Court Opinion

ID: 2961802
Source: CourtListenerOpinion
Date Created: 2015-09-21 20:48:04.427929+00
Date Added: 2024-06-11T13:14:11.106831
License: Public Domain

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