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 ex-
emption from subparagraphs (1) and (2) is claimed pursu-
ant to this subclause, the requirements of such subpara-
graphs shall not apply to any food product if—
‘‘(I) the labeling for such product does not pro-
vide 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 employ-
ees,
‘‘(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 Unit-
ed 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.
‘‘(ii) During the 12-month period after the applicable
date referred to in this sentence, the requirements of sub-
paragraphs (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 employ-
ees 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 prod-
uct an exemption from such subparagraphs em-
ployed fewer than an average of 300 full-time equiv-
alent 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 prod-
uct an exemption from such subparagraphs em-
ployed fewer than an average of 200 full-time equiv-
alent 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 pre-
ceding 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 antici-
pates 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 Sec-
retary has questioned the validity of such informa-
tion.
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 exemp-
tion under subclause (i) or (ii), if, during the period of
such exemption, the number of full-time equivalent em-
ployees 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 employ-
ees or food products sold exceeded the applicable number.
‘‘(v) For any food product first introduced into inter-
state 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,