Notes on 21 U.S.C. § 343 : US Code - Notes

Search Notes on 21 U.S.C. § 343 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,
Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I, Sec.
102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),
formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
Pub. L. 94-278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat.
411; Pub. L. 95-203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat.
1452, 1453; Pub. L. 101-535, Secs. 2(a), 3(a), 7, Nov. 8, 1990, 104
Stat. 2353, 2357, 2364; Pub. L. 102-108, Sec. 2(a), (c), Aug. 17,
1991, 105 Stat. 549; Pub. L. 102-571, title I, Sec. 107(5), (6),
Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 2(b), 3(j),
Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103-417, Secs. 6, 7(a)-
(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104-
124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-115, title
III, Secs. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub. L. 106-
554, Sec. 1(a)(1) [title V, Sec. 517], Dec. 21, 2000, 114 Stat.
2763, 2763A-73; Pub. L. 107-171, title X, Secs. 10806(a)(2),
(b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L.
107-188, title III, Sec. 308(b), June 12, 2002, 116 Stat. 672; Pub.
L. 108-282, title II, Sec. 203(a), Aug. 2, 2004, 118 Stat. 906.)
AMENDMENTS
2004 - Pars. (w), (x). Pub. L. 108-282 added pars. (w) and (x).
2002 - Par. (h). Pub. L. 107-171, Sec. 10808(b), added subpar.
(3) and concluding provisions.
Par. (t). Pub. L. 107-171, Sec. 10806(a)(2), added par. (t).
Par. (u). Pub. L. 107-171, Sec. 10806(b)(2), added par. (u).
Par. (v). Pub. L. 107-188 added par. (v).
2000 - Par. (o). Pub. L. 106-554, which directed repeal of
section 403(o) of the Food, Drug, and Cosmetic Act, was executed by
repealing par. (o) of this section, which is section 403 of the
Federal Food, Drug, and Cosmetic Act, to reflect the probable
intent of Congress. Prior to repeal, par. (o) provided that a food
containing saccharin was to be deemed misbranded unless a specified
warning statement was placed in a conspicuous place on its label.
1997 - Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)
generally. Prior to amendment, cl. (B) read as follows: "If a claim
described in subparagraph (1)(A) is made with respect to a nutrient
in a food, the label or labeling of such food shall contain,
prominently and in immediate proximity to such claim, the following
statement: 'See _____ for nutrition information.'. In the statement
-
"(i) the blank shall identify the panel on which the
information described in the statement may be found, and
"(ii) if the Secretary determines that the food contains a
nutrient at a level which increases to persons in the general
population the risk of a disease or health-related condition
which is diet related, taking into account the significance of
the food in the total daily diet, the statement shall also
identify such nutrient."
Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G)
and (H).
Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C)
and (D).
Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after
second sentence "If the Secretary does not act within such 100
days, the petition shall be deemed to be denied unless an extension
is mutually agreed upon by the Secretary and the petitioner.",
inserted "or the petition is deemed to be denied" after "If the
Secretary denies the petition", and inserted at end "If the
Secretary does not act within such 90 days, the petition shall be
deemed to be denied unless an extension is mutually agreed upon by
the Secretary and the petitioner. If the Secretary issues a
proposed regulation, the rulemaking shall be completed within 540
days of the date the petition is received by the Secretary. If the
Secretary does not issue a regulation within such 540 days, the
Secretary shall provide the Committee on Commerce of the House of
Representatives and the Committee on Labor and Human Resources of
the Senate the reasons action on the regulation did not occur
within such 540 days."
Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).
1996 - Par. (p). Pub. L. 104-124 struck out par. (p), which
deemed products containing saccharin and offered for sale, but not
for immediate consumption, by retail establishment, to be
misbranded, unless notice of information required by subsec. (o)
was provided by manufacturer and prominently displayed near
product.
1994 - Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl.
(F) generally. Prior to amendment, cl. (F) read as follows: "If a
food to which section 350 of this title applies (as defined in
section 350(c) of this title) contains one or more of the nutrients
required by subparagraph (1) or (2) to be in the label or labeling
of the food, the label or labeling of such food shall comply with
the requirements of subparagraphs (1) and (2) in a manner which is
appropriate for such food and which is specified in regulations of
the Secretary."
Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).
Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).
Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: "A
dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings."
Pub. L. 103-417, Sec. 7(a), added par. (s).
1993 - Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted
"count, except that" for "count: Provided, That".
Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted "unless sold
as spices, flavorings, or such colors" for ", other than those sold
as such" and "naming each. To the extent" for "naming each:
Provided, That, to the extent".
Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted ", except
that" for ": Provided, That".
Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted "chemical,
except that" for "chemical: Provided, however, That".
Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E)
and redesignated former cls. (E) and (F) as (F) and (G),
respectively.
Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted
"(5)(D)" for "5(D)".
Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted
"paragraph" for "subsection".
1992 - Par. (i). Pub. L. 102-571, Sec. 107(5), substituted
"379e(c)" for "376(c)".
Par. (m). Pub. L. 102-571, Sec. 107(6), substituted "379e" for
"376".
1991 - Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory
language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment
note below.
Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted "(D)" for
"(C)".
1990 - Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L.
102-108, Sec. 2(c), substituted "Unless" for "If it is not subject
to the provisions of paragraph (g) unless", inserted "and if the
food purports to be a beverage containing vegetable or fruit juice,
a statement with appropriate prominence on the information panel of
the total percentage of such fruit or vegetable juice contained in
the food", and substituted "colors not required to be certified
under section 376(c) of this title" for "colorings" the first time
appearing.
Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).
Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).
1977 - Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).
Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).
1976 - Par. (a). Pub. L. 94-278 inserted "(1)" after "If" and
inserted ", or (2) in the case of a food to which section 350 of
this title applies, its advertising is false or misleading in a
material respect or its labeling is in violation of section
350(b)(2) of this title" after "any particular".
1970 - Par. (n). Pub. L. 91-601 added par. (n).
1960 - Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide
chemicals when used in or on a raw agricultural commodity which is
the produce of the soil.
Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).
Par. (m). Pub. L. 86-618 added par. (m).
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.
Committee on Labor and Human Resources of Senate changed to
Committee on Health, Education, Labor, and Pensions of Senate by
Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
1999.
EFFECTIVE DATE OF 2004 AMENDMENT
Amendment by Pub. L. 108-282 applicable to any food that is
labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
282, set out as a note under section 321 of this title.
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 1994 AMENDMENT
Section 7(e) of Pub. L. 103-417 provided that: "Dietary
supplements -
"(1) may be labeled after the date of the enactment of this Act
[Oct. 25, 1994] in accordance with the amendments made by this
section [amending this section and section 350 of this title],
and
"(2) shall be labeled after December 31, 1996, in accordance
with such amendments."
EFFECTIVE DATE OF 1990 AMENDMENT
Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided
that:
"(1) Except as provided in paragraph (2) -
"(A) the amendments made by section 2 [amending this section]
shall take effect 6 months after -
"(i) the date of the promulgation of all final regulations
required to implement section 403(q) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 343(q)], or
"(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347],
except that section 403(q)(4) of such Act shall take effect as
prescribed by such section,
"(B) the amendments made by section 3 [amending this section]
shall take effect 6 months after -
"(i) the date of the promulgation of final regulations to
implement section 403(r) of the Federal Food, Drug, and
Cosmetic Act, or
"(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any
person marketing a food the brand name of which contains a term
defined by the Secretary under section 403(r)(2)(A)(i) of the
Federal Food, Drug, and Cosmetic Act shall be given an
additional 6 months to comply with section 3,
"(C) the amendments made by section 4 [amending section 337 of
this title] shall take effect 24 months after the date of the
enactment of this Act [Nov. 8, 1990], except that such amendments
shall take effect with respect to such dietary supplements
[probably means dietary supplements of vitamins, minerals, herbs,
or other similar nutritional substances, see section 202(a)(1) of
Pub. L. 102-571, set out below] on December 31, 1993, and
"(D) the amendments made by section 5 [amending sections 321
and 345 of this title] shall take effect on the date the
amendments made by section 3 take effect.
