FDA’s Poison Prevention Packaging Rule: A Bitter Pill the FDA is Forced to Swallow

By John M. Desiderio

The U.S. Court of Appeals for the Second Circuit recently ruled unanimously that the Food and Drug Administration (FDA) is not authorized to regulate the packaging of solid dosage dietary supplements and drugs for poison prevention purposes.1 The court held that FDA exceeded its statutory jurisdiction when it issued regulations requiring unit-dose packaging for dietary supplement and drug capsules and tablets that contain thirty milligrams or more of iron per unit dose.2 A lower court had upheld FDA’s regulations.

The plaintiff in the case, the Nutritional Health Alliance (NHA), contended that regulation of packaging under the Poison Prevention Packaging Act of 1970 (PPPA)3 falls within the exclusive jurisdiction of the Consumer Products Safety Commission (CPSC) and that CPSC’s “special packaging” regulations for iron-containing dietary supplements and drugs are in full force and effect.

NHA also contended that, under the PPPA, the government may mandate special packaging standards to protect young children against dangerous consumer products, but may not mandate any specific type of special packaging to be used for that purpose. The PPPA allows industry to choose any special packaging that meet CPSC’s child-resistant, safety standards. FDA’s unit-dose regulations thus violated the express provisions of the PPPA.

FDA attempted to justify regulating the packaging of iron-containing drugs and dietary supplements under the authority given to it by the Federal Food, Drug, and Cosmetic Act (FDCA)4 to deem such products “adulterated” a) if “packed” under “insanitary conditions” that may “render” them “injurious to health,”5 or b) if not “packed” in conformity with current good manufacturing practices (CGMPs).6 NHA contended, and the court agreed, that the FDCA’s adulteration provisions relate only to requirements for ensuring that iron-containing products do not deteriorate or become contaminated in the manufacturing or distribution process.7

The court held that FDA’s requirement of single unit-dose packaging “simply bears no relationship to the unambiguous authority to protect against ‘insanitary conditions’ that may cause contamination or render the product injurious.”

FDA had argued, “[W]here health risks associated with an unintended yet predictable use (or misuse) of an unadulterated product, such as the accidental ingestion of iron-containing products by children, may be alleviated through special packaging, failure to use such packaging renders the product adulterated.”

Rejecting FDA’s argument, the Second Circuit held that “the risk that a product will be used or misused in an unintended manner is simply unrelated to ‘adulteration’ under any reasonable interpretation of that term.” Indeed, the court said:

In a sense, the FDA argues that inadequately protective packaging is itself an adulterant. This argument is nonsensical, however, because packaging does not cause a deleterious change in the product. With or without packaging, the iron-containing product is not subject to contamination, deterioration, or any other change that causes it to be unsafe.8

In deciding against the government, the Second Circuit gave FDA a “master class” in statutory interpretation and administrative law. The court applied a classic Chevron-style analysis9 to FDA’s construction of the adultration provisions of the FDCA. The court noted that the FDCA does provide FDA with broad regulatory authority to ensure public health and safety; consequently, courts generally read the FDCA “in a liberal manner” and work in “constructive cooperation” with FDA when the agency’s rulemaking serves the statutory purpose. Nevertheless, the court emphasized that its responsibility was to ensure that FDA’s regulatory authority was “actually rooted in the statute”—in accordance with the following formula:

When we interpret a statute and attempt to divine the intended scope of a delegation, statutory purpose, to
the extent that such purpose is evident, sets boundaries and requires consistency between purpose and textual interpretation. Statutory purpose, however, is not in itself a source of delegated power.10

The court went on to say, “[W]e cannot simply conclude that because the FDA is charged with regulation of food and drugs in order to protect public health, and its unit-dose packaging regulations were promulgated in response to a public health problem, therefore the FDA acted pursuant to delegated authority.”

The Second Circuit’s Chevron Analysis

In determining whether Congress has spoken “unambiguously” on the scope of FDA’s delegated authority—the first step of its Chevron analysis—the court in NHA v. FDA said that the FDCA’s grant of authority to regulate adulterated products “plainly categorizes the types of health and safety risks that Congress was concerned with and that the FDA was delegated to address.” Noting that adulteration is “concerned solely with deterioration and contamination of the commodity itself,” the court found that “the plain meaning of the term imposes an important textual limit on the scope of Congress’ delegation to the FDA . . . .” Accordingly, the court concluded that reliance on FDCA’s adulteration provisions, as authority for FDA’s unit-dose packaging rule, was “misplaced” because the public health risks the rule sought to address “are so dissimilar to adulteration risks.” The iron-containing products of concern in the case are not banned as unsafe, “even though the products naturally pose some safety risks to consumers,” because, “absent packaging,” the products nevertheless “are considered safe for their intended use.” As to the risks posed by possible misuse of the products, the court said:

Regardless of whether the product is used or misused in an unintended manner, the iron-containing product is not subject to contamination, deterioration, or any other change that causes it to be unsafe [for its intended use].11

Therefore, the court held that “the plain language of both the injurious to health and CGMP provisions of the [FDCA] unambiguously fail to delegate to the FDA authority to require manufacturers of iron-containing products to use unit-dose packaging in the absence of any showing by the FDA that iron-containing product may be adulterated without such packaging.”

