Opposition Brief — Nutritional Health Alliance v. Shalala

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No. 98-235 |

In the Supreme Court of the GawAeSwatoys |

OCTOBER TERM, 1998

NUTRITIONAL HEALTH ALLIANCE, ET AL.,

PETITIONERS

Vv.

DONNA SHALALA, SECRETARY OF

HEALTH AND HUMAN SERVICES, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

BRIEF FOR THE RESPONDENTS IN OPPOSITION

SETH P. WAXMAN

Solicitor General

Counsel of Record

FRANK W. HUNGER

Assistant Attorney General

DOUGLAS N. LETTER

KATHLEEN MORIARTY MUELLER

Attorneys

Department of Justice

Washington, D.C. 20530-0001

(202) 514-2217

QUESTIONS PRESENTED

Pursuant to the Nutrition Labeling and Education

Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353, 21

U.S.C. 343, the Food and Drug Administration (FDA)

has issued regulations that require persons who want to

make a health claim in the labeling of a dietary supple-

ment to petition the FDA for authorization to make

such a claim. Under the regulations, FDA will grant

authorization only when it determines that there

is “significant scientific agreement” that a health claim

is valid. § 3(r)(3)(B)(i), 104 Stat. 2359, 21 U.S.C.

343(r)(3)(B)(i). Petitioners are a dietary supplement

retailer and an association of consumers, producers, and

retailers of dietary supplements who have challenged

the regulations on First Amendment grounds. The

questions presented are:

1, Whether the preauthorization requirement is an

unconstitutional prior restraint of commercial speech.

2. Whether petitioners have satisfied standing and

ripeness standards for challenging the “significant sci-

entific agreement” standard when they have not al-

leged that they want to make any particular health

claim that has not been authorized by FDA.

3. Whether the “significant scientific agreement”

standard violates the First Amendment to the Consti-

tution.

(I)

TABLE OF CONTENTS

Page

Opinions below 1

Jurisdiction 1

Statement

Argument es 8

Conclusion 18

TABLE OF AUTHORITIES

Allied Tube & Conduit Corp. v. Indian Head, Inc.,

486 U.S. 492 (1988) 15

Burson v. Freeman, 504 U.S. 191 (1992) 16

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

Comm'n, 447 U.S. 557 (1980) 5, 7, 9, 10, 14, 15

44 Liquormart, Inc. v. Rhode Island, 517 U.S.

484 (1996) 16, 18

Friedman v. Rogers, 440 U.S. 1 (1979) 14

Kleiner v. First Nat'l Bank, 751 F.2d 1198 (11th

Cir. 1985) 10

Lujan v. Defenders of Wildlife, 504 U.S. 555

(1992) 8

Metromedia, Inc. v. City of San Diego, 453 U.S.

490 (1981) 16

NLRB v. Retail Store Employees Union, Local 101,

447 U.S. 607 (1980) 15

National Council for Improved Health v. Shalala,

122 F.3d 878 (10th Cir. 1997) 6-7, 12

Ohralik v. Ohio State Bar Ass’n, 486 U.S. 447

(1978) 14

Renne v. Geary, 501 U.S. 312 (1991) 12

Shapero v. Kentucky Bar Ass'n, 486 U.S. 466

(1988) 9

Texas v. United States, 118 S. Ct. 1257 (1998) «00... 13

Thomas v. Union Carbide Agric. Prods. Co.,

473 U.S. 568 (1985) 13

(IIT)

Cases—Continued: Page

United Public Workers v. Mitchell, 380 U.S. 75

(1947) 11

United States v. Edge Broad. Co., 509 U.S. 418

(1993) . 16

United States Postal Serv. v. Athena Prods., Ltd.,

654 F.2d 362 (5th Cir. 1981), cert. denied, 456 U.S.

915 (1982) 10

Virginia State Bd. of Pharmacy v. Virginia

Citizens Consumer Council, 425 U.S. 748

(1976) 9, 18, 17

Constitution, statutes and regulations:

U.S. Const.:

Art. ITI 8,

Amend. I 5, 9, 11, 12, 17

Dietary Supplement Health and Education Act of

1994, Pub. L. No. 103-417, 108 Stat. 4825, 21 U.S.C.

