752, 8760 (1996). The FDA declined to consider appellants'

suggested alternative of permitting the claim while requiring

a corrective disclaimer such as "The FDA has determined

that the evidence supporting this claim is inconclusive."3

A more general folate-neural tube defect claim supported

by appellants--that consumption of folate reduces the risk of

neural tube defects--was initially rejected but ultimately

approved for both dietary supplement and food labels. See

__________

3 In general, the FDA appears quite reluctant to approve

health claims on dietary supplements; only two are currently

authorized. See 21 C.F.R. 101.72(c)(2)(ii)(C) (calcium-

osteoporosis); id. 101.79(c)(2)(ii)(B) (folate-neural tube defects).

The FDA has, however, approved several health claims on foods.

See, e.g., id. 101.72(c)(2)(ii) (calcium-osteoporosis); id. 101.76

(fiber-containing products-cancer); id. 101.78 (fruits and vegeta-

bles-cancer); id. 101.79 (folate-neural tube defects); id. 101.81

(soluble fiber-coronary heart disease).

21 C.F.R. 101.79 (1998). The parties disagree on what

caused the FDA's change of position on this claim. Appel-

lants contend that political objections--Senator Hatch was

one of the complainers--concentrated the agency's mind.

The FDA insists that its initial denial of the claim was based

on a concern that folate consumption might have harmful

effects on persons suffering from anemia, and that its concern

was alleviated by new scientific studies published after the

initial denial of the claim.

Appellants sought relief in the district court, raising APA

and other statutory claims as well as a constitutional chal-

lenge, but were rebuffed. Pearson v. Shalala, 14 F. Supp. 2d

10 (D.D.C. 1998).4

II.

Appellants raise a host of challenges to the agency's action.

But the most important are that their First Amendment

rights have been impaired and that under the Administrative

Procedure Act the FDA was obliged, at some point, to

articulate a standard a good deal more concrete than the

undefined "significant scientific agreement." Normally we

__________

4 Two of our sister circuits have been presented with challenges

to the general regulation, 21 C.F.R. 101.14. (Appellants here

challenge not only the general regulation but also its application to

deny four specific health claims.) The Tenth Circuit held that the

challengers did not have standing because their failure to identify a

single claim they wish to make, which could be prohibited under the

regulations indicated a lack of a concrete, particularized injury. See

National Council for Improved Health v. Shalala, 122 F.3d 878,

884-85 (10th Cir. 1997). The Second Circuit held that the absence

of a specific proposed health claim rendered a challenge to the

general regulation unripe for judicial resolution. See Nutritional

Health Alliance v. Shalala, 144 F.3d 220, 225-227 (2d Cir. 1998),

cert. denied, 67 U.S.L.W. 3113, 3122 (Dec. 7, 1998). The Second

Circuit did find the challenge to the claim-review procedure as a

prior restraint to be ripe for review, holding on the merits that a

restraint of up to 540 days was a reasonable and narrowly tailored

mechanism by which the FDA could evaluate whether the proposed

claims were truthful and non-misleading. See id. at 227-228.

would discuss the non-constitutional argument first, particu-

larly because we believe it has merit. We invert the normal

order here to discuss first appellants' most powerful constitu-

tional claim, that the government has violated the First

Amendment by declining to employ a less draconian meth-

od--the use of disclaimers--to serve the government's inter-

ests, because the requested remedy stands apart from appel-

lants' request under the APA that the FDA flesh out its

standards. That is to say, even if "significant scientific

agreement" were given a more concrete meaning, appellants

might be entitled to make health claims that do not meet that

standard--with proper disclaimers.

Appellants also claim that the agency's "non-definition"

runs afoul of Fifth Amendment concerns for vagueness. This

contention is, however, closely connected to appellants' APA

challenge and may well not be implicated if appellants' APA

challenge affords ultimate relief. Therefore we will defer it

until our APA analysis.

