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), respectively, 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 exemption 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 reasonably anticipated to be sold in the United States during the

period for which such exemption is claimed.

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‘‘(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 preceding 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 equivalent 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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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 commerce 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 package 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 subsections (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 inserting 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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(g) SECTION 307.—Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A))

is amended by striking out ‘‘Act’’ and inserting in lieu thereof

‘‘section’’.

(h) SECTION 401.—Section 401 (21 U.S.C. 341) is amended

by striking out ‘‘and/or reasonable standards of fill of container:

Provided, That no’’ and inserting in lieu thereof ‘‘or reasonable

standards of fill of container. No’’.

(i) SECTION 402.—Section 402 (21 U.S.C. 342) is amended—

(1) by striking out ‘‘; or’’ at the end of subparagraphs

(1) and (2) of paragraph (a) and inserting in lieu thereof a

period and by striking out ‘‘if it’’ at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof ‘‘If

it’’,

(2) in paragraph (d)(1), by striking out ‘‘: Provided, That

this clause’’ and inserting in lieu thereof ‘‘, except that this

subparagraph’’, and

(3) in paragraph (d)(3), by striking out ‘‘: Provided, That

this clause’’ and inserting in lieu thereof ‘‘, except that this

subparagraph’’ and by striking out ‘‘: And provided further,

That the Secretary may, for the purpose of avoiding or resolving

uncertainty as to the application of this clause’’ and inserting

in lieu thereof ‘‘, except that the Secretary may, for the purpose

of avoiding or resolving uncertainty as to the application of

this subparagraph’’.

(j) SECTION 403.—Section 403 (21 U.S.C. 343) is amended—

(1) in paragraph (e), by striking out ‘‘: Provided, That’’

and inserting in lieu thereof ‘‘, except that’’,

(2) in paragraph (i), by striking out ‘‘, other than those

sold as such’’ and inserting in lieu thereof ‘‘unless sold as

spices, flavorings, or such colors’’ and by striking out ‘‘: Provided, That, to the extent’’ and inserting in lieu thereof a

period and ‘‘To the extent’’,

(3) in paragraph (k), by striking out ‘‘: Provided, That’’

and inserting in lieu thereof ‘‘, except that’’,

(4) in paragraph (l), by striking out ‘‘: Provided, however,

That’’ and inserting in lieu thereof ‘‘, except that’’,

(5) in paragraph (r)(1)(B), by striking out ‘‘5(D)’’ and inserting in lieu thereof ‘‘(5)(D)’’, and

(6) in paragraph (r)(4)(B), by striking out ‘‘subsection’’ and

inserting in lieu thereof ‘‘paragraph’’.

(k) SECTION 408.—Section 408 (21 U.S.C. 346a) is amended—

(1) in subsection (a)(1), by striking out ‘‘Secretary of Health

and Human Services’’ and inserting in lieu thereof ‘‘Administrator of the Environmental Protection Agency (hereinafter in

this section referred to as the ‘Administrator’)’’,

(2) in subsection (d)(5), by striking out ‘‘section 7(c) of

the Administrative Procedure Act (5 U.S.C., sec. 1006(c))’’ and

inserting in lieu thereof ‘‘section 556(c) of title 5, United States

Code’’,

(3) in subsection (l), by striking out ‘‘It the event’’ and

inserting in lieu thereof ‘‘In the event’’,

(4) in subsection (n), by striking out ‘‘of the Federal Food,

Drug, and Cosmetic Act’’,

(5) in subsection (o), by striking out ‘‘Secretary of Health

and Human Services’’ each place it occurs and inserting in

lieu thereof ‘‘Administrator’’, and

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(6) by striking out ‘‘Secretary’’ each place it occurs except

when followed by ‘‘of Agriculture’’ and inserting in lieu thereof

‘‘Administrator’’.

(l) SECTION 412.—Section 412(h) (21 U.S.C. 350a(h)) is amended

by striking out ‘‘(c)(1)(B),’’ and inserting in lieu thereof ‘‘(e)(1)(B)’’.

