v.
Defendant.
INTRODUCTION
In this action, plaintiffs seek preliminary and permanent injunctive relief barring the
Federal Trade Commission (FTC or the Commission) from enforcing the FTC Act’s prohibition
against false and misleading advertising against plaintiffs. Plaintiffs allege that the FTC
substantiation. All that has occurred at this point, however, is that the FTC staff has sent a letter
to plaintiffs indicating that the staff has reason to believe that plaintiffs are making advertising
claims that are in violation of the prohibitions of the FTC Act. The letter offers an attempt to
settle the matter but notes that if it is not settled, the staff would refer it to the full FTC
Commission for further proceedings. These further proceedings could result in an administrative
administrative or judicial. Plaintiffs’ complaint can be dismissed for this reason. An even more
basic reason that the complaint should be dismissed is that it is an attempt to enjoin an action that
has not yet been filed, and thus does not present a ripe case or controversy. The cases
recognizing these principles have held that government enforcement actions provide an adequate
forum for claims such as those alleged by plaintiffs, and the existence of this forum satisfies due
process considerations. For these reasons, the complaint should be dismissed and plaintiffs’
Plaintiffs allege that they sell herbs and herbal remedies “which have been used in
traditional folk medicine around the world.” Complaint ¶ 6. Plaintiffs assert that they have “the
right to disseminate information about the historical use of an herb, without qualification,
limitation or restriction.” Complaint ¶ 20. They assert that the FTC’s position, “which in effect
prohibits sellers of herbs from disseminating information about the historical use of herbs for
serious illnesses is constitutionally defective.” Id. ¶ 28. Plaintiffs seek declaratory and
injunctive relief prohibiting the FTC from enforcing its advertising rules. Id. ¶¶ 2, 20, 31
(“Plaintiffs seek a permanent injunction barring the FTC from prohibiting them or any other
company from making statements that an herb has a documented historical use, even if that use
is for a serious or life-threatening medical condition. . . .”); and at page 10. Plaintiffs also argue
that “the FTC’s ‘substantiation’ requirement is based on a biased and flawed methodology.” Id.
¶ 42.
In their motion for a preliminary injunction, plaintiffs make clear that they seek an
injunction “prohibiting the defendant from enforcing its historical use guideline against them or
any other herb sellers.” Memorandum of Law in Support of Plaintiffs’ Motion for a Preliminary
Injunction at 1 (hereinafter “Pl. Mem.”); see also id. at 3, 6. Although plaintiffs argue that the
FTC has placed a “ban on historical use claims for herbs,” id. at 3, plaintiffs recognize that the
only claims that would be “banned” (if the FTC were to bring an enforcement action) are those
that are not substantiated with competent and reliable scientific evidence. Id. at 5 (quoting the
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plaintiffs seem to be conceding that “historical claims” can never be supported by competent and
reliable scientific evidence. In addition, plaintiffs go so far as to “contend that an historical use
claim with an implicit disclaimer could never, in and of itself, be inherently misleading as a
Plaintiffs allege that in April 2008 they received a letter from the FTC informing them
that their website contained “false, misleading, or unsubstantiated information” with respect to
plaintiffs’ herbal products. Complaint ¶ 12 (the letter is attachment A to plaintiffs’ motion for
preliminary injunction). In this letter, the FTC staff stated that it was conducting “a non-public
investigation into advertising claims made by” plaintiffs. Letter at 1. The letter further stated
that the FTC’s Bureau of Consumer Protection “has determined that there is reason to believe
that Native Essence has violated the FTC Act by making false and/or unsubstantiated claims” for
various products. Id. The FTC staff also stated: “Before recommending that the Commission
proceed against Native Essence in court, however, the Bureau has authorized us to attempt to
resolve this matter with you through negotiating a settlement.” Id. Further: “False or
unsubstantiated claims made to consumers about diseases like cancer can cause serious and
immediate harm.” Id. at 2. The letter provided a date by which the FTC staff requested a
response to the letter, and then stated: “If we do not hear from you or your counsel by this date,
we will ask the Commission to authorize us to commence legal action against Native Essence
Herb Company. . . .” Id. Although the letter stated that the Bureau had directed the staff to seek
redress of an amount equal to all revenues for the products in question, the letter made clear that
In the draft complaint attached to the letter, the FTC staff noted some of the claims made
on plaintiffs’ website: “Thousands of people over the years have testified that Rene Caisse’s
formula has cured their cancer, diabetes, ulcers and many other ailments”; “I was battling
lymphoma for 10 years and was in horrendous pain. I began taking Native Essence Plus and
3
began feeling better right away. . . .”; “I am glad my wife is taking these herbs (Native Essence
tea) you are giving her. . . . [T]he cancer cells in her blood stream went from 10 to 1.05.”;
“Japanese researchers have claimed kelp has been conclusively proven to prevent breast cancer”;
and “Maitake is said to aid in cancer prevention, immune stimulation in people with cancer,
support people undergoing chemotherapy and benefit people with the AIDS virus.” Draft
Complaint at 5-7.
