DOJ's REPLY BRIEF
STATEMENT OF JURISDICTION
Plaintiff-Appellant Paul Mason brought this suit in United
States District Court for the Northern District of California
challenging alleged inaction by the U.S. Food and Drug
Administration ("FDA") with respect to the levels of magnesium in
bottled water. Subject matter jurisdiction in the district court
was promised on 28 U.S.C. § 1331. On May 11, 1999, the
district court entered an order granting the defendants' motion
to dismiss or, in the alternative, for summary judgment. On June
8, 1999, the court entered final judgment, dismissing Mason's
complaint with prejudice. Mason filed a timely notice of appeal
on June 15, 1999. See Fed. R. App. P.
4 (a) (1). This Court has jurisdiction under 28 U.S.C. §
1291 to review final decisions of the district courts of the
United States.
ISSUES PRESENTED FOR
REVIEW
(1) Whether the district court properly dismissed Mason's
claims challenging FDA's refusal to prohibit the sale of certain
bottled waters, when such decisions are committed to the agency's
discretion by law and, thus, are not subject to judicial
review.
(2) Whether the district court properly awarded summary
judgment to FDA with respect to Mason's challenge to the agency's
regulation defining the "reference amount customarily consumed"
for water, when the regulation is a reasonable interpretation of
the "serving size" for food set forth in the Federal Food, Drug,
and Cosmetic Act.
STATEMENT OF THE
CASE
A. Nature of the Case
Plaintiff-Appellant Paul Mason brought this action against the
Secretary of the Department of Health and Human Services and the
Commissioner of the Food and Drug Administration (hereafter
collectively referred to as "FDA" or "the agency") 1/ to challenge various FDA actions
with respect to the magnesium content of bottled water. Mason
claims to own a magnesium-rich natural mineral spring from which
he sells water in bulk. In this action, he challenged FDA's
refusal to prohibit the sale of bottled water that he contends is
adulterated under the Federal Food, Drug, and Cosmetic Act ("FDC
Act" or "the Act") because of the removal of magnesium. Mason
also challenged FDA's definition of the "reference amount
customarily consumed" for water, as set forth in the agency's
food labeling regulations, 21 C.F.R. § 101.12.
The district court granted summary judgment to FDA on the
latter claim and dismissed the remainder of Mason's complaint for
failure to state a claim upon which relief could he granted.
Mason now appeals from that decision, asserting that the district
court erred in a variety of ways.
B. Course of Proceedings and Disposition
Below
Mason filed his initial complaint on August 4, 1997, and an
amended complaint on November 6, 1997. See Docket Nos. 1, 95. Among other things, Mason
alleged that the FDA, in concert with other government agencies,
had caused financial harm to his business by allowing the sale of
allegedly adulterated water (water from which magnesium had been
removed). Amended Complaint ¶¶ 19, 21, 34 (SER 63-65,
66, 69).2/ Mason also
contended that FDA's food labeling regulations, as applied to his
bottled water, were nonsensical and misleading to consumers and,
thus, caused "great financial loss" to his business. Id. ¶ 25 (SER, 66-67). Mason further claimed
that, by permitting the widespread sale of assertedly adulterated
water, FDA had contributed to the population's magnesium
deficiency, thereby causing the deaths of hundreds of thousands
of consumers each year. Id.
¶¶ 26, 34 (SER 67, 69).
Based on these allegations, Mason brought nine claims for
relief, seeking, among other things, a declaratory judgment that
FDA had violated various laws by not prohibiting the sale of
allegedly adulterated bottled water (Claim Three), a declaratory
judgment that FDA must amend its regulations with respect to
bottled water (Claim Five), and an award of attorneys fees,
costs, and expenses in the amount of $1 for every American death
resulting from magnesium deficiency (Claim Nine). Id. (SER 69-71) 3/
On July 13, 1998, FDA moved to dismiss Mason's
amended complaint on the grounds that, inter
alia, Mason did not have standing to sue; he had failed to
exhaust his administrative remedies; and the court lacked
jurisdiction to review the challenged FDA decisions because they
were committed to agency discretion by law and thus unreviewable
under the Administrative Procedure Act ("APA"), 5 U.S.C.
§§ 551-706. See Docket No.
51. In the alternative, FDA argued that it should be granted
summary judgment because Mason failed to demonstrate that any of
the agency's actions were arbitrary or capricious under the APA.
Id. In support of its motion, FDA
filed the 10-volume administrative record underlying its
challenged actions. See Administrative
Record ("AR"), Volumes I-X, pp. 1-1350 (Docket Nos. 52-61).
Mason filed an opposition to FDA's motion on October 13, 1998,
together with his own motion for judgment on the pleadings.
See. Docket Nos. 83, 85. Mason also
moved to Strike FDA's motion to dismiss on the ground that it
violated Rule 11 of the Federal Rules of Civil Procedure.
See Docket No. 82 (ER 41-43). FDA
filed a reply to Mason's opposition on October 25, 1998, together
with responses to Mason's motions. See
Docket Nos. 89, 92 & 93.
On May 11, 1999, the district court entered an order granting
FDA's motion to dismiss and denying Mason's motion to strike and
motion for judgment on the pleadings. Order Granting Motion to
Dismiss and Partial Summary Judgment (hereafter "Order") at 9 (ER
236). The court observed that the bulk of Mason's claims "request
a determination either that defendants wrongfully have failed in
the past to prevent magnesium deficiencies or a determination
that defendants must in the future undertake measures to correct
the alleged problem." Id. at 5 (ER
232). As the court recognized, such claims "would require the
Court to review defendants, decisions not to take enforcement
actions to protect public health," decisions which, under
Heckler v. Chaney, 470 U.S. 821
(1985), are "not subject to judicial review." Order at 5 (ER
232). The court therefore concluded that these claims must be
dismissed, holding that "it is for the agencies to decide if,
when, and how the alleged health threat posed by magnesium
deficiencies is to be addressed, if ever." Id. at 5-6 (ER 232-33).
