H. R. 2900
One Hundred Third Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fifth day of January, one thousand nine hundred and ninety-three
An Act
To clarify and revise the small business exemption from the nutrition labeling
requirements of the Federal Food, Drug, and Cosmetic Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Nutrition Labeling and Education
Act Amendments of 1993’’.
SEC. 2. SMALL BUSINESS EXEMPTION.
(a) APPLICATION OF EXISTING EXEMPTION.—
(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 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.
(b) NEW EXEMPTION.—Section 403(q)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by
redesignating clauses (E) and (F) as clauses (F) and (G), respec-
tively, and by adding after clause (D) the following:
‘‘(E)(i) During the 12-month period for which an exemption
from subparagraphs (1) and (2) is claimed pursuant to this
subclause, the requirements of such subparagraphs shall not apply
to any food product if—
‘‘(I) the labeling for such product does not provide nutrition
information or make a claim subject to paragraph (r),
‘‘(II) the person who claims for such product an exemption
from such subparagraphs employed fewer than an average of
100 full-time equivalent employees,
‘‘(III) such person provided the notice described in subclause
(iii), and
‘‘(IV) in the case of a food product which was sold in
the 12-month period preceding the period for which an exemp-
tion was claimed, fewer than 100,000 units of such product
were sold in the United States during such preceding period,
or in the case of a food product which was not sold in the
12-month period preceding the period for which such exemption
is claimed, fewer than 100,000 units of such product are reason-
ably anticipated to be sold in the United States during the
period for which such exemption is claimed.
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H. R. 2900—2
‘‘(ii) During the 12-month period after the applicable date
referred to in this sentence, the requirements of subparagraphs
(1) and (2) shall not apply to any food product which was first
introduced into interstate commerce before May 8, 1994, if the
labeling for such product does not provide nutrition information
or make a claim subject to paragraph (r), if such person provided
the notice described in subclause (iii), and if—
‘‘(I) during the 12-month period preceding May 8, 1994,
the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 300
full-time equivalent employees and fewer than 600,000 units
of such product were sold in the United States,
‘‘(II) during the 12-month period preceding May 8, 1995,
the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 300
full-time equivalent employees and fewer than 400,000 units
of such product were sold in the United States, or
‘‘(III) during the 12-month period preceding May 8, 1996,
the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 200
full-time equivalent employees and fewer than 200,000 units
of such product were sold in the United States.
‘‘(iii) The notice referred to in subclauses (i) and (ii) shall
be given to the Secretary prior to the beginning of the period
during which the exemption under subclause (i) or (ii) is to be
in effect, shall state that the person claiming such exemption for
a food product has complied with the applicable requirements of
subclause (i) or (ii), and shall—
‘‘(I) state the average number of full-time equivalent
employees such person employed during the 12 months preced-
ing the date such person claims such exemption,
‘‘(II) state the approximate number of units the person
claiming the exemption sold in the United States,
‘‘(III) if the exemption is claimed for a food product which
was sold in the 12-month period preceding the period for which
the exemption was claimed, state the approximate number
of units of such product which were sold in the United States
during such preceding period, and, if the exemption is claimed
for a food product which was not sold in such preceding period,
state the number of units of such product which such person
reasonably anticipates will be sold in the United States during
the period for which the exemption was claimed, and
‘‘(IV) contain such information as the Secretary may require
to verify the information required by the preceding provisions
of this subclause if the Secretary has questioned the validity
of such information.
If a person is not an importer, has fewer than 10 full-time equiva-
lent employees, and sells fewer than 10,000 units of any food
product in any year, such person is not required to file a notice
for such product under this subclause for such year.
‘‘(iv) In the case of a person who claimed an exemption under
subclause (i) or (ii), if, during the period of such exemption, the
number of full-time equivalent employees of such person exceeds
the number in such subclause or if the number of food products
sold in the United States exceeds the number in such subclause,
such exemption shall extend to the expiration of 18 months after
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H. R. 2900—3
the date the number of full-time equivalent employees or food
products sold exceeded the applicable number.
‘‘(v) For any food product first introduced into interstate com-
merce after May 8, 2002, the Secretary may by regulation lower
the employee or units of food products requirement of subclause
(i) if the Secretary determines that the cost of compliance with
such lower requirement will not place an undue burden on persons
subject to such lower requirement.
‘‘(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)—
‘‘(I) the term ‘unit’ means the packaging or, if there is
no packaging, the form in which a food product is offered
for sale to consumers,
‘‘(II) the term ‘food product’ means food in any sized pack-
age which is manufactured by a single manufacturer or which
bears the same brand name, which bears the same statement
of identity, and which has similar preparation methods, and
‘‘(III) the term ‘person’ in the case of a corporation includes
all domestic and foreign affiliates of the corporation.’’.
SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND
COSMETIC ACT.
(a) REFERENCE.—Whenever in this section an amendment or
repeal is expressed in terms of an amendment to, or repeal of,
a section or other provision, the reference shall be considered to
be made to a section or other provision of the Federal Food, Drug,
and Cosmetic Act.
(b) SECTION 201.—Paragraphs (w), (x), (y), (z), (aa), (bb), (cc),
(dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated
as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee)
respectively.
(c) SECTION 301.—Section 301 (21 U.S.C. 331) is amended—
(1) in subsection (j), by striking out ‘‘721, or 708’’ and
inserting in lieu thereof ‘‘708, or 721’’; and
(2) in subsection (s), by striking out ‘‘412(d)’’ and inserting
in lieu thereof ‘‘412(e)’’.
(d) SECTION 302.—Section 302 (21 U.S.C. 332) is amended—
(1) in subsection (a), by striking out ‘‘, and subject to’’
and all that follows through ‘‘381),’’, and
(2) in subsection (b), by striking out the second sentence.
(e) SECTION 303.—Section 303 (21 U.S.C. 333) is amended by
redesignating the second subsection (e) and subsection (f) as sub-
sections (f) and (g), respectively.
(f) SECTION 304.—Section 304 (21 U.S.C. 334) is amended—
(1) in subsection (a)(1), by striking out ‘‘: Provided, however,
That no’’ and inserting in lieu thereof a period and ‘‘No’’,
and
(2) in subsection (d)(1)—
(A) by striking out ‘‘: Provided, That after’’ and insert-
ing in lieu thereof a period and ‘‘After’’,
(B) by striking out ‘‘: Provided, however, That the’’
and inserting in lieu thereof a period and ‘‘The’’,
(C) by striking out ‘‘: And provided further, That where’’
and inserting in lieu thereof a period and ‘‘Where’’, and
(D) by striking out ‘‘the foregoing proviso’’ and inserting
in lieu thereof ‘‘the preceding sentence’’.
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