ARGUMENT
pursuant to Rule 12(b)(1) of the Federal Rules of Civil Procedure because it is an attempt to
enjoin an enforcement action that does not yet exist. Rule 12(b)(1) empowers a court to dismiss
a complaint for “lack of jurisdiction over the subject matter.” When making a Rule 12(b)(1)
motion, a party may go beyond the allegations in the complaint to challenge the facts upon which
jurisdiction depends by relying on affidavits or any other evidence properly before the court.
Holt v. United States, 46 F.3d 1000, 1003 (10th Cir. 1995). It is not necessary to do so,
however, when – as here – the allegations in the complaint, even when accepted as true, make
clear that there is no jurisdiction in this Court. See E.F.W. v. St. Stephen’s Indian High School,
264 F.3d 1297, 1302-03 (10th Cir. 2001). While the Court is to accept plaintiff’s allegations of
fact for purposes of a facial motion to dismiss, id., it does not accept plaintiff’s allegations of
law. See, e.g., Papasan v. Allain, 478 U.S. 265, 286 (1986) (“Although for the purposes of this
motion to dismiss we must take all of the factual allegations fo the complaint as true, we are not
bound to accept as true a legal conclusion couched as a factual allegation.”); Dry v. United
States, 235 F.3d 1249, 1255 (10th Cir. 2000) (“our standard of review does not require that we
4
quoting in part Hackford v. Babbitt, 14 F.3d 1457, 1465 (10th Cir. 1994).
I. PLAINTIFFS’ COMPLAINT SHOULD BE DISMISSED BECAUSE
IT DOES NOT PRESENT A RIPE CASE OR CONTROVERSY
Whether the Court accepts plaintiff’s allegations as true or goes beyond the allegations in
the complaint, the complaint should be dismissed. When, as here, an enforcement action is not
yet in existence, a challenge to such a possible action should be dismissed because it does not
present a ripe case or controversy. The federal judicial power is limited by Article III of the
Constitution to the resolution of “cases” and “controversies.” See, e.g., Valley Forge Christian
College v. Americans United for Separation of Church and State, Inc., 454 U.S. 464, 471 (1982).
To invoke federal court jurisdiction, a party must establish the existence of a “justiciable
controversy” – one that is “definite and concrete, touching the legal relations of parties having
adverse legal interests.” Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240-41 (1937). The
doctrines of mootness, ripeness, and standing all flow from this constitutional requirement. See
Allen v. Wright, 468 U.S. 737, 750 (1984); Warth v. Seldin, 422 U.S. 490, 499 n.10 (1975). “A
claim is not ripe for adjudication if it rests upon contingent future events that may not occur as
anticipated, or indeed may not occur at all.” Texas v. United States, 523 U.S. 296, 300 (1998)
(citations omitted). See also Keyes v. School District No. 1, 119 F.3d 1437, 1444 (10th Cir.
1997).
The ripeness doctrine serves “to prevent the courts, through avoidance of premature
and also to protect the agencies from judicial interference until an administrative decision has
been formalized and its effects felt in a concrete way by the challenging parties.” Ohio Forestry
Ass’n v. Sierra Club, 523 U.S. 726, 732-33 (1998). Analyzing whether a ripe case or
controversy has been presented requires an evaluation of “(1) the fitness of the issues for judicial
decision and (2) the hardship to the parties of withholding court consideration.” Nat’l Park
5
Hospitality Ass’n v. Dep’t of Interior, 538 U.S. 803, 808 (2003). See also Abbott Labs. v.
