Public Law 103–80

Application of Existing Exemption.—

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)“(E)

(i)(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)“(I)

the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r),

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“(II)“(II)

the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 100 full-time equivalent employees,

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“(III)“(III)

such person provided the notice described in subclause (iii), and

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“(IV)“(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)“(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)“(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,

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“(II)“(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 unite of such product were sold in the United States, or

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“(III)“(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.

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“(iii)“(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 snail—

“(I)“(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,

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“(II)“(II)

state the approximate number of units the person claiming the exemption sold in the United States,

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“(III)“(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

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“(IV)“(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.

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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 or such product under this subclause for such year.

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“(iv)“(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 the date the number of full-time equivalent employees or food products sold exceeded the applicable number.

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“(v)“(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.

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“(vi)“(vi)

For purposes of subclauses (i), (ii), (iii), (iv), and (v)—

“(I)“(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,

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“(II)“(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

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“(III)“(III)

the term ‘person’ in the case of a corporation includes all domestic and foreign affiliates of the corporation.”.

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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

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.

Section 301.—

Section 301 (21 U.S.C. 331) is amended—

Section 302.—

Section 302 (21 U.S.C. 332) is amended—

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.

Section 304.—

Section 304 (21 U.S.C. 334) is amended—

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”.

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”.

Section 402.—

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

Section 403.—

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

Section 408.—

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

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)”.

Section 502.—

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

Section 505.—

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

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”.

Section 507.—

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

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”.

Section 512.—

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

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”.

Section 515.—

Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is amended by striking out “refer such application”.

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)”;

Section 527.—

Section 527(b) (21 U.S.C. 36Occ(b)) is amended—

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”.

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”.

Section 701.—

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

Section 703.—

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

Section 704.—

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

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”.

Section 801.—

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

Agriculture.—

Safe Medical Devices Act of 1990.—

Medical Device Amendments of 1992.—

Section 6(a) of the Medical Device Amendments of 1992 (Public Law 102–300)

21 USC 321.

is amended by inserting “wherever appearing” after “ ‘any of its principal’”.

Nutrition Labeling and Education Act of 1990.—

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

21 USC 371.

by striking the period at the end and inserting close quotation marks and a period.