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UNITED STATES DISTRICT COURT

DISTRICT OF NEW MEXICO

MARK HERSHISER, MARIANNE


HERSHISER, AND NATIVE
ESSENCE HERB COMPANY,

Plaintiffs, Civil No. 08–cv-0603 BB/RHS

v.

FEDERAL TRADE COMMISSION,

Defendant.

MEMORANDUM IN SUPPORT OF THE


FEDERAL TRADE COMMISSION’S MOTION TO DISMISS

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

improperly prohibits speech by seeking to ensure that advertising is backed up by proper

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

complaint, a federal court complaint, or nothing at all.

It is well-established that parties cannot enjoin an enforcement action – whether

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’

motion for preliminary injunction denied.


STATEMENT OF FACTS

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

Advertising Guide attached to the preliminary injunction memorandum). In essence, then,

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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

matter of law, and arguably cannot ever be misleading.” Id. at 12.

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

Native Essence was free to attempt to negotiate a lower amount. Id.

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

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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

THE COMPLAINT SHOULD BE DISMISSED BECAUSE IT IS AN ATTEMPT TO


ENJOIN AN ENFORCEMENT ACTION AND BECAUSE IT RAISES ISSUES THAT
ARE NOT RIPE

Plaintiffs’ complaint is subject to dismissal for lack of subject matter jurisdiction

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

accept ‘conclusory allegations, unwarranted inferences, or legal conclusions’ in a complaint.”),

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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

adjudication, from entangling themselves in abstract disagreements over administrative policies,

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

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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

inquiry must be made . . . .”).

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,

then it must be dismissed as an impermissible attempt to enjoin an ongoing enforcement action.

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If the two actions are not related, then this action must be dismissed for failure to present a ripe

claim for judicial adjudication.” Id.

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

for other relief on the basis of these violations.” Id. at 1117.


In Floersheim v. Engman, 494 F.2d 949 (D.C. Cir. 1973), plaintiff, who sold forms used

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

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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

District Court to give the relief sought.” Id.

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

anything else.” Id. at 942-43.

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

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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

action is ripe.” Id. at 1424.

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:

The letters do contain conclusions by subordinate officials of the FDA that


products offered by Biotics . . . are in violation of federal law and also indicate a
readiness on the part of the FDA to initiate enforcement procedures if corrective
measures are not taken. As the Secretary points out, however, such letters do not
commit the FDA to enforcement action.

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

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Similarly, the complaint in the instant case can be dismissed because there has been no
final agency action. 5 U.S.C. § 704.

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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

An alternative reason that the complaint should be dismissed is that it is an attempt to

enjoin an enforcement action. Whether an enforcement action is simply contemplated or it has

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

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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

and initiate enforcement proceedings . . . , a review clearly proscribed by Ewing.”); Pharmadyne

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

administrative enforcement action).

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 –

and unprecedented – judicial review of preliminary agency decisions:

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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

performing a valuable public service – the issuing of informal advisory opinions.”).

Under these principles, plaintiffs’ complaint should be dismissed. Plaintiffs are


attempting to enjoin a nonexistent enforcement action, and the issues they seek to raise cannot be

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

For the foregoing reasons, the complaint should be dismissed.

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Respectfully submitted,

GREGORY G. KATSAS
Assistant Attorney General

C. FREDERICK BECKNER III


Deputy Assistant Attorney General
OF COUNSEL:
EUGENE M. THIROLF
WILLIAM BLUMENTHAL Director
General Counsel

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

Filed Electronically 7/31/2008


JAN ELIZABETH MITCHELL
Assistant U.S. Attorney
U.S. Attorney’s Office
P.O. Box 607
Albuquerque, NM 87103
505-346-7274
jan.mitchell@usdoj.gov

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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

electronic means, as more fully reflected on the Notice of Electronic Filing:

Richard Jaffe, Attorney for Plaintiffs


E-mail: rickjaffeesq@aol.com
Judith A. Rosenstein, Attorney for Plaintiffs
E-mail: jrosenstein7@cybermesa.com

/s
JAN ELIZABETH MITCHELL
Assistant U.S. Attorney

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