Nutritional Health Alliance v. Fda

• Decision Date: 21 January 2003
• Docket Number: Docket No. 01-6011.
• Citation: 318 F.3d 92
• Parties: NUTRITIONAL HEALTH ALLIANCE, Plaintiff-Appellant, v. FOOD AND DRUG ADMINISTRATION and Donna Shalala, in her official capacity as Secretary, U.S. Department of Health and Human Services, Defendants-Appellees.
• Court: U.S. Court of Appeals — Second Circuit

Page 92

318 F.3d 92

NUTRITIONAL HEALTH ALLIANCE, Plaintiff-Appellant, v. FOOD AND DRUG ADMINISTRATION and Donna Shalala, in her official capacity as Secretary, U.S. Department of Health and Human Services, Defendants-Appellees.

Docket No. 01-6011.

United States Court of Appeals, Second Circuit.

Argued: November 6, 2001.

Decided: January 21, 2003.

COPYRIGHT MATERIAL OMITTED

John M. Desiderio, Desiderio, PC & Associates, New York, NY, (Robert Ullman and H. Elliot Wales on the brief) for Appellant.

Charles S. Kleinberg, Assistant U.S. Attorney, U.S. Attorney's Office, Brooklyn, NY, (Alan Vinegrad, U.S. Attorney and Deborah B. Zwany, Assistant U.S. Attorney on the brief) for Appellees.

Before: KEARSE, MINER, F.I. PARKER Circuit Judges.

F.I. PARKER, Circuit Judge.

Plaintiff-appellant, Nutritional Health Alliance ("NHA"), appeals from a judgment entered on November 15, 2000 by the United States District Court for the Eastern District of New York (Sterling Johnson, Jr., Judge) denying NHA's motion for summary judgment and granting the cross-motion of defendants-appellees, the Food and Drug Administration ("FDA") and Secretary of Health and Human Services ("Secretary"), for summary judgment dismissing NHA's complaint.

The issue raised by this appeal is whether the FDA has been delegated authority by Congress to regulate the packaging of solid dosage dietary supplements and drugs for the purpose of poison prevention. In an attempt to protect children from accidental iron poisoning, the FDA promulgated regulations requiring drug and dietary supplement manufacturers to distribute their products containing thirty milligrams or more of iron per dosage unit in unit-dose packages [hereinafter "unitdose packaging rule"]. In response, NHA, an association including manufacturers and distributors of iron-containing dietary supplements, filed a complaint seeking both a declaration that the regulations were "invalid and without legal force and effect" and a permanent injunction barring the defendants from enforcing the regulations. The basis for NHA's claims is that the FDA lacked statutory authority to promulgate and enforce poison prevention packaging regulations.

The FDA argues that it acted pursuant to the broad authority delegated to it by the Food, Drug and Cosmetic Act ("FDC Act"), 21 U.S.C. §§ 301, et seq., to regulate dietary supplements and drugs for safety. Specifically, the FDA points to the "injurious to health" provisions of the FDC Act as the primary source of statutory authority for its unit-dose packaging rule,¹ and to the "current good manufacturing practices" provisions of the FDC Act as an alternative basis for the rule.²

NHA argues principally that in 1972, Congress transferred jurisdiction over the Poison Prevention Packaging Act ("PPP Act") and subject matter within the scope of the PPP Act from the FDA to the Consumer Product Safety Commission ("CPSC") by enacting the Consumer Product Safety Act ("CPS Act"). See 15 U.S.C. §§ 1471 et seq. (PPP Act); 15 U.S.C. §§ 2051 et seq. (CPS Act). According to NHA, authority to regulate "poison prevention packaging," was exclusively vested in the CPSC and, therefore, the FDA overstepped its statutory authority by issuing the unit-dose packaging rule. On appeal, the FDA does not dispute that its rule is a poison prevention packaging rule, but rather contends that the CPSC and the FDA share concurrent, overlapping authority to promulgate and enforce poison prevention packaging regulations. NHA responds that even if we decide that the CPS Act left open the possibility that the CPSC and the FDA have concurrent jurisdiction over poison prevention packaging, the FDA's proffered construction of the FDC Act is impermissible.

The District Court agreed with the FDA's position and held that the defendants prevail under either prong of a Chevron analysis. See Chevron U.S.A., Inc. v. Natural Resources Def. Council, Inc., 467 U.S. 837, 842-43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). The District Court dismissed NHA's argument regarding the CPS Act's transfer of regulatory authority from the FDA to the CPSC by concluding that NHA "has not provided sufficient evidence for the Court to conclude that in passing the [PPP Act] or transferring its administration to the CPSC[,] Congress intended to eliminate entirely the authority of the FDA to regulate the packaging of drugs and dietary supplements when it finds it to be injurious to the health of consumers." Memorandum and Order, 97 CV 5042(SJ) at 6 (E.D.N.Y. Nov. 1, 2000). The District Court also reasoned that NHA failed to "successfully show[] that the [PPP Act] and the FDC Act are irreconcilable such that an inquiry into whether there was an implied repeal would be justified at this time." Id.

