I 
119TH CONGRESS 
2D SESSION 
H. R. 7050 
To amend the Federal Food, Drug, and Cosmetic Act with respect to 
homeopathic drug products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 14, 2026 
Mr. SESSIONS (for himself, Mr. KENNEDY of Utah, and Mr. JACKSON of Illi-
nois) 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 with 
respect to homeopathic drug products, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Homeopathic Drug Product Safety, Quality, and Trans-
parency Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Purpose; sense of Congress. 
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Sec. 3. Definitions. 
Sec. 4. Safety, quality, and transparency requirements for homeopathic drug 
products. 
Sec. 5. Conforming amendments. 
Sec. 6. Withdrawal of guidance. 
Sec. 7. Severability. 
SEC. 2. PURPOSE; SENSE OF CONGRESS. 
(a) PURPOSE.—The purpose of this Act is to address 
consumer and practitioner needs for continued access to 
homeopathic drug products that meet requirements for 
safety, quality, and transparency. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that— 
(1) homeopathic medicines are important to 
millions of American consumers, and continued con-
sumer access to safe homeopathic products is best 
ensured by enacting a distinct statutory pathway for 
the regulation of homeopathic drug products; and 
(2) while the Federal Government should con-
tinue to take appropriate action against products 
that are adulterated or misbranded, Federal agen-
cies should not impose regulatory barriers that un-
reasonably limit or prevent consumer and health 
care provider access to safe products and accurate 
information. 
SEC. 3. DEFINITIONS. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended— 
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(1) in paragraph (p), by striking ‘‘except a new 
animal drug or an animal feed bearing or containing 
a new animal drug’’ each place it appears and in-
serting ‘‘except a new animal drug, an animal feed 
bearing or containing a new animal drug, or a home-
opathic drug product’’; 
(2) in paragraph (v), by inserting before the pe-
riod at the end the following: ‘‘, and that a homeo-
pathic drug product is not a new animal drug’’; and 
(3) by adding at the end the following: 
‘‘(tt) The term ‘homeopathic drug product’ means a 
drug that— 
‘‘(1) contains 1 or more homeopathic ingredi-
ents; and 
‘‘(2) contains no other active ingredient. 
‘‘(uu) The term ‘homeopathic ingredient’ means an 
ingredient— 
‘‘(1) listed in the Homeopathic Pharmacopoeia 
of the United States or a State homeopathic for-
mulary; or 
‘‘(2) prepared pursuant to homeopathic safety 
and quality standards described in— 
‘‘(A) the Homeopathic Pharmacopoeia of 
the United States or any other officially recog-
nized homeopathic pharmacopoeia; or 
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‘‘(B) any accredited voluntary consensus 
standard for homeopathic drug products, as de-
termined by the Secretary in compliance with 
section 12(d) of the National Technology 
Transfer and Advancement Act of 1995.’’. 
SEC. 4. SAFETY, QUALITY, AND TRANSPARENCY REQUIRE-
MENTS FOR HOMEOPATHIC DRUG PROD-
UCTS. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503D (21 U.S.C. 353d) the 
following: 
‘‘SEC. 503E. HOMEOPATHIC DRUG PRODUCTS. 
‘‘(a) PROVISIONS APPLICABLE
TO HOMEOPATHIC 
DRUG PRODUCTS.— 
‘‘(1) CHAPTER V PROVISIONS.—No section of 
this chapter shall apply to homeopathic drug prod-
ucts except this section and sections 501, 502, and 
510. 
‘‘(2) REQUIREMENTS FOR ALL PROVISIONS.— 
No provision of law, a regulation, or a guidance doc-
ument (including sections 501, 502, and 510 and 
any applicable provisions of this Act outside of this 
chapter) shall apply to homeopathic drug products 
unless such provision— 
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National Technology Transfer and Ad-
vancement Act of 1995; or 
‘‘(B) in the case that no standard or man-
ufacturing practice described in subparagraph 
(A) applies to such homeopathic drug product, 
the regulations described in paragraph (2). 
‘‘(2) ALTERNATIVE REGULATIONS.—The regu-
lations described in this paragraph are the following: 
‘‘(A) Good manufacturing practice regula-
tions promulgated under section 501(a)(2) or 
related guidance documents, provided that such 
regulations or related guidance documents do 
not conflict with any other provision of this sec-
tion. 