With respect to Mason's remaining claim, challenging FDA's
regulation defining The "reference amount customarily consumed"
of water as 8 ounces, the court found as a matter of law that
"FDA acted reasonably in defining the 'reference amount
customarily consumed' as being the amount consumed 'per eating
[or drinking] occasion.' " Id. at 7
(ER 233). Accordingly, the district court dismissed all of
Mason's claims that were based on FDA's asserted failure to
prohibit the sale of bottled water from which magnesium had been
removed, and awarded summary judgement to FDA on Mason's
remaining claim concerning the validity of the regulations
defining the "reference amount customarily consumed."
Id. at 9 (ER 236). Judgment was
entered on June 8, 1999, dismissing Mason's complaint with
prejudice. See Docket No. 105 (ER
238). This appeal followed.
STATEMENT OF FACTS
A. Statutory and Regulatory
Background
1. The FDC Act
The FDC Act, 21 U.S.C. § 321 (f), defines food as, among
other things, "articles used for food or drink for man or other
animals." 21 U.S.C. § 321 (f). Water is therefore a food
under the Act. A food is deemed to be "adulterated" if, among
other things, "it bears or contains any poisonous or deleterious
substance which may render it injurious to health. . . ." 21
U.S.C. § 342 (a) (1). A food is also deemed adulterated
under the Act "[i]f any valuable constituent has been in whole or
in part omitted or abstracted therefrom . . . ." 21 U.S.C. §
342 (b) (1).
A food is deemed to be "misbranded" under the Act if, among
other things, its label or labeling fails to bear the following
nutrient information: the serving size of the food, the number of
servings per container, the total number of calories in each
serving size, the amount of various nutrients (total fat,
saturated fat, cholesterol, sodium, total carbohydrates, complex
carbohydrates, sugars, dietary fiber, and total protein)
contained in each serving size, and the amount of certain other
nutrients (including vitamins and minerals). 21 U.S.C. § 343
(q) (1); see also 21 C.F.R. §
101.9 (c) .4/ The serving
size of a food is "an amount customarily consumed and which is
expressed in a common household measure that is appropriate to
the food." 21 U.S.C. § 343 (q) (1) (A) (i). The agency may
by regulation require that information relating to additional
nutrients be included in the label or labeling of food. 21 U.S.C.
§ 343 (q) (2) (A).
A food is also deemed misbranded if its label or labeling
contains a claim that characterizes the level of any nutrient
("nutrient content claim") unless the claim's characterization of
the nutrient level uses terms that are defined by regulation and
the claim complies with other statutory requirements. 21 U.S.C.
§§ 343 (r) (1) (A), 343 (r) (2).5/ Food whose label or labeling
contains a claim that characterizes the relationship of the
nutrient to a disease or health-related condition ("health
claim") is likewise deemed misbranded, unless the claim is made
in accordance with the conditions specified in regulations
authorizing that claim.6/
21 U.S.C. §§ 343 (r) (1) (B), 343 (r) (3) (A) and (B)
.
Any person may petition the agency to issue regulations
approving nutrient content and health claims for food. 21 U.S.C.
§ 343 (r) (4) (A) (i). Under the statute, FDA may promulgate
regulations authorizing health claims "only if [FDA] determines,
based on the totality of publically available scientific evidence
(including evidence from well-designed studies conducted in a
manner which is consistent with generally recognized scientific
procedures and principles), that there is significant scientific
agreement, among experts qualified by scientific training and
experience to evaluate such claims, that the claim is supported
by such evidence." 21 U.S.C. § 343 (r) (3) (B) (i).
2. FDA Regulations
FDA regulations set forth the nutrition labeling requirements
for foods, including the content and format of the declaration of
nutrition information (the "nutrition facts panel"), in
accordance with the above statutory provisions. See 21 C.F.R. § 101.9. A food is not required
to bear a nutrition facts panel if the food contains
insignificant amounts (as specified by regulation) Of all of the
nutrients and food components otherwise required to be included
in the declaration of nutrition information. 21 C.F.R. §
101.9 (j) (4). Bottled waters, for instance, typically are exempt
from the nutrition facts panel requirement, because the water
does not contain significant amounts of any of these nutrients.
However, if a manufacturer makes nutrition claims about a food --
either on its label or in labeling or advertising -- then the
food must bear the nutrition facts panel. 21 C.F.R. § 101.9
(j) (4).
The regulations require that the declaration of the amount of
vitamins and minerals in a food include vitamin A, vitamin C,
calcium, and iron. 21 C.F.R. § 101.9 (c) (8) (ii). Other
vitamins and minerals, such as magnesium, must be included on the
nutrition facts panel when they are added to the food as a
nutrient supplement or when a claim is made about them.
Id. Under the regulations, the
indicated amount per serving for vitamins and minerals is to be
calculated as a percentage of the Recornmended Daily intake
("RDI'') for the nutrient. 21 C.F.R. § 101.9 (c) (8). The
RDI for magnesium is 400 milligrams. 21 C.F.R. § 101.9 (c)
(8) (iv).
A "serving" or "serving size" of a food is in turn defined by
the regulations as the "amount of food customarily consumed per
eating occasion by persons 4 years of age or older which is
expressed in a common household measure that is appropriate to
the food." 21 C.F.R. § 101.9 (b) (1) . Serving sizes for
each type of food are set forth in regulations specifying the
"Reference Amounts Customarily Consumed Per Eating Occasion ..."
(hereafter "reference amounts"), 21 C.F.R. §§ 101.9 (b)
(2), 101.12, which are based upon data gathered in appropriate
national food consumption Surveys. 21 C.F.R. § 101.12 (a)
(1). The reference amount for a beverages such as water, is 8
fluid ounces. 21 C.P.R. § 101.12 (b). Any interested person
may petition the FDA to establish or amend a reference amount for
a food. 21 C.F.R. § 101.12 (h). Such petitions must include
certain data and be submitted in a specific format. Id.
FDA regulations authorize the making of nutrient content
claims when a food contains the requisite amount of a particular
nutrient. For instance, the label of a food may state that the
food is a "good source" of a specified nutrient if, among other
things, the reference amount customarily consumed for that food
contains 10 to 19 percent of the nutrient's total RDA. 21 C.F.R.
§ 101.54 (c). The regulations also permit certain health
claims to be made, such as a claim concerning the relationship
between calcium and osteoporosis, under specified conditions. 21
C.F.R. §§ 101.72 - 81. Any interested person may
petition FDA to issue a regulation with respect to a nutrient
content claim, 21 C.P.R. § 101.69, or a health claim, 21
C.F.R. § 101.70, for a nutrient in food. Such petitions must
include certain data and be submitted in a specific format. 21
C.F.R. §§ 101.69 (m), 101.70 (f).
