§ 348. — Food additives.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC348]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 348. Food additives
(a) Unsafe food additives; exception for conformity with exemption or
regulation
A food additive shall, with respect to any particular use or
intended use of such additives, be deemed to be unsafe for the purposes
of the application of clause (2)(C) of section 342(a) of this title,
unless--
(1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (j) of this
section;
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section
prescribing the conditions under which such additive may be safely
used; or
(3) in the case of a food additive as defined in this chapter
that is a food contact substance, there is--
(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under this
section prescribing the conditions under which such additive may
be safely used; or
(B) a notification submitted under subsection (h) of this
section that is effective.
While such a regulation relating to a food additive, or such a
notification under subsection (h)(1) of this section relating to a food
additive that is a food contact substance, is in effect, and has not
been revoked pursuant to subsection (i) of this section, a food shall
not, by reason of bearing or containing such a food additive in
accordance with the regulation or notification, be considered
adulterated under section 342(a)(1) of this title.
(b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls;
samples; notice of regulation
(1) Any person may, with respect to any intended use of a food
additive, file with the Secretary a petition proposing the issuance of a
regulation prescribing the conditions under which such additive may be
safely used.
(2) Such petition shall, in addition to any explanatory or
supporting data, contain--
(A) the name and all pertinent information concerning such food
additive, including, where available, its chemical identity and
composition;
(B) a statement of the conditions of the proposed use of such
additive, including all directions, recommendations, and suggestions
proposed for the use of such additive, and including specimens of
its proposed labeling;
(C) all relevant data bearing on the physical or other technical
effect such additive is intended to produce, and the quantity of
such additive required to produce such effect;
(D) a description of practicable methods for determining the
quantity of such additive in or on food, and any substance formed in
or on food, because of its use; and
(E) full reports of investigations made with respect to the
safety for use of such additive, including full information as to
the methods and controls used in conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish (or,
if the petitioner is not the manufacturer of such additive, the
petitioner shall have the manufacturer of such additive furnish, without
disclosure to the petitioner) a full description of the methods used in,
and the facilities and controls used for, the production of such
additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as components
thereof, and of the food in or on which the additive is proposed to be
used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days after
filing.
(c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors
(1) The Secretary shall--
(A) by order establish a regulation (whether or not in accord
with that proposed by the petitioner) prescribing, with respect to
one or more proposed uses of the food additive involved, the
conditions under which such additive may be safely used (including,
but not limited to, specifications as to the particular food or
classes of food in or in which such additive may be used, the
maximum quantity which may be used or permitted to remain in or on
such food, the manner in which such additive may be added to or used
in or on such food, and any directions or other labeling or
packaging requirements for such additive deemed necessary by him to
assure the safety of such use), and shall notify the petitioner of
such order and the reasons for such action; or
(B) by order deny the petition, and shall notify the petitioner
of such order and of the reasons for such action.
(2) The order required by paragraph (1)(A) or (B) of this subsection
shall be issued within ninety days after the date of filing of the
petition, except that the Secretary may (prior to such ninetieth day),
by written notice to the petitioner, extend such ninety-day period to
such time (not more than one hundred and eighty days after the date of
filing of the petition) as the Secretary deems necessary to enable him
to study and investigate the petition.
(3) No such regulation shall issue if a fair evaluation of the data
before the Secretary--
(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified in the
regulation, will be safe: Provided, That no additive shall be deemed
to be safe if it is found to induce cancer when ingested by man or
animal, or if it is found, after tests which are appropriate for the
evaluation of the safety of food additives, to induce cancer in man
or animal, except that this proviso shall not apply with respect to
the use of a substance as an ingredient of feed for animals which
are raised for food production, if the Secretary finds (i) that,
under the conditions of use and feeding specified in proposed
labeling and reasonably certain to be followed in practice, such
additive will not adversely affect the animals for which such feed
is intended, and (ii) that no residue of the additive will be found
(by methods of examination prescribed or approved by the Secretary
by regulations, which regulations shall not be subject to
subsections (f) and (g) of this section) in any edible portion of
such animal after slaughter or in any food yielded by or derived
from the living animal; or
(B) shows that the proposed use of the additive would promote
deception of the consumer in violation of this chapter or would
otherwise result in adulteration or in misbranding of food within
the meaning of this chapter.