"(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act
(as added by section 2) shall not apply with respect to food which
was labeled before the effective date of the amendments made by
section 2 and section 403(r) of the Federal Food, Drug, and
Cosmetic Act (as added by section 3) shall not apply with respect
to food which was labeled before the effective date of the
amendments made by section 3.
"(3)(A) If the Secretary finds that a person who is subject to
section 403(q)(4) of such Act is unable to comply with the
requirements of such section upon the effective date of final
regulations to implement section 403(q) of such Act or of proposed
regulations to be considered as such final regulations because the
Secretary has not made available to such person the information
required by such section, the Secretary shall delay the application
of such section to such person for such time as the Secretary may
require to provide such information.
"(B) If the Secretary finds that compliance with section 403(q)
or 403(r)(2) of such Act would cause an undue economic hardship,
the Secretary may delay the application of such sections for no
more than one year."
Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,
Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,
Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
"(1) Except as provided in paragraphs (2) and (3), the amendments
made by section 7 [amending this section] shall take effect one
year after the date of the enactment of this Act [Nov. 8, 1990].
"(2)(A) If a food subject to section 403(g) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or
more colors required to be certified under section 721(c) [of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a
label which was printed before July 1, 1991, and which is attached
to the food before May 8, 1993, such food shall not be subject to
the amendments made by section 7(1) and section 7(3) [amending this
section].
"(B) If a food described in subparagraph (A) -
"(i) bears a label which was printed after July 1, 1991, but
before the date the proposed regulation described in clause (ii)
takes effect as a final regulation and which was attached to the
food before May 8, 1993, and
"(ii) meets the requirements of the proposed regulation of the
Secretary of Health and Human Services published in 56 Fed. Reg.
28592-28636 (June 21, 1991) as it pertains to the amendments made
by this Act [see Short Title of 1990 Amendment note set out under
section 301 of this title],
such food shall not be subject to the amendments made by section
7(1) and section 7(3) [amending this section].
"(3) A food purported to be a beverage containing a vegetable or
fruit juice which bears a label attached to the food before May 8,
1993, shall not be subject to the amendments made by section 7(2)
[amending this section]."
EFFECTIVE DATE OF 1977 AMENDMENT
Section 4(a)(2) of Pub. L. 95-203 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply only with
respect to food introduced or delivered for introduction in
interstate commerce on and after the 90th day after the date of the
enactment of this Act [Nov. 23, 1977]."
Section 4(b)(2) of Pub. L. 95-203 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply with
respect to food which is sold in retail establishments on or after
the 90th day after the effective date of the regulations of the
Secretary of Health, Education, and Welfare [now Secretary of
Health and Human Services] under paragraph (p)(4) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)]."
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
subsections effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain
labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
an Effective Date; Postponement in Certain Cases note under section
301 of this title.
CONSTRUCTION OF AMENDMENT BY PUB. L. 108-282
Pub. L. 108-282, title II, Sec. 203(b), Aug. 2, 2004, 118 Stat.
908, provided that: "The amendments made by this section [amending
this section and sections 321 and 343-1 of this title] that require
a label or labeling for major food allergens do not alter the
authority of the Secretary of Health and Human Services under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to
require a label or labeling for other food allergens."
CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188
Nothing in amendment by Pub. L. 107-188 to be construed to limit
authority of Secretary of Health and Human Services or Secretary of
the Treasury to require marking of articles of food imported or
offered for import into the United States which are refused
admission, see section 308(c) of Pub. L. 107-188, set out as a note
under section 381 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Section 9 of Pub. L. 101-535 provided that: "The amendments made
by this Act [enacting section 343-1 of this title and amending this
section and sections 321, 337, 345, and 371 of this title] shall
not be construed to alter the authority of the Secretary of Health
and Human Services and the Secretary of Agriculture under the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the
Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry
Products Inspection Act [21 U.S.C. 451 et seq.], and the Egg
Products Inspection Act [21 U.S.C. 1031 et seq.]."
