Full opinion text
OPINION AND ORDER RE: REPORT AND RECOMMENDATION OF MAGISTRATE JUDGE; INJUNCTIVE RELIEF AND DISGORGEMENT SPATT, District Judge: Before the Court are the objections of the defendant Nature’s Bounty, Inc. (“Nature’s Bounty” or “defendant”) to the Report and Recommendation of United States Magistrate Judge Allyne R. Ross — now a United States District Judge in this district — dated September 23, 1994 (“Report”), regarding the defendant’s nasally administered vitamin B-12 preparation called Ener-B Nasal Gel (“Ener-B”). This Court referred to Judge Ross the issue of whether Ener-B is a “food” or a “drug” within the meaning given to these terms by the Federal Food, Drug and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. §§ 301-395 (1988 & Supp. V 1993) (unless otherwise indicated, all citations to the U.S.C. are to the 1988 edition and 1993 volume supplement). Judge Ross found that the Food and Drug Administration (“FDA”) reasonably determined that Ener-B was a drug and not a “food” within the meaning of sections 201(f) and 201(g)(1)(C) of the Act, 21 U.S.C. §§ 321(f) and 321(g)(1)(C), and recommended that the Court defer to the agency’s determination. Her well-reasoned and thorough Report merits publication and is appended at the end of this opinion. BACKGROUND The defendant markets Ener-B, which is intended to be applied to the inside of one’s nose. As intended to be used, the vitamin B-12 contained in Ener-B bypasses digestion through the gastrointestinal tract, where it would be absorbed into the body through the intestines. Instead, Ener-B’s vitamin B-12 is absorbed directly into the blood stream through the nasal mucosa. On February 26, 1987, the FDA notified Nature’s Bounty that the FDA considered Ener-B to be a “drug” under the FDCA, and that Ener-B was being marketed illegally because it had not received recognition or approval as a “new drug” under the Act. The FDA also alleged that Ener-B was misbranded and improperly labelled under the Act. The FDA’s notice informed Nature’s Bounty that the Act provided for the seizure of illegal products, and for an injunction against the distributor of such products. Nature’s Bounty responded to the FDA’s letter, and on April 2, 1987 filed a Citizen Petition with the FDA pursuant to 21 C.F.R. § 10.30 (1994). In its petition Nature’s Bounty essentially contended that Ener-B was a dietary supplement which was considered a “food” under the Act, and Ener-B’s route of administration into the body bypassing digestion through the gastrointestinal tract did not reconstitute it as a “drug” under the Act. The petition requested (i) that the FDA establish and make public its policy regarding whether the method of ingestion of a substance otherwise classified as a food may make it a drug under the Act; (ii) promulgate a rule or guideline subject to notice and comment with respect to its policy; and (iii) refrain from taking any administrative or enforcement action against Ener-B in the absence of any policy delineated by a rule or guideline. On May 24, 1988, the FDA denied Nature’s Bounty’s petition. As described in greater detail later in this Opinion, the FDA explained its denial on the grounds that it considered Ener-B to be a “drug” within the meaning of the Act because Ener-B affected the structure of the human body, and that Ener-B could not be a “food” within the meaning of the relevant statutory section because it was not ingested — namely, it was not enterally administered into the gastrointestinal tract. Subsequent to the denial of Nature’s Bounty’s Citizen Petition, the United States (“Government” or “plaintiff’), on behalf of the FDA, instituted an in rem proceeding against Ener-B pursuant to 21 U.S.C. § 334 on September 28, 1988, and seized ten cartons of Ener-B from Nature’s Bounty. Approximately eighteen months later, on May 11, 1990, the Government brought a second action against Nature’s Bounty in personam, pursuant to 21 U.S.C. § 332(a), seeking to permanently enjoin Nature’s Bounty from selling Ener-B. In October of 1991 the Government moved for summary judgment in its favor on the complaints in both of these cases. Relying on the depositions and declarations of two FDA scientists, the Government expounded on the rationale for denying Nature’s Bounty’s Citizen Petition and contended that Ener-B is a drug within the scope of 21 U.S.C. § 321(g)(1)(C) because it is labelled and marketed as a product which “affects the structure or function of the body.” That section defines the term “drug” as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The Government also contended that Ener-B cannot be a “food” within the meaning of the parenthetical exception “(other than food)” found in section 321(g)(1)(C), because the phrase “other than food” is, according to the Government, construed to mean food in the conventional sense; namely, articles which are ingested through the mouth for the primary purposes of nutrition, taste or aroma, and^*which are absorbed into the body through the gastrointestinal tract. According to the Government, a vitamin nasal gel by which the vitamins are absorbed into the blood stream through the nasal mucosa hardly fits the conventional meaning of the term “food.” In addition, the Government contended that Ener-B is a drug within the meaning of 21 U.S.C. § 321(g)(1)(B), in-so-far as the defendant’s labelling and promotional material claimed that Ener-B mitigates the effects of several medical conditions, including lack of the “intrinsic factor,” a substance produced by the stomach which is required for the absorption of vitamin B-12. Section 321(g)(1)(B) defines the term “drug” as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” In opposing the Government’s motion, the defendant submitted the declarations of seven experts, including medical doctors, attesting to the fact that Ener-B is a food, as well as the declaration of the Executive Vice-President of Nature’s Bounty attesting to the company’s marketing practices. Essentially, the defendant contended that Ener-B is a food because it functions as a “food for special dietary use” within the meaning of section 411 of the FDCA, 21 U.S.C. § 350, which is the section governing the regulation of vitamins and minerals. As written prior to its amendment in 1994, section 350 provides that, subject to certain exceptions not relevant here, the FDA may not (1) establish maximum limits on the potency of vitamins or minerals, (2) classify any vitamin or mineral as a drug solely on the basis that it exceeds a level of potency which the FDA determines is nutritionally rational or useful, or (3) limit the combination or number of any vitamin, mineral or other ingredient of food. Section 350 further provides that these proscriptions apply to “a food to which this section applies.” See 21 U.S.C. § 350(a). At the time of the Government’s summary judgment motion, the statute defined “a food to which this section applies” as follows: For purposes of this section, the term “food to which this section applies” means a food for humans which is a food for special dietary use— (A) which is or contains any natural or synthetic vitamin or mineral, and (B) which— (i) is intended for ingestion in tablet, capsule, or liquid form, or (ii) if not intended for ingestion in such a form, does not simulate and is not represented as conventional food and is not represented