(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is required in
order to assure that the proposed use of an additive will be safe, the
Secretary--
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the physical
or other technical effect for which such additive is intended; and
(B) shall not establish a regulation for such proposed use if he
finds upon a fair evaluation of the data before him that such data
do not establish that such use would accomplish the intended
physical or other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall consider
among other relevant factors--
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the additive;
(B) the cumulative effect of such additive in the diet of man or
animals, taking into account any chemically or pharmacologically
related substance or substances in such diet; and
(C) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of
animal experimentation data.
(d) Regulation issued on Secretary's initiative
The Secretary may at any time, upon his own initiative, propose the
issuance of a regulation prescribing, with respect to any particular use
of a food additive, the conditions under which such additive may be
safely used, and the reasons therefor. After the thirtieth day following
publication of such a proposal, the Secretary may by order establish a
regulation based upon the proposal.
(e) Publication and effective date of orders
Any order, including any regulation established by such order,
issued under subsection (c) or (d) of this section, shall be published
and shall be effective upon publication, but the Secretary may stay such
effectiveness if, after issuance of such order, a hearing is sought with
respect to such order pursuant to subsection (f) of this section.
(f) Objections and public hearing; basis and contents of order;
statement
(1) Within thirty days after publication of an order made pursuant
to subsection (c) or (d) of this section, any person adversely affected
by such an order may file objections thereto with the Secretary,
specifying with particularity the provisions of the order deemed
objectionable, stating reasonable grounds therefor, and requesting a
public hearing upon such objections. The Secretary shall, after due
notice, as promptly as possible hold such public hearing for the purpose
of receiving evidence relevant and material to the issues raised by such
objections. As soon as practicable after completion of the hearing, the
Secretary shall by order act upon such objections and make such order
public.
(2) Such order shall be based upon a fair evaluation of the entire
record at such hearing, and shall include a statement setting forth in
detail the findings and conclusions upon which the order is based.
(3) The Secretary shall specify in the order the date on which it
shall take effect, except that it shall not be made to take effect prior
to the ninetieth day after its publication, unless the Secretary finds
that emergency conditions exist necessitating an earlier effective date,
in which event the Secretary shall specify in the order his findings as
to such conditions.
(g) Judicial review
(1) In a case of actual controversy as to the validity of any order
issued under subsection (f) of this section, including any order
thereunder with respect to amendment or repeal of a regulation issued
under this section, any person who will be adversely affected by such
order may obtain judicial review by filing in the United States Court of
Appeals for the circuit wherein such person resides or has his principal
place of business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry of such
order, a petition praying that the order be set aside in whole or in
part.
(2) A copy of such petition shall be forthwith transmitted by the
clerk of the court to the Secretary, or any officer designated by him
for that purpose, and thereupon the Secretary shall file in the court
the record of the proceedings on which he based his order, as provided
in section 2112 of title 28. Upon the filing of such petition the court
shall have jurisdiction, which upon the filing of the record with it
shall be exclusive, to affirm or set aside the order complained of in
whole or in part. Until the filing of the record the Secretary may
modify or set aside his order. The findings of the Secretary with
respect to questions of fact shall be sustained if based upon a fair
evaluation of the entire record at such hearing.
(3) The court, on such judicial review, shall not sustain the order
of the Secretary if he failed to comply with any requirement imposed on
him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce
additional evidence, the court may order such additional evidence to be
taken before the Secretary and to be adduced upon the hearing in such
manner and upon such terms and conditions as to the court may seem
proper, if such evidence is material and there were reasonable grounds
for failure to adduce such evidence in the proceedings below. The
Secretary may modify his findings as to the facts and order by reason of
the additional evidence so taken, and shall file with the court such
modified findings and order.