FINDINGS
Pub. L. 108-282, title II, Sec. 202, Aug. 2, 2004, 118 Stat. 905,
provided that: "Congress finds that -
"(1) it is estimated that -
"(A) approximately 2 percent of adults and about 5 percent of
infants and young children in the United States suffer from
food allergies; and
"(B) each year, roughly 30,000 individuals require emergency
room treatment and 150 individuals die because of allergic
reactions to food;
"(2)(A) eight major foods or food groups - milk, eggs, fish,
Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans -
account for 90 percent of food allergies;
"(B) at present, there is no cure for food allergies; and
"(C) a food allergic consumer must avoid the food to which the
consumer is allergic;
"(3)(A) in a review of the foods of randomly selected
manufacturers of baked goods, ice cream, and candy in Minnesota
and Wisconsin in 1999, the Food and Drug Administration found
that 25 percent of sampled foods failed to list peanuts or eggs
as ingredients on the food labels; and
"(B) nationally, the number of recalls because of unlabeled
allergens rose to 121 in 2000 from about 35 a decade earlier;
"(4) a recent study shows that many parents of children with a
food allergy were unable to correctly identify in each of several
food labels the ingredients derived from major food allergens;
"(5)(A) ingredients in foods must be listed by their 'common or
usual name';
"(B) in some cases, the common or usual name of an ingredient
may be unfamiliar to consumers, and many consumers may not
realize the ingredient is derived from, or contains, a major food
allergen; and
"(C) in other cases, the ingredients may be declared as a
class, including spices, flavorings, and certain colorings, or
are exempt from the ingredient labeling requirements, such as
incidental additives; and
"(6)(A) celiac disease is an immune-mediated disease that
causes damage to the gastrointestinal tract, central nervous
system, and other organs;
"(B) the current recommended treatment is avoidance of glutens
in foods that are associated with celiac disease; and
"(C) a multicenter, multiyear study estimated that the
prevalence of celiac disease in the United States is 0.5 to 1
percent of the general population."
REGULATIONS
Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
4501, provided that:
"(1) The Secretary of Health and Human Services shall issue
proposed regulations to implement section 403(q) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months
after the date of the enactment of this Act [Nov. 8, 1990], except
that the Secretary shall issue, not later than June 15, 1993,
proposed regulations that are applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
to implement such section. Not later than 24 months after the date
of the enactment of this Act, the Secretary shall issue final
regulations to implement the requirements of such section, except
that the Secretary shall issue, not later than December 31, 1993,
such a final regulation applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances..[sic] Such regulations shall -
"(A) require the required information to be conveyed to the
public in a manner which enables the public to readily observe
and comprehend such information and to understand its relative
significance in the context of a total daily diet,
"(B) include regulations which establish standards, in
accordance with paragraph (1)(A), to define serving size or other
unit of measure for food,
"(C) permit the label or labeling of food to include nutrition
information which is in addition to the information required by
such section 403(q) and which is of the type described in
subparagraph (1) or (2) of such section, and
"(D) permit the nutrition information on the label or labeling
of a food to remain the same or permit the information to be
stated as a range even though (i) there are minor variations in
the nutritional value of the food which occur in the normal
course of the production or processing of the food, or (ii) the
food is comprised of an assortment of similar foods which have
variations in nutritional value.
"(2) If the Secretary of Health and Human Services does not
promulgate final regulations under paragraph (1) upon the
expiration of 24 months after the date of the enactment of this
Act, the proposed regulations issued in accordance with paragraph
(1) shall be considered as the final regulations upon the
expiration of such 24 months, except that the proposed regulations
applicable to dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances shall not be considered to be
final regulations until December 31, 1993. There shall be promptly
published in the Federal Register notice of new status of the
proposed regulations [see 57 F.R. 56347].
"(3) If the Secretary of Health and Human Services does not
promulgate final regulations under section 403(q)(4) of the Federal
Food, Drug, and Cosmetic Act upon the expiration of 6 months after
the date on which the Secretary makes a finding that there has been
no substantial compliance with section 403(q)(4)(C) of such Act,
the proposed regulations issued in accordance with such section
shall be considered as the final regulations upon the expiration of
such 6 months. There shall be promptly published in the Federal
Register notice of new status of the proposed regulations."