$48:

— & CO

§ 6(r)(6), 108 Stat. 4329 (21 U.S.C. 348(r)(6)) .............+

§ 6(r)(6)(B), 108 Stat. 4329 (21 U.S.C. 343(r)(6)(B)) ....

§ 6(r)(6)(C), 108 Stat. 4829 (21 U.S.C. 348(r)(6)(C))

Food and Drug Modernization Act of 1997, Pub. L.

No. 105-115, 111 Stat. 2296:

§ 302(r)(4)(A)(i), 111 Stat. 2350 (to be codified at

21 U.S.C. 343(r)(4)( A)(i)) 4

§ 308(r)(3)(C), 111 Stat. 2351 (to be codified at

21 U.S.C. 343(r)(8)(C)) 3

Nutrition Labeling and Education Act of 1990, Pub.

L. No. 101-535, 104 Stat. 2353 (21 U.S.C. 348) ................. 2

§ 3(r)(1)(B), 104 Stat. 2357 (21 U.S.C. 343(r)(1)(B)) .... 2

§ 3(r)(3)(B)(i), 104 Stat. 2359 (21 U.S.C.

343(r)(8)(B)@)) 2

§ 3(r)(4)(A)@, 104 Stat. 2360 (21 U.S.C.

843(r)(4)(A)()) 4d

§ 3(r)(5)(D), 104 Stat. 2360 (21 U.S.C. 343(r)(5)(D)) ... 2

21 C.F.R.:

Section 101.14 2

Section 101.14(a)(1) ... 2

Regulations—Continued:

Section 101.14(c)

Section 101.14(d)

Section 101.70

Section 101.70(a)

Section 101.70(j)(2)

Section 101.70(j)(8)

Section 101.70(j)(4)

Section 101.70(j)(4)(i)

Section 101.70(j)(4)(ii)

Miscellaneous:

58 Fed. Reg. (1993):

p. 2478

pp. 2524-2528 :

59 Fed. Reg. (1994):

pp. 404-405

62 Fed. Reg. 28,230 (1997)

63 Red. Reg. (1998):

p. 34,084

p. 34,085

H.R. Rep. No. 538, 101st Cong., 2d Sess. (1990) ........-.00+

ar nD >} & & DO DO CO

In the Supreme Court of the United States

OCTOBER TERM, 1998

No. 98-235

NUTRITIONAL HEALTH ALLIANCE, ET AL.,

PETITIONERS

Vv.

DONNA SHALALA, SECRETARY OF

HEALTH AND HUMAN SERVICES, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

BRIEF FOR THE RESPONDENTS IN OPPOSITION

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-17a)

is reported at 144 F.3d 220. The opinion of the district

court (Pet. App. 25a-40a) is reported at 953 F. Supp.

526. The order granting summary judgment in part

(Pet. App. 20a-24a) is unreported.

JURISDICTION

The judgment of the court of appeals was entered on

May 15, 1998. The petition for a writ of certiorari was

filed on August 5, 1998. The jurisdiction of this Court is

invoked under 28 U.S.C. 1254(1).

(1)

STATEMENT

1. a. Under the Nutrition Labeling and Education

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

2358, 21 U.S.C. 348, a health claim’ may be made on a

food label or labeling only if the Food and Drug Ad-

ministration (FDA) has determined in a regulation that,

“based on the totality of publicly available scientific evi-

dence (including evidence from well-designed studies

conducted in a manner which is consistent with gener-

ally recognized scientific procedures and principles),

* * * there is significant scientific agreement, among

experts qualified by scientific training and experience

to evaluate such claims, that the claim is supported by

such evidence.” § 3(r)(8)(B)(), 104 Stat. 2359, 21 U.S.C.

343(r)(3)(B)(Gi). NLEA also required FDA to establish,

by regulation, a “procedure and standard” for determin-

ing the validity of health claims in the labeling of “die-

tary supplement(s] of vitamins, minerals, herbs, or

other similar nutritional substances.” § 3(r)(5)(D), 104

Stat. 2360, 21 U.S.C. 343(r)(5)(D).