(m) SECTION 502.—Section 502 (21 U.S.C. 352) is amended—

(1) in paragraph (e)(3), by striking out ‘‘: Provided further,

That’’ and inserting in lieu thereof ‘‘, except that’’,

(2) in paragraph (f), by striking out ‘‘: Provided, That’’

and inserting in lieu thereof ‘‘, except that’’,

(3) in paragraph (g), by striking out ‘‘: Provided, That

the method’’ and inserting in lieu thereof a period and ‘‘The

method’’ and by striking out ‘‘: Provided further, That,’’ and

inserting in lieu thereof ‘‘, except that’’, and

(4) in paragraph (n), by striking out ‘‘: Provided, That’’

and inserting in lieu thereof ‘‘, except that’’.

(n) SECTION 505.—Section 505 (21 U.S.C. 355) is amended—

(1) in subsection (j)(6)(A)—

(A) by striking out ‘‘Secretry’’ in clause (ii) and inserting in lieu thereof ‘‘Secretary’’, and

(B) by inserting a comma after ‘‘Secretary’’ the first

time it appears in clause (iii).

(2) in subsection (k)(1), by striking out ‘‘: Provided, however,

That regulations’’ and inserting in lieu thereof a period and

‘‘Regulations’’.

(o) SECTION 506.—Section 506(a) (21 U.S.C. 356(a)) is amended

by striking out ‘‘Federal Security Administrator’’ and ‘‘Administrator’’ each place it appears and inserting in lieu thereof ‘‘Secretary’’.

(p) SECTION 507.—Section 507 (21 U.S.C. 357) is amended—

(1) in subsection (a), by striking out ‘‘Federal Security

Administrator’’ and ‘‘Administrator’’ each place it appears and

inserting in lieu thereof ‘‘Secretary’’,

(2) in subsection (e)—

(A) by striking out ‘‘section 507’’ each place it occurs

and inserting in lieu thereof ‘‘this section’’,

(B) by striking out ‘‘or 507’’ and inserting in lieu thereof

‘‘or this section’’, and

(C) by striking out ‘‘: Provided, That, for purposes’’

and inserting in lieu thereof a period and ‘‘For purposes’’,

(3) in subsection (g)(1), by striking out ‘‘: Provided, however,

That regulations’’ and inserting in lieu thereof a period and

‘‘Regulations’’, and

(4) in subsection (h), by striking out ‘‘507’’.

(q) SECTION 508.—Subsections (c) and (e) of section 508 (21

U.S.C. 358) are each amended by striking out ‘‘section 4 of the

Administrative Procedure Act (5 U.S.C. 1003)’’ and inserting in

lieu thereof ‘‘section 553 of title 5, United States Code’’.

(r) SECTION 512.—Section 512 (21 U.S.C. 360b) is amended—

(1) in subsection (c)(2)(A)(ii), by inserting ‘‘in’’ after ‘‘provided’’,

(2) in subsection (c)(2)(F)(i), by striking out ‘‘(C)(iii)’’ and

inserting in lieu thereof ‘‘(D)(iii)’’,

(3) in subsection (c)(2)(H), by striking out ‘‘subclause’’ the

first time it appears and inserting in lieu thereof ‘‘subclauses’’,

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(4) in subsection (d)(1), by striking out ‘‘subparagraphs

(A) through (G)’’ and inserting in lieu thereof ‘‘subparagraphs

(A) through (I)’’, and

(5) in subsection (n)(1)—

(A) by striking out ‘‘201(w)’’ in subparagraphs (B)(ii)(II)

and (C)(ii)(I) and inserting in lieu thereof ‘‘201(v)’’, and

(B) by striking out in the last sentence ‘‘(H)’’ and

inserting in lieu thereof ‘‘(I)’’.

(s) SECTION 513.—Section 513(b)(3) (21 U.S.C 360c(b)(3)) is

amended by striking out ‘‘5703(b)’’ and inserting in lieu thereof

‘‘5703’’.

(t) SECTION 515.—Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A))

is amended by striking out ‘‘refer such application’’.

(u) SECTION 519.—Section 519(a) (21 U.S.C. 360i(a)) is amended

by striking out ‘‘paragraph (4)’’ and inserting in lieu thereof ‘‘paragraph (7)’’.

