I
105TH CONGRESS
1ST SESSION
H. R. 2469
To amend the Federal Food, Drug, and Cosmetic Act and other statutes
to provide for improvements in the regulation of food ingredients, nutri-
ent content claims, and health claims, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 11, 1997
Mr. WHITFIELD (for himself, Mr. TOWNS, Mr. KLUG, Mr. HALL of Texas,
Mr. GREENWOOD, Mr. MANTON, Mr. BURR of North Carolina, Ms.
MCCARTHY of Missouri, Mr. BARTON of Texas, Mr. COBURN, Mr.
UPTON, Mr. DEAL of Georgia, Mr. BILIRAKIS, Mr. ENGEL, and Mr. DIN-
GELL) introduced the following bill; which was referred to the Committee
on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and
other statutes to provide for improvements in the regula-
tion of food ingredients, nutrient content claims, and
health claims, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON-
TENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Food and Nutrition Information Reform Act’’.
(b) REFERENCE.—Unless otherwise stated, whenever
in this Act an amendment or repeal is expressed in terms
of an amendment to, or repeal of, a section or other provi-
sion, the reference shall be considered to be made to a
section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
(c) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title; reference; table of contents.
TITLE I—IMPROVING THE REGULATION AND LABELING OF FOOD
Sec. 101. Flexibility for regulations regarding claims.
Sec. 102. Petitions for claims.
Sec. 103. Health claims for food products.
Sec. 104. Nutrient content claims.
Sec. 105. Referral statements.
Sec. 106. Disclosure of irradiation.
Sec. 107. Margarine.
TITLE II—EFFECTIVE DATE
Sec. 201. Effective date.
TITLE I—IMPROVING THE REGU-
LATION AND LABELING OF
FOOD
SEC. 101. FLEXIBILITY FOR REGULATIONS REGARDING
CLAIMS.
Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended
by adding at the end the following:
‘‘(D) Proposed regulations under this paragraph may
be made effective upon publication at the discretion of the
Secretary, notwithstanding the provisions of 5 U.S.C. 553,
pending consideration of public comment and publication
of a final regulation. Such regulations shall be effective
for a period not to exceed 270 days and shall be deemed
final agency action for purposes of judicial review.’’.
SEC. 102. PETITIONS FOR CLAIMS.
Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended
as follows:
(1) By adding after the second sentence the fol-
lowing: ‘‘If the Secretary does not act within such
100 days, the petition shall be deemed to be de-
nied.’’.
(2) In the fourth sentence of subparagraph
(A)(i) (as amended by paragraph (1)) by inserting
immediately before the comma the following: ‘‘or the
petition is deemed to be denied’’.
(3) Subparagraph (A)(i) is amended by adding
at the end the following: ‘‘If the Secretary does not
act within such 90 days, the petition shall be deemed
to be denied. If the Secretary issues a proposed reg-
ulation, the rulemaking shall be completed within
540 days of the date the petition is received by the
Secretary and the proposed regulation shall be con-
sidered a final regulation if the Secretary does not
complete the rulemaking within such 540 days.’’.
SEC. 103. HEALTH CLAIMS FOR FOOD PRODUCTS.
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended
by adding at the end thereof the following:
‘‘(C) Notwithstanding the provisions of clauses (A)(i)
and (B), a claim of the type described in subparagraph
(1)(B) which is not authorized by the Secretary in a regu-
lation promulgated in accordance with clause (B) shall be
authorized and may be made with respect to a food if—
‘‘(i) a scientific body of the United States Gov-
ernment with official responsibility for public health
protection or research directly relating to human nu-
trition (such as the National Institutes of Health,
the Centers for Disease Control and Prevention, or
the National Academy of Sciences or subdivisions of
such scientific body) has published an authoritative
statement, which is currently in effect, about the re-
lationship between a nutrient and a disease or
health-related condition to which the claim refers;
‘‘(ii) a person has submitted to the Secretary,
at least 120 days before the first introduction into
interstate commerce of the food with a label contain-
ing the claim, a notice of the claim, including a con-
cise description of the basis upon which such person
relied for determining that the requirements of sub-
clause (i) have been satisfied;
‘‘(iii) the claim and the food for which the claim
is made are in compliance with clause (A)(ii) and
are otherwise in compliance with paragraph (a) and
section 201(n); and
‘‘(iv) the claim is stated in a manner so that
the claim is an accurate representation of the au-
thoritative statement referred to in clause (i) and so
that the claim enables the public to comprehend the
information provided in the claim and to understand
the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded
as an authoritative statement of such a scientific body de-
scribed in subclause (i) only if the statement is published
by the scientific body and shall not include a statement
of an employee of the scientific body made in the individ-
ual capacity of the employee.
‘‘(D) A claim submitted under the requirements of
clause (C) may be made until—
‘‘(i) such time as the Secretary issues a regula-
tion under the standard in clause (B) (I) prohibiting
or modifying the claim and the regulation has be-
come effective, or (II) finding that the requirements
of clause (C) have not been met; or
‘‘(ii) a district court of the United States in an
enforcement proceeding under chapter III has deter-
mined that the requirements of clause (C) have not
been met.’’.
SEC. 104. NUTRIENT CONTENT CLAIMS.
Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended
by adding at the end the following:
‘‘(G) A claim of the type described in subparagraph
(1)(A) for a nutrient, for which the Secretary has not pro-
mulgated a regulation under clause (A)(i), shall be author-
ized and may be made with respect to a food if—
‘‘(i) a scientific body of the United States Gov-
ernment with official responsibility for public health
protection or research directly relating to human nu-
trition (such as the National Institutes of Health,
the Centers for Disease Control and Prevention, or
the National Academy of Sciences or subdivisions of
such scientific body) has published an authoritative
statement, which is currently in effect, which sets
forth a basis for such claim;
‘‘(ii) a person has submitted to the Secretary,
at least 120 days before the first introduction into
interstate commerce of the food with a label contain-
ing the claim, a notice of the claim, including a con-
cise description of the basis upon which such person
relied for determining that the requirements of sub-
clause (i) have been satisfied;
‘‘(iii) the claim and the food for which the claim
is made are in compliance with clauses (A) and (B),
and are otherwise in compliance with paragraph (a)
and section 201(n); and
‘‘(iv) the claim is stated in a manner so that
the claim is an accurate representation of the au-
thoritative statement referred to in subclause (i) and
so that the claim enables the public to comprehend
the information provided in the claim and to under-
stand the relative significance of such information in
the context of a total daily diet.
For purposes of this clause, a statement shall be regarded
as an authoritative statement of such a scientific body de-
scribed in subclause (i) only if the statement is published
by the scientific body and shall not include a statement
of an employee of the scientific body made in the individ-
ual capacity of the employee.
‘‘(H) A claim submitted under the requirements of
clause (G) may be made until—
‘‘(i) such time as the Secretary issues a regula-
tion (I) prohibiting or modifying the claim and the
regulation has become effective, or (II) finding that
‘‘(3) lines generally parallel to the base on
which the package rests as it is designed to be dis-
played.’’.
(c) ACT OF MARCH 16, 1950.—Sections 3(a) and 6
of the Act of March 16, 1950 (21 U.S.C. 347a, 347b),
are repealed.
TITLE II—EFFECTIVE DATE
SEC. 201. EFFECTIVE DATE.
The amendments made by this Act shall take effect
on the date of the enactment of this Act. The Secretary
of Health and Human Services shall not enforce any regu-
lation that is inconsistent with the amendment made by
section 101 after the date of the enactment of this Act.
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