B. Relevant Facts
Mason claims to own a natural mineral spring, Adobe Springs,
from which he sells water in bulk. Amended Complaint ¶ 19
(SER 63-64). According to Mason, the water produced at his spring
contains high levels of magnesium. Id.
¶ Mason asserts that the average U.S. bottled water contains
a lower level of magnesium, because the mineral is typically
removed during processing. Id. Mason
further asserts that dietary magnesium deficiencies cause up to
150,000 deaths each year in the United States. Id. ¶ 20 (SER 65-66).
On October 6, 1994, Mason filed a citizen petition with FDA
pursuant to 21 C.F.R. § 10.30. See AR, Vol. I, pp. 1-14 (SER 9- 22). In his
petition, Mason requested, among other things, that FDA make a
public announcement that "a good case can be made for the
correlation of cardiovascular death with magnesium deficient
water" and recommending that bottlers fortify water and
water-based beverages with magnesium. Id. at 2 (SER 10).
On November 22, 1995, Mason filed another citizen petition,
requesting that FDA "classify as 'good source' any water or
water-based beverage that provides 33 percent of the RDA
(recomended daily allowance for any mineral when the RDA of that
water or water-based beverage is consumed (eight 8-oz. portions
per day) ." AR, Vol. VII, pp. 1184-87 (SER 41-44).
Mason filed a third citizen petition with FDA on December 26,
1995. AR, Vol, IX, pp. 1212-15 (SER 45-48). This time, Mason
requested that FDA make a public announcement urging Americans to
consume bottled beverages containing magnesium. Id. at 1213 (SER 46). Less then a month later, on
January 25, 1996, Mason filed yet another citizen petition,
requesting that FDA make a public announcement recommending that
consumers drink hard water as an important source of magnesium.
AR, Vol. VIII, pp. 1200-02 (SER 49-51) .7/
While Mason's citizen petitions were under review by FDA, the
National Academy of Sciences ("NAS") developed a proposal for an
eighteen month study to review the scientific literature on the
intake and health effects of calcium and related nutrients,
including magnesium. AR, Vol. X, pp. 1307-22 (SER 23-28). The
proposal stated that NAS would review existing data and develop
estimates of the dietary intake levels of each nutrient studied
which are compatible with good nutrition throughout the lifespan
and which may result in decreasing risk of chronic disease.
Id. at 1309 (SER 25).
On June 6, 1996, FDA published a notice in the Federal
Register to announce that NAS would undertake these studies and
would provide the opportunity for oral presentations at two
public meetings on July 9 and 10, 1996, and July 15 and 16, 1996.
AR, Vol. X, pp. 1323-24 (SER 52-53). An FDA official left a
phone message with Mason on June 14, 1996, to advise him of
the Federal Register notice. AR, Vol. V, p. 1157 (SER 54). FDA
also faxed a copy of the Federal Register notice to Mason that
same day. Id.
On July 18, 1996, FDA denied Mason's citizen petitions without
prejudice. AR, Vol. V, p. 1158-63 (SER 55-60). In so doing, FDA
gave full consideration to Mason's requests regarding magnesium
and bottled water, including the articles that he had submitted,
but concluded that the evidence failed to show that any
individual was at risk of developing a disease condition related
to the intake of magnesium. Id. at
1159 (SER 56). FDA explained that the failure of individuals to
consume the Recommended Daily Allowances (RDA) for magnesium,
upon which Mason based his extrapolations for the harm to the
U.S. population from magnesium deficiency, did not demonstrate a
disease condition in these individuals, especially because RDA
values exceeded most individual's actual requirements for the
nutrient by a "safety factor". Id.
The agency further explained that, in order to change its
position and programs with respect to magnesium, such as by
making public announcements regarding the health effects of
magnesium or recommending fortification in certain water-based
beverages, the scientific evidence would need to show an
association between cardiovascular disease and habitual low
magnesium intakes. Id. The agency thus
concluded that Mason failed to provide sufficient scientific
evidence in his petition to justify any change in agency policy
with respect to magnesium in water.
In addition, FDA pointed out that evidence on magnesium (as
well as other nutrients) and disease, including evidence
submitted by Mason, was being reviewed by NAS in an eighteen-
month study, and that the findings from this review would be
published. Id. at 1160 (SER 57). The
agency noted that NAS had invited the submission of further
scientific data and information on the needs of the American
public for calcium and related nutrients, including magnesium.
Id. FDA thus explained to Mason that
any further analysis of the issue would be premature until NAS
had issued a report based on its review of the available data.
Id.at 1161 (SER 58). The agency
provided Mason with the opportunity to resubmit his requests
after the NAS findings were publicized. Id.
FDA also rejected Mason's request that FDA classify as a "good
source" any water or water-based beverage that provides 33
percent of the RDA for any mineral when 64 ounces of that water
or beverage is consumed, because this proposed change in the
definition of "good source" is inconsistent with the statutory
and regulatory definition for "serving size" and "Reference
Amount Customarily Consumed Per Eating Occasion," which are based
upon amounts customarily consumed per eating occasion, rather
than per day. AR, Vol. V, pp.1161-63 (SER 58-60). See 21 U.S.C. § 343 (q) (1); 21 C.F.R.
§§ 101.9 ( b) (1), (b) (2), 101.12. As the agency
pointed out, FDA regulations authorize a food to be labeled as a
"good source" of a particular nutrient if, among other things,
the reference amount customarily consumed for that food contains
10 to 19 percent of the nutrient's total RDI. AR, Vol. V, at 1162
(SER 59). See 21 C.F.R. § 101.54
(c). The agency thus explained that, because the reference amount
for a beverage such as water is 8 fluid ounces and the RDI for
magnesium is 400 milligrams, an 8-ounce bottle of water must
contain at least 40 milligrams of magnesium (10% of RDI) in order
for the bottled water to be labeled as a "good source" of
magnesium. AR, Vol. V at 1162 (SER 59). See 21 C.F.R. §§ 101.9 (c) (6) (iv);
101.12 (b).
