US v. Ten Cartons, Ener-B Nasal Gel

• Decision Date: 24 March 1995
• Docket Number: 90-1635 (ADS).,No. CV 88-3000 (ADS),CV 88-3000 (ADS)
• Parties: UNITED STATES of America, Plaintiff, v. TEN CARTONS, more or less, of an article of drug, .... * * * ENER-B NASAL GEL, etc., et al., Defendants. UNITED STATES of America, Plaintiff, v. NATURE'S BOUNTY, INC., Defendant.
• Court: U.S. District Court — Eastern District of New York

888 F. Supp. 381

UNITED STATES of America, Plaintiff, v. TEN CARTONS, more or less, of an article of drug, .... * * * ENER-B NASAL GEL, etc., et al., Defendants.

UNITED STATES of America, Plaintiff, v. NATURE'S BOUNTY, INC., Defendant.

Nos. CV 88-3000 (ADS), 90-1635 (ADS).

United States District Court, E.D. New York.

March 24, 1995.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Zachary W. Carter, U.S. Atty. E.D.N.Y., Brooklyn, NY (Charles S. Kleinberg, Asst. U.S. Atty., Denise Zavagno, Matthew E. Eckel, of counsel), for plaintiff.

Bass & Ullman, New York City (Milton A. Bass, Robert Ullman, Jacob Laufer, James N. Czaban, of counsel), for defendants.

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(c)(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 plaintiff's motion for summary judgment. The Court's Memorandum Decision and Order is reported at 1991 WL...