Gardner, 387 U.S. 136, 149 (1967); Toilet Goods Ass’n v. Gardner, 387 U.S. 158, 162 (1967)
(“In determining whether a challenge to an administrative regulation is ripe for review a twofold
The issues raised by plaintiffs do not, absent application in a particular case, present an
issue “fit for judicial decision.” These issues are not capable of analysis in the abstract. The
Advertising Guide that plaintiffs attached to their memorandum in support of their motion for
preliminary injunction makes this clear. The Guide states: “The FTC’s substantiation standard is
a flexible one that depends on many factors.” Advertising Guide at 2. Substantiation “depends
greatly on what claims are being made, how they are presented in the context of the entire ad,
and how they are qualified.” Id. at 4. “A number of factors determine the appropriate amount
and type of substantiation.” Id. at 5. “Claims that, if unfounded, could present a substantial risk.
. . .” Id. at 10 (emphasis added). A review of the Guide makes it obvious that the substantiation
inquiry does not present an issue fit for judicial review, but depends on its application in a
particular case. See National Park, 538 U.S. at 812 (“we conclude that judicial resolution of the
question presented here should await a concrete dispute about a particular concession contract.”).
Courts have applied these principles to many FTC actions similar to the instant case, and
have concluded that such challenges are not ripe. In a recent decision issued by the District
Court of Massachusetts, the court rejected an argument very similar to the one made here. Direct
Marketing Concepts, Inc. v. FTC, Civ. No. 05-11930-GAO, 2008 WL 2756923 (D. Mass. July
14, 2008). In Direct Marketing, the FTC had filed an enforcement action, but Direct Marketing
sued the FTC, challenging – as here – the FTC’s substantiation standard as a violation of the
First Amendment. Id. at *1. The court held that the case should be dismissed whether or not the
enforcement action had already been filed: “If this action is related to the enforcement action,
6
If the two actions are not related, then this action must be dismissed for failure to present a ripe
Many other courts have reached similar results. In General Finance Corp. V. FTC, 700
F2d 366 (7th Cir. 1983), the court held that there was no federal court jurisdiction to enjoin the
FTC from investigating plaintiffs. In Flowers Industries v. FTC, 849 F.2d 551 (11th Cir. 1988),
the FTC issued a letter approving a certain purchaser in a divestiture matter. The District Court
entered a preliminary injunction against the FTC barring an enforcement action based on the
letter, but the Court of Appeals reversed, holding that the preliminary injunction was improper
because the FTC letter was not self-executing, and the “FTC can only enforce the divestiture by
bringing an enforcement action seeking civil penalties. . . .” Id. at 553. The court went further
and held that the case was not ripe: “The FTC must seek to enforce the divestiture through civil
penalties before [plaintiff] can assert its defenses in a court of law.” Id. For that reason, the
court ordered the District Court to dismiss the action. Id. at 554. Similarly, in Brown &
Williamson Tobacco Corp. v. Engman, 527 F.2d 1115 (2d Cir. 1975), plaintiffs challenged an
FTC staff interpretation of a consent order “prior to any enforcement proceedings brought by the
FTC.” Id. at 1116. The court denied the injunctive relief sought, even though the Commission
had, by letter, indicated that it agreed with the staff interpretation and that the Commission
“would notify the Attorney General of its intention to commence an action for civil penalties and
with collecting debts, was subject to a cease and desist order prohibiting certain deceptive and
misleading practices. The FTC informed plaintiff that some forms it sought to use did not
conform to the cease and desist order. Plaintiff brought suit in District Court seeking a
declaration that the forms did conform to the order and an injunction preventing the FTC from
seeking civil penalties based on non-compliance with the order. Although plaintiff argued that it
7
was subject to a daily civil penalty and criminal contempt for violation of the order, id. at 952,
the Court of Appeals held that there was no subject matter jurisdiction over plaintiff’s complaint:
“This is the kind of point that can be raised when an enforcement sanction is pursued. . . .” Id. at
954. The court directed the district court to dismiss the case: “There is no jurisdiction in the
The court reached a similar result in Alpine Industries v. FTC, 40 F. Supp. 2d 938 (E.D.
Tenn. 1998), aff’d, 238 F.3d 419 (2000) (Table). Alpine and the FTC had entered into a consent
decree in which Alpine agreed to refrain from making claims about its air purification machines
unless it possessed competent and reliable scientific evidence to support its claims. Id. at 939.
