I
119THCONGRESS
1
STSESSION 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
MARCH31, 2025
Mr. M
ENENDEZ(for himself, Mr. SMITHof New Jersey, Ms. SCHRIER, Mr.
V
EASEY, Mr. CARTERof Louisiana, Ms. NORTON, Mrs. MCIVER, Mrs.
W
ATSONCOLEMAN, Mr. SHERMAN, Mr. KENNEDYof New York, Ms.
T
LAIB, Mr. DELUZIO, Mr. GOLDMANof 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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Sarah Katz Caffeine 4
Safety Act’’. 5
SEC. 2. CAFFEINE LABELING REQUIREMENTS. 6
(a) I
NFORMATIONREQUIREDTOBEDISCLOSED BY 7
R
ESTAURANTS AND RETAILFOODESTABLISHMENTS.— 8
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(1) IN GENERAL.—Section 403(q)(5)(H) of the 1
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2
343(q)(5)(H)) is amended— 3
(A) by amending subclause (i) to read as 4
follows: 5
‘‘(i) G
ENERAL REQUIREMENTS FOR RES -6
TAURANTS AND SIMILAR RETAIL FOOD ESTABLISH -7
MENTS.— 8
‘‘(I) S
TANDARD MENU ITEMS .—Except for 9
food described in subclause (vii), in the case of 10
food that is a standard menu item that is of-11
fered for sale in a restaurant or similar retail 12
food establishment that is part of a chain with 13
20 or more locations doing business under the 14
same name (regardless of the type of ownership 15
of the locations) and offering for sale substan-16
tially the same menu items, the restaurant or 17
similar retail food establishment shall disclose 18
the information described in subclauses (ii) and 19
(iii). 20
‘‘(II) T
EMPORARY MENU ITEMS .— 21
‘‘(aa) I
N GENERAL.—In the case of 22
food that is a temporary menu item that is 23
offered for sale in a restaurant or similar 24
retail food establishment that is part of a 25
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chain with 20 or more locations doing busi-1
ness under the same name (regardless of 2
the type of ownership of the locations) and 3
offering for sale substantially the same 4
menu items, the restaurant or similar re-5
tail food establishment shall disclose the 6
information described in subclause (ii)(III). 7
‘‘(bb) T
EMPORARY MENU ITEM DE -8
FINED.—In this item, the term ‘temporary 9
menu item’ means a food that appears on 10
a menu or menu board for less than a total 11
of 60 days per calendar year. The 60 days 12
includes the total of consecutive and non- 13
consecutive days the item appears on the 14
menu.’’; 15
(B) in subclause (ii)— 16
(i) by redesignating items (III) and 17
(IV) as items (IV) and (V), respectively, 18
and moving the margins of such items 2 19
ems to the right; 20
(ii) by inserting after item (II) the fol-21
lowing: 22
‘‘(III) in the case of a standard menu item 23
or temporary menu item that contains any 24
added caffeine (as the Secretary shall by regu-25
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lation define) and at least 150 milligrams of 1
total caffeine per serving, the statement ‘High 2
caffeine’, or such other similar statement or 3
symbol as the Secretary determines appropriate, 4
adjacent to the name of the standard menu 5
item or temporary menu item, so as to be clear-6
ly associated with such menu item, on the menu 7
listing the item for sale and on the menu board, 8
including a drive through menu board;’’; and 9
(iii) in item (IV) (as so redesignated), 10
by inserting before the semicolon the fol-11
lowing: ‘‘and the number of milligrams of 12
caffeine in the item’’; and 13
(C) in subclause (vii)(I), by striking ‘‘Sub-14
clauses (i) through (vi)’’ and inserting ‘‘Subject 15
to subclause (i)(II), subclauses (i) through 16
(vi)’’. 17
(2) C
ONFORMING AMENDMENTS .—Section 18
403(q)(5) of the Federal Food, Drug, and Cosmetic 19
Act (21 U.S.C. 343(q)(5)) is amended— 20
(A) in clause (A)— 21
(i) in subclause (i), by striking 22
‘‘clause (H)(ii)(III)’’ and inserting ‘‘clause 23
(H)(ii)(IV)’’; and 24
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(ii) in subclause (ii), by striking 1
