United States 118th Congress Status: In Committee 11 D cosponsors

HR 6756 — Baby Food Safety Act of 2023

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

To amend the Federal Food, Drug, and Cosmetic Act to establish limits on certain toxic elements in infant and toddler food, and for other purposes.

Bill Text

Sections of law this bill changes

4 sections in 1 law

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-121).

Federal food, drug, and cosmetic act · 21 U.S.C. ch. 9 3 sections Amends the act as a whole
  • § 321 Definitions; generally Amends

    21 U.S.C. § 321

    The law today

    For the purposes of this chapter— (a) (1) The term “State”, except as used in the last sentence of section 372(a) of this title, means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. (b) The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. (c) The term “Department” means Department of Health and Human Services. (d) The term “Secretary” means the Secretary of Health and Human Services. (e) The term “person” includes individual, partnership, corporation, and association. (f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (g) (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement. (2) The term “counterfeit drug” means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor. (h) (1) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 360j(o) of this title. (2) The term “counterfeit device” means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or im...

    77 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

  • § 342 Adulterated food Amends

    21 U.S.C. § 342

    The law today

    A food shall be deemed to be adulterated— (a) Poisonous, insanitary, etc., ingredients (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.1 (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title. (b) Absence, substitution, or addition of constituents (1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. (c) Color additives If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title. (d) Confectionery containing alcohol or nonnutritive substance If it is confectionery, and— (1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health; (2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale; or (3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to t...

    20 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

  • § 350l Mandatory recall authority Amends

    21 U.S.C. § 350l — at 350l(a)

    The law today

    (a) Voluntary procedures If the Secretary determines, based on information gathered through the reportable food registry under section 350f of this title or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 342 of this title or misbranded under section 343(w) of this title and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 350f of this title) with an opportunity to cease distribution and recall such article. (b) Prehearing order to cease distribution and give notice (1) In general If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to— (A) immediately cease distribution of such article; and (B) as applicable, immediately notify all persons— (i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and (ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.1 (2) Required additional information (A) In general If an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based third party logistics provider to identify the food. (B) Rules of construction Nothing in this paragraph shall be construed— (i) to exempt a warehouse-based third party logistics provider from the requirements of this chapter, including the requirements in this section and section 350c of this title; or (ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order. (3) Determination to limit areas affected If the Secretary requires a responsible party to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Secretary may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health. (c) Hearing on order The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled. (d) Post-hearing recall order and modification of order (1) Amendment of order If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate— (A) amend the order to require recall of such article or other appropriate action; (B) specify a timetable in which the recall shall occur; (C) require periodic reports to the Secretary describing the progress of the recall; and (D) provide notice to consumers to whom such article was, or may have been, distributed. (2) Vacating of order If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order. (e) Rule regarding alcoholic beverages The Secretary shall not initiate a mandatory recall or take any other actio...

    6 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

How this bill changes current law

7 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill establishes specific definitions and limits for toxic elements in infant and toddler food and introduces mandatory recall authority for such foods exceeding these limits.

  • 21 U.S.C. 321

    (tt) The term `infant and toddler food'-- (1) means foods intended for infants and children less than two years of age; and (2) includes infant formula.

    Defines 'infant and toddler food' for regulatory purposes.

  • 21 U.S.C. 342

    (j) If it is an article of infant and toddler food in final product form that bears or contains any toxic element in excess of a limit established under section 425(a) taking into consideration variability of the validated method of analysis.

    Adds a new category for adulteration based on toxic element limits in infant and toddler food.

  • 21 U.S.C. 350l(a)

    or if the Secretary determines through any means that an article of infant and toddler food (other than infant formula) bears or contains a toxic element that renders the product adulterated under section 402(a)(1) or 402(j),

    Expands the Secretary's authority to initiate voluntary recalls to include articles of infant and toddler food containing excessive toxic elements.

  • 21 U.S.C. 341

    SEC. 425. TOXIC ELEMENTS IN INFANT AND TODDLER FOOD. (a) In General.--The Secretary, by administrative order-- (1) shall establish limits for lead, cadmium, mercury, and inorganic arsenic in infant and toddler food; and (2) if determined by the Secretary to be appropriate upon review of relevant health data and other relevant information, may-- (A) establish limits for additional toxic elements in infant and toddler food; and (B) revise limits established pursuant to paragraph (1) or subparagraph (A).

    Requires the Secretary to set limits for toxic elements in infant and toddler foods.

  • 21 U.S.C. 341

    (b) Procedure.--In establishing or revising any limit under subsection (a), the Secretary shall-- (1) evaluate relevant health data and other relevant information; (2) take into account relevant differences among infant and toddler food types, groups, or categories, as appropriate, including-- (A) the feasibility of achieving the limit based on the food type, group, or category; and (B) the extent to which the level of a toxic element in infant and toddler food is as low as reasonably achievable;

    Mandates a structured process for establishing or revising limits on toxic elements.

  • 21 U.S.C. 341

    (g) Guidance.--Whenever the Secretary publishes a new or revised limit for a toxic element under this section, the Secretary shall publish, together with the administrative order establishing or revising such limit, guidance concerning compliance with such limit.

    Requires the publication of guidance for compliance whenever new limits for toxic elements are established.

  • 21 U.S.C. 341

    (h) Periodic Review.--The Secretary shall periodically, or as relevant data is made available, review the limits and guidance established under this section to consider whether such limits and guidance should be revised, following the applicable procedures and criteria under this section.

    Establishes a mechanism for the periodic review of limits on toxic elements.

Action History

  1. Referred to the Subcommittee on Health.

  2. Introduced in House

  3. Introduced in House

  4. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 10 co-sponsors · 536 not signed on

Sponsors (1)

Co-sponsors (10)

Not signed on (536)

536 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare agriculture
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Frequently asked questions

What does HR 6756 do?
To amend the Federal Food, Drug, and Cosmetic Act to establish limits on certain toxic elements in infant and toddler food, and for other purposes.
Who sponsors HR 6756?
HR 6756 is sponsored by Krishnamoorthi, Raja (Democratic), Cárdenas, Tony (Democratic), Sykes, Emilia Strong (Democratic), Norton, Eleanor Holmes (Democratic), Grijalva, Raúl M. (Democratic), Matsui, Doris O. (Democratic), Tlaib, Rashida (Democratic), Stansbury, Melanie A. (Democratic), Magaziner, Seth (Democratic), Trone, David J. (Democratic), and Dean, Madeleine (Democratic).
What is the current status of HR 6756?
This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 6756?
Track HR 6756 free on One Click Politics — get push/email alerts when it moves.

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