A. Electronic Product Radiation Control
In 1990, the Radiation Control for Health and Safety Act, 42 U.S.C. Â§Â§
263c-263n, was renamed Electronic Product Radiation Control and recodified
as Subchapter C of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.
Â§Â§ 360hh-360ss ("Radiation Control Program"). The Radiation Control
Program applies to products such as x-ray units, suntanning bulbs, sonography
equipment, microwaves, lasers, and televisions, 21 U.S.C. Â§Â§ 360hh(1),
(2), and to persons who import, assemble, sell and manufacture electronic
products. 21 U.S.C. Â§ 360hh(3).
The Secretary of Health and Human Services implements and enforces the
Radiation Control Program, 21 U.S.C. Â§ 360ii, and has delegated those functions
to FDA. 21 C.F.R. Â§ 5.10(a)(3). The statute authorizes FDA to issue performance
standards for electronic products. 21 U.S.C. Â§ 360kk. FDA's regulations,
21 C.F.R. Subchapter J, include performance standards for products such
as x-ray units, CT scan equipment, microwave emitting products, lasers,
sonic, and ultrasonic products. 21 C.F.R. Part 1010 - 1050.
The Radiation Control Program establishes record keeping requirements for
manufacturers and importers of regulated products. It also mandates that
assemblers and installers file reports with FDA. Manufacturers must also
repair, replace or refund the cost of defective products. 21 U.S.C. Â§ 360ll(f).
The Radiation Control Program prohibits regulated persons from failing
to: 1) keep required records, 2) furnish required reports, or, 3) repair,
replace or refund the cost of a defective electronic product. 21 U.S.C.
Â§ 360oo. Section 360pp specifically authorizes the United States to
file actions in federal district court for civil penalties and for injunctive
relief. For each violation of 21 U.S.C. Â§ 360oo, each named defendant
is subject to a civil penalty of up to $1,000. (In fact, civil penalty
maximums for all statutes have been adjusted upward, generally by 10%,
to account for inflation. Regular upward adjustments will be made in
the future pursuant to the Civil Monetary Penalties Provision of the
Debt Collection Improvement Act of 1996.) Thus, if both a corporation
and an individual are named as defendants, each may be held separately
liable for civil penalties. United States v. Hodges X-Ray, 759
F.2d 557 (6th Cir. 1985); United States v. DeHaven & Associates,
et al., No. 95-1177(F) (E.D. La., February 9, 1996) (holding both
corporation and its president liable for civil penalties on summary
Although under Tull v. United States, 481 U.S. 412 (1987), liability
for civil penalties is a fact issue to be decided by a jury, the amount
of civil penalties to be assessed is determined by the court without
a jury. Tull, 481 U.S. at 426. The amount of civil penalties
may be determined on the briefs and without an evidentiary hearing.
Hodges, 759 F.2d at 564-65; DeHaven. Unlike the Federal
Trade Commission Act, 15 U.S.C. Â§ 45(m)(1), Section 360pp of the FDCA
does not specify the factors that a court must consider in determining
the amount of a civil penalty. However, it is likely that a court, in
its discretion, would consider those factors, which include ability
to pay, degree of culpability and history of prior violations.
The procedure for the referral and handling of cases under the Electronic
Product Radiation Control provisions is the same as that for other FDA cases.
B. The Fair Packaging and Labeling Program
This statute, 15 U.S.C. Â§Â§ 1451-1461, enacted in 1966 and substantially
amended in 1992, prohibits any person who packages or labels consumer commodities,
as defined, from distributing commodities that are not packaged and labeled
as required by this program and its implementing regulations. 15 U.S.C.
Â§ 1452. The law is designed to ensure that consumers receive accurate and
usable information about consumer commodities from the labeling on their
Consumer commodities include any food, drug, device or cosmetic, as defined
by FDA, and any other article, product or commodity customarily produced
or distributed through retail sales agencies for use or consumption by individuals.
15 U.S.C. Â§ 1459(a). Meat, poultry, tobacco products, and specified beverages,
drugs, and agricultural products regulated under other statutes and programs
are excluded from the definition of consumer commodity. 15 U.S.C. Â§ 1459(a)(1)-(5).
The law specifies the kind of information that must be provided to consumers.
Required items include the net quantity of contents and an identification
of the manufacturer. Such information be conspicuously displayed. 15 U.S.C.
"Secret ingredients" which FDA recognizes as trade secrets do not
need to be separately identified on the package. In cases in which FDA
denied trade secret status, manufacturers sometimes challenge FDA's
administrative procedures for making such determinations. Zotos International,
Inc. v. Young, 830 F.2d 350 (D.C. Cir. 1987); Carson Products
Co. v. Califano, 594 F.2d 453 (5th Cir. 1979); Del Laboratories,
Inc. v. United States, 86 F.R.D. 676 (D.D.C. 1980).