for use as a sole item of a meal or of a diet. 21 U.S.C. § 350(e)(1). The October, 1994 amendment of the statute is discussed in greater detail later in this Opinion. According to Nature’s Bounty, Ener-B met the definition of a “food to which [section 350] applies,” because it is a “food for special dietary use” which contains a vitamin that is not intended for ingestion, and does not simulate or represent itself to be a conventional food or the sole item of a meal or of a diet. Moreover, Nature’s Bounty contended that because Ener-B is a “food for special dietary use,” Ener-B also met the statutory definition of “food” in 21 U.S.C. § 321(f). Section 321(f) provides that the term “food” means “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” In addition, Nature’s Bounty contended that nowhere in the FDCA is the classification of a product as a food or a drug dependent on its route of administration or place of absorption. Rather, the defendant contended that the function of Ener-B as a “food for special dietary use,” and not its route of absorption into the body, is the relevant factor for determining whether or not Ener-B is a food under the meaning given to that term by the Act. Finally, Nature’s Bounty contended that it had been arbitrarily and capriciously discriminated against by the Government, because manufacturers of other vitamin B-12 tablets that allegedly also are not ingested, such as “sublinguals” absorbed under the tongue, were not subject to the Government’s enforcement efforts. On October 9, 1991 this Court issued its decision denying the plaintiffs motion for summary judgment. The Court’s Memorandum Decision and Order is reported at 1991 WL 641573, 1991 U.S.Dist. LEXIS 14872 (E.D.N.Y.1991) (“Decision”). After considering the contentions of both parties, the Court found that, in view of the contradictory affidavits of the parties’ experts, there were genuine material issues of fact regarding the nature of Ener-B which precluded granting summary judgment. Noting that in analogous circumstances the United States Court of Appeals for the Second Circuit had remanded cases involving the interpretation of the term “drug” under the FDCA for a hearing to be conducted that would enhance the record, the Court referred the matter of whether Ener-B was a “drug” or “food” under the Act to Judge Ross for a hearing and report and recommendation. The hearing was to include the testimony of expert witnesses, if offered. FINDINGS AND CONCLUSIONS BY JUDGE ROSS Judge Ross conducted a five-day evidentiary hearing, which took place on June 16-18, 1993, and July 6 and 7, 1993. Seven expert witnesses were called, three by the Government and four by the defendant. Judge Ross found that the credible expert testimony offered at the hearing, by both the Government’s and the defendant’s experts, strongly supported the conclusion that the common sense and scientific definitions of “food” entail two elements: (i) nutrient intake, and (ii) ingestion into the gastrointestinal tract of such nutrients, also known as enteral administration of nutrients. According to Judge Ross, ingestion into the gastrointestinal tract was viewed as a necessary element of a food by the medical and scientific communities: [The] common sense and scientific definitions of “food ... for man” that incorporate as a necessary element ingestion into the gastrointestinal tract are both reasonable and accepted by a substantial segment of the medical and scientific community. As evidenced by certain defense expert definitions, other respectable segments of the scientific community apparently adopt a more expansive definition that includes parenterally administered nutrients as well. This showing, however, does not impeach the evidence that a definition requiring enteral administration is reasonable and is also well accepted by credible scientists. Report at 9-10. Indeed, to highlight the point Judge Ross cited to the testimony of the defendant’s expert Dr. Raymond R. Brown, retired Professor Emeritus at the University of Wisconsin Medical School, who acknowledged in his testimony that “whether Ener-B is drug is a question as to which reasonable scientists could reasonably disagree.” Report at 12, 27 (citing Tr. at 545). Judge Ross also found that the Government adduced substantial evidence through learned treatises and expert testimony regarding the different physiologies of the digestive and respiratory systems, including the mechanisms present in the gastrointestinal tract for the transport, storage and absorption of nutrients. This evidence was not disputed by the defendant’s experts. According to Judge Ross, the experts also agreed “virtually unanimously” that the mucosa lining the nasal cavity are functionally dissimilar to the membranes lining the gastrointestinal tract. As a result of this difference, Judge Ross found that both parties’ experts acknowledged (1) “that parenteral administration bypasses the normal physiological safety mechanisms present in the gastrointestinal tract,” and (2) that the route of exposure to the nutrients, namely whether absorption occurs through the nasal mucosa or through ingestion, has an impact on toxicity. Report at 11-12. Based on these findings, Judge Ross concluded that the agency’s determination that Ener-B is not a food based on its route of administration into the body is reasonable, and in accord with the Second Circuit’s interpretation of the term “food” in the parenthetical exception to section 321(g)(1)(C); namely, that Congress intended the term to have “the everyday meaning of food.” Report at 25 (citing American Health Products v. Hayes, 574 F.Supp. 1498, 1504 (S.D.N.Y. 1983) (construing the term “food” in the parenthetical exception to section 321(g)(1)(C) as having been intended by Congress to refer to its “common usage”), aff'd, 744 F.2d 912 (2d Cir.1984)). Moreover, Judge Ross concluded that the agency’s determination regarding Ener-B is consistent with the FDA’s prior actions categorizing parenterally administered nutrients as non-foods under the Act. Judge Ross supported this conclusion by pointing to (i) the October, 1981 FDA Vitamin/Mineral Task Force’s Conclusions and Recommendations regarding the regulation of orally ingested vitamin preparations, which recommended that all ingested vitamin/mineral products be regulated as foods, while injectable or topical vitamin/mineral preparations be regulated as drugs, (ii) the agency’s regulation of injectable vitamins as drugs, see 49 Fed.Reg. 36446, 36448 (1984), (iii) the FDA’s Aminoplex Notice, see 52 Fed.Reg. 25072-75 (1987), which stated that amino acids, vitamins and other nutrients intended as injections “have been regarded as drugs by the medical profession, by FDA, and by the regulated industry for more than 40 years,” and (iv) the FDA’s May 24, 1984 response to the defendant’s Citizen Petition, which stated that “[t]he Agency has consistently regulated vitamin and mineral parenteral and topically-administered nutritive products as drugs,” and “[t]he standard the Agency applies for classification of vitamin, mineral or other dietary products is the route of administration.” According to Judge Ross: “no evidence disputes that route of administration has been a criterion consistently invoked by the agency in determining whether the Act requires regulation of a product as a food or a drug.” Report at 25. With