I 
119TH CONGRESS 
1ST SESSION H. R. 2511 
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 
Mr. MENENDEZ (for himself, Mr. SMITH of New Jersey, Ms. SCHRIER, Mr. 
VEASEY, Mr. CARTER of Louisiana, Ms. NORTON, Mrs. MCIVER, Mrs. 
WATSON COLEMAN, Mr. SHERMAN, Mr. KENNEDY of New York, Ms. 
TLAIB, Mr. DELUZIO, Mr. GOLDMAN of New York, and Ms. UNDER-
WOOD) introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish certain labeling requirements for caffeine, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 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.— 
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(1) IN GENERAL.—Section 403(q)(5)(H) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(5)(H)) is amended— 
(A) by amending subclause (i) to read as 
follows: 
‘‘(i) 
GENERAL
REQUIREMENTS
FOR
RES-
TAURANTS AND SIMILAR RETAIL FOOD ESTABLISH-
MENTS.— 
‘‘(I) STANDARD MENU ITEMS.—Except for 
food described in subclause (vii), in the case of 
food that is a standard menu item that is of-
fered 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 substan-
tially the same menu items, the restaurant or 
similar retail food establishment shall disclose 
the information described in subclauses (ii) and 
(iii). 
‘‘(II) TEMPORARY MENU ITEMS.— 
‘‘(aa) IN GENERAL.—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 
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lation 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 clear-
ly associated with such menu item, on the menu 
listing the item for sale and on the menu board, 
including a drive through menu board;’’; and 
(iii) in item (IV) (as so redesignated), 
by inserting before the semicolon the fol-
lowing: ‘‘and the number of milligrams of 
caffeine in the item’’; and 
(C) in subclause (vii)(I), by striking ‘‘Sub-
clauses (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 (21 U.S.C. 343(q)(5)) is amended— 
(A) in clause (A)— 
(i) in subclause (i), by striking 
‘‘clause (H)(ii)(III)’’ and inserting ‘‘clause 
(H)(ii)(IV)’’; and 
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(ii) in subclause (ii), by striking 
‘‘clause (H)(ii)(III)’’ and inserting ‘‘clause 
(H)(ii)(IV)’’; and 
(B) in clause (H)— 
(i) in subclause (ii)(V) (as redesig-
nated by subsection (a)(1)(B)(i) of this 
section), by striking ‘‘item (III)’’ and in-
serting ‘‘item (IV)’’; 
(ii) in subclause (vi), by striking ‘‘sub-
clause (ii)(III)’’ each place it appears and 
inserting ‘‘subclause (ii)(IV)’’; and 
(iii) in subclause (vii)(II), by striking 
‘‘subclauses (ii)(III) and (vi)’’ and insert-
ing ‘‘subclauses (ii)(IV) and (vi)’’. 
(b) CAFFEINE LABELING REQUIREMENTS FOR FOOD 
AND DIETARY SUPPLEMENTS.—Section 403 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 
amended by adding at the end the following: 
‘‘(z) If it is a food (including a dietary supplement) 
that contains more than 10 milligrams of caffeine, unless 
the label of such food includes— 
‘‘(1) the number of milligrams of caffeine in the 
food; 
‘‘(2) a statement of whether the caffeine in the 
food is naturally occurring or an additive; and 
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‘‘(3) 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 ‘‘Commissioner’’) shall conduct a review of 
the safety of caffeine and other stimulants, as the 
Commissioner determines appropriate, in food (in-
cluding beverages) and dietary supplements. 
(2) ELEMENTS.—In conducting the review 
under paragraph (1), the Commissioner shall con-
sider the following: 
(A) Whether caffeine should be considered 
to be generally recognized to be safe, with re-
spect to consumption by healthy populations, 
under section 201(s) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(s)). 
(B) 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. 
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(C) The safety of guarana, taurine, and 
similar substances in food and dietary supple-
ments with added caffeine. 
(D) 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. 
(E) 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— 
(A) shall, in considering the results of such 
review, make a determination regarding wheth-
er caffeine is generally recognized to be safe, 
with respect to consumption by healthy popu-
lations, under section 201(s) of the Federal 
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Food, Drug, and Cosmetic Act (21 U.S.C. 
321(s)); and 
(B) may consider the results of such re-
view 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 (21 U.S.C. 343) (as inserted by subsection 
(a)(1)(B)(ii), and added by subsection (b), of 
section 2 of this Act). 
(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 re-
ferred to as the ‘‘Director’’) shall conduct or support 
a review of the effect of the consumption of caffeine 
and other stimulants, as the Director determines ap-
propriate, on the vulnerable populations described in 
paragraph (2). The Director may enter into a con-
tract with an appropriate entity under which such 
entity will conduct such review. 
(2) VULNERABLE POPULATIONS.—The ‘‘vulner-
able populations’’ described in this paragraph are 
the following: 
(A) Children and adolescents. 
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(B) Individuals with underlying heart con-
ditions. 
(C) Pregnant and breast-feeding women. 
(D) Individuals with seizure disorders. 
(E) Individuals with mental health condi-
tions that may be worsened by stimulants. 
(F) Caffeine-sensitive individuals. 
(G) 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 re-
port detailing the results of the review under para-
graph (1). 
(c) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated— 
(1) $1,000,000 for the purpose of carrying out 
subsection (a); and 
(2) $1,000,000 for the purpose of carrying out 
subsection (b). 
SEC. 4. PUBLIC EDUCATION CAMPAIGN ON CAFFEINE SAFE-
TY. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, in con-
sultation with the Director of the Centers for Disease Con-
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trol and Prevention, and working with consumer advocacy 
and patient groups, shall conduct a public education cam-
paign on the safe consumption of caffeine and caffeinated 
food (including beverages) and dietary supplements. Such 
campaign shall pay special attention to the following: 
(1) The dangers of the overconsumption of caf-
feine. 
(2) The health impacts caffeine can have on 
certain vulnerable populations, including— 
(A) children and adolescents; 
(B) individuals with underlying heart con-
ditions; 
(C) pregnant and breast-feeding women; 
(D) individuals with seizure disorders; 
(E) individuals with mental health condi-
tions that may be worsened by stimulants; and 
(F) caffeine-sensitive individuals. 
(3) How caffeine is marketed to children and 
adolescents. 
(4) How guarana, taurine, and similar sub-
stances impact safety. 
(5) How to safely consume caffeine. 
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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— 
(1) ways in which the marketing of caffeinated 
beverages (including to children and adults) may be 
misleading; and 
(2) how the marketing of such caffeinated bev-
erages 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 adminis-
trative action to address the misleading marketing of 
caffeinated beverages or the targeted marketing of such 
beverages to children and teens. 
Æ 
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