‘‘clause (H)(ii)(III)’’ and inserting ‘‘clause 2
(H)(ii)(IV)’’; and 3
(B) in clause (H)— 4
(i) in subclause (ii)(V) (as redesig-5
nated by subsection (a)(1)(B)(i) of this 6
section), by striking ‘‘item (III)’’ and in-7
serting ‘‘item (IV)’’; 8
(ii) in subclause (vi), by striking ‘‘sub-9
clause (ii)(III)’’ each place it appears and 10
inserting ‘‘subclause (ii)(IV)’’; and 11
(iii) in subclause (vii)(II), by striking 12
‘‘subclauses (ii)(III) and (vi)’’ and insert-13
ing ‘‘subclauses (ii)(IV) and (vi)’’. 14
(b) C
AFFEINELABELINGREQUIREMENTS FOR FOOD 15
ANDDIETARYSUPPLEMENTS.—Section 403 of the Fed-16
eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 17
amended by adding at the end the following: 18
‘‘(z) If it is a food (including a dietary supplement) 19
that contains more than 10 milligrams of caffeine, unless 20
the label of such food includes— 21
‘‘(1) the number of milligrams of caffeine in the 22
food; 23
‘‘(2) a statement of whether the caffeine in the 24
food is naturally occurring or an additive; and 25
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‘‘(3) an advisory statement indicating that the 1
daily recommended limit of caffeine for healthy 2
adults is 400 milligrams (or such other limit as the 3
Secretary determines appropriate).’’. 4
SEC. 3. FDA AND NIH REVIEWS OF SAFETY OF CAFFEINE. 5
(a) FDA R
EVIEW OFCAFFEINE ASGRAS.— 6
(1) I
N GENERAL.—The Secretary of Health and 7
Human Services, acting through the Commissioner 8
of Food and Drugs, (in this subsection referred to 9
as the ‘‘Commissioner’’) shall conduct a review of 10
the safety of caffeine and other stimulants, as the 11
Commissioner determines appropriate, in food (in-12
cluding beverages) and dietary supplements. 13
(2) E
LEMENTS.—In conducting the review 14
under paragraph (1), the Commissioner shall con-15
sider the following: 16
(A) Whether caffeine should be considered 17
to be generally recognized to be safe, with re-18
spect to consumption by healthy populations, 19
under section 201(s) of the Federal Food, 20
Drug, and Cosmetic Act (21 U.S.C. 321(s)). 21
(B) The safety of added caffeine or other 22
stimulants, or a complex blend containing a 23
combination of caffeine and other stimulants, in 24
food and dietary supplements. 25
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(C) The safety of guarana, taurine, and 1
similar substances in food and dietary supple-2
ments with added caffeine. 3
(D) Thresholds for the amount of caffeine, 4
or the amount of a complex blend containing a 5
combination of caffeine and other stimulants, 6
that should be generally recognized as safe 7
when included in food or dietary supplements. 8
(E) Whether any regulations relating to 9
caffeine in food and dietary supplements should 10
be issued or updated. 11
(3) R
EPORT.—Not later than 6 months after 12
the date of enactment of this Act, the Commissioner 13
shall submit to Congress and make publicly available 14
a report detailing the results of the review under 15
paragraph (1). 16
(4) C
ONSIDERATION OF RESULTS .—Following 17
the completion of the review under paragraph (1), 18
the Secretary of Health and Human Services— 19
(A) shall, in considering the results of such 20
review, make a determination regarding wheth-21
er caffeine is generally recognized to be safe, 22
with respect to consumption by healthy popu-23
lations, under section 201(s) of the Federal 24
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Food, Drug, and Cosmetic Act (21 U.S.C. 1
321(s)); and 2
(B) may consider the results of such re-3
view in making a determination pursuant to 4
paragraph (q)(5)(H)(ii)(III) or (z)(3) of section 5
403 of the Federal Food, Drug, and Cosmetic 6
Act (21 U.S.C. 343) (as inserted by subsection 7
(a)(1)(B)(ii), and added by subsection (b), of 8
section 2 of this Act). 9
(b) NIH R
EVIEW OFCAFFEINE INVULNERABLE 10
P