Pursuant to that mandate, FDA promulgated the re-

gulations at issue here, which apply the same procedure

and standard for dietary supplement labeling that Con-

gress established for conventional food labeling. See 21

C.F.R. 101.14, 101.70. The regulations permit a health

claim to be made in the labeling of a dietary supplement

only if the claim is based on and consistent with an

FDA regulation. 21 C.F.R. 101.14(c) and (d). FDA will

promulgate a regulation authorizing a health claim

1 A “health claim” is “any claim made on the label or in labeling

of a food, including a dietary supplement, that expressiy or by

implication * * * characterizes the relationship of any substance

to a disease or health-related condition.” 21 C.F.R. 101.14(a)(1);

see also § 3(r)(1)(B), 104 Stat. 2357, 21 U.S.C. 343(r)(1)(B).

when it determines that there is “significant scientific

agreement, 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).

Since the issuance of the regulations, Congress has

significantly modified the regulatory scheme for health

claims. Section 303(r)(8)(C) of the Food and Drug Mod-

ernization Act of 1997, Pub. L. No. 105-115, 111 Stat.

2351 (to be codified at 21 U.S.C. 343(r)(8)(C)), permits a

manufacturer to make a health claim that is based on an

“authoritative statement” from certain governmental

scientific bodies or the National Academy of Sciences,

provided that FDA is given 120 days pre-marketing

notice. Although that provision applies to conventional

foods and not dietary supplements, FDA has stated its

intent to publish a proposed rule that applies that

provision to dietary supplements. 63 Fed. Reg. 34,084,

34,085 (1998).

In addition, the Dietary Supplement Health and Edu-

cation Act of 1994, Pub. L. No. 103-417, § 6(r)(6), 108

Stat. 4329, 21 U.S.C. 343(r)(6), amended the regulatory

scheme for dietary supplements to permit three other

types of claims to be made without FDA pre-approval:

(1) statements that a supplement will have a benefit

related to a classical nutrient deficiency disease; (2)

statements that describe or characterize a nutrient’s

role in the structure or function of the body; and (3)

statements that describe general well-being from con-

sumption of a dietary supplement. Such claims are per-

mitted if the manufacturer has “substantiation” that

the statement is truthful and non-n.isleading, if the

label states that the FDA has not eva,uated the claim,

and if the FDA was notified within 30 days of the

marketing of the product. § 6(r)(6)(B) and (C), 108 Stat.

4329, 21 U.S.C. 343(r)(6)(B) and (C).

b. Any person may petition FDA to issue a regula-

tion authorizing a health claim in dietary supplement

labeling. § 3(r)(4)(A)(i), 104 Stat. 2360, 21 U.S.C.

343(r)(4)(A)(i); 21 C.F.R. 101.70(a). Within 100 days of

the receipt of a petition, FDA will either deny the

petition or “file” it for more comprehensive review.

§ 3(r)(4)(A)(i), 104 Stat. 2360, 21 U.S.C. 343(r)(4)(A)(i);

21 C.F.R. 101.70G)(2). If the petition is “filed,” the

agency has an additional 90 days to deny the petition or

issue a proposed regulation authorizing the health

claim. § 3(r)(4)(A)(i), 104 Stat. 2360, 21 U.S.C.

343(r)(4)(A)(Gi); 21 C.F.R. 101.70(j)(8). Before the pre-

sent litigation, there was no statutory or regulatory

deadline by which FDA was required to publish a final

regulation approving or denying the health claim. In

response to the district court’s initial decision in this

case, FDA issued a regulation under which a final rule

approving or denying the proposed health claim must

be issued within 270 days of the date of publication of

the proposed rule. 21 C.F.R. 101.70(j)(4)(i).. That dead-

line may be extended for not more than 180 days for

good cause. 21 C.F.R. 101.70(j)(4)(ii).

That regulatory scheme gives FDA at least 460 days

and at most 640 days from the time a health claim is

submitted before it must publish a final regulation.

After FDA issued its regulatory response to the dis-

trict court’s decision in this case, Congress added a

requirement that FDA complete its rulemaking within

540 days of the filing of the petition. See Food and

Drug Administration Modernization Act of 1997, Pub.

L. No. 105-115, § 302(r)(4)(A)(i), 111 Stat. 2350 (to be

codified at 21 U.S.C. 343(r)(4)(A)G@)). FDA amended its

regulations to provide that the agency may extend the

regulatory deadline for the final rule only if the

publication date of the final rule, as extended, is within

the statutory deadline. 21 C.F.R. 101.70(j)(4)(i).

2. a. Petitioners are an organization of manufactur-

ers, retailers, and consumers of dietary supplements

and an individual health food store. Pet. App. 27a.

