                             UNPUBLISHED

                    UNITED STATES COURT OF APPEALS
                        FOR THE FOURTH CIRCUIT


                             No. 05-1937



DURK PEARSON; SANDY SHAW,

                                           Plaintiffs - Appellants,


           versus

MICHAEL LEAVITT, in his official capacity as
Secretary of the U.S. Department of Health and
Human Services; LESTER M. CRAWFORD, in his
official capacity as Acting Commissioner of
the U.S. Food and Drug Administration; UNITED
STATES FOOD AND DRUG ADMINISTRATION; U.S.
DEPARTMENT OF HEALTH & HUMAN SERVICES; UNITED
STATES OF AMERICA,

                                            Defendants - Appellees.


Appeal from the United States District Court for the District of
Maryland, at Greenbelt. Alexander Williams, Jr., District Judge.
(CA-04-3600-AW)


Argued:   May 22, 2006                      Decided:   June 23, 2006


Before WILKINSON and TRAXLER, Circuit Judges, and Richard L.
WILLIAMS, Senior United States District Judge for the Eastern
District of Virginia, sitting by designation.


Affirmed by unpublished per curiam opinion.


ARGUED: Jonathan Walker Emord, EMORD & ASSOCIATES, P.C., Reston,
Virginia, for Appellants. Matthew Miles Collette, UNITED STATES
DEPARTMENT OF JUSTICE, Civil Division, Appellate Section,
Washington, D.C., for Appellees. ON BRIEF: Michelle C. Gayeski,
EMORD & ASSOCIATES, P.C., Reston, Virginia, for Appellants. Peter
D. Keisler, Assistant Attorney General, Rod J. Rosenstein, United
States Attorney, Douglas N. Letter, UNITED STATES DEPARTMENT OF
JUSTICE, Civil Division, Appellate Section, Washington, D.C., for
Appellees.


Unpublished opinions are not binding precedent in this circuit.
See Local Rule 36(c).




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PER CURIAM:

     Durk Pearson and Sandy Shaw (“Appellants”) sought and were

denied declaratory and injunctive relief to preclude the Food and

Drug Administration (“FDA”) and the Department of Health and Human

Services (“HHS”)(collectively “Appellees”) from taking action to

prevent Appellants from selling a report published by the United

States government that suggests that dietary supplements containing

S-adenosyl-L-methionine(“SAMe”)              were       a   possible   treatment       for

various diseases.         Appellants claimed that the potential for FDA

enforcement      of   its    regulations         chilled     their   constitutionally

protected First Amendment free speech rights.                      Finding that there

is   not    a    sufficient       factual       basis       upon   which   to   make     a

determination of Appellants’ claims, we agree with the district

court’s ruling that the controversy is not ripe and accordingly

affirm the dismissal of the claim under Rule 12(b)(6) of the

Federal Rules of Civil Procedure.



                                            I.

     Durk       Pearson     and   Sandy   Shaw      are     formulators    of   dietary

supplements containing SAMe. Appellants receive royalties from

distributors who are licensed to sell their products. SAMe is an

amino acid created within human cells by the energy molecule ATP

and the amino acid methionine. SAMe plays a role in many of the

biochemical reactions in the human body. SAMe has been the subject


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of research by privately funded organizations and by federal

government agencies.

      In October 2002, the Agency for Healthcare Research and

Quality (“AHRQ”), a division of HHS, published a report entitled

“S-Adenosyl-L-Methionine        for    the     Treatment      of   Depression,

Osteoarthritis,   and    Liver      Disease”(the   “Report”).      The   Report

summarized the conclusions of various published studies examining

the effect of SAMe on the treatment of depression, osteoarthritis,

and   liver   disease.        The   Report   concluded     that    supplements

containing SAMe are more effective than placebos in the treatment

of depression and osteoarthritis but were no more effective in

treating liver disease.         The Report was made available to the

public on at least seven different websites.

      In 2004, Appellants wrote a prologue to the Report, touting

its findings and explaining the role of SAMe in bodily processes.

Appellants intended to sell a bound volume consisting of their

prologue and the Report (collectively the “Publication”) to the

general public through their licensees.

      Appellants refrained from selling the Publication because of

fear of prosecution by the FDA. Specifically, Appellants feared

that the FDA, under their administrative enforcement policy, would

use the Publication as evidence of the “intended use” of the

dietary supplements and reclassify Appellants’ SAMe-containing

dietary   supplements    as    “new   drugs”    under   the    Food   Drug   and


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Cosmetics Act (“FDCA”), thus prohibiting sale of the Publication to

consumers.

       In November 2004, Appellants brought this action seeking a

declaration that the potential enforcement of FDA regulations was

a   violation     of   their    First     Amendment       right    to     free   speech.

Appellants also sought to enjoin Appellees from declaring the

Publication as evidence of an intent to sell the SAMe-containing

dietary supplements as “new drugs” and from taking any action to

prohibit Appellants’ licensees from selling the Publication to the

public.     At   the   time    the   action      was     filed,    the    FDA    had   not

threatened or implemented any procedures to either prohibit the

sale   of   the   Publication        or   to    prosecute     Appellants         for   FDA

violations.