(5) The judgment of the court affirming or setting aside, in whole
or in part, any order under this section shall be final, subject to
review by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28. The commencement
of proceedings under this section shall not, unless specifically ordered
by the court to the contrary, operate as a stay of an order.
(h) Notification relating to food contact substance
(1) Subject to such regulations as may be promulgated under
paragraph (3), a manufacturer or supplier of a food contact substance
may, at least 120 days prior to the introduction or delivery for
introduction into interstate commerce of the food contact substance,
notify the Secretary of the identity and intended use of the food
contact substance, and of the determination of the manufacturer or
supplier that the intended use of such food contact substance is safe
under the standard described in subsection (c)(3)(A) of this section.
The notification shall contain the information that forms the basis of
the determination and all information required to be submitted by
regulations promulgated by the Secretary.
(2)(A) A notification submitted under paragraph (1) shall become
effective 120 days after the date of receipt by the Secretary and the
food contact substance may be introduced or delivered for introduction
into interstate commerce, unless the Secretary makes a determination
within the 120-day period that, based on the data and information before
the Secretary, such use of the food contact substance has not been shown
to be safe under the standard described in subsection (c)(3)(A) of this
section, and informs the manufacturer or supplier of such determination.
(B) A decision by the Secretary to object to a notification shall
constitute final agency action subject to judicial review.
(C) In this paragraph, the term ``food contact substance'' means the
substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical substance
manufactured or prepared by a person other than the manufacturer
identified in the notification.
(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where the
Secretary determines that submission and review of a petition under
subsection (b) of this section is necessary to provide adequate
assurance of safety, or where the Secretary and any manufacturer or
supplier agree that such manufacturer or supplier may submit a petition
under subsection (b) of this section.
(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b) of this section, and shall consider criteria such as the
probable consumption of such food contact substance and potential
toxicity of the food contact substance in determining the circumstances
in which a petition shall be filed under subsection (b) of this section.
(4) The Secretary shall keep confidential any information provided
in a notification under paragraph (1) for 120 days after receipt by the
Secretary of the notification. After the expiration of such 120 days,
the information shall be available to any interested party except for
any matter in the notification that is a trade secret or confidential
commercial information.
(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless--
(I) an appropriation equal to or exceeding the applicable amount
under clause (iv) is made for such fiscal year for carrying out such
program in such fiscal year; and
(II) the Secretary certifies that the amount appropriated for
such fiscal year for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds the
amount appropriated for the Center for fiscal year 1997, excluding
any amount appropriated for new programs.
(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the notification
program established under this subsection if--
(I) an appropriation equal to or exceeding the applicable amount
under clause (iii) is made for the last six months of fiscal year
1999 for carrying out such program during such period; and
(II) the Secretary certifies that the amount appropriated for
such period for the Center for Food Safety and Applied Nutrition of
the Food and Drug Administration (exclusive of the appropriation
referred to in subclause (I)) equals or exceeds an amount equivalent
to one-half the amount appropriated for the Center for fiscal year
1997, excluding any amount appropriated for new programs.
(iii) For the last six months of fiscal year 1999, the applicable
amount under this clause is $1,500,000, or the amount specified in the
budget request of the President for the six-month period involved for
carrying out the notification program in fiscal year 1999, whichever is
less.
(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal year
involved for carrying out the notification program under this
subsection, whichever is less.
(B) For purposes of carrying out the notification program under this
subsection, there are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 1999 through fiscal year 2003,
except that such authorization of appropriations is not effective for a
fiscal year for any amount that is less than the applicable amount under
clause (iii) or (iv) of subparagraph (A), whichever is applicable.
(C) Not later than April 1 of fiscal year 1998 and February 1 of
each subsequent fiscal year, the Secretary shall submit a report to the
Committees on Appropriations of the House of Representatives and the
Senate, the Committee on Commerce of the House of Representatives, and
the Committee on Labor and Human Resources of the Senate that provides
an estimate of the Secretary of the costs of carrying out the
notification program established under this subsection for the next
fiscal year.
(6) In this section, the term ``food contact substance'' means any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if such
use is not intended to have any technical effect in such food.