Apparently unsatisfied with FDA's response to his citizen
petitions, Mason filed the instant lawsuit on August 4, 1997. In
his complaint, as amended on November 6, 1997, Mason made
numerous inflammatory allegations against FDA and requested a
variety of declaratory relief, most of which sought to compel FDA
to take certain measures with respect to alleged magnesium
deficiencies in water. Amended Complaint (SER 61-73). On May 9,
1999, the district court entered an order dismissing all but one
of Mason's claims, holding that FDA's decisions not to take
particular actions with respect to magnesium in water were not
subject to judicial review. Order 5-6 (ER 232-33). The court
granted summary judgment to FDA on Mason's remaining claim,
upholding as a matter of law the reasonableness of the agency's
regulations defining the "reference amount customarily consumed"
for water. Id. at 6 (SER 233).
Mason now appeals the district court's decision, raising
numerous issues, none of which have merit.
SUMMARY OF THE
ARGUMENT
As the district court correctly recognized, Mason's claims in
this case were primarily based upon his view that FDA, had failed
take appropriate action with respect to the magnesium content of
bottled water, and he sought to compel the agency to take certain
actions to remedy these alleged past failures. Consideration of
these claims would have required the district court to review
FDA's decisions not to take enforcement action. As the Supreme
Court has made clear, however, FDA's exercise of its enforcement
authority is committed to the agency's discretion by law and is
therefore not subject to judicial review. Accordingly, the
district court properly dismissed all but one of Mason's
claims.
Mason's remaining claim challenged FDA regulations defining
the serving size of foods for the purpose of nutrition labeling.
Because the regulations are based upon reasonable interpretations
of the statute and foster its underlying goal of providing clear
and uniform nutrition information on food labels, the district
court was warranted in upholding the regulations as a matter of
law. Accordingly, the court's decision to grant summary judgment
to FDA on this claim was proper.
Although Mason purports to identify a host of other errors
allegedly committed by the district court in this matter, none of
the additional arguments Mason attempts to advance have any merit
or even any relevance to the issues actually before this Court.
As demonstrated more fully below, the district court's decision
to dismiss the bulk of Mason's claims and grant summary judgment
to FDA on the remaining claim was fully supported by law and
correct in all respects. Accordingly, the judgment should be
affirmed.
ARGUMENT
1. STANDARD OF REVIEW
When a complaint is dismissed for failure to state a claim or
for lack of jurisdiction, this Court reviews the district court's
decision de novo. See
Fort Ord Toxics Project, Inc. v. California
Environmental Protection Agency, et al., 1999 WL 680343
(9th Cir. Sept. 2, 1999); see
also Senate of the
State of California v. Mosbacher, 968 F. 2d 974, 975 (9th
Cir. 1992). A grant of summary judgment is likewise reviewed
de novo. . Department of Health and
Human Services v. Chater, 163 F.3d 1129, 1133 (9th Cir.
1998). The denial of a Rule 11 motion is reviewed for abuse of
discretion, Gotro v. R&B Realty
Group, 69 F. 3d 1485, 1488 (9th Cir. 1995), as is a
district court judge's decision not to recuse himself.
United States v. Chischilly, 30 F.3d
1144, 1149-50 (9th Cir. 1994), cert.
denied, 513 U.S. 1132 (1995).
II. THE DISTRICT COURT PROPERLY DISMISSED
THOSE CLAIMS CHALLENGING FDA'S EXERCISE OF ENFORCEMENT
DISCRETION
As noted above, the district court dismissed the bulk of
Mason's amended complaint based upon the Supreme Court's holding
in Heckler v. Chaney, 470 U.S. 821,
830 (1985). As the court explained, Mason's claims sought, in
essence, a determination that FDA had wrongfully failed to
prevent magnesium deficiencies and a determination that the
agency must take various actions to correct the alleged problem.
Order at 5 (ER 232). Such claims, however, would have required
the district court to review FDA's exercise of its enforcement
discretion, decisions which, under Chaney , are not subject to judicial review. The
court therefore properly dismissed Mason's claims for failure to
state a claim. Id. at 9 (ER 236).
On appeal, Mason contends that the district court made "an
error of law" by applying Chaney ,
insisting, without elaboration or support, that Chaney is inapplicable to cases in which an
agency's "motives" are challenged. Appellant's Brief at 23.
Nothing in either the Chaney opinion
or Ninth Circuit caselaw, however, even remotely supports Mason's
contention. To the contrary, the Chaney decision is clearly applicable to the case
at bar. While the inflammatory rhetoric contained in Mason's
amended complaint may indeed impugn the "motives" of FDA
officials, his actual claims for relief nonetheless challenge
FDA's exercise of its enforcement discretion. By seeking in some
instances to compel FDA to take specific actions and by
challenging, in other instances, the agency's alleged failure to
take particular actions, Mason's claims fall squarely within the
Chaney doctrine and are thus
unreviewable.
In Chaney , the Supreme Court
explicitly considered the enforcement provisions of the FDC Act
and concluded that FDA'S decisions not to take enforcement action
were unreviewable, because the Act did not provide a specific
standard for the agency to follow in exercising its enforcement
authority. Chaney, 470 U.S. at 835-37.
As the Court explained, agency action is not reviewable when "the
statute is drawn so that a court would have no meaningful
standard against which to judge the agency's exercise of
discretion." Id. at 830; see also Adams v. FAA,, I F. 3d 955, 956 (9th Cir.
1993), cert. denied , 510 U.S. 1044 (1994). Thus, when "agency
action is committed to agency discretion by law," 5 U.S.C. §
701 (a) (2), the Administrative Procedure Act does not confer
jurisdiction on courts to review the actions of agency officials,
even for abuse of discretion: "[I]f no judicially manageable
standards are available for judging how and when an agency should
exercise its discretion, then it is impossible to evaluate agency
action for 'abuse of discretion','' Chaney, 470 U.S. at 830; see also Webster v.
Doe, 486 U.S. 592, 599-600 (1988); citizens to Preserve Overton Park, Inc. v. Volpe,
401 U.S. 402, 410 (1971).
Because an agency decision not to take enforcement action is
"a decision generally committed to an agency's absolute
discretion," such decisions are therefore presumptively
unreviewable. Chaney, 470 U.S. at 831.