While this holding on the “plain meaning” of the FDCA was dispositive of the case under step one of the Chevron analysis, the court nevertheless chose to address the second prong of Chevron (i.e., whether FDA’s construction of its own statutory authority would be “permissible” if congressional intent had not been “unambiguously expressed”). In this regard, the court said that “[e]ven if there were some ambiguity in the statutory text of the [FDCA], we would find the FDA’s proposed construction impermissible.”

The court in NHA v. FDA noted that the construction of any ambiguous terms of the FDCA necessarily would require an analysis of the PPPA and the Consumer Products Safety Act (CPSA),12 both of which are administered by the CPSC and both of which were enacted subsequent to the FDCA. On this point, the Second Circuit cited the Supreme Court’s “instructive guidance” in the Brown & Williamson case: that “the implications of a statute may be altered by the implications of a later statute,” and that “a specific policy embodied in a later federal statute should control . . . construction of [an] [earlier] statute, even though it has not been expressly amended.”13 The Second Circuit said that these principles “would clearly apply to this case if it were necessary to shift our analysis into the second prong of Chevron.”14

The NHA court noted: a) that the PPPA, enacted in 1970, “specifically targeted the problem of accidental poisoning of children caused by the ingestion of (or exposure to) a wide range of ordinary household products, including drugs and medicines, with a comprehensive yet circumscribed regulatory solution”; b) that the PPPA conferred authority on FDA to establish regulatory standards for “special packaging” found necessary to protect children from hazardous “household substances”; c) that the PPPA expressly prohibited FDA from prescribing “specific packaging designs because Congress believed such decisions should be left to industry”; and d) that “in 1972, the FDA was stripped of its PPPA authority when Congress enacted the [CPSA].”

In light of these facts, the Second Circuit said that “we would not defer to the FDA regarding its interpretation of ambiguous language in the [FDCA] where doing so would allow the FDA to circumvent the detailed regulatory scheme, including the express constraints, set forth by Congress in the [PPPA].”

Thus, even assuming arguendo that the [FDCA] provisions relied upon by the FDA were ambiguous,we would find the FDA’s interpretation of those provisions impermissible because (1) the [PPPA] specifically and unambiguously targets the accidental poisoning problem and prescribes a specific regulatory approach to addressing the problem through packaging standards, (2) the [CPSA] unambiguously transferred authority to administer and enforce the [PPPA] from the FDA to the CPSC, and (3) the FDA’s assertion of concurrent jurisdiction rings a discordant tone with the regulatory structure created by Congress.15

Finally, the court in NHA v. FDA noted that “FDA’s dubious construction of the ‘injurious to health’ and CGMP provisions would further cement our conclusions under the second prong of Chevron that its proffered interpretation is not reasonable.” As further indication of its disagreement with FDA’s arguments in the case, the court emphasized that FDA “relies on select terms from the statutory text piecemeal and fails to give meaning to other important terms,”16 but that “[w]e, however, must give effect, if possible, to every clause and word of the statute.”

What the Second Circuit Left Unsaid

While the Second Circuit confined its opinion to a strict Chevron analysis of FDA’s authority under FDCA, it is interesting to note that the court had before it legislative history of both the PPPA and the CPSA that conclusively undercut FDA’s position in the case. Legislative history submitted by NHA showed clearly that, prior to the enactment of the PPPA, FDA did not believe that the FDCA provided authority for it to require poison prevention packaging—either for drugs or for any other hazardous substances17—at a time when the most numerous incidents of accidental childhood poisonings involved aspirin,18 which then, as now, was clearly under FDA jurisdiction. Indeed, FDA had urged passage of the PPPA to obtain such authority, and it was FDA’s own witnesses who testified before Congress that the choice of specific poison prevention packaging designs should be left to industry.19

NHA also submitted CPSA legislative history showing that it was Congress’ clear intent that there not be any overlapping jurisdiction between FDA and the CPSC once all PPPA functions were transferred to the CPSC.20 In fact, the legislative history shows that Congress actually was displeased with FDA’s stewardship of the PPPA because, during the interval when FDA was responsible for PPPA implementation and enforcement, FDA had not prescribed even a single standard for child-resistant safety closures.21

We cannot know the court’s purpose in not referring to the pertinent legislative history. One possible reason, however, is that the court wanted to emphasize its own perception of the unquestionable clarity of the FDCA’s “adulteration” provisions and the patently “unambiguous” nature of their “plain meaning.” The court obviously believes that FDA also should have understood the clear and unambiguous limitations of that language on FDA’s statutory jurisdiction.