(i) Amendment or repeal of regulations
The Secretary shall by regulation prescribe the procedure by which
regulations under the foregoing provisions of this section may be
amended or repealed, and such procedure shall conform to the procedure
provided in this section for the promulgation of such regulations. The
Secretary shall by regulation prescribe the procedure by which the
Secretary may deem a notification under subsection (h) of this section
to no longer be effective.
(j) Exemptions for investigational use
Without regard to subsections (b) to (i), inclusive, of this
section, the Secretary shall by regulation provide for exempting from
the requirements of this section any food additive, and any food bearing
or containing such additive, intended solely for investigational use by
qualified experts when in his opinion such exemption is consistent with
the public health.
(June 25, 1938, ch. 675, Sec. 409, as added Pub. L. 85-929, Sec. 4,
Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86-546, Sec. 2, June 29,
1960, 74 Stat. 255; Pub. L. 87-781, title I, Sec. 104(f)(1), Oct. 10,
1962, 76 Stat. 785; Pub. L. 98-620, title IV, Sec. 402(25)(B), Nov. 8,
1984, 98 Stat. 3359; Pub. L. 105-115, title III, Sec. 309, Nov. 21,
1997, 111 Stat. 2354.)
Amendments
1997--Subsec. (a). Pub. L. 105-115, Sec. 309(a)(4), in closing
provisions, substituted ``While such a regulation relating to a food
additive, or such a notification under subsection (h)(1) of this section
relating to a food additive that is a food contact substance, is in
effect, and has not been revoked pursuant to subsection (i) of this
section, a food shall not, by reason of bearing or containing such a
food additive in accordance with the regulation or notification, be
considered adulterated under section 342(a)(1) of this title.'' for
``While such a regulation relating to a food additive is in effect, a
food shall not, by reason of bearing or containing such an additive in
accordance with the regulation, be considered adulterated within the
meaning of clause (1) of section 342(a) of this title.''
Subsec. (a)(1). Pub. L. 105-115, Sec. 309(a)(1), substituted
``subsection (j)'' for ``subsection (i)''.
Subsec. (a)(3). Pub. L. 105-115, Sec. 309(a)(1)(B), (2), (3), added
par. (3).
Subsec. (h). Pub. L. 105-115, Sec. 309(b)(2), added subsec. (h).
Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 105-115, Sec. 309(b)(1), (3), redesignated
subsec. (h) as (i) and inserted at end ``The Secretary shall by
regulation prescribe the procedure by which the Secretary may deem a
notification under subsection (h) of this section to no longer be
effective.''
Subsec. (j). Pub. L. 105-115, Sec. 309(b)(1), (4), redesignated
subsec. (i) as (j) and substituted ``subsections (b) to (i)'' for
``subsections (b) to (h)''.
1984--Subsec. (g)(2). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the disposition
of all causes filed therein pursuant to this section.
1962--Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from
applying to use of a substance as an ingredient of feed for animals
raised for food production, if under conditions of use specified in
proposed labeling, and which conditions are reasonably certain to be
followed in practice, such additive will not adversely affect the
animals and no residue will be found in any edible portion of such
animal after slaughter, or in any food from the living animal.
1960--Subsec. (g)(2). Pub. L. 86-546 substituted ``forthwith
transmitted by the clerk of the court to the Secretary, or any officer''
for ``served upon the Secretary, or upon any officer'', ``shall file in
the court the record of the proceedings on which he based his order, as
provided in section 2112 of title 28'' for ``shall certify and file in
the court a transcript of the proceedings and the record on which he
based his order'', and ``Upon the filing of such petition the court
shall have jurisdiction, which upon the filing of the record with it
shall be exclusive,'' for ``Upon such filing, the court shall have
exclusive jurisdiction'', and inserted sentence authorizing the
Secretary to modify or set aside his order until the filing of the
record.
Change of Name
Committee on Commerce of House of Representatives changed to
Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and
insurance generally transferred to Committee on Financial Services of
House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
Effective Date of 1997 Amendment
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997,
except as otherwise provided, see section 501 of Pub. L. 105-115, set
out as a note under section 321 of this title.