A. Disclaimers

It is undisputed that FDA's restrictions on appellants'

health claims are evaluated under the commercial speech

doctrine. See Bolger v. Youngs Drug Prods. Corp., 463 U.S.

60, 67-68 (1983). It seems also undisputed that the FDA has

unequivocally rejected the notion of requiring disclaimers to

cure "misleading" health claims for dietary supplements. (Al-

though the general regulation does not in haec verba preclude

authorization of qualified claims, see Melinda Ledden Sidak,

Dietary Supplements and Commercial Speech, 48 Food &

Drug L.J. 441, 455 (1993), the government implied in its

statement of basis and purpose that disclaimers were not

adequate, see 59 Fed. Reg. at 405, and did not consider their

use in the four sub-regulations before us, see 21 C.F.R.

101.71(a), (c), (e); id. 101.79(c)(2)(i)(G)). The govern-

ment makes two alternative arguments in response to appel-

lants' claim that it is unconstitutional for the government to

refuse to entertain a disclaimer requirement for the proposed

health claims: first, that health claims lacking "significant

scientific agreement" are inherently misleading and thus

entirely outside the protection of the First Amendment; and

second, that even if the claims are only potentially mislead-

ing, under Central Hudson Gas & Elec. Corp. v. Public Serv.

Comm'n of New York, 477 U.S. 557, 566 (1980), the govern-

ment is not obliged to consider requiring disclaimers in lieu of

an outright ban on all claims that lack significant scientific

agreement.

If such health claims could be thought inherently mislead-

ing, that would be the end of the inquiry.

Truthful advertising related to lawful activities is entitled

to the protections of the First Amendment. But when

the particular content or method of the advertising sug-

gests that it is inherently misleading or when experience

has proved that in fact such advertising is subject to

abuse, the States may impose appropriate restrictions.

[Inherently m]isleading advertising may be prohibited

entirely. But the States may not place an absolute

prohibition on ... potentially misleading information ...

if the information also may be presented in a way that is

not deceptive.

In re R.M.J., 455 U.S. 191, 203 (1982); see also Ibanez v.

Florida Dep't of Business and Prof'l Regulation, 512 U.S.

136, 144-46 (1994); Peel v. Attorney Registration and Disci-

plinary Comm'n of Illinois, 496 U.S. 91, 99-111 (1990). As

best we understand the government, its first argument runs

along the following lines: that health claims lacking "signifi-

cant scientific agreement" are inherently misleading because

they have such an awesome impact on consumers as to make

it virtually impossible for them to exercise any judgment at

the point of sale. It would be as if the consumers were asked

to buy something while hypnotized, and therefore they are

bound to be misled. We think this contention is almost

frivolous. See Peel, 496 U.S. at 105 (rejecting paternalistic

assumption that the recipients of a letterhead are "no more

discriminating than the audience for children's television").

We reject it. But the government's alternative argument is

more substantial. It is asserted that health claims on dietary

supplements should be thought at least potentially misleading

because the consumer would have difficulty in independently

verifying these claims. We are told, in addition, that consum-

ers might actually assume that the government has approved

such claims.

Under Central Hudson, we are obliged to evaluate a gov-

ernment scheme to regulate potentially misleading commer-

cial speech by applying a three-part test. First, we ask

whether the asserted government interest is substantial.

Central Hudson, 447 U.S. at 566. The FDA advanced two

general concerns: protection of public health and prevention

of consumer fraud. The Supreme Court has said "there is no

question that [the government's] interest in ensuring the

accuracy of commercial information in the marketplace is

substantial," Edenfield v. Fane, 507 U.S. 761, 769 (1993), and

that government has a substantial interest in "promoting the

health, safety, and welfare of its citizens," Rubin v. Coors

Brewing Co., 514 U.S. 476, 485 (1995). At this level of

generality, therefore, a substantial governmental interest is

undeniable.

