United States v. 29 Cartons

• Court: Court of Appeals for the First Circuit
• Decided: March 3, 1993
• Docket: 92-1945
• Status: Published

Opinion

USCA1 Opinion

March 3, 1993

                            UNITED STATES COURT OF APPEALS
                                FOR THE FIRST CIRCUIT

                              _________________________

          No. 92-1945

                              UNITED STATES OF AMERICA,
                                Plaintiff, Appellant,

                                          v.

                    29 CARTONS OF * * * AN ARTICLE OF FOOD, ETC.,
                                      Defendant.
                              _________________________

                            OAKMONT INVESTMENT CO., INC.,
                                 Claimant, Appellee.
                              _________________________

                     APPEAL FROM THE UNITED STATES DISTRICT COURT
                          FOR THE DISTRICT OF MASSACHUSETTS

                     [Hon. Joseph L. Tauro, U.S. District Judge]
                                            ___________________

                              _________________________

                                        Before

                                Selya, Circuit Judge,
                                       _____________

                            Aldrich, Senior Circuit Judge,
                                     ____________________

                               and Cyr, Circuit Judge.
                                        _____________
                              _________________________

               Robert  D.  Kamenshine,  Attorney,  Civil  Division,  United
               ______________________
          States Dept. of  Justice, with whom  Stuart M. Gerson,  Assistant
                                               ________________
          Attorney  General, A.  John Pappalardo,  United  States Attorney,
                             ___________________
          Douglas N. Letter, Attorney,  Civil Division, Margaret J. Porter,
          _________________                             __________________
          Chief  Counsel, United  States  Food &  Drug Administration,  and
          Leslie Kux,  Associate Chief Counsel,  United States Food  & Drug
          __________
          Administration, were on brief, for appellant.
               Robert Ullman,  with whom Jacob Laufer,  Steven Shapiro, and
               _____________             ____________   ______________
          Bass & Ullman were on brief, for appellee.
          _____________

                              _________________________

                                    March 3, 1993

                              _________________________

SELYA, Circuit Judge.  The government seized, and seeks
                    SELYA, Circuit Judge.
                           _____________

          to condemn,  twenty-nine cartons  of undiluted black  currant oil

          (BCO),  in  capsule  form,  owned  by  claimant-appellee  Oakmont

          Investment Co. (Oakmont), alleging that BCO is a food additive of

          questionable safety.   Because we believe  that encapsulated BCO,

          intended to be ingested as purchased, cannot properly be termed a

          food  additive as defined in the Federal Food, Drug, and Cosmetic

          Act (the  Act), as amended, 21  U.S.C.    301 et  seq. (1988), we
                          __ _______                    __  ____

          affirm the district court's dismissal  of the government's in rem
                                                                     __ ___

          complaint.

          I.  BACKGROUND
          I.  BACKGROUND

                    On October  11, 1988, the  United States Food  and Drug

          Administration  (FDA)  seized 200  bottles  of encapsulated  BCO,

          packed in  twenty-nine  cartons, and  brought  an in  rem  action
                                                            __  ___

          contending  that, under  21 U.S.C.    342(a)(2)(C),  the capsules

          should be condemned as "adulterated" food  because they contain a

          "food additive," the BCO, that Oakmont had not proven to be safe.

                    At   the  ensuing  bench   trial,  certain  facts  were

          uncontradicted.   BCO is  a  liquid obtained  by squeezing  black

          currant berry  seeds.   It is  composed of  polyunsaturated fatty

          acids.   In  its pure  liquid  form, it  can be  ingested by  the

          spoonful  as a dietary supplement.   However, Oakmont markets BCO

          in  capsules which  are  to be  swallowed  whole.   The  capsules

          contain pure BCO   nothing more.   They are made from gelatin and

          glycerin (or  an equivalent plasticizer) and  have no independent

          nutritional  value.  Rather, a capsule serves a dual purpose as a

2

container  (enabling consumers to ingest predetermined quantities

          of  BCO in solid form) and as  a prophylactic (protecting the BCO

          from rancidity).