Moreover, the Ninth Circuit has recognized the expansion of the
Chaney doctrine to other types of
informal agency actions where decisions are likewise committed by
law to the agency's discretion and the relevant statute provides
no meaningful standard to apply. See, e.g.
Senate of the State of California v. Mosbacher, 968 F.2d
at 976 (agency's decision not to release internal information to
public was unreviewable act of agency discretion under
Chaney); Araabri-Q]3-t -V. llnit-i-d
35 P.3d 472, 475 (9th Cir. 1994)
(IRS decision to deny refund of penalty interest was
unreviewable act of agency discretion under Changy); Adams v. FAA, I P.3d at 956 (FAA decision
not to renew pilot examiner designation was unreviewable act of
agency discretion under Chaney).
Here, as the district court correctly recognized, Mason's
allegations plainly sought to challenge FDA's exercise of its
enforcement discretion. Specifically, Mason claimed that FDA had
failed to enforce the provisions of the FDC Act to prevent the
sale of allegedly adulterated bottled water from which magnesium
had been removed. Amended Complaint ¶ 19 (SER
63-64).8/ Mason sought,
among other things, a declaratory judgment that FDA had failed to
prohibit the sale of adulterated bottled water (Claim Three); a
declaratory judgment that FDA must immediately promulgate an
emergency minimum standard of magnesium content for bottled water
(Claim Six); and a declaratory judgment that FDA must make
various public statements regarding the asserted magnesium
deficiency in the United States (Claim Right). Amended Complaint
(SER 69-71). Indeed, all of the claims dismissed by the district
court either directly challenged or sought relief based upon
FDA's alleged failure to take enforcement action to prohibit the
sale of water that Mason contended was adulterated.
See Amended
Complaint, Claims one, Two, Three, Four, Six, Seven, Eight and
Nine (SER 63-64). The ageny's failure to take enforcement action,
however, is precisely the type of action that is not subject to
review under Chaney. Accordingly, the
district court properly dismissed Mason's claims.
III. THE DISTRICT COURT PROPERLY UPHELD
FDA'S LABELING REGULATIONS ON SUMMARY JUDGMENT
Mason's remaining claim challenged FDA's food labeling
regulation defining the "reference amount customarily consumed"
for water as 8 ounces. According to Mason, this regulation
requires him to label his bottled water in a manner that provides
a "misleadingly low impression of the recommended daily allowance
of magnesium his water can supply and precludes him from labeling
his water as a "good source" of magnesium. Appellant's Brief at
26. Mason therefore sought to compel FDA to amend the regulation
to change the "reference amount customarily consumed" for water
from 8 ounces to 64 ounces. Amended Complaint (Claim 5) (SER 70).
Mason's "theory," as described by the district court, was "that
persons ordinarily consume 64 ounces of water per day (eight
glasses of eight ounces each).
Thus [Mason] would like his bottlers to be able to label his
water to show the percentage of the daily recommended allowance
of magnesium a person would receive by drinking a day's supply of
the water." Order at 6 (ER 233).
Having succinctly stated Mason's claim for relief, and the
theory behind it, the district court had no difficulty rejecting
this claim on its face. The court concluded as a matter of law
that "FDA acted reasonably in defining the 'reference amount
customarily consumed' as being the amount consumed 'per eating
(or drinking) occasion.' " Id. at 7
(SER 234). By contrast, the court found Mason's preferred
approach -- linking the reference amount to total daily intake --
unnecessarily confusing. The court explained;
Were Mason's approach adopted, the potential
confusion to the consumer could be much greater. Suppose, for
instance, a bottler sold Mason's water in an eight ounce
bottle. It the label reflected the percentage of the daily
recommended allowance of magnesium provided by 64
ounces of the water, how would the consumer know that he or she
needed to drink seven more bottles of Mason's water that day
(rather than switching to another brand) to achieve that
percentage?
Id.
The court pointed out that FDA regulations call for the
serving size of a food or beverage to appear on its label, see 21
C.F.R. § 101.9, and observed that consumers are aware of how
many servings per day they are consuming. Order at 7 (SER 234).
Under these circumstances, the court concluded, "labels which
reflect the percentage contribution to recommended daily
allowances of various nutrients on a per serving basis simply are
not misleading . . ." Id... Accordingly, the court granted
summary judgment for FDA on Mason's remaining claim for
relief.
On appeal, Mason asserts that the district court's ruling
"defies logic and reason, and thus is clearly judicial error."
Appellant's Brief at 26. Mason continues to insist, as he did
below, that it is misleading for FDA regulations to set forth
reference amounts in term of single eating (or drinking)
occasions rather than total daily consumption. Id. at 26. Mason's argument, however, ignores the
fact that the challenged FDA regulations are based upon the FDC
Act, which defines a food's "serving size" as "an amount
customarily consumed." See 21 U.S.C.
§ 343 (q) (1) (A) (i); 21 C.F.R. § 101.12. As the
district court made clear, FDA's interpretation of the statutory
term "amount customarily consumed" to mean the amount consumed
per eating occasion is plainly reasonable. See Order at
7 (SER 234). Because FDA's regulations reflect -- at the very
least -- one permissible construction of the statute, the
district properly rejected Mason's request to substitute his
proffered interpretation for that of the agency.
Indeed, it is well settled that an agency's interpretation of
a statutory provision need not be the only possible
interpretation so long as it is a permissible construction of the
statute. As this Court has made clear, "[a] court should accept
the 'reasonable' interpretation of a statute chosen by an
administrative agency except when it is clearly contrary to the
intent of Congress." Dioxin/Organochlorine
center v. Clarke, 57 F.3d 1517, 1525 (9th Cir. 1995);
see Chevron,
U.S.A., Inc. v. Natural Resources Defense Council, 467
U.S. 837, 842-44 (1984). " '[I]f the statute is silent or
ambiguous with respect to the specific issue, the question for
the court is whether the agency's answer is based on a
permissible construction of the statute.' " Dioxin/Organochlorine center, 57 F.3d at 152S
(quoting Chevron, 467 U.S. at 843). So
long as the agency's interpretation is a permissible construction
of the statute, it does not matter that there may be other
equally plausible interpretations. Thus, a court "need not
conclude that the agency's answer is the only reasonable one, or
even the 'best' one," nor may a court "substitute its own
construction of a statutory provision for a reasonable
interpretation made by the administrator of an agency."