The more significant questions under Central Hudson are

the next two factors: "whether the regulation directly ad-

vances the governmental interest asserted," Central Hudson,

447 U.S. at 566 (emphasis added), and whether the fit be-

tween the government's ends and the means chosen to accom-

plish those ends "is not necessarily perfect, but reasonable,"

Board of Trustees of the State University of New York v. Fox,

492 U.S. 469, 480 (1989) (discussing Central Hudson, 447 U.S.

at 564-66).5 We think that the government's regulatory

approach encounters difficulty with both factors.

__________

5 In Fox, the University had banned sellers of certain products

from operating on its property; its principal interest was to pro-

mote an educational rather than commercial atmosphere on the

campus. Fox, 492 U.S. at 475 (Unlike our case, there was no

contention that the commercial speech was misleading. Id.). The

district court found for the University, and the Second Circuit

reversed on the ground that the district court had failed to inquire

under the final step of Central Hudson whether the regulation was

It is important to recognize that the government does not

assert that appellants' dietary supplements in any fashion

threaten consumer's health and safety.6 The government

simply asserts its "common sense judgment" that the health

of consumers is advanced directly by barring any health

claims not approved by the FDA. Because it is not claimed

that the product is harmful, the government's underlying--if

unarticulated--premise must be that consumers have a limit-

ed amount of either attention or dollars that could be devoted

to pursuing health through nutrition, and therefore products

that are not indisputably health enhancing should be discour-

aged as threatening to crowd out more worthy expenditures.

We are rather dubious that this simplistic view of human

nature or market behavior is sound, but, in any event, it

surely cannot be said that this notion--which the government

does not even dare openly to set forth--is a direct pursuit of

consumer health; it would seem a rather indirect route, to

say the least. See Bates v. State Bar of Arizona, 433 U.S.

350, 375 (1977) ("[W]e view as dubious any justification that is

based on the benefits of public ignorance."); cf. 44 Liquor-

mart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion

of Stevens, J., joined by Kennedy, J., and Ginsburg, J.) ("The

First Amendment directs us to be especially skeptical of

regulations [of indisputably non-misleading information] that

seek to keep people in the dark for what the government

perceives to be their own good.").

On the other hand, the government would appear to ad-

vance directly its interest in protecting against consumer

fraud through its regulatory scheme. If it can be assumed--

and we think it can--that some health claims on dietary

__________

the "least restrictive measure" that could effectively protect the

state's interests, and remanded for further factfinding. Id. at 472-

73. The Supreme Court in turn reversed, explaining that Central

Hudson does not impose a "least restrictive means" requirement,

but only mandates a "reasonable" fit between means and ends, id.

at 480, and remanded for application of this standard, id. at 486.

6 Drugs, on the other hand, appear to be in an entirely different

category--the potential harm presumably is much greater.

supplements will mislead consumers, it cannot be denied that

requiring FDA pre-approval and setting the standard ex-

tremely, perhaps even impossibly, high will surely prevent

any confusion among consumers. We also recognize that the

government's interest in preventing consumer fraud/confusion

may well take on added importance in the context of a

product, such as dietary supplements, that can affect the

public's health.

The difficulty with the government's consumer fraud justifi-

cation comes at the final Central Hudson factor: Is there a

"reasonable" fit between the government's goals and the

means chosen to advance those goals? Fox, 492 U.S. at 480.

The government insists that it is never obliged to utilize the

disclaimer approach, because the commercial speech doctrine

does not embody a preference for disclosure over outright

suppression. Our understanding of the doctrine is otherwise.

In Bates v. State Bar of Arizona, 433 U.S. 350 (1977), the

Supreme Court addressed an argument similar to the one the

government advances. The State Bar had disciplined several

attorneys who advertised their fees for certain legal services

in violation of the Bar's rule, and sought to justify the rule on

the ground that such advertising is inherently misleading

"because advertising by attorneys will highlight irrelevant

factors and fail to show the relevant factor of skill." Id. at

372. The Court observed that the Bar's concern was "not

without merit," but refused to credit the notion that "the

public is not sophisticated enough to realize the limitations of

advertising, and that the public is better kept in ignorance

than trusted with correct but incomplete information." Id. at

374-75. Accordingly, the Court held that the "incomplete"

attorney advertising was not inherently misleading and that

"the preferred remedy is more disclosure, rather than less."