Alpine provided some studies to the FTC, and the FTC stated that the material did not meet the
competent and reliable evidence standard and that it was recommending to the Justice
Department that an enforcement action be initiated against Alpine. Id. at 939-40. Alpine filed
suit against the FTC, seeking a declaration that it had provided adequate scientific substantiation
to the FTC or a declaration that the FTC be required to identify the deficiencies in Alpine’s
studies. Id. at 940. Although the court did not rule on the ripeness issue, id. at 940 n.1, it
dismissed Alpine’s complaint because the FTC’s actions were not subject to review under the
APA. Id. at 942-43. The court held that what Alpine actually sought to do was enjoin an
enforcement action. The court rejected Alpine’s contention that the case was simply a “request
for interpretation of the Consent Decree”: “[W]hile Alpine contends this case is not an attempt
to impinge upon the FTC’s discretion to bring an enforcement action, this case cannot be about
In Jerome Milton, Inc. v. FTC, 734 F.Supp. 1416 (N.D. Ill. 1990), plaintiff entered into a
consent decree with the FTC in which the plaintiff agreed that it would not make certain claims
about its toothpaste unless it had competent and reliable evidence substantiating the claims. Id.
at 1418. Subsequently, plaintiff submitted a study to the FTC that it claimed substantiated the
8
claims it sought to make. Id. at 1418-19. The Commission itself wrote a letter to plaintiff stating
that the studies were inadequate and that if plaintiff undertook future advertising without
substantiation, the “Commission may consider instituting appropriate action. . . .” Id. at 1419.
Plaintiff filed suit against the FTC arguing, among other things, that its studies “constitute
‘competent and reliable evidence’ within the meaning of the consent order.” Id. The court
dismissed the case, holding that the FTC conduct challenged by plaintiff was not final agency
action. Id. at 1420-24. Among other things, the court held that the “unlikelihood of any change
in position by the agency” did not constitute “ground for reviewing otherwise non-final agency
action.” Id. at 1421.1 The court did not reach the ripeness issue, but noted that “many of the
factors considered in this opinion would also countenance against a finding that the agency’s
Courts have reached the same conclusion with respect to activities of the United States
Food and Drug Administration (FDA) that are very similar to those challenged here. In Biotics
Research Corp. v. Heckler, 710 F.2d 1375 (9th Cir. 1983), the FDA sent regulatory letters to
Biotics stating that Biotics’ drug products were in violation of the law and threatening
enforcement action if Biotics did not take corrective measures. Id. at 1376. The court held that
these letters did not constitute final agency action and that there was no jurisdiction over Biotics’
complaint:
Id. at 1378. Similarly, in Estee Lauder, Inc. v. FDA, 727 F. Supp. 1 (D.D.C. 1989), Estee Lauder
challenged letters from FDA stating that some of Estee Lauder’s products were drugs, and
1
Similarly, the complaint in the instant case can be dismissed because there has been no
final agency action. 5 U.S.C. § 704.
9
sought to enjoin future FDA enforcement action. Id. One of the FDA letters stated: “If you are
unwilling to make the changes identified in this letter, please advise us of that fact within 10
days.” Id. at 5. The letter went on to say that if Estee Lauder were unwilling to make the
changes, “the agency is prepared to take the regulatory measures discussed in our previous
letters.” Id. The court held that this agency action was not ripe for review and was not final
agency action. Id. at 4-5. In IMS Ltd. v. Califano, 453 F. Supp. 157 (C.D. Cal. 1977), FDA sent
a letter to IMS stating that IMS was in violation of the Food, Drug, and Cosmetic Act and
threatened regulatory sanctions should IMS fail to respond to the letter. Id. at 158. Although the
court viewed IMS’ challenge as an assertion that FDA had improperly applied a regulation to
IMS’ product, it held that the letter did not constitute final agency action. Id. at 158-60. See
also Schering Corp. v. Heckler, 779 F.2d 683, 686 n.18 (D.C. Cir. 1985) (statements by FDA
officials regarding whether a product was a “new animal drug” and the government’s position in
previously filed enforcement actions did not constitute final agency action).
For these reasons, this case does not present a ripe case or controversy and should be
dismissed.
II. PLAINTIFFS’ COMPLAINT SHOULD BE DISMISSED BECAUSE
IT IS AN ATTEMPT TO ENJOIN AN ENFORCEMENT ACTION
already been filed, it is well-established that those subject to enforcement action may not file a
separate challenge, but must raise any defenses they have in the enforcement case itself. See
Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594, 598 (1950) (opportunity for court hearing
in enforcement action “satisfies the requirements of due process.”); X-tra Art v. CPSC, 969 F.2d
793, 796 (9th Cir. 1992) (same); United States v. Alcon Laboratories, 636 F.2d 876, 882 (1st Cir.