regard to the defendant’s contention that Ener-B was a “food for special dietary use” under the Vitamins and Minerals section of the FDA, Judge Ross concluded that the contention was untenable because that section applies to “food for humans which is a food for special dietary use.” See 21 U.S.C. § 350(c)(1). Interpreting the statute as requiring that the vitamin or mineral must first be a “food for humans” within the meaning of section 321(f)(1) before it can be subject to section 350(e)’s provisions as a “food for special dietary use,” Judge Ross determined that Ener-B was unqualified as a food for special dietary use, because it was not a “food” within the meaning of section 321(f)(1). Report at 29-30. In addition, Judge Ross concluded that the defendant’s construction of section 350(c)(l)(B)(ii) was erroneous. As mentioned earlier, section 350(c)(1)(B) provides that a food for special dietary use must “(i) [be] intended for ingestion in tablet, capsule, or liquid form, or (ii) if not intended for ingestion in such a form, does not simulate and is not represented as conventional food ... [or] for use as a sole item of a meal or of a diet.” Nature’s Bounty contended that Ener-B is a “food for special dietary use” because under section 350(c)(l)(B)(ii) it is “not intended for ingestion.” Judge Ross determined that the defendant’s construction did not accord with the language of section 350(c)(l)(B)(ii), because the defendant selectively interpreted the statute by neglecting the words “in such form” at the end of the phrase “is not intended for ingestion in such form.” According to Judge Ross, the words “in such form” are properly interpreted as referring to the forms of ingestion specified in the previous section of the statute, 350(c)(l)(B)(i), namely “tablet, capsule or liquid form.” Thus, Judge Ross interpreted the language of section 350(c)(l)(B)(ii) as supporting the FDA’s contention that Ener-B was not a “food,” since the forms of ingestion specified in the statute involve enteral administration of the vitamin by swallowing. In further support of this construction of section 350(e)(l)(B)(ii), Judge Ross cited to the legislative history of the section, which expressly stated that section 350 prohibited the FDA from regulating oral preparations of vitamins or minerals. Report at 31. Finally, Judge Ross determined that there was no merit to Nature’s Bounty’s discrimination claim based on the allegations that the FDA has failed to regulate sublingual tablets as drugs, and has failed to undertake enforcement actions against manufacturer’s of sublingual vitamins. According to Judge Ross: There is no evidence in the record suggesting that the FDA has affirmatively adopted [an] inconsistent approach to the regulation of sublinguals and Ener-B. Indeed, while it is true that no enforcement action has as yet been taken against sublinguals, the FDA has never taken the position that sublingual tablets are foods. Report at 33. Based on her findings and conclusions, Judge Ross recommended that this Court (1) defer to the agency’s determination that Ener-B is an unapproved “new drug” pursuant to 21 U.S.C. § 321(p), (2) that as such, Ener-B is subject to condemnation under 21 U.S.C. § 334, and (3) that Nature’s Bounty be permanently enjoined from selling EnerB, pursuant to 21 U.S.C. § 332. Report at 34. NATURE’S BOUNTY’S OBJECTIONS In response to Judge Ross’s Report, Nature’s Bounty filed its Objections to the Report and Recommendation of Judge Ross (“Objections”) contending that Judge Ross erred both legally and factually. Oral argument was heard on the Objections on March 10, 1995. Nature’s Bounty first objects that Judge Ross did not follow this Court’s directions, but “merely abstracted” from the record those portions of the testimony which supported the plaintiffs claims. Moreover, Nature’s Bounty contends that Judge Ross failed to report to the Court the “extensive expert testimony” that supported classifying Ener-B as a food. The defendant further objects that Judge Ross directly contravened this Court’s October 9, 1991 Decision, by holding that the defendant’s intent to sell Ener-B as a food for special dietary use is irrelevant in determining the classification of Ener-B as a food or drug. In addition to the above, Nature’s Bounty also makes the following objections: 1. The Report and Recommendation is based on Judge Ross’s fragmented reading of the statutory definition of food under section 321(f), resulting in erroneous legal and factual determinations; 2. The FDA’s determination that the statutory definition of “food” must be defined by its common sense use is contrary to the language of the statute, irrational and arbitrary, and deference to the Agency in this case is not warranted; 3. Judge Ross’s construction of the statutory definition of “food” would alter the meaning of the term “food” such that food supplements in unusual forms, such as tablets or capsules, would no longer meet the definition of food under the Act. This result would be contrary to congressional intent, and directly at odds with the FDA’s regulation of other unusual methods of administration, such as tubes and sublinguals, as foods; 4. Judge Ross ignored testimony and evidence which conclusively demonstrated that Ener-B is intended to deliver vitamin B-12 for nutritive value, and that the vitamin B-12 supplied by Ener-B functions in every way the same as vitamin B-12 obtained from any other food source; 5. Judge Ross improperly based her recommendation on alleged safety concerns; 6. The Government altered its litigation position since this Court’s denial of its summary judgment motion, and Judge Ross based her conclusions on “pure post hoe rationalizations invented” by the Government; 7. The prior agency actions relied upon by Judge Ross as indicative of a consistent FDA policy to not regulate products parenterally administering nutrients as foods are irrelevant, because the agency’s actions in these cases were not based on route of administration of the product; 8. Judge Ross erred in determining that the Government did not discriminate against Nature’s Bounty, and the fact that FDA has not taken any enforcement action against sublinguals supports the defendant’s contention that the FDA treats sublinguals as food. 9. Judge Ross erred in three evidentiary rulings. These rulings concerned a motion by Nature’s Bounty to supplement the record, and two requests by the defendant to, respectively, call all of its experts to testify and introduce a report into evidence. After Nature’s Bounty filed its Objections, Congress enacted the Dietary Supplement Health and Education Act of 1994, Pub.L. No. 103-417, 1994 U.S.C.C.A.N. (108 Stat.) 4325 (codified at various sections of 21 U.S.C. § 301-395 and 42 U.S.C. §§ 281(b)(2) and 287c-3) (enacted on October 25,1994, hereinafter “DSHEA”). The DSHEA, among other things, amends the FDCA by providing that subject to certain exceptions, products defined as “dietary supplements,” which include vitamins, minerals, amino acids and herbs, are a “food” and are not to be classified as a “drug” under section 321(g)(1) solely because of any statements on the products’ labelling regarding claims to alleviating a nutritional deficiency or disease. See DSHEA §§ 3, 10 (defining a “dietary supplement” and amending 21 U.S.C. § 321(g)(1); respectively codified at 21 U.S.C.A. §§ 