Queen of Angels/Hollywood Presbyterian
Medical Ctr. V. Shalala, 65 F.3d 1472, 1477 (9th Cir.
1995) (quoting Chevron 467 U.S. at 843
n. 11.9/
Here, Congress enacted the food labeling provisions of the FDC
Act, 21 U.S.C. §§ 343 (q) and (r), in order to ensure
that consumers receive meaningful nutrition information on food
labels. See Nutrition Labeling and
Education Act of 1990, Pub. L. 101-535, 104 Stat. 2353, 2357,
2364; H.R. Rep. No. 101-538, at 7 (1990), reprinted in
1990 U.S.C.C.A.N. 3336, 3337. The Act therefore requires a food's
label, with some exceptions not relevant here, to list the amount
of various nutrients per serving size, see 21 U.S.C. § 343 (q) (1) (C), (D), and
(E), and defines the serving size of a food as "an amount
customarily consumed and which is expressed in a Common household
measure that is appropriate to the food." 21 U. S. C § 343
(q) (1) (A) (i).
FDA's regulations further define "serving size" as the amount
of food customarily consumed "per eating occasion by persons 4
years of age or older," and set forth specific "reference
amounts" for each type of food. 21 C.F.R. § 101.9(b)(1)
& (2); 21 C.F.R. § 101.12. As noted above, the
regulations define the reference amount for water as 8 ounces. 21
C.F.R. § 101-12. In addition, the regulations require that
the presence of minerals, such as magnesium, be indicated on the
label of a food or beverage as a percentage of the recommended
daily intake (RDI) for the mineral. In this way, FDA's
regulations allow the consumer to easily determine at each eating
occasion what contribution a serving of a particular food or
beverage will make to a nutrient's total RDI. Thus, in the case
of bottled water, a consumer can easily calculate the water's
contribution to the RDI of a particular nutrient based upon the
consumer's consumption of 8 ounces of water, the amount typically
consumed at each drinking occasion. See 21 C.F.R §§ 101.9 (b) (1), 101.9 (c)
(8), 101.12 (b).
As the district court found, FDA's regulations defining
"serving size" and "reference amount'" constitute a clearly
reasonable interpretation of the labeling provisions of the FDC
Act, in that the regulations enable consumers to readily
understand the nutrient content information contained on food
labels. Order at 7 (ER 234); 21 U.S.C. § 341 (q) (1) (A)
(i).
The regulations are also fully consistent with Congress' goal
in enacting the food labeling provisions of the FDC Act.
See H.R. Rep. No. 101-538, at 7
(1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337 ("in
order to make this [nutrient) information meaningful, the bill
requires the FDA to issue standards providing that uniform
serving size information and information concerning the number of
servings be furnished on the food label"). As such, the
regulations reflect a reasonable construction of the FDC Act by
the agency charged with its administration, and must therefore be
upheld even if Mason's proposed reading of the statute is itself
permissible. See Queen of Angels/Hollywood Presbyterian, 65 F.3d at
1477; Dioxin/Organochlorine center ,
57 F.3d at 1525.
In light of the above, Mason's additional contention that he
should be allowed to label his water as a "good source" of
magnesium is equally baseless. The FDC Act provides that a food,
such as water, may make a claim on the label that characterizes
the level of certain nutrients if, among other things, the claim
uses terms that are defined in FDA regulations. 21 U.S.C.
§§ 343 (r) (1) (A), 343 (r) (2). The regulations, as
discussed above, permit a food to be labeled as a "good source"
of a particular nutrient, such as magnesium, only if the food
contains 10 to 19 percent of the recommended daily intake (RDI)
per reference amount customarily consumed. 21 C.P.R. §§
101.13 and 101.54 (c). Based on Mason's claim that 64 ounces of
his bottled water provides 52 percent of the RDI for magnesium,
Appellant's Brief at 17, one serving of his water (8 ounces)
would provide only approximately 6 percent of the RDI for
magnesium, a level well below the minimum necessary to qualify
for a "good source" labeling claim. See 21 C.F.R. §§ 101.12 & 101.54 (c)
10/
Mason also asserts on appeal, apparently in the alternative,
that, even it he is not allowed to make label claims for his
water based on the contribution to the RDI for magnesium of a
daily consumption of 64 ounces, he should nevertheless be
permitted to list on the label the percentage contribution to the
RDI provided by (a) the quantity of water in the container; (b)
an 8-ounce serving of the water; and (c) "the daily
magnesium contribution if consumed as a sole source of liquid"
(i.e. the magnesium contribution to RDI of 64 ounces of his
water). Appellant's Brief at 26-27. Mason did not raise this
argument in the district court, however. Accordingly, he is
precluded from raising it now for the first time on appeal.
See Slaven v.
American Trading Transportation Co., 146 F.3d 1066, 1069 (9th Cir. 1998)
(appellate court will not consider issues that were not properly
raised before the district court).11/
Under the circumstances, the district court properly rejected
Mason's claims with respect to the labeling of his water as a
matter of law. The court's grant of partial summary judgment
should therefore be affirmed.
IV. MASON'S OTHER ARGUMENTS ARE
MERITLESS
Mason contends that the district court erred in a number of
additional ways, each of which, in his view, warrants reversal of
the court's decision and a remand for trial on the merits. All of
these claims, however, are baseless.
A. Summary Judgment Was
Appropriate
Mason contends that the district court deprived him of his
constitutional right to a jury trial by "unreasonably" granting
summary judgment when questions of fact were in dispute.
Appellant's brief at 18. In so arguing, however, Mason ignores
the fact that all but one of his claims were resolved not by
surmnary judgment but by dismissal. See order at 6 (ER 233). In ruling on FDA's motion
to dismiss these claims, the court accepted all of Mason's
factual allegations as true for purposes of the motion.
Id, at 3 (ER 230). Thus, Mason's
contention that there were disputed issues of fact inappropriate
for summary resolution is irrelevant with respect to most of
Mason's claims.