We conclude that the provisions of the FDC Act relied upon by the FDA unambiguously fail to provide the FDA with authority to regulate packaging for poison prevention purposes. The provisions that the FDA relies upon are plainly limited to delegation of authority to the FDA to regulate conditions under which a drug or dietary supplement product may be adulterated precisely to prevent the manufacture and distribution of adulterated products. The risk of accidental poisoning that the FDA sought to address through its unit-dose packaging regulation is unrelated to adulteration under any reasonable interpretation of that term. Accordingly, we reverse and remand.

I. BACKGROUND

The facts in this case are undisputed. We briefly summarize the relevant facts and note that an extensive administrative record has been developed by the FDA. See, e.g., Final Rule, Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements, 62 Fed.Reg. 2218 (Jan. 15, 1997); Proposed Rule, 59 Fed.Reg. 51,030 (Oct. 6, 1994).

This case involves a challenge to an FDA rule requiring that solid dose dietary supplements and drugs containing thirty milligrams or more of iron per dosage unit be packaged in "unit-dose packaging." 62 Fed.Reg. 2218. "Unit-dose packaging" means "a method of packaging a product into a nonreusable container designed to hold a single dosage unit intended for administration directly from that container, irrespective of whether the recommended dose is one or more than one of these units." 21 C.F.R. §§ 111.50 (dietary supplements), 310.518(a) (drugs).

The challenged regulation was issued in response to a widespread problem of "acute iron poisonings, including deaths, in children less than 6 years of age attributable to accidental overdoses of iron-containing products." 62 Fed.Reg. at 2218; see also 59 Fed.Reg. at 51,032-36. Data obtained by the FDA showed that from 1986 through 1992, there were nearly 63,000 reports to poison control centers of iron overdoses involving adult products, with over 47,000 of these reports involving children under six years of age. Id. at 51,032. For pediatric iron-containing products, there were over 76,000 reports during the same time period, including over 69,000 reports involving children under six years of age. Id.

According to evidence presented by the American Association of Poison Control Centers ("AAPCC"), iron products are a leading cause of poisoning deaths in children under six years of age. See id. Iron poisoning is a particular threat to young children because of their lower body weight, which raises the likelihood of serious injury or death in some cases. Id. at 51,031. In addition, many iron-containing tablets resemble candy and are therefore particularly appealing to young children. See 62 Fed.Reg. at 2231.

In October 1994, following several citizen petitions requesting that the FDA address the iron poisoning problem, the FDA issued a proposed rule requiring a new warning label and unit-dose packaging for products containing thirty milligrams or more of iron per dosage unit. 59 Fed.Reg. at 51,057-58. The proposed rule was revised on February 16, 1995, and the comment period reopened after the passage of the Dietary Supplement Health and Education Act ("DSHEA") of 1994, Pub.L. No. 103-417, 108 Stat. 4325. See 60 Fed.Reg. 8989 (1995).

On January 15, 1997, the FDA issued its final rule. 62 Fed.Reg. 2218. The rule requires unit-dose packaging for drug products and dietary supplements offered in solid oral dose form that use iron and iron salts as iron sources and contain thirty milligrams or more of iron per dosage unit. 21 C.F.R. §§ 111.50 (dietary supplements), 310.518 (drugs). The scientific analysis and public health considerations underlying the rule are set forth in the Federal Register publications and show that the action was taken in response to the large number of acute iron poisonings in children under the age of six. 62 Fed. Reg. 2218, 2229. The FDA determined that requiring individually-dosed packaging would limit the number of capsules or tablets a child could consume if the child accidentally gained access to the product.

Notably, in its Proposed Rule, the FDA expressly acknowledged the statutory authority of the CPSC under the CPS Act and the PPP Act as well as the existence of the CPSC's special packaging regulations pertaining to products containing iron. 59 Fed.Reg. at 51,047, 51,049. In its Final Rule, the FDA explained that it intended "to reduce the risk of accidental iron poisonings of young children" by supplementing and strengthening "the existing requirements of the [CPSC] for childresistant packaging for household substances." 62 Fed.Reg. at 2218; see also 59 Fed.Reg. at 51,038. The FDA amended the wording of its proposed regulations before issuing them in final form to conform to the CPSC's request³ that the FDA clarify that manufacturers of ironcontaining products must comply with both the CPSC child-resistant packaging regulations and the FDA unit-dose packaging regulations. See 62 Fed.Reg. at 2228; 21 C.F.R. §§ 111.50, 310.518 (stating that iron-containing products subject to the unit-dose packaging regulations are also...