                    On these and other  facts, the district court dismissed

          the  government's complaint  and  ordered the  capsules released.

          See United States v. 29 Cartons,  Etc., 792 F. Supp. 139, 142 (D.
          ___ _____________    _________________

          Mass. 1992).  The court reasoned that when, as in  this case, BCO

          comprises the only active ingredient within a gelatin capsule, it

          can  properly  be classified  as  a "food,"  but  not as  a "food

          additive."   See id.  at 141-42.   Accordingly, the FDA  erred in
                       ___ ___

          seizing the bottles on the  ground that they "allegedly contain[]

          an unsafe food additive."  Id. at 142.
                                     ___

                    When the  FDA appealed,  the district court  stayed its

          release order.

          II.  THE REGULATORY LANDSCAPE
          II.  THE REGULATORY LANDSCAPE

                    To put  this case  into workable perspective,  we first

          review the relevant statutory provisions.  The Act defines "food"

          as:

                    (1) articles  used for food or  drink for man
                    or other  animals, (2)  chewing gum,  and (3)
                    articles  used  for  components  of  any such
                    article.

          21 U.S.C.   321(f).   The FDA concedes that pure BCO  (sold, say,

          as  a bottled  liquid)  falls within  section  321(f)(1) and  is,

          therefore, "food."  Substances  classified as "food" are presumed

          safe.  Thus, the FDA can prevent sale of bottled BCO or any other

          "food" only if it proves by a preponderance of the  evidence that

          the food is "injurious to health."   21 U.S.C.   342(a)(1);  see,
                                                                       ___

                                          3

e.g.,  United States v. Lexington  Mill & Elevator  Co., 232 U.S.
          ____   _____________    _______________________________

          399, 411 (1914); United States v. An Article of Food [FoodScience
                           _____________    _______________________________

          Labs., Inc.], 678 F.2d 735, 741 n.3 (7th  Cir. 1982) (Cudahy, J.,
          ____________

          concurring).    Although   the  FDA  suspects  that  BCO  may  be

          unhealthful, it is unable  at the present time to  translate this

          suspicion into legally competent proof.

                    In  addition to regulating the sale of food per se, the
                                                                ___ __

          Act contains  provisions anent food additives.   These provisions

          are  designed to  protect consumers  against the  introduction of

          untested  and  potentially  unsafe  substances, such  as  flavor,

          texture, or preservative agents, into food.  A gloss was added to

          the treatment of food additives in 1958.  See Pub. L. No. 85-929,
                                                    ___

          72 Stat.  1784  (1958)  (codified in  scattered  sections  of  21

          U.S.C.).   Unlike section  342(a)(1), which places  the burden of

          proving injuriousness  upon the  government in respect  to foods,

          the  food   additives  amendment   allocates  the   burden  quite

          differently:  the FDA can prevent the sale of products containing

          a food additive  unless and  until the processor  shows that  the

          substance, when added  to food, is  generally recognized as  safe

          (in the  vernacular, "GRAS").  See S.  Rep. No. 2422, 85th Cong.,
                                         ___

          2d  Sess. (1958),  reprinted in  1958 U.S.C.C.A.N.  5300, 5301-02
                             _________ __

          (explaining  the  processor's burden  "of  proving  that a  newly

          discovered substance  which . . . [is] add[ed] to the food we eat

          is  safe").  Thus, in contrast to  the Act's treatment of "food,"

          any  substance  that  meets  the  Act's  definition  of  a  "food

          additive"  is presumed to be "unsafe" under 21 U.S.C.   348 until

4

the  FDA,  or more  particularly,  the Commissioner  of  Food and

          Drugs,  has  promulgated  a  regulation   prescribing  conditions

          assuring safe  use.   See  21  U.S.C.    348(a)(2); 21  C.F.R.   
                                ___

          5.10(a)(1) (1992).