‘‘(B) In the case that no regulation de-
scribed in subparagraph (A) applies to the ho-
meopathic drug product, a new good manufac-
turing practice regulation, which shall be pro-
mulgated by the Secretary after notice and op-
portunity for public comment pursuant to chap-
ter 5 of title 5, United States Code— 
‘‘(i) that does not conflict with any 
other provision of this section; 
‘‘(ii) that is specific to and appro-
priate for homeopathic drug products; and 
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‘‘(iii) with respect to which the Sec-
retary has requested and received a favor-
able recommendation from the Homeo-
pathic Drug Product Advisory Committee. 
‘‘(3) PETITION FOR EXEMPTION, VARIANCE, OR 
ALTERNATIVE STANDARD OR PRACTICE.— 
‘‘(A) PETITION.—A manufacturer of a ho-
meopathic drug product subject to a good man-
ufacturing practice regulation may submit to 
the Secretary a petition for an exemption, vari-
ance, or alternative standard or practice with 
respect to such product. The Secretary shall 
refer such petition to the Homeopathic Drug 
Product Advisory Committee, which shall report 
its recommendation to the Secretary not later 
than 60 days after receiving such petition. 
‘‘(B) DEADLINE
FOR
APPROVAL.—The 
Secretary shall make a decision on a petition 
submitted under subparagraph (A) not later 
than 180 days after the submission of the peti-
tion. If the Secretary fails to make a decision 
on such a petition within such 180-day period, 
the petition shall be deemed approved and the 
proposed exemption, variance, or alternative 
standard or practice established. 
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‘‘(C) STANDARD
FOR
APPROVAL.—The 
Secretary may approve a petition submitted 
under subparagraph (A) and establish the pro-
posed exemption, variance, or alternative stand-
ard or practice with respect to the homeopathic 
drug product only if such exemption, variance, 
or alternative standard or practice does not af-
fect the safety of the homeopathic drug prod-
uct. 
‘‘(D) JUDICIAL
REVIEW.—For the pur-
poses of chapter 7 of title 5, United States 
Code, a decision of the Secretary on a petition 
submitted under subparagraph (A) shall be con-
sidered final agency action. 
‘‘(4) FINAL
AND
INTERMEDIATE
PRODUCT 
TESTING.— 
‘‘(A) FINAL
PRODUCT
TESTING.—A fin-
ished homeopathic drug product shall be exempt 
from the requirement for a laboratory deter-
mination of identity and strength of each active 
ingredient described in section 211.165(a) of 
title 21, Code of Federal Regulations (or any 
successor regulation), but shall continue to be 
required to meet other final specifications, such 
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as testing for contaminants and defects of the 
finished product, consistent with this section. 
‘‘(B) INTERMEDIATE
TESTING
FOR
CER-
TAIN STARTING MATERIALS.— 
‘‘(i) IN GENERAL.—The manufacturer 
of a homeopathic drug product made from 
a starting material containing a substance 
which may present a substantial risk of ill-
ness or injury in its undiluted form shall 
ensure and document that the amount of 
such substance in an intermediate level 
preparation used to make all further at-
tenuations does not exceed a safe level, as 
determined by the Secretary under this 
subparagraph. 
‘‘(ii) SAFE LEVEL DEFINED.—In this 
subparagraph, 
the 
term 
‘safe 
level’ 
means— 
‘‘(I) a level set by nationally rec-
ognized standards for safety, includ-
ing the Homeopathic Pharmacopoeia 
of the United States or an accredited 
voluntary consensus standard for ho-
meopathic drug products, as deter-
mined by the Secretary in compliance 
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with section 12(d) of the National 
Technology Transfer and Advance-
ment Act of 1995; or 
‘‘(II) in the absence of a stand-
ard described in subclause (I), a level 
below an analytically detectable pres-
ence. 
‘‘(iii) PUBLICATION
OF
SAFE
LEV-
ELS.—The Secretary may issue an order, 
notice of which shall be published in the 
Federal Register, establishing a safe level, 
based on appropriate scientific and tech-
nical data, for a substance under clause 
(i). Such notice shall include— 
‘‘(I) a statement of the basis for 
the Secretary’s finding that there is a 
reasonable probability that the sub-
stance may present a substantial risk 
of illness or injury in its undiluted 
form; 
‘‘(II) a statement of the basis for 
the establishment of the safe level, in-
cluding any available methods to es-
tablish such level; and 
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‘‘(III) a request for public com-
ments. 