As noted above, the district court did award summary judgment
to FDA with respect to Mason's remaining claim concerning the
agency's labeling regulations. See
id., at 7 (ER 234). In granting
summary judgment, however, the district court was required only
to determine whether, as a matter of law, the challenged
regulations were reasonable. Id. at
6-7. Thus, there were no material issues of fact in dispute with
respect to this claim. As this Court has recognized, summary
judgment is an appropriate vehicle for determining, as a legal
matter, the validity of an agency regulation. Cf, Department of Health and Human Services v. Chater,
163 F.3d at 1133. Contrary to Mason's contention, the granting of
summary judgment in such circumstances does not violate a party's
constitutional right to a jury trial. See Sengupta v.
Morrison-Knudsen Co., 804 F.2d 1072, 1077-78 n..3 (9th
Cir. 1986). Accordingly, Mason's argument must fail.
D. The District Court's Treatment Of
Mason's Genocide Allegations Was Not Error
Mason devotes a substantial portion of his brief to the
district court's treatment of his allegations that the FDA had
perpetrated "genocide." Among other things, Mason asserts that:
(1) the district court issued an unconstitutional "advisory
opinion" that the "vast deaths caused by the FDA did not
constitute genocide," Appellant's Brief at 18-19; (2) the court
erred by "unreasonably inventing and using its own unique
definition of genocide, unsupported by law and history,
id, at 19-22; and (3) the court
contradicted itself in its discussion of Mason's genocide
allegations. Id. at 25. Mason also
claims that the court unconstitutionally "abdicated its mandate
and duty to be a check and balance" of the executive branch to
stop the FDA from willfully perpetuating millions of deaths,"
Id. at 24, and erred by "effectively
pardoning or extending amnesty" to FDA by issuing "an
un-Constitutional advisory opinion that 'no genocide had
occurred.' " Id. at 24-25.
Needless to say, these assertions are facially absurd and, in
any event, wholly irrelevant to any issue before this Court. To
the extent the district court discussed Mason's allegations of
genocide, the court did so in the context of evaluating Mason's
claims for relief, which the FDA had moved to dismiss.
See Order at 3-5 (ER 230-32). While
some of the court's discussion could perhaps be viewed as dicta,
there was nothing "advisory" about the court's opinion inasmuch
as it arose out of, and dispositively resolved, an actual case or
controversy between litigants. See
Flast v. Cohen, 392 U.S. 83, 97 (1968)
(Article III jurisdiction of federal courts is limited to
resolving "cases and controversies" between litigants with
concrete interests and not addressing theoretical issues).
The fact that the court took issue with Mason's
characterization of the FDA's actions as "genocide" is of no
legal import. The court was certainly well justified in doing so,
and, while Mason may disagree with the court's assessment, he has
failed to show how the "errors" he has raised with respect to
this issue in any way entitle him to a reversal of the court's
decision. As demonstrated above, the court's decision to dismiss
most of Mason's claims and grant summary judgment to FDA on the
remaining claim was proper and legally supportable in all
respects.
C. The District Court Properly Denied
Mason's Rule 11 Motion
Mason also contends that the district court improperly denied
his motion to strike FDA's motion to dismiss based on alleged
violations of Rule 11 by government counsel. Mason alleges, as he
did below, that the government's motion to dismiss was filed "for
the improper purpose of benefiting a client agency even though
defense counsel knew it would perpetuate vast deaths."
Appellant's Brief at 22. Mason characterizes this issue as a
question of fact and insists, without citation to any support,
that he was entitled to have a jury determine whether FDA's
motion was in fact filed for this assertedly "improper purpose."
Id., at 23.
Rule 11 of the Federal Rules of Civil Procedure requires an
attorney to certify that a pleading, written motion, or other
paper f iled with the Court is not "being presented for any
improper purpose, such as to harass or to cause unnecessary delay
or needless increase in the cost of litigation" and that the
claims, defenses, and other legal contentions therein are
"warranted by existing law." Fed. R. Civ. P. 11 (b) (1), (2).
See also
Townsend v. Holman Consulting
Corporation, 929 F.2d 1358, 1362 (9th Cir. 1991)
("frivolous" paper filed "without a reasonable and competent
inquiry" violates Rule 11) . Courts apply an objective
reasonableness test to determine whether an attorney or
unrepresented party has violated Rule 11. Id.; In re Keegan Management
Co- Securities Litigation, 78 F-3d 431, 434 (9th Cir.
1996).
FDA's motion in this case obviously caused no delay or
increase in the cost of the litigation, but just the opposite.
The motion successfully sought to dispose of Mason's claims on
purely legal grounds without the need for discovery or trial,
thereby expediting the case and minimizing the expenditure of
resources on both sides. Thus, it is clear that FDA's motion was
neither "presented for any improper purpose" within the meaning
of Rule 11, nor "[un]warranted by existing law," as evidenced by
the fact that the district court granted the motion and dismissed
Mason's complaint on most claims and awarded summary judgment to
FDA on the remaining claim. As the court succinctly explained,
defendants motion was meritorious. Therefore it did not violate
Rule 11." Order at 7 (ER 234). Under these circumstances, the
district court did not abuse its discretion in denying Mason's
Rule 11 motion.
1). The District Court Did Not Demonstrate
Any Bias Against Mason
Finally, Mason questions the impartiality of the district
court judge and suggests that the court's opinion demonstrated
bias in favor of FDA. Appellant's Brief at 28-29. Mason's
assertion is groundless. The statutory standard for recusal is
"whether a reasonable person with knowledge of all the facts
would conclude that judge's impartiality might reasonably be
questioned." United States v. Studley,
783 F.2d 934, 939 (9th Cir. 1986) (internal citations omitted),
see 28 U.S.C. §§ 144 &
455. A federal judge need only recuse himself when he has a
personal bias, or when certain "rare circumstances" prevent the
judge from putting out of his mind previously expressed views or
findings. United States v. Huckins, 53
F.3d 276, 280 (9th Cir. 1995); 28 U.S.C. §§ 144,
455(a).
Mason fails to identify any evidence in the record that even
remotely suggests that the district court was biased against him.
In fact, as the court's opinion makes clear, the court thoroughly
and conscientiously considered Mason's arguments in this matter.