FDA is authorized to issue regulations relating to the packaging and labeling
of foods, drugs, medical devices, and cosmetics. 15 U.S.C. Â§Â§ 1453, 1454.
FDA labeling requirements under the FDCA may be found at 21 C.F.R. Part
1, Subpart B (general), Part 101 (food), Part 201 (drugs), and Part 801
(devices). Labeling requirements issued under this Act for cosmetics are
codified at 21 C.F.R. Part 701. The FTC is authorized to issue similar regulations
for all other consumer commodities, 15 U.S.C. Â§Â§ 1453, 1454, and those regulations
have been codified at 16 C.F.R. Subchapter E (Parts 500-503). In 1992 the
Act was amended to authorize the regulating agency to issue additional packaging
and labeling standards upon determining those measures are required to prevent
deception of consumers or to facilitate value comparisons. 15 U.S.C. Â§ 1454(c).
The Fair Packaging and Labeling Act contains a savings provision that
makes clear that it shall not be deemed to repeal the FTC Act, any antitrust
law, the FDCA, or the Federal Hazardous Substances Labeling Act. 15
U.S.C. Â§ 1460. There is also a preemption provision setting forth Congress'
intent to supersede less stringent state laws. 15 U.S.C. Â§ 1461. After
passage of the Act, the issue of whether particular state laws were
preempted by the Fair Packaging and Labeling Act was litigated. See,
e.g., Jones v. Rath Packing Co., 430 U.S. 519 (1977), reh'g.
denied, 431 U.S. 925 (1977) (California law preempted); L & L
Started Pullets, Inc. v Gourdine, 762 F.2d 1 (2d Cir. 1985) (New
York law not preempted).
Foods, drugs, medical devices or cosmetics introduced into commerce with
packaging or labeling that does not conform to law are misbranded. 15 U.S.C.
Â§ 1456(a). Distribution of such articles may be enjoined or the articles
may be seized pursuant to 21 U.S.C. Â§ 334. Violations of the Act which involve
other consumer commodities constitute unfair or deceptive practices under
15 U.S.C. Â§ 45(a), and are subject to enforcement under 15 U.S.C. Â§ 45(b).
15 U.S.C. Â§ 1456(b). The United States Customs Service is authorized to
enforce the Act with respect to violative consumer commodities imported
into the United States. Enforcement procedures are the same as for FDCA
cases and FTC cases.
C. The Public Health Service Act
The Public Health Service Act, 42 U.S.C. Â§ 262, 264, regulates certain
biologic products such as blood, tissues, vaccines, and genetically
engineered products. The law is designed to protect both donors and
recipients from communicable diseases and other illness. 42 U.S.C. Â§
262 provides for the licensing of biological products and clinical laboratories.
Both the establishments and the products for which the license is desired
must meet regulatory standards designed to insure the continued safety,
purity and potency of the products. The products may only be licensed
upon a showing that they meet such standards.(1)
Violations are punishable by a civil penalty of up to $100,000 per
day of violation, or by criminal prosecution. 42 U.S.C. Â§ 262(d), (f).
See United States v. Blood Systems, Inc. and J. Daniel Connor,
Civil No. 96-0967 (D. Ariz., April 22, 1996)(consent decree requiring
the second largest blood bank in United States and its President/CEO
to take measures to insure safety and integrity of blood and blood products);
United States v. American Red Cross, 1993 WL 186094, Civil No.
93-0949 (D.D.C., May 12, 1993)(consent decree against Red Cross for
violations of PHSA); United States v. Steinschreiber, 219 F.
Supp. 373 (S.D.N.Y. 1963), aff'd, 326 F.2d 759 (2d Cir. 1964), cert.
denied, 376 U.S. 962 (1964) (criminal); United States v. Calise,
217 F. Supp. 705 (S.D.N.Y. 1962) (criminal).
42 U.S.C. Â§ 264 authorizes the issuance of regulations to control communicable
diseases. Violations of any regulation issued under this provision may
be prosecuted criminally. 42 U.S.C. Â§ 271(a). FDA refers cases for enforcement
of the PHSA through the same procedures applicable to referrals under
has promulgated regulations governing the licensing of biologics for
commercial use. 21 C.F.R. Subchapter F (Parts 600 - 680), 21 C.F.R.
Part 1270 (human tissue transplants). Biologics are not "new drugs"
under the FDCA, but biologics have a secondary regulatory status as
either drugs or devices which governs the clinical investigation procedures
that must be followed prior to licensing a product. See, for example,
21 C.F.R. Part 312 (requirements for investigational new drug applications).
In addition, manufacturers of biologics must comply with certain requirements
as a pre-condition to obtaining an establishment license. 21 C.F.R.
Part 601, Subpart B. In Berlex Laboratories v. FDA, 942 F. Supp.
19 (D.D.C. 1996), the Court rejected a challenge, based in part on the
PHSA, to FDA's approval of a competitor's biologic product.