HLD, v. 31, n. 4 (April 2003)
Second Circuit Holds FDA Exceeded Its Authority To Regulate
Dosage Packaging Of Supplements
In 1997, the Food and Drug Administration (FDA) issued a final
rule requiring unit-dose packaging for drug products in solid dose form that
use iron sources of thirty milligrams or more in response to the widespread
problem of acute iron poisoning in children. The FDA contended it acted under
the authority delegated to it by the Food, Drug, and Cosmetic Act (FDCA) to
regulate drug safety and dietary supplements. The Nutritional Health Alliance
(NHA) brought suit against the FDA in federal district court seeking
declaratory and injunctive relief that the FDA had exceeded its authority when
it promulgated the regulations. Both sides filed for summary judgment following
a hearing in which the parties agreed there were no material facts in dispute.
The district court granted summary judgment to the FDA, and NHA appealed.
The Second Circuit reversed the district court's summary
judgment for the FDA on the grounds that the agency had exceeded its authority
under the FDCA when it promulgated the final regulation. The FDA argued that it
was delegated broad authority by Congress to regulate products that are
"injurious to health." The NHA argued that the Poison Prevention Packaging Act
(PPP Act) gives "exclusive" jurisdiction for poison prevention to the Consumer
Product Safety Commission (CPSC) and through the Consumer Product Safety Act.
The appeals court noted that, in an analysis of the FDA's jurisdiction to regulate
a specific product, the two-prong test in Chevron U.S.A., Inc. v. Natural
Res. Def. Council, Inc., 467 U.S. 837 (2000), must be applied. The district
court had applied Chevron and determined that, under the first prong,
Congress had intended to delegate the authority to the FDA to regulate the
products, and under the second prong, even if the statute was ambiguous, the
FDA's interpretation of the statute was reasonable.
According to the appeals court, the general construction of the
FDCA provides the FDA with broad authority to regulate food, drug, and dietary
supplements for the express purpose of ensuring public health and safety, but
the FDCA has certain limits. The FDA contended that its authority to regulate
supplements containing iron came from the provision of the FDCA defining
"adulterated products" as a product that may be injurious to health, and from a
second provision that a product may be deemed adulterated if it was packaged
under conditions that do not conform to "current good manufacturing practices."
Applying the first prong of Chevron and reading the plain language of
the FDCA, the appeals court determined that the FDA was only delegated the
authority to regulate the manufacturing of products where conditions give rise
to the risk of adulteration. The public health risk for unit-dose packaging is
not related to the public health risk for adulteration because the iron-based
products, absent the packaging, were not considered to be unsafe. Rejecting the
FDA's argument that the packaging of the product can result in "adulteration,"
the appeals court concluded that the plain language of the FDCA failed to
delegate the authority to the FDA to require iron-containing products to be
packaged in a certain way absent a showing that the product could be
adulterated without the packaging.
The appeals court noted that if it had to apply the second prong
of Chevron, the FDA's proposed construction of the FDCA would still be
impermissible because it was clear that in the PPP Act Congress delegated to the
CPSC the authority that the FDA formerly had to regulate poison prevention
packaging. Accordingly, the appeals court reversed the district court's
judgment and remanded the case.
Nutritional Heath Alliance v. Food & Drug Admin., No.
01-6011, 2003 WL 139789 (2d Cir. Jan. 21, 2003) (13 pages).