                    The 1958 amendment defines a food additive in pertinent

          part as:

                    any  substance  the  intended  use  of  which
                    results  or  may  reasonably be  expected  to
                    result,  directly  or   indirectly,  in   its
                    becoming a component  or otherwise  affecting
                    the  characteristics  of any  food (including
                    any substance intended for use  in producing,
                    manufacturing,      packing,      processing,
                    preparing, treating, packaging, transporting,
                    or holding food; and including any  source of
                    radiation intended for any such use), if such
                    substance is not generally  recognized, among
                    experts qualified by scientific  training and
                    experience  to evaluate its safety, as having
                    been  adequately   shown  through  scientific
                    procedures  .  .  .  to  be  safe  under  the
                    conditions of its intended use . . . .

          21  U.S.C.    321(s).   To be  labeled a  food additive,  then, a

          substance must (1) be intended, or reasonably expected, to become

          a component of food or to otherwise affect the characteristics of

          food, and (2) not be GRAS.

                    The Act  thus creates  a distinction between  foods and

          food additives which  has meaningful  consequences for  purveyors

          and for the  public.  The distinction also  significantly affects

          the ease with which the FDA may regulate a substance's sale.

          III.  THE ISSUE
          III.  THE ISSUE

                    This appeal revolves around the question of whether the

          FDA or Oakmont must carry out the research necessary to show that

          BCO is, or is not, GRAS.  The issue reduces to whether  pure BCO,

                                          5

when sold in  encapsulated form,  must be regulated  as a  "food"

          within  the meaning  of section  321(f) or  as a  "food additive"

          within the meaning of section 321(s).

                    The  meat of  the parties'  disagreement lies  in their

          differing interpretations of that portion of the Act which states

          that  a substance  can  be a  food additive  if its  intended use

          results,  or  may  be expected  to  result,  "in  its becoming  a

          component  or  otherwise  affecting the  characteristics  of  any

          food."  21  U.S.C.   321(s).1  The FDA  reads the quoted language

          as  creating  two  independent  and disjunctive  standards:    to

          satisfy  the  first prong  of  the  food additive  definition,  a

          substance  must either  (1)  be  a  component  of  food,  or  (2)

          otherwise  affect  the characteristics  of  food.   Because  each

          constituent part or element of a food (that is, each "component")

          necessarily affects the food's characteristics, the FDA considers

          every component, at least potentially, see  infra note 3, to be a
                                                 ___  _____

          food  additive.2  Drawing on this interpretation, the FDA asserts

          that  the  seized  capsules  are  composed  of  three  consumable

          components   BCO,  gelatin, and glycerin    and that,  therefore,

          each  of   these  three  ingredients  is   subject  to  potential
                              
          ____________________

               1The  district court  bifurcated the  trial and,  during the
          initial phase, determined only  that BCO does not meet  the first
          prong  of the  bipartite  food additive  definition.   Thus,  the
          district court had no  occasion to reach the second  prong, viz.,
                                                                      ____
          whether BCO is GRAS.  Hence, that issue is not before us.

               2In  the  FDA's view,  the  second  of the  two  independent
          standards  confers potential food  additive status  on substances
          that,  while  they  are not  constituent  parts  of  a food,  may
          nevertheless have deleterious effects on food.  One example might
          be chemicals used in packaging food.

                                          6

regulation as a food additive.3

                    As  Oakmont  parses  the  statute, it  creates  only  a

          single, unitary food additive standard.  The phrase "or otherwise

          affecting  the  characteristics  of  any  food"  signals  that  a

          component is potentially a  food additive only if it  affects the

          characteristics of  some food to  which it is added.   Unlike the

          FDA's  interpretation,  Oakmont's   interpretation  attaches   no

          significance to a substance's  mere presence as a component  of a

          whole.   It focuses instead on the substance's affirmative use in

          a way that affects food.