They allege that the preauthorization requirement is an

unconstitutional “prior restraint” and that the “signifi-

cant scientific agreement” standard violates their con-

stitutional right truthfully to inform the public of the

relationships between the consumption of dietary

supplement products and diseases or health-related

conditions. Jd. at 8a-9a. Petitioners did not allege that

they ever filed a petition requesting permission to make

a specific health claim in dietary supplement labeling.

Id. at 10a. Nor did petitioners allege that they wish to

make any health claim that is not already authorized by

an existing FDA regulation. bid. The government

moved to dismiss the complaint for lack of standing and

failure to state a claim, and petitioners moved for

summary judgment. /d. at 3a.

b. The district court denied in part the government’s

motion to dismiss and granted in part petitioners’

motion for summary judgment. Pet. App. 25a-40a. The

court first held that petitioners had standing to chal-

lenge the regulations. Jd. at 3la-32a. The court then

analyzed petitioners’ claim under the four-part test

established in Central Hudson Gas & Electric Corp. v.

Public Service Commission, 447 U.S. 557 (1980), for

determining whether government regulations of com-

mercial speech are consistent with the First Amend-

ment. Pet. App. 32a-33a.

The court concluded that the government had three

substantial interests at issue in this case: “preventing

the spread of unsubstantiated health claims on labels so

that consumers may not be deceived and follow un-

sound health practices; ensuring the reliability of

scientific information disseminated in connection with

the sale of dietary supplements; and protecting consum-

ers from being induced to purchase products by mis-

leading information on labels.” Pet. App. 33a-34a. The

court also determined that the NLEA and FDA’s regu-

lations “directly and materially advance [those] sub-

stantial interests.” Jd. at 34a. The court concluded,

however, that, in light of the absence of any deadline

for the final authorization of a proposed health claim,

the regulations were more extensive than necessary to

accomplish the government’s substantial interests. Jd.

at 35a-39a. The court directed FDA to “establish and

submit to the Court for approval, a reasonable time

limit for the promulgation of a final rule for a health

claim on dietary supplement labels.” Jd. at 39a.

ce. In response to the district court’s decision, FDA

promulgated the regulation previously noted that re-

quires publication of a final rule authorizing or declining

to authorize the proposed health claim within 270 days

of the date of publication of the proposed rule, unless

the agency extends the deadline for good cause. See 21

C.F.R. 101.70(j)(4); 62 Fed. Reg. 28,230 (1997). The

district court upheld that regulation, Pet. App. 18a-19a,

finding that the “270 days, 75 to invite public comment

and roughly six months to allow the agency to assess

whatever it receives[,] is not unreasonable,” id. at 18a.

3. The court of appeals affirmed in part and vacated

in part. Pet. App. la-17a. The court first held that peti-

tioners’ challenge to the “significant scientific agree-

ment” is not ripe for review, because petitioners had

not specified any particular health claim that they wish

to make. /d. at 9a-14a. Agreeing with the Tenth Cir-

cuit’s reasoning in National Council for Improved

Health v. Shalala, 122 F.3d 878, 883 n.7 (1997), the

court concluded that “without a specific proposed

health claim to review, on evidence of record before the

FDA,” a court “cannot determine whether the ‘signifi-

cant scientific agreement’ requirement actually bars

any truthful, non-misleading speech.” Pet. App. 11a.

The court next held that petitioners’ claim that the

FDA authorization process constitutes an unconstitu-

tional prior restraint is ripe for review, because it

“involves a purely legal question that is eminently fit

for judicial review.” Pet. App. 14a. Even if FDA even-

tually authorizes petitioners’ desired health claims, the

court added, petitioners would be “subject to the alleg-

edly unconstitutional FDA preclearance procedure.”

Ibid.

On the merits, the court rejected petitioners’ claim

that the regulations impose an unconstitutional prior

restraint of commercial speech. Applying circuit prece-

dent, the court held that there must be “procedural

safeguards” for a prior restraint on commercial speech

that ensure that the restraint is “not more extensive

than necessary to serve [the asserted governmental]

interest.” Pet. App. 15a, 16a (quoting Central Hudson,

447 U.S. at 566). Applying that standard, the court

concluded that “given the need to protect consumers

before any harm occurs,” a “540-day prior restraint is

sufficiently narrowly tailored.” Ibid. The court ex-

plained that a 540-day period “grants a limited, but

reasonable, time within which the FDA can evaluate

the evidence in support of labeling claims.” Jbid. The

court also noted that the regulatory scheme places “suf-

ficiently definite” constraints on FDA’s authority to

deny a proposed health claim, since FDA is required to

approve such a claim if it satisfies the “significant scien-

tific agreement” standard. Ibid.