321(ff) and 321(g)(1) (West Supp.1994)). Significantly, the DSHEA also amends section 350(c)(1)(B) by adding the words “powder, softgel, and gelcap” after “capsule” in section 350(c)(l)(B)(i). See DSHEA § 3(c) (codified at 21 U.S.C.A. § 350(c)(l)(B)(i) (West Supp.1994)). Nature’s Bounty contends that the DSHEA substantially affects the posture of this ease, because the DSHEA has established a new class of products called “dietary-supplements” which are defined as foods and are allegedly excluded from regulation as a drug under section 321(g)(1)(C). According to the defendant, all of the testimony and evidence presented by the Government before Judge Ross to support its contention that Ener-B is not a food is “now moot.” Indeed, the defendant contends that the debate over the “food” exemption under section 321(g)(1)(C) is “totally irrelevant” in light of the DSHEA, and that the Court should disregard Judge Ross’s Report as well as the parties’ objections and response papers. Instead, Nature’s Bounty claims that the Court should focus on whether Ener-B is exempt from regulation as a “drug,” because it is a “dietary supplement” under the DSHEA that is subject to an entirely new statutory-regulatory framework. The Court will consider the defendant’s objections to Judge Ross’s Report, and its contentions regarding the affect of the DSHEA on this case, after reviewing the applicable standard governing review of this matter. DISCUSSION Applicable Standard of Review According to the statutory provisions governing the powers of a United States Magistrate Judge, a district judge may designate a magistrate judge to hear and determine any pre-trial matter pending before the court, except certain dispositive matters that include a motion for summary judgment. See 28 U.S.C. § 636(b)(1)(A). In cases involving these latter-kind matters that are excepted from a hearing and determination by the magistrate judge, the district court may designate the magistrate judge to conduct an evidentiary hearing on the matter, and to submit proposed findings of fact and recommendations to the district court. 28 U.S.C. § 636(b)(1)(B). The statute requires that with respect to such proposed findings and recommendations, the district court “shall make a de novo determination of those portions of the report or specified proposed findings or recommendations to which objection is made,” and that the court “may accept, reject, or modify, in whole or in part, the findings or recommendations made by the magistrate.” See 28 U.S.C. § 636(b)(1)(C). In order to make a sufficient de novo determination under the statute, the district court must conduct an independent review of all objections and responses to the magistrate’s findings and recommendations. See, e.g., United States v. Tortora, 30 F.3d 334, 337 (2d Cir.1994); Bristol-Myers Squibb Co. v. McNeil-P.P.C., Inc., 973 F.2d 1033, 1045 (2d Cir.1992). By using the phrase de novo determination, however, rather than de novo hearing, Congress intended “ ‘to permit whatever reliance a district judge, in the exercise of sound judicial discretion, chose to place on a magistrate’s proposed findings and recommendations.’ ” Grassia v. Scully, 892 F.2d 16, 19 (2d Cir.1989) (quoting United States v. Raddatz, 447 U.S. 667, 676, 100 S.Ct. 2406, 2412, 65 L.Ed.2d 424 (1980)). Thus, the statute does not require the district court to rehear the contested testimony in order to make its determination. Grassia, 892 F.2d at 19 (citing Raddatz, 447 U.S. at 674, 100 S.Ct. at 2411). 1. Construction of the Statutory Provision at Issue. The relevant statutory provision at issue is the meaning of the term “food” set forth in the parenthetical exception “(other than food)” in section 321(g)(1)(C). That meaning, in turn, is provided by the definition of “food” in section 321(f)(1), which states “food” is: “articles used for food or drink for man or other animals.” According to Nature’s Bounty, rather than considering whether Ener-B comes within the ambit of the entire relevant definition of “food,” namely whether Ener-B is an “article[ ] used for food ... for man,” Judge Ross erroneously formulated the issue to be determined by focusing her inquiry on the latter part of the definition at issue, that is, whether Ener-B is “food ... for man.” As a result, Nature’s Bounty objects to Judge Ross’s Report because it is allegedly premised on neglecting “key elements” of the statutory definition of food, specifically the phrase “used for food.” The Court disagrees with the defendant’s objection for two reasons. First, in the Court’s view, whether one concentrates on the phrase “used for food ... for man” or on the phrase “food ... for man,” the object of the statutory construction is the same; namely, determining what is denoted by the word “food.” In this regard, the meaning of the term “food” in the parenthetical exclusion of section 321(g)(1)(C) and in section 321(f)(1) has been construed to refer to that term’s “everyday meaning,” and a particular article’s “common usage” as food. See American Health Products Co., Inc. v. Hayes, 574 F.Supp. 1498, 1504-05, 1508 (S.D.N.Y.1983) (“The ordinary way in which an article is used ... should determine whether it is a food for the purpose of the parenthetical exclusion of section 321(g)(1)(C).”), aff'd, 744 F.2d 912 (2d Cir.1984), and Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 337-338 (7th Cir.1983) (the term “food” in section 321(f)(1) is to be defined in terms of its function, and means “articles used by people in the ordinary way most people use food — primarily for taste, aroma or nutritive value.”). Moreover, the common-use meaning given to the term “food” in the parenthetical exclusion of section 321(g)(1)(C) and in section 321(f)(1) is more circumscribed and not identical to the statutory meaning of “food” under section 321(f). See Am. Health Prods., 574 F.Supp. at 1504 (“[T]he meaning of the term “food” for purposes of the parenthetical exclusion and its technical statutory meaning for purposes of the coverage of the food provisions cannot be identical.”). Judge Ross appropriately relied on this interpretation of the phrase “used for food ... for man” to reach her own conclusions and recommendations. See Report at 25-26. Thus, the Court believes that Judge Ross did not completely neglect to consider the phrase “used for food,” and did not commit any error in arriving at her recommendation based upon a definition of “food” by reference to the everyday meaning of the word. Second, and more significant, the Court believes that Judge Ross properly concentrated on construing the term “food” by focusing on its context in the phrase “food ... for man” rather than “use for food.” The pivotal and novel issue presented in this case is not so much whether Ener-B is a food, as it is whether the FDA may consider the route of administration of a product in determining its classification as a food or a drug under the Act. Given that the definition of a food in section 321(f)(1) already entails consideration of the functional, everyday-use aspect of food, see Am. Health Prods., 574 F.Supp. at 1505, emphasis on the human — “for man” — aspect of the “use of food” seems appropriate and rational when determining whether the route of administration can be a factor in classification. Indeed, with regard to humans it is the Court’s view that the route of administration cannot