Effective Date of 1984 Amendment
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date
note under section 1657 of Title 28, Judiciary and Judicial Procedure.
Effective Date of 1962 Amendment; Exceptions
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section 107
of Pub. L. 87-781, set out as an Effective Date of 1962 Amendment note
under section 321 of this title.
Effective Date
Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85-929,
set out as an Effective Date of 1958 Amendment note under section 342 of
this title.
Transfer of Functions
Functions vested in Secretary of Health, Education, and Welfare [now
Health and Human Services] in establishing tolerances for pesticide
chemicals under this section together with authority to monitor
compliance with tolerances and effectiveness of surveillance and
enforcement and to provide technical assistance to States and conduct
research under this chapter and section 201 et seq. of Title 42, The
Public Health and Welfare, transferred to Administrator of Environmental
Protection Agency by Reorg. Plan No. 3 of 1970, Sec. 2(a)(4), eff. Dec.
2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out in the Appendix to Title
5, Government Organization and Employees.
Glass and Ceramic Ware
Section 308 of Pub. L. 105-115 provided that:
``(a) In General.--The Secretary may not implement any requirement
which would ban, as an unapproved food additive, lead and cadmium based
enamel in the lip and rim area of glass and ceramic ware before the
expiration of one year after the date such requirement is published.
``(b) Lead and Cadmium Based Enamel.--Unless the Secretary
determines, based on available data, that lead and cadmium based enamel
on glass and ceramic ware--
``(1) which has less than 60 millimeters of decorating area
below the external rim, and
``(2) which is not, by design, representation, or custom of
usage intended for use by children,
is unsafe, the Secretary shall not take any action before January 1,
2003, to ban lead and cadmium based enamel on such glass and ceramic
ware. Any action taken after January 1, 2003, to ban such enamel on such
glass and ceramic ware as an unapproved food additive shall be taken by
regulation and such regulation shall provide that such products shall
not be removed from the market before 1 year after publication of the
final regulation.''
Moratorium on Authority of Secretary With Respect to Saccharin
Pub. L. 95-203, Sec. 3, Nov. 23, 1977, 91 Stat. 1452, as amended by
Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub.
L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42, Sec. 2, Aug. 14,
1981, 95 Stat. 946; Pub. L. 98-22, Sec. 2, Apr. 22, 1983, 97 Stat. 173;
Pub. L. 99-46, May 24, 1985, 99 Stat. 81; Pub. L. 100-71, title I,
Sec. 101, July 11, 1987, 101 Stat. 431; Pub. L. 102-142, title VI, Oct.
28, 1991, 105 Stat. 910; Pub. L. 104-180, title VI, Sec. 602, Aug. 6,
1996, 110 Stat. 1594, provided that: ``During the period ending May 1,
2002, the Secretary--
``(1) may not amend or revoke the interim food additive
regulation of the Food and Drug Administration of the Department of
Health and Human Services applicable to saccharin and published on
March 15, 1977 (section 180.37 of part 180, subchapter B, chapter 1,
title 21, Code of Federal Regulations (42 Fed. Reg. 14638)), or
``(2) may, except as provided in section 4 [enacting section
343a of this title, amending sections 321 and 343 of this title, and
enacting provisions set out as notes under section 343 of this
title] and the amendments made by such section, not take any other
action under the Federal Food, Drug, and Cosmetic Act [this chapter]
to prohibit or restrict the sale or distribution of saccharin, any
food permitted by such interim food additive regulation to contain
saccharin, or any drug or cosmetic containing saccharin,
solely on the basis of the carcinogenic or other toxic effect of
saccharin as determined by any study made available to the Secretary
before the date of the enactment of this Act [Nov. 23, 1977] which
involved human studies or animal testing, or both.''
For definition of ``saccharin'' as used in this note, see section
2(d) of Pub. L. 95-203.
Section Referred to in Other Sections
This section is referred to in sections 321, 331, 342, 343-3, 346a,
379e, 453, 601, 1033 of this title; title 7 sections 136, 450i; title 15
section 1262; title 35 section 155.
