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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.

  Respectfully submitted,

 

DAVID W. OGDEN

 

Acting Assistant Attorney General

 

EUGENE M. THIROLE

 

Director

 

Office of Consumer Litigation

OF COUNSEL:

 

 

 

MARGARET JANE PORTER

 

Chief Counsel

 

 

 

 

ANDREW E. CLARK

KEVIN M. FAIN

Attorney

Associate Chief Counsel

Office of Consumer Litigation

Food and Drug Administration

U.S. Department of Justice

5600 Fishers Lane

P.O. Box 386

Rockville, MD

20857 Washington, D.C. 20044

(301) 827-1147

(202) 307-0067

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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