be ignored when considering the everyday, common use aspect of a particular article as food. The Court further believes that by contending Ener-B is a “food” because it is “used for food,” the defendant has lost sight of the real issue in this case. Nature’s Bounty’s syllogism is as follows: the phrase in the statute “used for food” means using a product to introduce nutritive substances into the body; vitamin B-12 is an essential nutrient for humans and is used for food; Ener-B provides vitamin B-12 for the body; Ener-B, therefore, meets the statutory definition of food because it is “an article used for food” for man. The problem with this reasoning is that it presumes to answer the very question at issue by substituting the “article” Ener-B for the “food” vitamin B-12. As explained above, the phrase “used for food for man” in section 321(f)(1) is interpreted by the everyday meaning and common usage of the term food. Although vitamin B-12 may commonly be used as a food, gels containing vitamin B-12 that are administered through the nose hardly meet the every day definition of food and are not commonly used as food, anymore than an enema containing vitamin B-12 meets the everyday definition of food. The defendant also misconstrues the pertinent case law and this Court’s October 9, 1991 Decision by contending that the key in determining whether a product is a food or a drug is the vendor’s intent. The vendor’s intent is a key .element only with respect to the statutory definition of a drug under sections 321(g)(1)(B) and 321(g)(1)(C). See Nat’l Nutritional Foods Ass’n v. Mathews, 557 F.2d 325, 333 (2d Cir.1977) (the vendors’ intent in selling the product to the public is the key element in the definition of a “drag” under section 321(g)(1)(B)). That is not the case, however, with regard to determining whether a product is a food. As the court in American Health Products stated: The ordinary way in which an article is used, therefore, not any marketing claim on the part of the manufacturer or distributer as to specific physiological purpose of that use, should determine whether it is a food for the purpose of the parenthetical exclusion of section 321(g)(1)(C). Am. Health Prod., 574 F.Supp. at 1505. Accord Nutrilab, 713 F.2d at 337 (“Defining food as articles intended by the manufacturer to be used as food is problematic,” and noting that the definition of food in section 321(f) omits any reference to intent.). This Court’s statement in its October 9, 1991 Decision that “where the substance in question is not recognized in official pharmacopoeia, ‘the vendor’s intent in selling the product to the public is the key element in this statutory definition,’ ” 1991 WL 641573, at *9, 1991 U.S.Dist. Lexis 14872 at *23 (quoting Mathews, 557 F.2d at 333), is not to the contrary. In its Decision, the Court was referring to a vendor’s intent with regard to the definition of a drag, not of a food. Moreover, the Court notes that although the vendor may not intend to sell an item as a drag, the product may still be regulated as such. See, e.g., Mathews, 557 F.2d at 334 (the FDA is not bound by the manufacturer’s subjective claims of intent, and can classify an article as a drag based on objective evidence of therapeutic intent). Accordingly, Judge Ross properly formulated the statutory issue to be construed, and did not err or contravene this Court’s September 29, 1991 Decision by discounting the defendant’s proclaimed intent that Ener-B is a food because it is to be used for its nutritional value. 2. Ener-B is Neither a Food to Which Section 350 Applies, nor a Dietary Supplement under the DSHEA. In 1976, Congress amended the FDCA by enacting section 411 of the Act, 21 U.S.C. § 350, governing the regulation of vitamins and minerals. See Pub.L. 94-278, § 501(a), 90 Stat. 410 (1976), commonly known as the Proxmire Amendments. The underlying purpose of this amendment involves the promotion of concentrated vitamins to help supplement peoples’ diets. Basically, section 350 precludes the FDA from regulating a vitamin or mineral solely on the basis of its potency or combination with another vitamin or mineral. The provisions of section 350 apply to certain vitamins or minerals which meet the definition in section 350(c) of a “food to which [section 350] applies.” Up until the enactment of the DSHEA, Nature’s Bounty contended that Ener-B met the criteria set forth in section 350(c) of a “food to which [section 350] applies.”' In order to further facilitate the use of vitamins and minerals to combat nutritional deficiencies and disease, portions of the FDCA, including section 350, were amended by the DSHEA in October, 1994. The basic purpose of the DSHEA amendments to the FDCA is to ensure that the public has over-the-counter access to “dietary supplements,” which include vitamins, minerals, amino acids and herbs. In order to accomplish this, the DSHEA precludes the FDA from regulating “dietary supplements” as a “drag” under section 321(g)(1)(C) solely because of any statements on the products’ labelling regarding claims that the product can treat or affect a nutritional deficiency or disease, unless the FDA determines that the product is not safe. Following the enactment of the DSHEA amendments to sections 321(g) and 350, Nature’s Bounty now contends that Ener-B is a “dietary supplement” as that term is defined in the DSHEA, and as such is excluded from regulation as a drag under the FDCA. The Court disagrees -with both of Nature’s Bounty’s contentions, and believes that Ener-B is neither a food to which section 350 applies, nor a dietary supplement under the DSHEA. A. Ener-B is Not a Food to which Section 350 Applies. In order to be excluded from regulation as a “drag” under the provisions of sections 350(a) and (b) — in other words, in order to be a “food to which this [section 350] applies” — , a product must, under the definition of that phrase in section 350(c) prior to the DSHEA amendments, be a “food for humans which is a food for special dietary use” which (A) is a vitamin or mineral, and (B) “which is (i) intended for ingestion in tablet, capsule, or liquid form, or (ii) if not intended for ingestion in such a form, does not simulate and is not represented as conventional food ... [or] for use as a sole item of a meal or of a diet.” As explained earlier, Nature’s Bounty contends that Ener-B meets the definition of a “food to which [section 350] applies,” because Ener-B is a food for special dietary use which is a vitamin, and which, according to the defendant, is “not intended for ingestion” within the meaning of section 350(c)(l)(B)(ii). While the defendant is correct to assert that Ener-B may be used for a “special dietary use” as that term is defined in section 350(c)(3)(B), namely “to supply a vitamin for use by man to supplement his [or her] diet,” the defendant’s contention that Ener-B is subject to the protection of section 350 ultimately fails, because the remaining requirements that are necessary for Ener-B to be a “food” to which section 350 applies are not met. Specifically, under section 350(c)(1)(B) Ener-B must be “intended for ingestion” either in a tablet, capsule or liquid form, or if not in that form, than it must be “intended for ingestion” in some other form. Ener-B however, is not intended for “ingestion” as that term is meant to be used in the statute. The defendant’s construction of section 350(e)(l)(B)(ii) to apply to foods for special dietary use that are “not intended for ingestion” is erroneous, because it reads out of the statute the words “in such form.” The basic canon of statutory construction is that interpretation of the statute must “begin with the language of the statute itself.” Pennsylvania Public Welfare Dept. v. Davenport, 495 U.S. 552, 557-58, 110 S.Ct. 2126, 2130, 109 L.Ed.2d 588 (1990). The usual “assumption [is] that the legislative purpose is expressed by the ordinary meaning of the words used,” Securities Industry Ass’n. v. Bd. of Governors, 468 U.S. 137, 149, 104 S.Ct. 2979, 2986, 82 L.Ed.2d 107 (1984), and “the plain meaning of the statute’s language should control except in the ‘rare cases [in which] the literal application of a statute will produce a result demonstrably at odds with the intentions of the drafters.’ ” Samuels, Kramer & Co. v. Commissioner of Internal Revenue, 930 F.2d 975, 979 (2d Cir.) (quoting Griffin v. Oceanic Contractors, Inc., 458 U.S. 564, 571, 102 S.Ct. 3245, 3250, 73 L.Ed.2d 973 (1982)), cert. denied, 502 U.S. 957, 112 S.Ct. 416, 116 L.Ed.2d 436 (1991). If the statute is clear and unambiguous that is the end of the matter, for the court must give effect to the unambiguously expressed intent of Congress. K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 291, 108 S.Ct. 1811, 1817, 100 L.Ed.2d 313 (1988) (citations, quotations and internal quotations omitted). “In ascertaining the plain meaning of the statute, the court must look to the particular statutory language at issue, as well as the language and design of the statute as a whole.” Id. at 291, 108 S.Ct. at 1818. The ordinary and plain meaning of the term “ingestion” means to take into the stomach and gastrointestinal tract by means of enteral administration. See Stedman’s Medical Dictionary (4th Lawyer’s Ed.1976) (defining ingestion as “the introduction of food and drink into the stomach.”); Webster’s Third New International Dictionary (1976) (defining ingestion as “the taking of material (as food) into the digestive system.”). Two of Nature’s Bounty’s expert witness agreed with this definition. See testimony of Richard S. Litman, M.D., Tr. at 678 (agreeing that ingestion means to take into the gastrointestinal tract for absorption in the digestive system), and testimony of Dr. Edward James Calabrese, Tr. at 859-60 (agreeing that the standard meaning of ingestion is to take food into the gastrointestinal tract for processing and absorption). The interpretation of the term “ingestion” to mean enteral administration into the stomach and gastrointestinal tract is also supported by the language of the statutory sections immediately preceding and following section 350(e)(l)(B)(ii). Section 350(c)(l)(B)(i) states that the vitamin must be intended for ingestion in tablet, capsule or liquid form. Each of these forms denotes a method of ingestion that involves swallowing into the stomach. Section 350(c)(2) states that a food is intended for ingestion in liquid form under section 350(c)(l)(B)(i) “only if it is formulated in a fluid carrier and is intended for ingestion in daily quantities measured in drops or similar small units of measure.” This elaboration of “liquid form” also denotes ingestion by swallowing the fluid. The legislative history of section 350 further supports this interpretation of “ingestion.” As Judge Ross correctly pointed out, the Senate Report accompanying the final version of the bill that was adopted by the Conference Committee with only two technical amendments, states that section 350 “prohibits the FDA from regulating the composition of oral preparations of vitamins and minerals.” S.Rep. No. 509, 94th Cong., 1st Sess. (1975) (emphasis supplied). Finally, interpretation of “ingestion” in section 350(c)(1)(B) to mean enteral administration into the stomach and gastrointestinal tract is not antithetical to the purposes underlying section 350, which primarily concern precluding the FDA from regulating vitamins and minerals based solely on their level of potency or combination. Accordingly, the Court agrees with Judge Ross’s construction of the phrase “intended for ingestion” in section 350(c)(1)(B), and her determination that Ener-B is not a food to which section 350 applies. B. Ener-B is Not a Dietary Supplement. The DSHEA defines a “dietary supplement” in relevant part, as follows: The term “dietary supplement”— (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin (2) means a product that— (A)(i) is intended for ingestion in a form described in section 411(c)(l)(B)(i); or (ii) complies with section 411(c)(l)(B)(ii); (B) is not represented for use as a conventional food or as a sole item of a meal or the diet. Except for purposes of section 201(g) [21 U.S.C. § 321(g)], a dietary supplement shall be deemed to be a food within the meaning of this Act. DSHEA § 3(a) (codified at 21 U.S.C.A. § 321(ff) (West Supp.1994)). Further, section 3(a) of the DSHEA amends section 350(c)(1)(B) by enumerating several additional forms of ingestion applicable to the definition of a food to which section 350 applies. The amendment reads: FORM OF INGESTION. — Section 411(c)(1)(B) [21 U.S.C. § 350(c)(1)(B) ] is amended— (1) in clause (i), by inserting “powder, softgel, gelcap,” after “capsule,”; and (2) in clause (ii), by striking “does not simulate and”. As amended, the language of section 350(c)(1) that is relevant to this case now reads: [T]he term “food to which this section applies” means a food for humans which is a food for special dietary use— (A) which is [a] vitamin ..., and (B) which— (i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or (ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of a diet. 21 U.S.C.A. § 350(c)(1) (West Supp.1994). Thus, the definition of a “dietary supplement” in the DSHEA incorporates part of the definition of a “food” to which section 350 applies: namely, the part which provides that the vitamin must be a product that is (i) “intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form,” or (ii) “if not intended for ingestion in such a form, is not represented as a conventional food and is not represented for use as a sole item of a meal or of a diet.” Accordingly, Ener-B cannot be a dietary supplement because, as shown earlier, EnerB is not “intended for ingestion” and, therefore, does not meet the criteria of section 350(c)(l)(B)(i) or (ii). Nature’s Bounty’s contention that Ener-B is perforce excluded from regulation as a drug under section 321(g)(1)(C), because it is a dietary supplement that the DSHEA defines as a food not subject to regulation under section 321(g)(1)(C), is a tautology. In order to be outside the reach of section 321(g)(1)(C), Ener-B must first meet the definition of a “dietary supplement.” It does not meet the definition, and unless Ener-B falls within the parenthetical exception in the statute — which it does not — the FDA can regulate Ener-B as a drug under section 321(g)(1)(C). Indeed, contrary to Nature’s Bounty’s claims, the amendments to section 350(c)(l)(B)(ii) support the interpretation of “intended for ingestion” as referring to enteral administration into the gastrointestinal tract. The DSHEA amended section 350(c)(l)(B)(ii) by adding several more forms by which the product can be ingested: powder, softgel, and gelcap. According to the ejusdem generis maxim