H.R. 2511

119th CONGRESS 1st Session

To amend the Federal Food, Drug, and Cosmetic Act to establish certain labeling requirements for caffeine, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES · March 31, 2025 · Sponsor: Mr. Menendez · Committee: Committee on Energy and Commerce

H.R. 2511

SEC. 1. Short title

This Act may be cited as the Sarah Katz Caffeine Safety Act.

SEC. 2. Caffeine labeling requirements

(a) Information required To be disclosed by restaurants and retail food establishments
- (1) In general
  - Section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 343(q)(5)(H)
    - (i) General requirements for restaurants and similar retail food establishments
      - Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii).
      - In the case of food that is a temporary menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclause (ii)(III).
      - In this item, the term temporary menu item means a food that appears on a menu or menu board for less than a total of 60 days per calendar year. The 60 days includes the total of consecutive and non-consecutive days the item appears on the menu.
    - by amending subclause (i) to read as follows:
    - in subclause (ii)—
      - (i) by redesignating items (III) and (IV) as items (IV) and (V), respectively, and moving the margins of such items 2 ems to the right;
      - (ii) by inserting after item (II) the following:
        
        in the case of a standard menu item or temporary menu item that contains any added caffeine (as the Secretary shall by regulation define) and at least 150 milligrams of total caffeine per serving, the statement ‘High caffeine’, or such other similar statement or symbol as the Secretary determines appropriate, adjacent to the name of the standard menu item or temporary menu item, so as to be clearly associated with such menu item, on the menu listing the item for sale and on the menu board, including a drive through menu board;
      - (iii) in item (IV) (as so redesignated), by inserting before the semicolon the following: ; and
    - in subclause (vii)(I), by striking Subclauses (i) through (vi)and inserting Subject to subclause (i)(II), subclauses (i) through (vi).
- (2) Conforming amendments
  - Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 343(q)(5)
    - in clause (A)—
      - (i) in subclause (i), by striking clause (H)(ii)(III)and inserting clause (H)(ii)(IV); and
      - (ii) in subclause (ii), by striking clause (H)(ii)(III)and inserting clause (H)(ii)(IV); and
    - in clause (H)—
      - (i) in subclause (ii)(V) (as redesignated by subsection (a)(1)(B)(i) of this section), by striking item (III)and inserting item (IV);
      - (ii) in subclause (vi), by striking each place it appears and inserting subclause (ii)(IV); and
      - (iii) in subclause (vii)(II), by striking subclauses (ii)(III) and (vi)and inserting subclauses (ii)(IV) and (vi).
(b) Caffeine labeling requirements for food and dietary supplements
- Section 403 of the Federal Food, Drug, and Cosmetic Act () is amended by adding at the end the following: 21 U.S.C. 343
  - If it is a food (including a dietary supplement) that contains more than 10 milligrams of caffeine, unless the label of such food includes—
    - the number of milligrams of caffeine in the food;
    - a statement of whether the caffeine in the food is naturally occurring or an additive; and
    - an advisory statement indicating that the daily recommended limit of caffeine for healthy adults is 400 milligrams (or such other limit as the Secretary determines appropriate).

SEC. 3. FDA and NIH reviews of safety of caffeine

(a) FDA review of caffeine as GRAS
- (1) In general
  - The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, (in this subsection referred to as the ) shall conduct a review of the safety of caffeine and other stimulants, as the Commissioner determines appropriate, in food (including beverages) and dietary supplements.
- (2) Elements
  - In conducting the review under paragraph (1), the Commissioner shall consider the following:
    - Whether caffeine should be considered to be generally recognized to be safe, with respect to consumption by healthy populations, under section 201(s) of the Federal Food, Drug, and Cosmetic Act (). 21 U.S.C. 321(s)
    - The safety of added caffeine or other stimulants, or a complex blend containing a combination of caffeine and other stimulants, in food and dietary supplements.
    - The safety of guarana, taurine, and similar substances in food and dietary supplements with added caffeine.
    - Thresholds for the amount of caffeine, or the amount of a complex blend containing a combination of caffeine and other stimulants, that should be generally recognized as safe when included in food or dietary supplements.
    - Whether any regulations relating to caffeine in food and dietary supplements should be issued or updated.
- (3) Report
  - Not later than 6 months after the date of enactment of this Act, the Commissioner shall submit to Congress and make publicly available a report detailing the results of the review under paragraph (1).
- (4) Consideration of results
  - Following the completion of the review under paragraph (1), the Secretary of Health and Human Services—
    - shall, in considering the results of such review, make a determination regarding whether caffeine is generally recognized to be safe, with respect to consumption by healthy populations, under section 201(s) of the Federal Food, Drug, and Cosmetic Act (); and 21 U.S.C. 321(s)
    - may consider the results of such review in making a determination pursuant to paragraph (q)(5)(H)(ii)(III) or (z)(3) of section 403 of the Federal Food, Drug, and Cosmetic Act () (as inserted by subsection (a)(1)(B)(ii), and added by subsection (b), of section 2 of this Act). 21 U.S.C. 343
(b) NIH review of caffeine in vulnerable populations
- (1) In general
  - The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, (in this subsection referred to as the ) shall conduct or support a review of the effect of the consumption of caffeine and other stimulants, as the Director determines appropriate, on the vulnerable populations described in paragraph (2). The Director may enter into a contract with an appropriate entity under which such entity will conduct such review.
- (2) Vulnerable populations
  - The described in this paragraph are the following: vulnerable populations
    - Children and adolescents.
    - Individuals with underlying heart conditions.
    - Pregnant and breast-feeding women.
    - Individuals with seizure disorders.
    - Individuals with mental health conditions that may be worsened by stimulants.
    - Caffeine-sensitive individuals.
    - Such other individuals as the Director determines appropriate.
- (3) Report
  - Not later than 6 months after the date of enactment of this Act, the Director shall submit to Congress and make publicly available a report detailing the results of the review under paragraph (1).
(c) Authorization of appropriations
- There is authorized to be appropriated—
  - $1,000,000 for the purpose of carrying out subsection (a); and
  - $1,000,000 for the purpose of carrying out subsection (b).

SEC. 4. Public education campaign on caffeine safety

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, in consultation with the Director of the Centers for Disease Control and Prevention, and working with consumer advocacy and patient groups, shall conduct a public education campaign on the safe consumption of caffeine and caffeinated food (including beverages) and dietary supplements. Such campaign shall pay special attention to the following:
- The dangers of the overconsumption of caffeine.
- The health impacts caffeine can have on certain vulnerable populations, including—
  - children and adolescents;
  - individuals with underlying heart conditions;
  - pregnant and breast-feeding women;
  - individuals with seizure disorders;
  - individuals with mental health conditions that may be worsened by stimulants; and
  - caffeine-sensitive individuals.
- How caffeine is marketed to children and adolescents.
- How guarana, taurine, and similar substances impact safety.
- How to safely consume caffeine.

SEC. 5. GAO study and report on marketing of caffeinated beverages

(a) In general
- The Comptroller General of the United States shall conduct a study on the marketing of caffeinated beverages in restaurants, in stores, and online (including on social media and by social media influencers). In conducting such study, the Comptroller General shall focus on—
  - ways in which the marketing of caffeinated beverages (including to children and adults) may be misleading; and
  - how the marketing of such caffeinated beverages is targeted at children and teens.
(b) Report
- Not later than 180 days after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report describing the results of the study conducted under subsection (a), including any recommendations for legislative or administrative action to address the misleading marketing of caffeinated beverages or the targeted marketing of such beverages to children and teens.