Conclusion

Unlike the district court below, the Second Circuit understood that the issue in the case was not whether children should be protected against the possibility of accidental poisoning. The court recognized that FDA had attempted to unilaterally expand its general statutory jurisdiction to cover an area that Congress had expressly delegated to another agency.

This is not the first time that FDA has attempted to expand its jurisdiction without congressional authority. FDA has a long history of seeking to aggrandize its powers under the banner of “public health.” Courts have not hesitated, however, to pull FDA up short when it has exceeded its statutory authority or impinged on the jurisdiction of another agency.22

Hopefully, after this latest judicial chastisement, FDA will focus its energies on those matters that are clearly within its statutory authority and will not attempt to stretch the jurisdictional envelope through any further “dubious constructions” of the FDCA.

 

1 Nutritional Health Alliance v. Food and Drug Admin., 318 F.3d 92 (2d Cir. 2003)

(hereinafter NHA v. FDA). Unless otherwise or specifically noted, this is the general

citation/reference for the Second Circuit’s decision, as discussed and quoted

throughout this article.

2 Id.; see 62 Fed. Reg. 2218 (Jan 15, 1997); 21 C.F.R. §§ 111.50 (dietary supplements),

310.518 (drugs).

3 15 U.S.C. §§ 1471 et seq.

4 21 U.S.C. § 351 et seq.

5 Id. § 351(a)(2)(A) (relating to drugs); id. § 342(a)(4) (relating to foods, which, for

purposes of FDCA’s “adulteration” provisions, include dietary supplements; see id. §

321(ff)).

6 Id. § 342(g) (dietary supplements); id. § 351(a)(2)(B)(drugs).

7 See NHA v. FDA, 318 F.3d at 95.

8 Id. at 101.

9 See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

10 NHA v. FDA, 318 F.3d at 98 (emphasis added).

11 Id. at 100-01.

12 15 U.S.C. §§ 2051 et seq.

13 Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 143

(2000).

14 NHA v. FDA, 318 F.3d at 102 (emphasis added).

15 Id. at 104.

16 Id. at 104-05 (“The FDA fails to recognize (or even attempt to grapple with) the fact

that the phrase ‘prepared, packed, or held under insanitary conditions’ has

consistently been interpreted to refer to the place where a product is prepared,

packed, or held . . . . Furthermore, the FDA completely ignores the term ‘renders,’

which indicates that a deleterious change in the product must occur while it is being

‘prepared, packed or held owing to insanitary conditions.”).

17 See Hearings on S. 2162 Before the Consumer Subcomm. of the Senate Comm. on

Commerce, 91st Cong., 1st Sess. 17-28 (1969); see also Hearings on H.R. 6179,

H.R. 6180, H.R. 16541, H.R. 16884, and S. 2162 Before the Subcomm. on Commerce

and Finance of the House Comm. on Interstate and Foreign Commerce, 91st Cong.,

2d Sess. 45-61 (1970).

18 See H.R. REP. NO. 91-1642, reprinted in 1970 U.S.C.C.A.N. 5326.

19 See supra note 17.

20 See S. REP. NO. 92-835 and S. CONF. REP. NO. 1593, reprinted in 1972 U.S.C.C.A.N.

4573, 4592; see also CONG. REC. 21,867 (June 21, 1972) (statement of Sen. Charles

Percy).

21 See CONG. REC. 21,867 (June 21, 1972) (statement of Sen. Frank Moss).

22 See, e.g., Brown & Williamson Tobacco Corp., 529 U.S. at 120; American

Pharmaceutical Ass’n v. Weinberger, 377 F. Supp. 824 (D.D.C. 1974), aff ’d sub.

nom., American Pharmaceutical Ass’n v. Matthews, 530 F.2d 1054 (D.C. Cir.

1976)(per curiam); United States v. Two Plastic Drums, 984 F.2d 814, 819 (7th Cir.

1993) (“The FDA’s food additive definition is so broad, however, that . . . . [t]he only

justification for this Alice-in-Wonderland approach is to allow the FDA to make an

end-run around the statutory scheme . . . .”); United States v. 29 Cartons of * * * An

Article of Food, 987 F.2d 33, 39 (1st Cir. 1993) (“[The FDA’s position] perverts the

statutory text, undermines legislative intent, and defenestrates common sense.”);

Brown-Forman Distillers v. Matthews, 435 F. Supp. 5, 17 (W.D. Ky. 1996) (“[T]he

scope of the FDA’s authority does not rest on its assertion of authority but on the

actual jurisdiction conferred upon it by Congress, through legislative enactment, as

construed by the Courts.”). See also Association of Amer. Physicians & Surgeons,

Inc. v. U.S. Food and Drug Admin., 226 F. Supp. 2d 204 (D.D.C. 2002).

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