Id. at 376. In more recent cases, the Court has reaffirmed

this principle, repeatedly pointing to disclaimers as constitu-

tionally preferable to outright suppression. See Peel, 496

U.S. at 110; R.M.J., 455 U.S. at 206 n.20; Shapero, 486 U.S.

at 478.

The government suggests that the Supreme Court's guid-

ance on this issue is not so consistent (or coherent?). It

points to Friedman v. Rogers, 440 U.S. 1 (1979), where the

Court, in the course of upholding a ban on the use of trade

names by optometrists, stated that "there is no First Amend-

ment rule ... requiring a State to allow deceptive or mislead-

ing commercial speech whenever the publication of additional

information can clarify or offset the effects of the spurious

communication." Id. at 12 n.1. To be sure, this language

cuts against the notion that government must, where possible,

regulate misleading commercial speech by requiring disclaim-

ers rather than by imposing an outright ban. But the Court

in Friedman made clear the narrowness of its holding as

limited to the special status of trade names:

We emphasize ... that the restriction on the use of trade

names has only the most incidental effect on the content

of the commercial speech of Texas optometrists.... [A]

trade name conveys information only because of the

associations that grow up over time between the name

and a certain level of price and quality of service....

Since the Act does not prohibit or limit the type of

informational advertising held to be protected in ...

Bates, the factual information associated with trade

names may be communicated freely and explicitly to the

public.

Id. at 15-16. The government does not assert here that

appellants' health claims convey no factual information, only

that the factual information conveyed is misleading. Fried-

man is thus not at odds with the relevant First Amendment

principles established in Bates, which in any event the Su-

preme Court has reaffirmed--post-Friedman--in R.M.J.,

Shapero, and Peel.