Mason contends, however, that the district court judge lacked
impartiality because he "was proposed, endorsed, and appointed by
members of the same party that proposed, endorsed, and enacted
the defendant FDA." Appellant's Brief at 28. This accusation, of
course, is patently absurd. Under Mason's theory of bias, no
judge appointed by the current administration would be able to
preside over any cases involving the government, a result clearly
not contemplated or called for by the relevant statutory
provisions. See 21 U.S.C. §§
144 & 455; cf. United States v. Gordon, 974 F.2d 1110, 1114 (9th
Cir. 1992) (finding no reason to believe judge would be biased in
case arising from threats toward former president where judge had
been appointed by that president).
In any event, Mason failed to seek the judge's recusal during
the proceedings below. See 28 U.S.C.
§ 144 (requiring a "timely and sufficient affidavit" to be
filed with the judge before whom the matter is pending);
United States v. Azhocar, 581 F.2d 735
(9th Cir.1978), cert. denied,, 440 U.S. 907. Under the circumstances,
Mason's argument must be rejected.
CONCLUSION
For the foregoing reasons, the judgment of the district court
should be affirmed.
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Respectfully submitted, |
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DAVID W. OGDEN
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Acting Assistant Attorney General
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EUGENE M. THIROLE
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Director
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Office of Consumer Litigation
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OF COUNSEL:
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MARGARET JANE PORTER
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Chief Counsel
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ANDREW E. CLARK
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KEVIN M. FAIN
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Attorney
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Associate Chief Counsel
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Office of Consumer Litigation
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Food and Drug Administration
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U.S. Department of Justice
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5600 Fishers Lane
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P.O. Box 386
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Rockville, MD
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20857 Washington, D.C. 20044
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(301) 827-1147
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(202) 307-0067
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FOOTNOTES
1/ Although Mason's
complaint names former Acting Commissioner Michael Friedman as a
defendant, Dr. Friedman no longer holds that position. Jane E.
Henney was appointed Commissioner of Food and Drugs after this
action was commenced. Accordingly, pursuant to Fed. R. Civ. P. 25
(d) (1) and Fed. R. App. Proc. 43 (c) (2), Comissioner Henney, in
her official capacity, has been substituted for former Acting
Commissioner Friedman as a defendant/appellee.
2/Pursuant to Ninth
Circuit Rule 28-2.8, references to matters in the record include,
where applicable, citations to the corresponding page of the
Excerpts of Record ("ER") filed by appellant or the Supplemental
Excerpts of Record ("SER") filed herewith by appellees.
3/ Mason also requested
a general declaratory judgment (Claim One); a jury trial (Claim
Two); a declaratory judgment that FDA had violated the Code of
Ethics of Government Service, 21 C.F.R. § 19.6 (1), (2) and
45 C.F.R. § 73.735-1302, and FDA's mission statement (Claim
Four); a declaratory judgment that FDA must immediately
promulgate an emergency minimum standard of magnesium content for
bottled water (Claim Six); a declaratory judgment that FDA must
bear the burden of proof that magnesium-free water, purified by
deionization, distillation, or other, is as healthy and as
life-sustaining as hard, magnesium-rich water (Claim Seven); and
a declaratory judgment that FI)A must immediately make public
statements announcing that magnesium deficiency is widespread in
the U.S. and that the most bio-available source of magnesium is
magnesium-rich hard waters (Claim Right). Amended Complaint (SER
69-71).
4/ Food that is served
in restaurants or other establishments in which food is served
for immediate human consumption or that is sold for sale or use
in such establishments, is exempt from these requirements,
provided no nutrition claims are made. 21 U.S.C. § 343 (q)
(5) (A) (i).
5/ The use of the
phrases "high," "rich in," or "excellent source of" a nutrient on
a food's label are examples of nutrient content claims. 21 C.F.R.
§ 101-54 (b).
6/ The specification on
a food's label of the relationship between fiber-containing grain
products, fruits and vegetables and cancer, is an example of a
health claim. See 21 C.F.R.
7/ Prior to filing his
citizens petitions, Mason sent FDA a steady stream of letters and
faxes on the topic of magnesium. AR, Vol. 111, pp. 671, 673, 705,
706-18, 753-69, 771-73, 774-86, 787-99, 800-06, 807-17. FDA
responded to Mason's correspondence in a thorough letter dated
March 25, 1994. AR, Vol. VII, pp. 1188-1195 (SER 1-8). FDA also
responded on October 4, 1995, to correspondence that Mason had
sent to First Lady Hillary Clinton concerning this topic. AR,
Vol. VII, pp. 1196-97 (SER 39-40).
8/ Mason contended that
the removal of magnesium from the water caused it to be
adulterated under 21 U.S.C. § 342 (b) (i) because a valuable
constituent has been in whole or in part omitted or abstracted
therefrom." Amended Complaint ¶ 19 (SER 63-64).
9/ An agency's
interpretation of its own regulations is likewise "entitled to a
high degree of deference and should be upheld as long as it is
not plainly erroneous or inconsistent with the language of the
regulation." Jacobsen v. U.S. Postal
Service, 993 F.2d 649 (9th Cir. 1993) (quoting
Stone Forest Indust. V. Robertson, 936
F.2d 1072, 1074 (9th Cir. 1991)); see
also Department of
Health and Human Services v. Chater, 163 F.3d 1129,
1133-35 (9th Cir. 1998); City & County of
San Francisco v. United States, 130. 3d 873, 880 (9th Cir.
1997); Inland Empire Public Lands Council v.
U.S. Forest Service, 88 F.3d 754, 760 (9th Cir. 1996).
10/As noted above, the
RDI for magnesium is 400 milligrams. 21 C.F.R. § 101.9 (c)
(6) (iv) . In order to be labeled as a "a good source" of
magnesium, therefore, a food or beverage would have to supply at
least 40 milligrams of magnesium in a single serving, thus
providing ten percent of the recommended daily intake.
11/ Even if this
argument were properly before the Court, it is unavailing. Mason,
in essence, seeks to include on the nutrition facts panel of his
water additional information that is not contemplated by the FDC
Act. Nothing in the statute authorizes a food label to list
nutrient information in the alternative, based upon the
contribution to RDI of varying serving sizes of the food.
See 21 U.S.C. § 343 (q) (1) (C),
(D), and (E). Indeed, Mason's proposal is completely inconsistent
with the underlying statutory goal of ensuring clarity and
uniformity in the nutritional information listed on food labels.
In any event, as noted above, Mason has failed to demonstrate
that the agency's labeling regulations are unreasonable in any
respect.
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