The court of appeals declined to consider whether it

would be constitutional for FDA to take more than 540

days to evaluate the validity of a proposed health claim.

The court held that a challenge to possible extensions to

the 540-day review process is not ripe because petition-

ers have not requested FDA review of any proposed

health claim. Pet. App. 17a n.17.

ARGUMENT

1. Petitioners contend (Pet. 14-21) that the FDA

regulation requiring FDA preauthorization of any

health claim made on the label of a dietary supplement

constitutes an unconstitutional prior restraint on com-

mercial speech. That contention is without merit and

does not warrant review.

a. As an initial matter, petitioners failed to establish

Article III standing to challenge the preauthorization

requirement. To establish Article III standing, peti-

tioners were required to show that the preauthorization

requirement caused them an “injury in fact” that is

“concrete and particularized” and “actual or imminent.”

Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992).

Petitioner failed to make that showing. As the court of

appeals noted, petitioners have not alleged that they

want to make any particular health claim that is not

currently permitted by FDA regulations. Nor have

petitioners alleged that the FDA has denied them

permission to make any particular claim. Pet. App.

10a. Petitioners therefore lack Article III standing to

challenge the preauthorization requirement.

b. In any event, petitioners’ contention that the pre-

authorization review requirement is an unconstitutional

prior restraint is without merit. As an initial matter,

the prior restraint doctrine does not appear to play any

distinct role in commercial speech cases, and there is no

reason why this sort of preauthorization process for the

commercial labeling of products with respect to health

claims should be subjected to a different First Amend-

ment standard than other means of regulating com-

merical speech concerning such products. That view is

supported by this Court’s recognition that commercial

speech is more hardy and resilient than other speech.

“Since advertising is the sine qua non of commercial

profits, there is little likelihood of its being chilled by

proper regulation and forgone entirely.” Virginia State

Bd. of Pharmacy v. Virginia Citizens Consumer

Council, Inc., 425 U.S. 748, 772 n.24 (1976). Consistent

with that recognition, the Court has expressed approval

of prior review requirements in commercial speech

cases. Shapero v. Kentucky Bar Ass’n, 486 U.S. 466,

476 (1988) (lawyer may be required to file solicitation

letter with State in advance, to give it “ample opportu-

nity to supervise mailings and penalize actual abuses”);

Central Hudson, 447 U.S. at 571 n.13 (State may re-

quire “a system of previewing advertising campaigns”).

Even assuming that the prior restraint doctrine has

some independent application to commercial speech

cases, however, it could not serve to invalidate the

preauthorization review procedures at issue here.

Given “the need to protect consumers before any harm

occurs,” Pet. App. 16a, there is an obvious governmen-

tal interest in some kind of preauthorization require-

ment. Moreover, as the court of appeals in this case

concluded, the preauthorization requirement at issue

here has adequate procedural safeguards to prevent

the two principal dangers of prior restraints—

unreasonable delay in the dissemination of protected

speech and unbridled governmental discretion to sup-

press speech. IJbid. The 540-day statutory review

period “grants a limited, but reasonable, time within

which the FDA can evaluate the evidence in support of

labeling claims.” Ibid. That is particularly true in light

of the complexity of the issues involved and the serious

public health consequences that could result from mis-

taken approvals. And the “significant scientific agree-

ment” standard for evaluating proposed health claims is

“sufficiently definite to constrain the FDA within rea-

sonable bounds.” Ibid. Thus, even assuming that the

prior restraint doctrine has some independent applica-

tion to commercial speech, the regulatory scheme at

issue here satisfies that doctrine as it has been applied

outside the commercial speech context. See Central

Hudson, 447 U.S. at 571 n.13 (in areas outside of com-

mercial speech, “prescreening arrangement can pass

constitutional muster if it includes adequate procedural

safeguards”).’