Nor do we agree with the FDA's suggestion (and the Ninth

Circuit's holding in Association of Nat'l Advertisers v. Lun-

gren, 44 F.3d 726, 736 (9th Cir. 1994)) that the Supreme

Court's decision in Fox--a case that did not involve asserted-

ly misleading commercial speech--mandates a more deferen-

tial review of government regulations on potentially mislead-

ing commercial speech. In Fox, the Court elaborated on the

degree of scrutiny appropriate under the Central Hudson

test, making clear that the final step does not require that

"the manner of restriction is absolutely the least severe that

will achieve the desired end," but only that the fit between

the legislature's ends and means is a "reasonable" one. Fox,

492 U.S. at 480. The Court gave no indication, however, that

it was retreating from its holdings in Shapero, R.M.J., and

Bates. Rather, the Court described those cases as examples

of restrictions that were "substantially excessive, disregard-

ing far less restrictive and more precise means." Fox, 492

U.S. at 479 (quoting Shapero, 486 U.S. at 476) (internal

quotation marks omitted). It is clear, then, that when gov-

ernment chooses a policy of suppression over disclosure--at

least where there is no showing that disclosure would not

suffice to cure misleadingness--government disregards a "far

less restrictive" means. In any event, we think the Supreme

Court's recent decision in 44 Liquormart undermines the

Ninth Circuit's holding. The Ninth Circuit relied heavily on

Fox's discussion of Posadas de Puerto Rico Assocs. v. Tour-

ism Co. of Puerto Rico, 478 U.S. 328 (1986), for the proposi-

tion that a court should not second guess a legislative decision

to restrict speech rather than to require more speech. Lun-

gren, 44 F.3d at 736 (citing Fox, 492 U.S. at 479 (quoting

Posadas, 478 U.S. at 344)). But the Supreme Court express-

ly disapproved of that aspect of Posadas in 44 Liquormart,

517 U.S. at 509-10 (plurality) ("Posadas clearly erred in

concluding it was 'up to the legislature' to choose suppression

over a less speech-restrictive policy.") (quoting Posadas, 478

U.S. at 344); 44 Liquormart, 517 U.S. at 531-32 (O'Connor,

J., concurring in the judgment).7

__________

7 The government is correct to observe that the existence of

sufficient alternative channels of communication would count in its

favor at the final step of Central Hudson, see Florida Bar v. Went

For It, Inc., 515 U.S. 618, 633-34 (1995), but we do not think it is

possible to so characterize the situation here. Although a dietary

supplement manufacturer remains free to publish articles and books

concerning health claims, and may market its dietary supplements

with certain physically separate peer-reviewed scientific literature,

see 21 U.S.C.A. 343-2 (Supp. 1998), those channels of communica-

tion reach consumers less effectively than does a claim made

Our rejection of the government's position that there is no

general First Amendment preference for disclosure over sup-

pression, of course, does not determine that any supposed

weaknesses in the claims at issue can be remedied by dis-

claimers and thus does not answer whether the sub-

regulations, 21 C.F.R. 101.71(a), (c), (e); id. 101-

79(c)(2)(i)(G), are valid. The FDA deemed the first three

claims--(1) "Consumption of antioxidant vitamins may reduce

the risk of certain kinds of cancers," (2) "Consumption of

fiber may reduce the risk of colorectal cancer," and (3)

"Consumption of omega-3 fatty acids may reduce the risk of

coronary heart disease"--to lack significant scientific agree-

ment because existing research had examined only the rela-

tionship between consumption of foods containing these com-

ponents and the risk of these diseases. The FDA logically

determined that the specific effect of the component of the

food constituting the dietary supplement could not be deter-

mined with certainty. (The FDA has approved similar health

claims on foods containing these components. See, e.g., 21

C.F.R. 101.79 (folate-neural tube defects).) But certainly

this concern could be accommodated, in the first claim for

example, by adding a prominent disclaimer to the label along

the following lines: "The evidence is inconclusive because

existing studies have been performed with foods containing

antioxidant vitamins, and the effect of those foods on reducing

the risk of cancer may result from other components in those

foods." A similar disclaimer would be equally effective for

the latter two claims.

The FDA's concern regarding the fourth claim--"0.8 mg of

folic acid in a dietary supplement is more effective in reducing

the risk of neural tube defects than a lower amount in foods

in common form"--is different from its reservations regard-

ing the first three claims; the agency simply concluded that

"the scientific literature does not support the superiority of

__________

directly on the label because they impose higher search costs on

consumers, see John E. Calfee & Janis K. Pappalardo, How Should

Health Claims for Foods Be Regulated? 26-27 (Bureau of Econom-

ics, Federal Trade Commission 1989).

any one source [of folic acid] over others." 61 Fed. Reg. at

8760. But it appears that credible evidence did support this

claim, see, e.g., Diet and Health: Implications for Reducing

Chronic Disease Risk 67 (Committee on Diet and Health,

Food and Nutrition Board 1989) (concluding that "[l]osses [of

folic acid] in cooking and canning [foods] can be very high due

to heat destruction"), and we suspect that a clarifying dis-

claimer could be added to the effect that "The evidence in

support of this claim is inconclusive." Cf. American Home

Prods. Corp. v. FTC, 695 F.2d 681, 684, 696-702 (3d Cir. 1983)

(upholding FTC order requiring advertiser who wished to

make an unsubstantiated scientific claim to include a disclaim-

er that the claim was open to substantial question).8

The government's general concern that, given the exten-

siveness of government regulation of the sale of drugs, con-

sumers might assume that a claim on a supplement's label is

approved by the government, suggests an obvious answer:

The agency could require the label to state that "The FDA

does not approve this claim." Similarly, the government's

interest in preventing the use of labels that are true but do

not mention adverse effects would seem to be satisfied--at

least ordinarily--by inclusion of a prominent disclaimer set-

ting forth those adverse effects.