of statutory construction, which states that items following an enumeration of particular things are to be construed as applying to the same class as those things enumerated, see e.g., Breininger v. Sheet Metal Workers Int’l Assoc., 493 U.S. 67, 92-93, 110 S.Ct. 424, 439, 107 L.Ed.2d 388 (1989), the addition of powder, softgel, and gelcap to the forms of tablet, capsule or liquid does not indicate any intent by Congress to change the scope of “foods to which section 350 applies” by including products that are to be administered into the body parenterally. If anything, the opposite intent can be inferred, because all the items listed, tablet, capsule, powder, softgel, gelcap, and liquid form, involve a form of the product that must be enterally administered into the stomach through swallowing. Accordingly, it is the Court’s view that Ener-B is not a dietary supplement within the meaning given to that term under the DSHEA. Moreover, the Court believes that the DSHEA amendments to section 350(c)(1)(B) do not alter, but rather support, the conclusion that Ener-B is not a “food to which [section 350] applies.” 3. The FDA’s Determination that Ener-B is Not a Food is Reasonable. Nature’s Bounty contends that the FDA’s determination that Ener-B is not a food is irrational and contrary to the holdings in Nutrilab and Am. Health Prods. Essentially, Nature’s Bounty contends that (1) the ingestibility of an article was explicitly excluded by the Nutrilab court as a factor by which to determine whether a particular article is food, (2) the fact that Ener-B is not consistent with the traditional notion of a “food” does not preclude its being regulated as a food, and (3) the FDA’s determination that Ener-B is not a food in irrational and arbitrary. A. Ingestibility as a Factor. In the Court’s opinion, Nature’s Bounty misinterprets the holding of Nutrilab with regard to ingestibility. In Nutrilab, the Court considered a challenge to the FDA’s classification of starehblockers as a drug. The starehblockers at issue in that case were in tablet and capsule form and used to control weight by blocking the digestion of starch. Id., 713 F.2d at 335-36. The district court construed section 321(f)(1) to mean that articles were used for food if they were solely used for taste, aroma or nutritive value. Id. at 338. The Seventh Circuit disagreed, and held that the district court’s interpretation was unduly restrictive, since foods like prune juice and coffee could be used for reasons other than taste, aroma and nutritive value. Instead, the Seventh Circuit held that the common-sense definition of a food under section 321(f)(1) encompassed “articles used by people in the ordinary way most people use food — primarily for taste, aroma, or nutritive value.” Id. (emphasis supplied). (To these uses the Court would also add aphrodisiacal purposes). In arriving at its decision, the Seventh Circuit rejected the industry’s argument that starehblockers were food because they were derived from a food, namely kidney beans. The Seventh Circuit held that the congressional intent underlying the definition of food in section 321(f)(1) indicates that “ ‘food’ is to be defined in terms of its function as food, rather than in terms of its source, biochemical composition or ingestibility.” Id. at 337. As an example, the court stated that although caffeine and penicillin are derived from foods, they are not foods. The Nutrilab court was, thus, emphasizing that neither an article’s source nor its ingestibility can be the sole criterion for classifying it as a food. However, stating that the ingestibility of an article cannot be the sole basis for classifying it as a food does not mean that an article’s administration through a route other than ingestion cannot be a basis for determining that it is a non-food. The two propositions are exclusive. Moreover, this Court does not read the Seventh Circuit’s holding as excluding consideration of ingestibility as a junctional factor when determining whether a particular article is a food. In the Court’s view, ingestion has everything to do with the common place and everyday meaning of “food,” and it is completely rational to use non-ingestion as a factor for determining that something is not as food. The mistake Nature’s Bounty makes here is in contending that (1) the Nutrilab court’s preclusion of ingestibility as a basis for determining whether an article is a food also precludes the converse, namely that non-ingestibility can be the basis for determining that an article is not a food, and (2) ingestion has nothing to do with the functional aspects of the everyday meaning of a food. For these reasons — and especially in light of the very clear holding in Am. Health Prods, that the term “food” in the parenthetical exception of section 321(g)(1)(C) refers to the term’s common usage — Nature’s Bounty’s contention that the FDA and Judge Ross erred in determining that Ener-B is not a food because it does not meet the traditional notion of a “food,” is untenable. Equally unconvincing is the defendant’s contention that nasal administration of a vitamin is no more unusual than administration by capsules and tablets once was. Assuming that one day in the future administration of vitamins through the nose will be as common as the taking of vitamin capsules and tablets now is, the decision to expedite the process is not for the Court to make in the first instance by declaring that Ener-B is a “food.” Rather, in this very nebulous area of the law where an article can be both a food and a drug, see Mathews, 557 F.2d at 335, the Court believes that the decision is for the FDA to make in the first instance, as it is the agency containing specialized knowledge that is charged with administering the statutory provisions of the FDCA. See Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837, 844-45 & n. 14, 104 S.Ct. 2778, 2782-83 & n. 14, 81 L.Ed.2d 694 (1984) (considerable weight should be accorded to an executive department’s construction of a statutory scheme when more than ordinary knowledge respecting the matters subjected to its regulation is required to understand a given situation); Friends of Shawangunks, Inc. v. Clark, 754 F.2d 446, 449 (2d Cir.1985) (considerable deference is afforded to any reasonable interpretation of a statute by the agency charged with administering it, “especially where specialized agency understanding is involved.”); Nat’l Nutritional Ass’n v. Weinberger, 512 F.2d 688, 701-02 (2d Cir.) (protection of the public health dictates that the FDA’s interpretation of section 821(g) “be given considerable weight.”), cert. denied, 423 U.S. 827, 96 S.Ct. 44, 46 L.Ed.2d 44 (1975). B. The FDA’s Determination is Not Irrational. The statutory language in sections 321(g)(1)(C) and 321(f)(1) regarding what is meant by the term “food” is ambiguous. Moreover, Congress has not directly addressed whether a nasal gel is a food, or whether route of administration of an article affects its classification as a food or drug. Accordingly, substantial deference to the FDA’s interpretation of the statute is warranted, so long as its interpretation is based on a permissible construction of the statute: [where] the court determines [that] Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute as would be necessary in the absence of an administrative interpretation. Rather, if 