                    Applying its interpretation of the statute to the facts

          at  bar, Oakmont  argued below,  as  it does  here, that  the BCO

          contained  in the  seized capsules  is itself  a food  and  not a

          component  of some other  food, that it is  intended so to serve,

          and  that  its  sale in  a  convenient  carrier  medium does  not

          transmogrify it  into a food additive.   In holding that  food is

          defined "by  its 'use[] for  food,'" 29 Cartons, 792  F. Supp. at
                                               __________

          141  (quoting 21  U.S.C.    321(f)), whereas  a food  additive is

          defined by its effect on another substance, see id., the district
                                                      ___ ___

          court substantially adopted Oakmont's reading  of the law and its

          focus on a substance's intended function.

                    In specific terms, then,  we must determine whether, as

          the FDA would have it, any element of any substance that has more
                                 ___            ___

____________________

               3We use the adjectival modifier "potential"  because gelatin
          and glycerin are concededly GRAS.  Hence, these components cannot
          be classified as  food additives because neither can  fulfill the
          definition's second prong.

                                          7

than  one component may be  branded a food  additive, or, rather,

          whether,  as Oakmont  urges and  the court  below believed,  such

          treatment  should be reserved for elements  which, when so added,

          effect  a change  (or, at  least, could be  expected to  effect a

          change) in some other active ingredient.

          IV.  FOOD FOR THOUGHT
          IV.  FOOD FOR THOUGHT

                    The  Seventh  Circuit  has  recently  grappled  with  a

          factually  similar case presenting  this very issue.   See United
                                                                 ___ ______

          States v.  Two Plastic Drums, Etc., ___  F.2d ___ (7th Cir. 1993)
          ______     _______________________

          [No. 92-1172].   Employing a perspicacious analysis  of the Act's

          text and legislative history, the court rejected the FDA's notion

          that  all   components  of  a  substance   are  necessarily  food
                ___

          additives.   The court observed  that the "'or otherwise'" phrase

          contained in the statutory definition of a  food additive targets

          only  those components  that  "have  the  purpose  or  effect  of

          altering a food's  characteristics."  Id. at ___ [slip  op. at 6-
                                                ___

          7].    The  subsequent  enumeration  of  sample  food  additives,

          describing  each substance by its "function or by [its] effect on

          food," makes it clear that an additive must stimulate some change

          in  a food to  which it is  added.  Id.  at ___ [slip  op. at 6].
                                              ___

          Turning  to the legislative history, the  court observed that the

          FDA's broad definition of  a food additive, which would  apply to

          all components, even a substance which comprises  the only active

          ingredient   of  the   whole,  subverts   congressional  purpose.

          Blurring the distinction between food additives  and food in this

          way would  permit  the  agency  to  tilt  a  delicately  balanced

8

statutory  scheme  that  allocates   the  burden  of  proving  an

          additive's safety to  the processors while leaving  the burden of

          establishing a food's safety with the  FDA.  See id. at ___ [slip
                                                       ___ ___

          op. at 8-9].

                    The Seventh Circuit also recognized the incongruity  of

          categorizing  a food's  single active  component as  an additive.

          Because   "that    single   component   does   not   affect   the

          characteristics  of the food in question   rather, it constitutes

          the food,"  id. at ___  [slip op. at 7],  it has no  place within
                      ___

          "the common  understanding of an additive, defined  by Webster as

          'a  substance  added  to another  .  .  .  to  impart or  improve

          desirable properties  or suppress undesirable  properties.'"  Id.
                                                                        ___

          at __ n.3 [slip op. at 7 n.3] (citation omitted).  Thus, in order

          to  qualify as a  food additive, a  component must be  added to a

          food in order  to change that food's properties.   See id. at ___
                                                             ___ ___

          [slip op. at 7-8].  On that basis, pure BCO, in  capsule form, is

          not a food additive.  See id. at ___ [slip op. at 11]. 
                                ___ ___

                    Judges should hesitate to write lengthy opinions merely

          for the sake  of committing their own prose to  posterity.  Given

          the existence  of  a  cogent,  well-reasoned,  eminently  correct

          opinion closely on  point, we  embrace it.   We will,  therefore,

          affirm  the   judgment  below   for  substantially   the  reasons

          elucidated in  Two  Plastic Drums.   We  pause, nevertheless,  to
                         __________________

          essay a few additional observations.