The government disputes that consumers would be able to

comprehend appellants' proposed health claims in conjunction

with the disclaimers we have suggested--this mix of informa-

tion would, in the government's view, create confusion among

consumers. But all the government offers in support is the

FDA's pronouncement that "consumers would be consider-

ably confused by a multitude of claims with differing degrees

of reliability." 59 Fed. Reg. at 405. Although the govern-

ment may have more leeway in choosing suppression over

disclosure as a response to the problem of consumer confu-

sion where the product affects health, it must still meet its

burden of justifying a restriction on speech--here the FDA's

__________

8 As we noted in Part I supra, there is no indication that the

FDA even considered disclaimers in the context of evaluating these

four health claims.

conclusory assertion falls far short. See Ibanez, 512 U.S. at

146 ("If the protections afforded commercial speech are to

retain their force, we cannot allow rote invocation of the

words 'potentially misleading' to supplant the [government's]

burden to demonstrate that the harms it recites are real and

that its restriction will in fact alleviate them to a material

degree.") (citations and internal quotation marks omitted);

Edenfield, 507 U.S. at 771 (invalidating a ban on in-person

solicitation by accountants where the government failed to

present "studies" or "anecdotal evidence" showing that such

solicitation posed dangers of fraud, overreaching, or compro-

mised independence).9

We do not presume to draft precise disclaimers for each of

appellants' four claims; we leave that task to the agency in

the first instance. Nor do we rule out the possibility that

where evidence in support of a claim is outweighed by

evidence against the claim, the FDA could deem it incurable

by a disclaimer and ban it outright.10 For example, if the

weight of the evidence were against the hypothetical claim

that "Consumption of Vitamin E reduces the risk of Alzheim-

er's disease," the agency might reasonably determine that

adding a disclaimer such as "The FDA has determined that

no evidence supports this claim" would not suffice to mitigate

the claim's misleadingness. Cf. FTC v. Brown & Williamson

Tobacco Corp., 778 F.2d 35, 42-43 (D.C. Cir. 1985) (holding, in

a false advertising case under the Lanham Act, that a pro-

posed disclaimer would not suffice to cure the misleadingness

__________

9 We recognize that the Supreme Court made these statements

in the context of discussing the direct advancement prong of

Central Hudson, not the final "reasonable fit" prong. As we noted

earlier, we think the government's consumer fraud justification

satisfies the direct advancement prong. We rely on Ibanez and

Edenfield here because we see no reason why the government's

evidentiary burden at the final step of Central Hudson should be

any less than at the direct advancement step.

10 Similarly, we see no problem with the FDA imposing an

outright ban on a claim where evidence in support of the claim is

qualitatively weaker than evidence against the claim--for example,

where the claim rests on only one or two old studies.

of an advertising claim). Finally, while we are skeptical that

the government could demonstrate with empirical evidence

that disclaimers similar to the ones we suggested above would

bewilder consumers and fail to correct for deceptiveness, we

do not rule out that possibility.

B. The Unarticulated Standard

Wholly apart from the question whether the FDA is

obliged to consider appropriate disclaimers is appellants'

claim that the agency is obliged to give some content to the

phrase "significant scientific agreement." Appellants contend

that the agency's failure to do so independently violates their

constitutional rights under the First and Fifth Amendments.

The First, because producers of dietary supplements are

assertedly subject to a "prior restraint" on their protected

speech--the labeling of products. The Fifth, because the

agency's approach is so vague as to deprive the producers of

liberty (and property?) without due process.

