Court Opinion

ID: 194573
Source: CourtListenerOpinion
Date Created: 2011-02-07 02:20:20+00
Date Added: 2024-06-11T09:34:51.037888
License: Public Domain

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

          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

          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

          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

          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

          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.
        

                    

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