[Section 202(a)(2)(C) of Pub. L. 102-571 provided that: "The
amendments made by subparagraph (B) [amending sections 2(b) and
3(b) of Pub. L. 101-535, set out above and below] shall not be
construed to modify the effective date of final regulations under
sections 2(b) and 3(b) of the Nutrition Labeling and Education Act
of 1990 [Pub. L. 101-535] (21 U.S.C. 343 note) with respect to
foods that are not such dietary supplements."]
Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
4501, provided that:
"(1)(A) Within 12 months of the date of the enactment of this Act
[Nov. 8, 1990], the Secretary of Health and Human Services shall
issue proposed regulations to implement section 403(r) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except
that the Secretary shall issue, not later than June 15, 1993,
proposed regulations that are applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
to implement such section. Such regulations -
"(i) shall identify claims described in section 403(r)(1)(A) of
such Act which comply with section 403(r)(2) of such Act,
"(ii) shall identify claims described in section 403(r)(1)(B)
of such Act which comply with section 403(r)(3) of such Act,
"(iii) shall, in defining terms used to characterize the level
of any nutrient in food under section 403(r)(2)(A)(i) of such
Act, define -
"(I) free,
"(II) low,
"(III) light or lite,
"(IV) reduced,
"(V) less, and
"(VI) high,
unless the Secretary finds that the use of any such term would be
misleading,
"(iv) shall permit statements describing the amount and
percentage of nutrients in food which are not misleading and are
consistent with the terms defined in section 403(r)(2)(A)(i) of
such Act,
"(v) shall provide that if multiple claims subject to section
403(r)(1)(A) of such Act are made on a single panel of the food
label or page of a labeling brochure, a single statement may be
made to satisfy section 403(r)(2)(B) of such Act,
"(vi) shall determine whether claims respecting the following
nutrients and diseases meet the requirements of section 403(r)(3)
of such Act: Calcium and osteoporosis, dietary fiber and cancer,
lipids and cardiovascular disease, lipids and cancer, sodium and
hypertension, and dietary fiber and cardiovascular disease,
"(vii) shall not require a person who proposes to make a claim
described in section 403(r)(1)(B) of such Act which is in
compliance with such regulations to secure the approval of the
Secretary before making such claim,
"(viii) may permit a claim described in section 403(r)(1)(A) of
such Act to be made for butter,
"(ix) may, in defining terms under section 403(r)(2)(A)(i),
include similar terms which are commonly understood to have the
same meaning, and
"(x) shall establish, as required by section 403(r)(5)(D), the
procedure and standard respecting the validity of claims made
with respect to a dietary supplement of vitamins, minerals,
herbs, or other similar nutritional substances and shall
determine whether claims respecting the following nutrients and
diseases meet the requirements of section 403(r)(5)(D) of such
Act: folic acid and neural tube defects, antioxident [sic]
vitamins and cancer, zinc and immune function in the elderly, and
omega-3 fatty acids and heart disease.
"(B) Not later than 24 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
section 403(r) of the Federal Food, Drug, and Cosmetic Act, except
that the Secretary shall issue, not later than December 31, 1993,
such a final regulation applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances..[sic]
"(2) If the Secretary does not promulgate final regulations under
paragraph (1)(B) upon the expiration of 24 months after the date of
the enactment of this Act, the proposed regulations issued in
accordance with paragraph (1)(A) shall be considered as the final
regulations upon the expiration of such 24 months, except that the
proposed regulations applicable to dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances shall not
be considered to be final regulations until December 31, 1993.
There shall be promptly published in the Federal Register notice of
the new status of the proposed regulations [see 57 F.R. 56347]."
[For construction of amendment made by section 202(a)(2)(B) of
Pub. L. 102-571 to section 3(b) of Pub. L. 101-535 set out above,
see section 202(a)(2)(C) of Pub. L. 102-571 set out above following
section 2(b) of Pub. L. 101-535.]