Petitioners contend (Pet. 18-21) that the court of

appeals’ prior restraint analysis was incomplete

because it did not assess the merits of the “significant

scientific agreement” standard under the Central Hud-

son four-part test. The court of appeals did not engage

in that analysis, however, because it had already con-

2 Two courts of appeals have upheld prior restraints that, like

the FDA regulations at issue here, protect the public from decep-

tive, misleading, or overreaching commercial speech. See Kleiner

v. First Nat'l Bank, 751 F.2d 1193, 1206-1207 (11th Cir. 1985) (in

class action against a bank, the district court properly imposed a

prior restraint on the bank’s communications with customers to

protect potential class members from coercion); United States

Postal Serv. v. Athena Prods., Lid., 654 F.2d 362 (5th Cir. 1981)

(affirming preliminary injunction permitting the Postal Service to

detain incoming mail for up to 120 days to determine whether the

recipient was using the mai! to obtain money through false

pretenses), cert. denied, 456 U.S. 915 (1982). None of the cases

cited by petitioners (Pet. 15-16) suggests that such a prior re-

straint would be unconstitutional.

cluded that petitioners’ challenge to the “significant

scientific agreement” standard is not ripe for review.

Pet. App. 9a-14a. Having concluded that petitioners’

challenge to that standard is not ripe, the court of ap-

peals correctly declined to assess the merits of that

standard as part of its inquiry into whether the

preauthorization review constitutes an unconstitutional

prior restraint.

2. Petitioners next contend (Pet. 22-26) that the

court of appeals erred in holding that their challenge to

the “significant scientific agreement” standard is not

ripe. That contention is without merit and does not

warrant review.

As we have noted, petitioners’ complaint did not

allege that they wished to make any particular health

claim. Nor have they ever sought FDA authorization to

make a particular claim. Pet. App. 10a. In those cir-

cumstances, petitioners’ constitutional challenge to the

“significant scientific agreement” standard is entirely

abstract and hypothetical. See United Public Workers

v. Mitchell, 330 U.S. 75, 90-91 (1947) (federal employees

lacked standing to bring a First Amendment challenge

to restrictions on political activity where the Court

could “only speculate as to the kinds of political activity

the appellants desire to engage in or as to the contents

of their proposed public statements or the circum-

stances of their publication”).

Moreover, the central premise of petitioners’ consti-

tutional challenge to the “significant scientific agree-

ment” standard is that it bars the dissemination of

truthful, non-misleading information. As the court of

appeals concluded, that contention cannot be intelli-

gently evaluated in the absence of a concrete FDA

decision barring a particular labeling claim. As the

court explained (Pet. App. lla), “without a specific

proposed health claim to review, on evidence of record

before the FDA, we cannot determine whether the

‘significant scientific agreement’ requirement actually

bars any truthful, non-misleading speech.” The court of

appeals therefore correctly concluded that petitioners’

challenge to the “significant scientific agreement” stan-

dard is not ripe for review. See Renne v. Geary, 501

U.S. 312, 321-322 (1991) (First Amendment challenge to

election regulations not ripe where the factual record

was not sufficient to present the constitutional issues in

a “clean-cut and concrete form”).

The reasoning of the court below tracks the reason-

ing of the Tenth Circuit in National Council for Im-

proved Health v. Shalala, supra. In that case, the

Tenth Circuit rejected on standing grounds a First

Amendment challenge to the same statute and regula-

tions at issue in this case. The court explained:

[A] critical issue in evaluating the constitutionality

of commercial speech is whether the speech at issue

is truthful or misleading. Without knowing what

claims plaintiffs seek to disseminate, this court

cannot assess whether such claims are truthful and

not misleading. Therefore, an analysis of this issue

would rest on mere speculation.

122 F.3d at 883 n.7 (citation omitted).

Thus, the only two appellate courts that have ad-

dressed the issue have both concluded that the consti-

tutionality of the “significant scientific agreement”

standard should be resolved in the context of a specific

claim that has been rejected by the FDA. Review of

that issue is not warranted.

b. Petitioners also contend (Pet. 25-26) that the

court of appeals erred in declining to review on ripeness

grounds their claim that the 540-day deadline is inade-

quate because FDA may act beyond the 540-day period

as long as it provides to Congress the reasons for the

delay. As this Court recently reiterated, however, “[a]

claim is not ripe for adjudication if it rests upon ‘contin-

gent future events that may not occur as anticipated, or

indeed may not occur at t all. ” Texas v. United States,

118 S. Ct. 1257, 1259 (1998) (quoting Thomas v. Union

Carbide Agric. Prods. Co., 473 U.S. 568, 581 (1985)).