1981) (“The Supreme Court’s decision in Ewing precludes judicial interference with the FDA’s
10
decision to institute enforcement actions, whatever the precise context.”); Southeastern Minerals,
Inc. v. Harris, 622 F.2d 758, 764 (5th Cir. 1980) (“in seeking to enjoin federal officials from
interfering with the manufacturing and marketing of their product, the appellees necessarily
sought pre-enforcement review of the FDA’s determination that probable cause existed to seize
Labs, Inc. v. Kennedy, 596 F.2d 568, 570-71 (3d Cir. 1979) (no jurisdiction to enjoin
enforcement actions under Ewing); Parke, Davis & Co. v. Califano, 564 F.2d 1200, 1206 (6th
Cir. 1977) (“it was an abuse of discretion to enjoin the FDA in the circumstances of this case
where pending enforcement actions provided an opportunity for a full hearing before a court.”);
Genendo Pharmaceutical v. Thompson, 308 F. Supp.2d 881, 883 (N.D. Ill. 2003) (it “is well-
settled that the district courts lack jurisdiction to enjoin enforcement proceedings. . . .”).
In addition to this rule against enjoining enforcement actions that have been filed in a
United States District Court, parties are prohibited from attempting to enjoin administrative
enforcement actions. In FTC v. Standard Oil Co., 449 U.S. 232 (1980), the Supreme Court held
that the FTC’s issuance of an administrative complaint was not final agency action subject to
judicial review, even though the complaint was “definitive” on the question regarding whether
the Commission had “reason to believe” that Standard Oil was violating the Federal Trade
Commission Act. Id. at 241. The complaint was only a determination that adjudicatory
proceedings would commence. Although the Court recognized that the burden of responding to
this complaint would be “substantial,” it did not constitute irreparable injury. Id. at 244. Accord
Great Plains Coop v. CFTC, 205 F.3d 353 (8th Cir. 2000) (no jurisdiction to enjoin
One of the principal reasons for these holdings is that permitting judicial review of
agency actions in a forum other than an actual enforcement action would result in inefficient –
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[I]t has never been held that the hand of government must be stayed until the
courts have an opportunity to determine whether the government is justified in
instituting suit in the courts. Discretion of any official may be abused. Yet it is
not a requirement of due process that there be judicial inquiry before discretion
can be exercised. It is sufficient, where only property rights are concerned, that
there is at some stage an opportunity for a hearing and a judicial determination.
Ewing, 339 U.S. at 599. See also FTC v. Standard Oil, 449 U.S. at 242-43 (judicial intervention
into the agency process “leads to piecemeal review which at the least is inefficient and upon
completion of the agency process might prove to have been unnecessary. . . . Finally, every
respondent to a Commission complaint could make the claim that [plaintiff] had made.”)
(citations omitted); Alcon Laboratories, 636 F.2d at 886 (“the imposition of any formal, pre-
enforcement hearing requirement might seriously impair the effectiveness of the Act’s
enforcement provisions.”); Jerome Milton, Inc., 734 F.Supp. at 1423 (“exercise of judicial
review at this stage would interfere with the proper relationship between the judiciary and the
agency. . . . Judicial review at this stage would bypass the entire agency process envisioned by
Congress.”); Estee Lauder, 727 F.Supp. at 5-6 (“If the FDA were subject to suit each time it
warned a company that its product violated the Act, the Administration would be inhibited from
analyzed in the abstract; the only appropriate forum would be an FTC enforcement action. This
is true whether the enforcement action is simply a possibility – as here – or it has already been
filed.
CONCLUSION
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Respectfully submitted,
GREGORY G. KATSAS
Assistant Attorney General
JOHN F. DALY
Deputy General Counsel
For Litigation
/s/
LESLIE RICE MELMAN DRAKE CUTINI
Attorney Attorney
Office of the General Counsel Office of Consumer Litigation
Federal Trade Commission Civil Division
Washington, DC 20850 Department of Justice
202-326-2478 P.O. Box 386
Washington, DC 20044
202-307-0044
drake.cutini@usdoj.gov
GREGORY J. FOURATT
United States Attorney
13
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on July 31, 2008, I filed the foregoing pleading electronically
through the CM/ECF system, which caused the following parties or counsel to be served by
/s
JAN ELIZABETH MITCHELL
Assistant U.S. Attorney