(v) SECTION 527.—Section 527(b) (21 U.S.C. 360cc(b)) is

amended—

(1) by striking out ‘‘507,,’’ and inserting in lieu thereof

‘‘507,’’, and

(2) in paragraph (1), by striking out ‘‘The’’ and inserting

in lieu thereof ‘‘the’’.

(w) SECTION 534.—Section 534(f)(2) (21 U.S.C. 360kk) is

amended by striking out ‘‘this Act’’ and inserting in lieu thereof

‘‘the Public Health Service Act’’.

(x) SECTION 601.—Section 601(a) (21 U.S.C. 361) is amended

by striking out ‘‘: Provided, That this’’ and inserting in lieu thereof

‘‘, except that this’’.

(y) SECTION 701.—Section 701 (21 U.S.C. 371) is amended—

(1) in subsection (e)(1), by striking out the period after ‘‘Regulations)’’ the second time it occurs, and (2) in subsection (f)(4), by striking out ‘‘sections 239 and

240 of the Judicial Code, as amended’’ and inserting in lieu

thereof ‘‘section 1254 of title 28, United States Code’’.

(z) SECTION 703.—Section 703 (21 U.S.C. 373) is amended—

(1) by striking out ‘‘: Provided, That’’ and inserting in

lieu thereof ‘‘, except that’’, and

(2) by striking out ‘‘: Provided further, That’’ and inserting

in lieu thereof ‘‘, and except that’’.

(aa) SECTION 704.—Section 704(a)(1) (21 U.S.C. 374(a)(1)) is

amended—

(1) by striking out the semicolon after ‘‘materials’’ and

inserting in lieu thereof a comma, and (2) by striking out ‘‘(j)’’ the first time it appears and insert- ing in lieu thereof ‘‘(k)’’.

(bb) SECTION 721.—Section 721(b)(5)(D) (21 U.S.C.

379e(b)(5)(D)) is amended by striking out ‘‘5703(b)’’ and inserting

in lieu thereof ‘‘5703’’.

(cc) SECTION 801.—Section 801(b) (21 U.S.C. 381(b)) is

amended—

(1) by striking out ‘‘Administrator’’ the first time it occurs

and inserting in lieu thereof ‘‘Secretary of Health and Human

Services’’,

(2) by striking out ‘‘Administrator’’ the second and third

time it occurs and inserting in lieu thereof ‘‘Secretary’’,

(3) by striking out ‘‘Administrator’s’’ and inserting in lieu

thereof ‘‘Secretary’s’’, and

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(4) by striking out ‘‘Federal Security Agency’’ and inserting

in lieu thereof ‘‘Department of Health and Human Services’’.

(dd) AGRICULTURE.—

(1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C.

321(c), 321(d), 371(b), and 381(a) are each amended by striking

out ‘‘Agriculture’’ each place it appears and inserting in lieu

thereof ‘‘Health and Human Services’’.

(2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376)

are each amended by striking out ‘‘of Agriculture’’ each place

it appears.

SEC. 4. TECHNICAL AMENDMENTS TO AMENDATORY ACTS.

(a) SAFE MEDICAL DEVICES ACT OF 1990.—

(1) Section 18(b) of the Safe Medical Devices Act of 1990

(Public Law 101–629) is amended by striking out ‘‘(b)(4)(B)’’

and inserting in lieu thereof ‘‘(b)’’, and

(2) Section 19(a)(4) of the Safe Medical Devices Act of

1990 (Public Law 101–629) is amended—

(A) by striking out ‘‘as amended by paragraphs (1)

and (2)’’ and inserting in lieu thereof ‘‘as amended by

paragraphs (1), (2), and (3)’’,

(B) by striking out ‘‘530’’ and inserting in lieu thereof

‘‘531’’, and

(C) by striking out ‘‘354’’ and inserting in lieu thereof

‘‘355’’.

(b) MEDICAL DEVICE AMENDMENTS OF 1992.—Section 6(a) of

the Medical Device Amendments of 1992 (Public Law 102–300)

is amended by inserting ‘‘wherever appearing’’ after ‘‘ ‘any of its

principal’ ’’.

(c) NUTRITION LABELING AND EDUCATION ACT OF 1990.—Section

8 of the Nutrition Labeling and Education Act of 1990 is amended

by striking the period at the end and inserting close quotation

marks and a period.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.

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