Appellants do not challenge the concept of a pre-screening

system per se; their complaint is with the FDA's lack of

guidance on which health claims will survive the pre-

screening process. But appellants never connected their

vagueness concern with their oblique First Amendment prior

restraint argument, and for that reason we need not decide

whether prior restraint analysis applies to commercial

speech.11 See Carducci v. Regan, 714 F.2d 171, 177 (D.C. Cir.

1983). On the other hand, appellants' Fifth Amendment

vagueness argument is squarely presented. Still, by prevail-

ing on their APA claim appellants would seem to gain the

same relief--invalidation of the FDA's interpretation of the

general standard and a remand for more guidance--as they

would through a successful Fifth Amendment claim (or in-

__________

11 Compare Nutritional Health Alliance, 144 F.3d at 227-28

(holding that prior restraint analysis applies to commercial speech

but that the general health claim regulation, 21 C.F.R. 101.14,

was sufficiently well-defined to survive prior restraint analysis) with

Central Hudson, 447 U.S. at 571 n.13 (suggesting in dicta that

"commercial speech is such a sturdy brand of expression that

traditional prior restraint doctrine may not apply to it").

deed a First Amendment prior restraint claim, if it had been

properly presented and assuming arguendo that prior re-

straint analysis applies in the commercial speech context).12

Consideration of this constitutional claim seems unneces-

sary because we agree with appellants that the APA requires

the agency to explain why it rejects their proposed health

claims--to do so adequately necessarily implies giving some

definitional content to the phrase "significant scientific agree-

ment." We think this proposition is squarely rooted in the

prohibition under the APA that an agency not engage in

arbitrary and capricious action. See 5 U.S.C. 706(2)(A)

(1994). It simply will not do for a government agency to

declare--without explanation--that a proposed course of pri-

vate action is not approved. See Motor Vehicle Mfrs. Ass'n v.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)

("[T]he agency must ... articulate a satisfactory explanation

for its action...."). To refuse to define the criteria it is

applying is equivalent to simply saying no without explana-

tion. Indeed, appellants' suspicions as to the agency's real

reason for its volte-face on the general folate-neural tube

defect claim highlight the importance of providing a govern-

ing rationale for approving or rejecting proposed health

claims.

To be sure, Justice Stewart once said, in declining to define

obscenity, "I know it when I see it," Jacobellis v. Ohio, 378

U.S. 184, 197 (1964) (Stewart, J., concurring), which is basical-

ly the approach the FDA takes to the term "significant

scientific agreement." But the Supreme Court is not subject

to the Administrative Procedure Act. Nor for that matter is

__________

12 To be sure, there could be some differences between an APA

analysis and a First or Fifth Amendment analysis. It is possible

that a standard may be sufficiently well-delineated to satisfy the

APA but not the First or Fifth Amendment. And, the APA may

allow the agency to provide guidance in implementation, whereas

the First or Fifth Amendment may require the agency to define its

standard up front. Neither of these issues is presently before us

(they could only conceivably arise after remand to the agency), and

we leave them for another day.

the Congress. That is why we are quite unimpressed with

the government's argument that the agency is justified in

employing this standard without definition because Congress

used the same standard in 21 U.S.C.A. 343(r)(3)(B)(i). Pre-

sumably--we do not decide--the FDA in applying that statu-

tory standard would similarly be obliged under the APA to

give it content.

That 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. But see n.12 supra. The agency is entitled to proceed

case by case or, more accurately, sub-regulation by sub-

regulation, but it must be possible for the regulated class to

perceive the principles which are guiding agency action. Ac-

cordingly, on remand, the FDA must explain what it means

by significant scientific agreement or, at minimum, what it

does not mean.

* * * *

For the foregoing reasons, we hold invalid the

four sub-regulations, 21 C.F.R. 101.71(a), (c), (e);

101.79(c)(2)(i)(G), and the FDA's interpretation of its gener-

al regulation, id. 101.14. The decision of the district court

is reversed, and the case is remanded to the district court

with instructions to remand in turn to the FDA for reconsid-

eration of appellants' health claims.

So ordered.
 

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