Since petitioners have not asked FDA to evaluate a

proposed health claim, it is impossible to determine

whether FDA would act on some hypothetical claim

beyond the 540-day limit, much less what FDA’s reason

for needing more time might be. The court of appeals

therefore correctly concluded (Pet. App. 17a n.17) that

any question about the constitutionality of a possible

extension of the 540-day review period is not ripe for

review.

3. Petitioners also argue (Pet. 26-28) that certiorari

should be granted to determine the constitutionality of

the “significant scientific agreement” standard. Be-

cause the court of appeals correctly concluded that that

issue is not ripe for review, however, it did not resolve

that issue on the merits. That question therefore is not

properly presented here. °

In any event, the “significant scientific agreement”

standard is constitutional. It is well-established that

the government may ban not only commercial speech

that is “provably false,” but also commercial speech

that is “deceptive or misleading.” Virginia State Bd. of

Pharmacy, 425 U.S. at 771-772. Of particular relevance

here, experience has shown that there is a substantial

potential for health claims on dietary supplements to be

deceptive and misleading in practice. Prior to the

enactment of the NLEA, “unfounded health claims

[were] being made in the marketplace.” H.R. Rep. No.

538, 101st Cong., 2d Sess. 9 (1990). Morever, health

claims address matters of great importance to the

public (such as ways to reduce cancer risk) and, when

made on labels, are likely to exert substantial influence

on purchasers at the point of sale. See 59 Fed. Reg.

395, 421 (1994) (incorporating by reference FDA’s ear-

lier analysis published in 58 Fed. Reg. 2478, 2524-2528

(1993)). Health claims also purport to contain or convey

scientific information and are based on studies that the

average consumer would have difficulty interpreting or

verifying, and consumers may rely on health claims

because they believe that the claims are regulated by

the government, whether they are or not. Thus, to

protect consumers from being misled, the government

may prohibit health claims that are not supported by

“significant scientific agreement.” Cf. Ohralik v. Ohio

State Bar Ass’n, 436 U.S. 447, 464 (1979) (upholding ban

on attorney’s in-person solicitation of clients where

experience supported State’s percepton of potential for

harm); Friedman v. Rogers, 440 U.S. 1, 18-15 (1979)

(upholding ban on practice of optometry under trade

name where “possibilities for deception” were numer-

ous and legislature had evidence of deceptive practices).

The significant potential for health claims on labeling

both to be deceptive or misleading and to have particu-

lar influence on consumers—coupled with the height-

ened governmental interest in protecting public health

and safety—are sufficient in themselves to sustain the

regulatory scheme adopted by Congress and FDA.’ In

8 This Court made clear in Central Hudson itself that “[tJhe

government may ban forms of communication more likely to

deceive the public than to inform it.” 447 U.S. at 563. In addition,

we argued below that the “significant scientific agreement” stan-

dard is constitutional because it imposes only an incidental restric-

tion on speech as part of a comprehensive regulatory scheme. See

any event, the most the government would have to

show to sustain the constitutionality of the “significant

scientific agreement” standard is that it satisfies the

second, third and fourth prongs of the Central Hudson

inquiry, i.e., that it is designed to serve substantial

governmental interests, that it directly advances those

interests, and that it is no more extensive than neces-

sary to serve those interests. See Central Hudson, 447

USS. at 566. The “significant scientific agreement” stan-

dard easily satisfies each of those prongs.

Petitioners assert (Pet. 28) that the government’s

interest at issue here is the impermissible one of pre-

venting consumers from making their own decisions on

the basis of truthful and non-misleading information.

That assertion mischaracterizes the government’s in-

terest. As the district court explained (Pet. App. 33a-

34a), the “significant scientific agreement” standard is

designed to serve three substantial governmental inter-

ests:

preventing the spread of unsubstantiated health

claims on labels so that consumers may not be

deceived and follow unsound health practices; en-

suring the reliability of scientific information dis-

seminated in connection with the sale of dietary

supplements; and protecting consumers from being

induced to purchase products by misleading infor-

mation on labels.