       Appellants moved for summary judgment and Appellees moved to

dismiss or, in the alternative, for summary judgment. The district

court ruled that there was not a sufficient factual record upon

which to make a determination regarding the validity of Appellants’

claims and that the case was not ripe, and granted Appellees’

motion to dismiss. This appeal followed.



                                          II.

       Ripeness requirements are relaxed in First Amendment cases

because     of   the   potential     chilling      effect     of    unconstitutional

restrictions      on   free     speech.        Forsyth    County     v.    Nationalist


                                           5
Movement, 505 U.S. 123, 129-30 (1992). To withstand a ripeness

challenge, a plaintiff must demonstrate “a live dispute involving

the actual or threatened application of [a statute or policy] to

bar particular speech.” Renne v. Geary, 501 U.S. 312, 320 (1991).

But without a factual record of an actual or threatened action

resulting in the suppression of free speech, no ripe, justiciable

controversy exists. Woodall v. Reno, 47 F.3d 656, 656 (4th Cir.

1995); see Jordahl v. Democratic Party of Virginia, 122 F.3d 192,

198 (4th Cir. 1997).

     In evaluating the ripeness of a claim for judicial review,

courts must consider (1) the fitness of the issues for judicial

decision and (2) the hardship to the parties of withholding court

consideration. Abbott Labs v. Gardner, 387 U.S. 136, 149 (1967);

overruled on other grounds by Califano v. Sanders, 430 U.S. 99

(1977). Regarding administrative agency cases, this court has held

that a claim is not ripe for review unless the issues to be

considered are purely legal ones and the agency rule giving rise to

the claim is final and not dependent on future uncertainties or

intervening agency rulings. Charter Fed. Sav. Bank v. Office of

Thrift Supervision, 976 F.2d 203, 208 (4th Cir. 1992). If certain

critical facts that would substantially assist the court in making

its determination are contingent or unknown, the case is not ripe

for judicial review. Arch Mineral Corp. v. Babbitt, 104 F.3d 660,

665-66 (4th Cir. 1997).


                                6
         Appellants have offered insufficient evidence to demonstrate

the fitness for judicial review that ripeness requires. Appellants

claim that the FDA will use their Publication as evidence of the

“intended use” of their SAMe containing supplements. However, the

record     is   devoid    of   any    evidence      that    would    support      this

contention.      There    is   no     indication     of     who    will    sell   the

Publication, how the Publication will be marketed, the purpose for

which the Publication will be used, or the way in which it will be

distributed. These factors are a necessary part of the analysis of

the “intended use” of a product.            In United States v. An Article of

Drug Consisting of 250 Jars etc. of U.S. Fancy Pure Honey, etc.,

218 F. Supp. 208, 209-11(E.D. Mich. 1963), aff’d, 344 F.2d 288 (6th

Cir. 1965), the court found that jars of honey were unapproved

drugs because booklets containing statements about the honey’s

disease-treating capacity were sold adjacent to the jars of honey.

In   United     States    v.   24    Bottles   ‘Sterling      Vinegar       &   Honey,

etc.’(Balanced Foods Inc.), 338 F.2d 157(2d Cir. 1964), the Second

Circuit held that booklets claiming the curative power of honey

were not evidence of intended use because they were shelved with

other publications and were not marketed with the honey in any way.

Accordingly, any determination of “intended use” must be grounded

in   a    fact-based     inquiry     and   cannot   be     based    on    speculative

contentions. Appellees have neither threatened nor taken action

against Appellants.        There has been no final agency determination


                                           7
of the Publication as evidence of intended use. Because Appellants

have not shown such action on the part of Appellees, there is no

issue to decide and judgment must be deferred.

        In a ripeness inquiry, hardship is determined by considering

(1) the immediacy of the threat and (2) the burden imposed upon the

party    compelled       to    act    under       threat    of    enforcement      of     the

challenged law. Charter, 976 F.2d at 208-09.                       The threatened harm

must    be   “immediate,       direct,       and    significant.”         West    Virginia

Highlands Conservancy, Inc. v. Babbit, 161 F.3d 797, 800 (4th Cir.

1998)(citations omitted).               Appellants’ complaint meets none of

these requirements. Appellants allege harms relating to the loss of

free speech, the right to sell the Publication via their licensees,

and the loss of royalties from sales of the Publication and their

SAMe dietary supplements. These alleged losses are not immediate,

Appellants     have      not     undertaken         any     campaign      to     sell     the

Publication,       and   the    FDA    has    not    made    a    final    determination

regarding the Publication as evidence of the “intended use” of

Appellants’ product. These issues prevent the court from making a

determination       as   to    whether       an    immediate      threat    exists      that

requires     the   injunction         that    Appellants         seek.    Any    losses    or

hardship suffered by Appellants would be contingent on these

factual circumstances.




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     For the foregoing reasons, we conclude that the instant matter

is not ripe for disposition and the district court’s decision is

                                                         AFFIRMED.




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