S.Amdt. 5334

1. Adds SEC. __. TEMPORARY EXEMPTIONS FROM FDA INFANT FORMULA REQUIREMENTS wherever appropriate

   Adds a section

   Inserted: SEC. __. TEMPORARY EXEMPTIONS FROM FDA INFANT FORMULA REQUIREMENTS.

   Inserted: (a) In General.--With respect to any infant formula described in subsection (e) and introduced or delivered for introduction into interstate commerce during the 187-day period beginning on the date of the enactment of this Act--

   Inserted: (1) the requirements under section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) shall not apply;

   Inserted: (2) such infant formula may be manufactured, processed, packed, or held in a domestic or foreign facility that is not registered under section 415 of such Act (21 U.S.C. 350d);

   Inserted: (3) the requirements under parts 106 and 107 of title 21, Code of Federal Regulations, shall not apply; and

   Inserted: (4) such infant formula shall not be considered to be misbranded or adulterated solely on the basis of not being in compliance with the requirements of such section 412 or 415, or such part 106 or 107.

   Inserted: (b) Notification Requirement.--

   Inserted: (1) In general.--A person who introduces or delivers for introduction into interstate commerce an infant formula as described in subsection (a) shall notify the Secretary of Health and Human Services (referred to in this subsection as the "Secretary") if such person has knowledge which reasonably supports the conclusion that such infant formula--

   Inserted: (A) may not provide the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)); or

   Inserted: (B) is a product that meets any criterion under section 402(a) of such Act (21 U.S.C. 342(a)), or which otherwise may be unsafe for infant consumption.

   Inserted: (2) Knowledge defined.--For purposes of paragraph (1), the term "knowledge" as applied to a person subject to such subparagraph means--

   Inserted: (A) the actual knowledge that the manufacturer had; or

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   Inserted: (B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.

   Inserted: (c) Recall Authority.--If the Secretary determines that infant formula described in subsection (e) and introduced or delivered for introduction into interstate commerce is a product described in subsection (b)(1)(B), the manufacturer or importer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary.

   Inserted: (d) Clarification.--Section 801(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(j)) shall apply with respect to any infant formula introduced or delivered for introduction into interstate commerce pursuant to this section during the 187-day period beginning on the date of the enactment of this Act.

   Inserted: (e) Infant Formula Described.--Infant formula is described in this subsection if the infant formula--

   Inserted: (1) is classified under heading 1901.10 of the Harmonized Tariff Schedule of the United States;

   Inserted: (2) was approved by the agency of the government of that country that regulates infant formula; and

   Inserted: (3) is imported from--

   Inserted: (A) Australia;

   Inserted: (B) Israel;

   Inserted: (C) Japan;

   Inserted: (D) New Zealand;

   Inserted: (E) Switzerland;

   Inserted: (F) South Africa;

   Inserted: (G) the United Kingdom;

   Inserted: (H) a member country of the European Union; or

   Inserted: (I) a member country of the European Economic Area.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

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As printed