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. Chevron, 467 U.S. at 843, 104 S.Ct. at 2782 (footnotes omitted). See also B.F. Goodrich Co. v. Murtha, 958 F.2d 1192, 1205 (2d Cir. 1992); Am. Health Prods., 574 F.Supp. at 1501 (the FDA’s interpretation that starch-blockers are drugs “merits substantial deference”) (citing Weinberger, 512 F.2d at 701-02). In determining whether a construction is permissible, “[t]he court need not conclude that the agency construction was the only one it permissibly could have adopted ... or even the reading the Court would have reached if the question initially had arisen in a judicial proceeding.” Chevron, 467 U.S. at 843 n. 11, 104 S.Ct. at 2782 n. 11. Rather, a permissible construction of the statute is one that “reflects a plausible construction of the plain language of the statute and does not otherwise conflict with Congresses’ expressed intent.” Rust v. Sullivan, 500 U.S. 173, 184, 111 S.Ct. 1759, 1767, 114 L.Ed.2d 233 (1991). Moreover, the court “may not substitute its own construction of a statutory provision for a reasonable interpretation” made by the agency. Id., 467 U.S. at 844, 104 S.Ct. at 2782. Here, the FDA’s determination that the term “food” in sections 321(g)(1)(C) and 321(f)(1) is to be interpreted according to the ordinary meaning of the term, and is to include foods that provide nutrition by enteral administration into the gastrointestinal tract—in other words, that the food is ingested—, is a permissible construction of the statute: it reflects a plausible construction of the plain language of the statute, and does not conflict in any way with the limited Congressional intent that can be gleaned regarding sections 321(g)(1)(C) and 321(f)(1). In addition to contending that the FDA has impermissibly used ingestion as a factor in determining that Ener-B is a not a food, Nature’s Bounty makes two more claims in support of its contention that the FDA’s determination is unreasonable. These are: (i) adopting the FDA’s and Judge Ross’s interpretation would render all dietary supplements in tablet and capsule form as drugs, because they are not “foods” in the common sense meaning of the term; and (ii) the FDA’s interpretation of the word “food” is in direct contradiction to the agency’s determination that nasal, esophagal and jejunal tubes used to feed people are “food,” even though these methods cannot be considered “ingesting food” in the common, everyday meaning of the term. The Court finds these contentions unconvincing. The first claim is rendered moot by the DSHEA, because under the DSHEA vitamins, minerals and other dietary supplements are expressly deemed to be a “food” within the meaning of the FDCA. See DSHEA § 3(a) (codified at 21 U.S.C.A. § 321(ff) (West Supp.1994)). Moreover, in order to ensure that a dietary supplement is not regulated as a drug under section 321(g)(1)(C), the DSHEA amends section 321(g)(1) and related labelling provisions of the FDCA to expressly provide that a dietary supplement cannot be regulated as a drug under section 321(g)(1)(C) on the basis of any claims in its labelling regarding benefits related to a disease or the process by which the supplement affects the structure of the body, provided the claim is truthful and not misleading. See DSHEA §§ 6 and 10 (codified at 21 U.S.C.A. §§ 343(r)(6) and 321(g)(1) (West Supp.1994)). With regard to the second claim, the Court believes that the defendant is confusing different definitions of “food” under the FDCA. The FDCA establishes a separate category of “medical foods” in order to accommodate the enteral feeding and dietary management of people who are ill or injured. The definition of a “medical food” provides in relevant part: “[t]he term medical food means a food which is formulated to be consumed or administered enterally under the supervision of a physieian[.]” 21 U.S.C.A. § 360ee(b)(3) (West Supp.1994). In the Court’s view, there is no contradiction between Congress’s special designation of a food that is formulated for enteral administration through devices such as nasal, esophagal or jejunal tubes to be a “medical food,” and the FDA’s determination that Ener-B is not a “food” because it is not “ingested.” In the former case, Congress simply created a special category of “food,” notwithstanding the unconventional method of delivery into the body, in order to serve a special medical purpose. Moreover, the statute’s premising of a “medical food” on enteral administration undercuts the defendant’s contention that a parenterally administered nutrient like Ener-B should also be considered a “food.” The regulatory interpretation of “medical food” makes it very clear that if the nutrient is not administered enterally, it is not a food: “Epjarenteral nutrients ... are drugs and not medical foods. By definition, medical foods are consumed or administered enterally.” 56 Fed.Reg. 60377-78 (Nov. 27, 1991). See also id. (“enteral nutrition is defined as nutrition provided through the gastrointestinal tract, taken by mouth or provided through a tube[.]”). Accordingly, the FDA’s determination that Ener-B is neither a “food” within the parenthetical exception of section 321(g)(1)(C) nor within the definition of that term in section 321(f)(1) is reasonable. Certainly, the FDA’s determination is not “so directly in conflict with the statutory definition, [that] it must be invalidated as arbitrary and capricious and not in accordance with law.” Mathews, 557 F.2d at 336. As a result, the Court determines that Judge Ross was correct in recommending that the Court defer to the FDA’s determination and interpretation of the statute. 4. Other Alleged Improper Bases for Judge Ross’s Report. Nature’s Bounty raises several other alleged bases for objecting to Judge Ross’s Report. These are: (i) Judge Ross based her conclusions on “post hoc rationalizations” reflecting an alleged changed litigation position by the Government subsequent to the denial of its summary judgment motion; (ii) Judge Ross erroneously relied on prior agency actions as indicative of consistent FDA policy; and (iii) Judge Ross improperly based her recommendations on alleged safety concerns regarding Ener-B. (i). Changed Agency Litigation Position. Nature’s Bounty objects that Judge Ross erred by ignoring “the fact that plaintiff has substantially altered its litigation position” since the denial of the Government’s summary judgment motion in October, 1991. Objections at 6. According to Nature’s Bounty, the Government’s present contention that food must be enterally administered into the gastrointestinal tract is an abandonment of its “key argument” at the time of its summary judgment motion, namely that food must be absorbed into the stomach. See also id. at 40. Nature’s Bounty characterizes this alleged alteration as a “pure post hoc rationalization.” Indeed, Nature’s Bounty goes as far as claiming that this alleged post hoc rationalization “has no resemblance to FDA’s original position as expressed in its response to Nature’s Bounty Citizen Petition.” Objections at 41. The Court finds this objection to be ludicrous, and agrees with Judge Ross that it “finds no support in the record.” Report at 20. The FDA’s response in May, 1988 to Nature’s Bounty’s Citizen Petition, see Plaintiffs Ex. 5, at 25-34, is identical to the Government’s position before Judge Ross and this Court. In rejecting the exact same contentions