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
RULEMAKING ON LABELING
Pub. L. 108-282, title II, Sec. 206, Aug. 2, 2004, 118 Stat. 910,
provided that: "Not later than 2 years after the date of enactment
of this Act [Aug. 2, 2004], the Secretary of Health and Human
Services, in consultation with appropriate experts and
stakeholders, shall issue a proposed rule to define, and permit use
of, the term 'gluten-free' on the labeling of foods. Not later than
4 years after the date of enactment of this Act, the Secretary
shall issue a final rule to define, and permit use of, the term
'gluten-free' on the labeling of foods."
Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat.
531, provided that: "The Secretary of Health and Human Services
(referred to in this section as the 'Secretary') shall publish a
proposed rule and, with due consideration to public comment, a
final rule to revise, as appropriate, the current regulation
governing the labeling of foods that have been treated to reduce
pest infestation or pathogens by treatment by irradiation using
radioactive isotope, electronic beam, or x-ray. Pending
promulgation of the final rule required by this subsection
[probably should be "this section"], any person may petition the
Secretary for approval of labeling, which is not false or
misleading in any material respect, of a food which has been
treated by irradiation using radioactive isotope, electronic beam,
or x-ray. The Secretary shall approve or deny such a petition
within 180 days of receipt of the petition, or the petition shall
be deemed denied, except to the extent additional agency review is
mutually agreed upon by the Secretary and the petitioner. Any
denial of a petition under this subsection shall constitute final
agency action subject to judicial review by the United States Court
of Appeals for the District of Columbia Circuit. Any labeling
approved through the foregoing petition process shall be subject to
the provisions of the final rule referred to in the first sentence
of the subparagraph on the effective date of such final rule."
COMMISSION ON DIETARY SUPPLEMENT LABELS
Section 12 of Pub. L. 103-417 provided that:
"(a) Establishment. - There shall be established as an
independent agency within the executive branch a commission to be
known as the Commission on Dietary Supplement Labels (hereafter in
this section referred to as the 'Commission').
"(b) Membership. -
"(1) Composition. - The Commission shall be composed of 7
members who shall be appointed by the President.
"(2) Expertise requirement. - The members of the Commission
shall consist of individuals with expertise and experience in
dietary supplements and in the manufacture, regulation,
distribution, and use of such supplements. At least three of the
members of the Commission shall be qualified by scientific
training and experience to evaluate the benefits to health of the
use of dietary supplements and one of such three members shall
have experience in pharmacognosy, medical botany, traditional
herbal medicine, or other related sciences. Members and staff of
the Commission shall be without bias on the issue of dietary
supplements.
"(c) Functions of the Commission. - The Commission shall conduct
a study on, and provide recommendations for, the regulation of
label claims and statements for dietary supplements, including the
use of literature in connection with the sale of dietary
supplements and procedures for the evaluation of such claims. In
making such recommendations, the Commission shall evaluate how best
to provide truthful, scientifically valid, and not misleading
information to consumers so that such consumers may make informed
and appropriate health care choices for themselves and their
families.
"(d) Administrative Powers of the Commission. -
"(1) Hearings. - The Commission may hold hearings, sit and act
at such times and places, take such testimony, and receive such
evidence as the Commission considers advisable to carry out the
purposes of this section.
"(2) Information from federal agencies. - The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section.
"(3) Authorization of appropriations. - There are authorized to
be appropriated such sums as may be necessary to carry out this
section.
"(e) Reports and Recommendations. -
"(1) Final report required. - Not later than 24 months after
the date of enactment of this Act [Oct. 25, 1994], the Commission
shall prepare and submit to the President and to the Congress a
final report on the study required by this section.
"(2) Recommendations. - The report described in paragraph (1)
shall contain such recommendations, including recommendations for
legislation, as the Commission deems appropriate.
"(3) Action on recommendations. - Within 90 days of the
issuance of the report under paragraph (1), the Secretary of
Health and Human Services shall publish in the Federal Register a
notice of any recommendation of Commission for changes in
regulations of the Secretary for the regulation of dietary
supplements and shall include in such notice a notice of proposed
rulemaking on such changes together with an opportunity to
present views on such changes. Such rulemaking shall be completed
not later than 2 years after the date of the issuance of such
report. If such rulemaking is not completed on or before the
expiration of such 2 years, regulations of the Secretary
published in 59 FR 395-426 on January 4, 1994, shall not be in
effect."
EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED
PRIOR TO AUGUST 8, 1994
Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: "That
before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the
provision of section 403(i) of such Act added by section 7(2) of
the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-535],
shall not apply with respect to a food product which is contained
in a package for which the label was printed before May 8, 1994 (or
before August 8, 1994, in the case of a juice or milk food product
if the person responsible for the labeling of such food product
exercised due diligence in obtaining before such date labels which
are in compliance with such sections 403(q) and 403(r)(2) and such
provision of section 403(i)), if, before June 15, 1994, the person
who introduces or delivers for introduction such food product into
interstate commerce submits to the Secretary of Health and Human
Services a certification that such person will comply with this
section and will comply with such sections 403(q) and 403(r)(2) and
such provision of section 403(i) after August 8, 1994."
LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION
Section 2(a) of Pub. L. 103-80 provided that:
"(1) Before may 8, 1995. - Before May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in
accordance with the regulations of the Secretary of Health and
Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).
"(2) After may 8, 1995. - After May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and
Cosmetic Act shall only be available with respect to food when it
is sold to consumers."
PROHIBITION ON IMPLEMENTATION OF PUB. L. 101-535 WITH RESPECT TO
DIETARY SUPPLEMENTS
Section 202(a)(1) of Pub. L. 102-571 provided that:
"Notwithstanding any other provision of law and except as provided
in subsection (b) [set out as a note below] and in the amendment
made by paragraph (2)(A) [amending provisions set out as notes
above], the Secretary of Health and Human Services may not
implement the Nutrition Labeling and Education Act of 1990 (Public
Law 101-535; 104 Stat. 2353) [see Short Title of 1990 Amendments
note set out under section 301 of this title], or any amendment
made by such Act, earlier than December 15, 1993, with respect to
dietary supplements of vitamins, minerals, herbs, or other similar
nutritional substances."
HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS
Section 202(b) of Pub. L. 102-571 provided that: "Notwithstanding
section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions
set out as notes above and amending provisions set out as notes
above and under section 343-1 of this title], the Secretary of
Health and Human Services may, earlier than December 15, 1993,
approve claims made with respect to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
that are claims described in clauses (vi) and (x) of section
3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990
[Pub. L. 101-535] (21 U.S.C. 343 note)."
UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS
Section 203 of Pub. L. 102-571 provided that: "Notwithstanding
any other provision of Federal law, no regulations that require the
use of, or are based upon, recommended daily allowances of vitamins
or minerals may be promulgated before November 8, 1993 (other than
regulations establishing the United States recommended daily
allowances specified at section 101.9(c)(7)(iv) of title 21, Code
of Federal Regulations, as in effect on October 6, 1992, or
regulations under section 403(r)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such
recommended daily allowances)."
CONSUMER EDUCATION
Section 2(c) of Pub. L. 101-535 provided that: "The Secretary of
Health and Human Services shall carry out activities which educate
consumers about -
"(1) the availability of nutrition information in the label or
labeling of food, and
"(2) the importance of that information in maintaining healthy
dietary practices."
STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD
AND IMPURITIES IN AND TOXICITY OF SACCHARIN
Section 2 of Pub. L. 95-203 directed Secretary of Health,
Education, and Welfare to conduct a study concerning carcinogenic
and other toxic substances in food and impurities in and toxicity
of saccharin and make a report respecting the carcinogenic and
other substances to Committee on Human Resources of the Senate
within 12 months of Nov. 23, 1977, and a report respecting
saccharin to such committee within 15 months of Nov. 23, 1977.
REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT
TO FORMER PAR. (O)(2)
Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was
to report to specified congressional committees any action taken
under former par. (o)(2) of this section.
STATE OR TERRITORIAL REQUIREMENTS
Section 2 of Pub. L. 86-537 provided that: "Nothing in the
amendments made by the first section of this Act [amending this
section] shall affect any requirement of the laws of any State or
Territory."
(!1) So in original. Probably should be followed by a comma.