Allied Tube & Conduit Corp. v. Indian Head, Inc., 486 U.S. 492,

507-509 (1988) (antitrust); NLRB v. Retail Store Employees

Union, Local 101, 447 U.S. 607, 616 (1980) (labor). Because the

“significant scientific agreement” standard readily satisfies the

more stringent Central Hudson test, we do not address that

alternative argument in detail here.

Those interests are plainly substantial. See 44 Liquor-

mart, Inc. v. Rhode Island, 517 U.S. 484, 501 (1996)

(plurality opinion) (protecting consumers from “mis-

leading, deceptive, or aggressive sales practices” is a

substantial reason for the government to regulate

commercial speech).

Petitioners also err in contending (Pet. 28) that the

government failed to satisfy the third prong of the

Central Hudson inquiry because it failed to introduce

empirical evidence that the challenged standard di-

rectly and materially advances the government’s im-

portant interests. FDA reached the commonsense

judgment that requiring health claims in dietary sup-

plement labeling to be scientifically valid will prevent

consumer fraud and protect the public health, thereby

directly advancing the government’s interests. 59 Fed.

Reg. 395, 423 (1994). Such commonsense judgments are

sufficient to satisfy the third prong of Central Hudson.

See Metromedia, Inc. v. City of San Diego, 453 U.S.

490, 509 (1981) (accepting the “commonsense judg-

ment{]” of the legislature that a restriction on bill-

boards advanced the government’s interest in traffic

safety); see also United States v. Edge Broad. Co., 509

U.S. 418, 427-429 (1993) (upholding Congress’s common-

sense judgment that prohibition on lottery advertising

directly served governmental interest); cf. Burson v.

Freeman, 504 U.S. 191, 211 (1992) (upholding restric-

tions under strict scrutiny standard based on history,

consensus, and “simple common sense”).

Finally, petitioners contend (Pet. 28) that the “signifi-

cant scientific agreement” standard is more restrictive

than necessary “given the availability of the regulatory

alternatives.” In the rulemaking process, however,

FDA considered less stringent standards for evaluating

dietary supplement health claims, but ultimately con-

cluded that none would satisfy the NLEA’s goal of

ensuring that health claims in labeling are scientifically

valid and understandable. 59 Fed. Reg. at 404-405. In

supplements under control, [the suggested alternatives}

would ratify the state of affairs that caused Congress to

act.” Id. at 405. No evidence was submitted showing

that “consumers would be able to understand grada-

tions of scientific reliability of claims on food labeling,”

nor was it clear that consumers could distinguish be-

tween preliminary and established claims. Jbid. It is

also significant that the regulations at issue here apply

only to health claims that are made on a product’s label

or labeling. Petitioners may therefore publish health

claims that are not supported by “significant scientific

agreement” in books, magazines, or scientific journals,

as long as those publications are not used as labeling.

In light of the record before it and the tailored scope of

the restriction, FDA reasonably determined that the

“significant scientific agreement” standard is no more

extensive than necessary to accomplish the govern-

ment’s important interests.

In the end, petitioners suggest (Pet. 29-30) that com-

mercial speech restrictions should be subjected to strict

scrutiny and that Central Hudson should be reconsid-

ered. This Court’s precedents both before and aiter

Central Hudson, however, recognize that the First

Amendment does not prevent the government from

regulating false, misleading, or deceptive commercial

speech. For that reason, regulations that protect cor-

sumers from misleading commercial claims, like the

FDA labeling regulation at issue in this case, are not

subject to the same strict scrutiny that attends regula-

tion of non-commercial speech. See, e.g., Virginia State

Bd. of Pharmacy, 425 U.S. at 771-772 & n. 24 (the First

Amendment places “no obstacle” to the government’s

dealing effectively with the problem of speech that is

false, deceptive, or misleading, and the “commonsense

differences” between commercial and non-commercial

speech “suggest that a different degree of protection is

necessary”); 44 Liquormart, 517 U.S. at 501 (plurality

opinion) (“When a State regulates commercial messages

to protect consumers from misleading, deceptive, or

aggressive sales practices, * * * the purpose of its

regulation is consistent with the reasons for according

constitutional protection to commercial speech and

therefore justifies less than strict review.”). Peti-

tioners offer no basis for reconsidering that well-

established understanding of the government’s power

to regulate misleading commercial speech.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.