                    First:    We are  reluctant  to  believe that  Congress
                    First:
                    _____

          traffics in absurdities.   Since  it defies common  sense to  say

9

that a  substance  can be  a  "food additive"  when  there is  no

          (other)  food  to which  it is  added,  we think  that  the FDA's

          reading of the Act is nonsensical, and, hence, must be incorrect.

          Moreover,  classifying BCO as a  "component" merely because it is

          combined with  two totally inert  substances serving collectively

          as a  carrier medium would  itself create a bizarre  paradox:  as

          the Seventh  Circuit noted, "to hold  that BCO is  a component of

          the dietary supplement  would be to find that BCO  is a component

          of itself."  Two Plastic Drums, ___ F.2d at ___ [slip op. at 5].
                       _________________

                    Second:    In  the  FDA's   estimation,  a  processor's
                    Second:
                    ______

          "subjective  intent"  that only  one  of  a product's  components

          constitutes  the food is irrelevant because  "it is the objective
                                                                  _________

          intended use, i.e., the intent to combine two or more components,
                        ____

          that  counts."   Appellant's  Brief at  11.   But,  this harangue

          misses  the mark.  We  fully agree that  a processor's subjective

          determination of what constitutes a food  is not determinative in

          cases of this stripe     but neither is the naked  fact that more

          than one component  has been  combined.  In  the final  analysis,

          what  counts is the use of an  ingredient for its effect on food.

          Here, from an objective standpoint, BCO is not being used for its

          effect on gelatin  and glycerine.   Thus, contrary  to the  FDA's

          loudly expressed fears, eschewing  its rendition of the statutory

          text will not supplant objectivity with subjectivity.4
                              
          ____________________

               4Moreover, if the  FDA worries that processors  may muck the
          statutory  classifications with convenient recitals of subjective
          intent,  we question the agency's  espousal of a  rule that would
          "arbitrarily classify a substance as either food or food additive
          by how it  is marketed rather than by  the nature and use  of the

                                          10

Third:    The  FDA  also maintains  that  because  "the
                    Third:
                    _____

          ingredients  of  multi-ingredient  food products,  such  as  cake

          mixes," indisputably fall  within the  food additive  definition,

          the  statute could  not possibly  contain a  "requirement  that a

          substance must be  added to a preexisting food, which  it must be
                                        ___________

          shown actually to affect."  Appellant's Brief at 9.  We disagree.

          Cake mixes are foods composed of many interacting food additives,

          each with  its particular effect on  the whole.5  Absent  any one

          ingredient, the  concoction remains a  cake mix, albeit  one that

          may be  short on sweetness or  lumpy in texture.   In that sense,

          cake mixes and products of that ilk are a far cry from a  dietary

          supplement  composed  of  a   single  active  ingredient.    What

          differentiates  this case is that, if the  BCO is removed, one is

          left with nothing but an empty capsule.

                    Fourth:   We  think it  advisable to mention  the FDA's
                    Fourth:
                    ______

          insistence, citing Chevron U. S. A.  Inc. v. NRDC, Inc., 467 U.S.
                             ______________________    __________

          837, 843 (1984), that we must obey its interpretation of the Act.

          In  our estimation, the purely  legal question facing  us in this

          case  presents no  occasion  for deference.    In this  realm  of

          judicial expertise,  the courts,  not the  agency, have  the last
                              
          ____________________

          substance itself."  Two Plastic Drums,  ___ F.2d at ___ [slip op.
                              _________________
          at 9].   In the words  of Sir Francis Bacon,  the FDA's suggested
          "remedy is worse than the disease."