OPULATIONS.— 11
(1) I
N GENERAL.—The Secretary of Health and 12
Human Services, acting through the Director of the 13
National Institutes of Health, (in this subsection re-14
ferred to as the ‘‘Director’’) shall conduct or support 15
a review of the effect of the consumption of caffeine 16
and other stimulants, as the Director determines ap-17
propriate, on the vulnerable populations described in 18
paragraph (2). The Director may enter into a con-19
tract with an appropriate entity under which such 20
entity will conduct such review. 21
(2) V
ULNERABLE POPULATIONS .—The ‘‘vulner-22
able populations’’ described in this paragraph are 23
the following: 24
(A) Children and adolescents. 25
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(B) Individuals with underlying heart con-1
ditions. 2
(C) Pregnant and breast-feeding women. 3
(D) Individuals with seizure disorders. 4
(E) Individuals with mental health condi-5
tions that may be worsened by stimulants. 6
(F) Caffeine-sensitive individuals. 7
(G) Such other individuals as the Director 8
determines appropriate. 9
(3) R
EPORT.—Not later than 6 months after 10
the date of enactment of this Act, the Director shall 11
submit to Congress and make publicly available a re-12
port detailing the results of the review under para-13
graph (1). 14
(c) A
UTHORIZATION OF APPROPRIATIONS.—There is 15
authorized to be appropriated— 16
(1) $1,000,000 for the purpose of carrying out 17
subsection (a); and 18
(2) $1,000,000 for the purpose of carrying out 19
subsection (b). 20
SEC. 4. PUBLIC EDUCATION CAMPAIGN ON CAFFEINE SAFE-21
TY. 22
The Secretary of Health and Human Services, acting 23
through the Commissioner of Food and Drugs, in con-24
sultation with the Director of the Centers for Disease Con-25
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trol and Prevention, and working with consumer advocacy 1
and patient groups, shall conduct a public education cam-2
paign on the safe consumption of caffeine and caffeinated 3
food (including beverages) and dietary supplements. Such 4
campaign shall pay special attention to the following: 5
(1) The dangers of the overconsumption of caf-6
feine. 7
(2) The health impacts caffeine can have on 8
certain vulnerable populations, including— 9
(A) children and adolescents; 10
(B) individuals with underlying heart con-11
ditions; 12
(C) pregnant and breast-feeding women; 13
(D) individuals with seizure disorders; 14
(E) individuals with mental health condi-15
tions that may be worsened by stimulants; and 16
(F) caffeine-sensitive individuals. 17
(3) How caffeine is marketed to children and 18
adolescents. 19
(4) How guarana, taurine, and similar sub-20
stances impact safety. 21
(5) How to safely consume caffeine. 22
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SEC. 5. GAO STUDY AND REPORT ON MARKETING OF 1
CAFFEINATED BEVERAGES. 2
(a) I
NGENERAL.—The Comptroller General of the 3
United States shall conduct a study on the marketing of 4
caffeinated beverages in restaurants, in stores, and online 5
(including on social media and by social media 6
influencers). In conducting such study, the Comptroller 7
General shall focus on— 8
(1) ways in which the marketing of caffeinated 9
beverages (including to children and adults) may be 10
misleading; and 11
(2) how the marketing of such caffeinated bev-12
erages is targeted at children and teens. 13
(b) R
EPORT.—Not later than 180 days after the date 14
of enactment of this Act, the Comptroller General of the 15
United States shall submit to Congress a report describing 16
the results of the study conducted under subsection (a), 17
including any recommendations for legislative or adminis-18
trative action to address the misleading marketing of 19
caffeinated beverages or the targeted marketing of such 20
beverages to children and teens. 21
Æ
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