               5We  do not quarrel with  those courts that  have held, when
          confronted with multi-ingredient products containing  two or more
          active ingredients, that each  active ingredient is potentially a
          food additive.   See, e.g.,  United States v.  45/194 Kg.  Drums,
                           ___  ____   _____________     __________________
          Etc., 961 F.2d 808, 812 n.3  (9th Cir.), cert. denied, 113 S. Ct.
          ____                                     _____ ______
          375 (1992); FoodScience,  678 F.2d  at 738; United  States v.  41
                      ___________                     ______________     __
          Cases, Etc., 420 F.2d 1126, 1130 (5th Cir. 1970).
          ___________

                                          11

word.  See id. at 843 n.9 ("The judiciary is  the final authority
                 ___ ___

          on issues  of statutory construction . . . ."); BATF v. FLRA, 464
                                                          ____    ____

          U.S. 89, 98 n.8  (1983) (observing that "deciding what  a statute

          means"  is  "the  quintessential  judicial  function");   FTC  v.
                                                                    ___

          Colgate-Palmolive  Co., 380  U.S. 374,  385 (1965)  (holding that
          ______________________

          "legal  standard[s] .  .  . must  get  their final  meaning  from

          judicial construction"); Wilcox v.  Ives, 864 F.2d 915,  924 (1st
                                   ______     ____

          Cir. 1988) (quoting BATF v. FLRA, supra).
                              ____    ____  _____

                    At any rate, the true  measure of a court's willingness

          to  defer to an agency's interpretation of a statute "depends, in

          the last  analysis, on the persuasiveness  of the interpretation,

          given all  the attendant circumstances."   Massachusetts Dep't of
                                                     ______________________

          Educ. v. United  States Dep't  of Educ., 837  F.2d 536, 541  (1st
          _____    ______________________________

          Cir. 1988).   "The simple fact that the agency has a position, in
                                                         ___

          and of itself,  is of  only marginal significance."   Mayburg  v.
                                                                _______

          Secretary of  HHS, 740 F.2d 100,  106 (1st Cir. 1984).   When, as
          _________________

          now,  a court  is  persuaded neither  by  "the validity  of  [the

          agency's]  reasoning," nor  by the  interpretive fit  between the

          agency's  rendition,  on  the  one  hand,  and  the  language and

          structure of  the statute, on the other  hand, a court should not

          defer.6  Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).
                   ________    ___________
                              
          ____________________

               6The longevity of an  agency's position is often significant
          in  assaying the degree  of deference owed  to it.   See Bowen v.
                                                               ___ _____
          Georgetown  Univ. Hosp.,  488 U.S. 204,  212 (1988)  (refusing to
          _______________________
          apply Chevron deference to  "agency litigating positions that are
                _______
          wholly unsupported  by  regulations, rulings,  or  administrative
          practice"); Skidmore, 323 U.S. at 140 (acknowledging the value of
                      ________
          "consistency" in  respect to gauging persuasiveness).   Here, the
          FDA's  position  is of  recent  vintage.    Indeed, the  original
          complaint in this action  pinned food additive status not  on BCO
          but  on gamma linolenic acid, BCO's fatty acid constituent.  And,
          in  a prior case  involving blue-green  algae in  gelatin capsule
          form,  the FDA argued that  the blue-green algae  was an additive

                                          12

V.  CONCLUSION
          V.  CONCLUSION

                    We  need go no further.  The proposition that placing a

          single-ingredient  food  product  into  an  inert  capsule  as  a

          convenient method  of ingestion  converts that  food into a  food

          additive  perverts  the  statutory  text,  undermines legislative

          intent, and  defenestrates common sense.   We cannot  accept such

          anfractuous reasoning.

Affirmed.
          Affirmed.
          ________

____________________

          because  it was  to be  consumed  with water  or  other foods  or
          liquids, not because of  its placement in gelatin capsules.   See
                                                                        ___
          United  States v. Articles  of Food  [Blue-Green Algae],  No. 83-
          ______________    _____________________________________
          1180-FR, 1984 WL 1981, at *3-*4 (D. Or. Nov. 8, 1984).

                                          13