‘‘(c) MISBRANDING.— 
‘‘(1) IN GENERAL.—A drug shall be deemed to 
be misbranded if— 
‘‘(A) it is not a homeopathic drug product, 
and its labeling bears the term ‘homeopathic’, 
‘homeopathy’, ‘homeopath’, or such similar 
term as determined by the Secretary; or 
‘‘(B) it is a homeopathic drug product, and 
its labeling does not comply with the require-
ments described in paragraph (2). 
‘‘(2) LABELING REQUIREMENTS.—With respect 
to the labeling of a homeopathic drug product, the 
requirements described in this paragraph are the re-
quirements for the labeling of a drug under this Act, 
subject to the following: 
‘‘(A) The labeling need not adhere to any 
requirement that does not apply to homeopathic 
drug products under subsection (a). 
‘‘(B) The dosage units of the homeopathic 
ingredients shall be expressed as attenuations 
particular to homeopathic ingredients (such as 
‘3x’ or ‘6c’). 
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‘‘(C) If the homeopathic drug product is 
not intended for retail sale, the label of such 
product need not contain a purpose or indica-
tion for use. 
‘‘(D) If the homeopathic drug product is 
intended for retail sale, the label of such prod-
uct shall contain— 
‘‘(i) 1 or more purposes or indications 
for use for self-limiting conditions that are 
supported by— 
‘‘(I) the Homeopathic Pharma-
copoeia of the United States, an offi-
cial pharmacopeia of another country 
where the practice of homeopathy is 
licensed or certified, or an accredited 
voluntary consensus standard for ho-
meopathic drug products, as deter-
mined by the Secretary in compliance 
with section 12(d) of the National 
Technology Transfer and Advance-
ment Act of 1995; 
‘‘(II) a traditional homeopathic 
reference, including a homeopathic 
Materia Medica in general use by li-
censed medical practitioners who prac-
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tice homeopathy or certified homeo-
paths in the United States or another 
country; 
‘‘(III) a peer-reviewed medical 
journal, including any homeopathic 
medical journal; 
‘‘(IV) citation to scientific evi-
dence, including clinical data or trials; 
‘‘(V) beneficial clinical usage doc-
umented by clinical reports from na-
tional or international organizations, 
professionally recognized publications 
of clinical indications and contra-
indications, national or international 
instructional courses providing train-
ing in the use of homeopathic drug 
products, or professional peer review 
presentations of physicians’ usage re-
sults with homeopathic drug products 
at local, county, State, national, or 
international meetings; or 
‘‘(VI) quality real-world data that 
provides sufficient evidence to support 
such purposes or indications for use; 
and 
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‘‘(ii) adjacent to such purposes or in-
dications for use, the following statement: 
‘These indications have not been evaluated 
by the Food and Drug Administration. 
This product is intended for traditional ho-
meopathic uses.’. 
‘‘(E) The labeling shall not be considered 
false or misleading for the purposes of section 
502(a)(1) due to the inclusion of a purpose or 
indication for use that is supported by any 
source described in subclauses (I) through (VI) 
of subparagraph (D)(i). 
‘‘(F)(i) Subject to clause (ii), the label 
shall describe— 
‘‘(I) the source relied upon for each 
purpose or indication for use under sub-
paragraph (D)(i); and 
‘‘(II) if applicable, the name and place 
of business of any parent, subsidiary, or 
affiliate company of the manufacturer of 
the homeopathic drug product, if under 
common ownership or control. 
‘‘(ii) If the label has insufficient space for 
the information required by clause (i), in lieu of 
such information the label may contain a quick 
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response code (commonly known as a ‘QR 
code’) or similar mechanism that links to a pub-
licly accessible website containing such informa-
tion. 
‘‘(3) APPLICATION
OF
OTHER
MISBRANDING- 
RELATED PROVISIONS.— 
‘‘(A) FTC ACT.—Labeling or marketing 
claims associated with a homeopathic drug 
product that are in compliance with this sub-
section may not be considered a false advertise-
ment or an unfair or deceptive act or practice 
in or affecting commerce for purposes of section 
5 or 12 of the Federal Trade Commission Act. 
‘‘(B) OTHER PROVISIONS OF FEDERAL OR 
STATE LAW.—If a homeopathic drug product’s 
label, labeling, advertising, and marketing ma-
terials are in compliance with this subsection, 
no other substantiation requirement in Federal 
or State law shall apply to such product. 
‘‘(C) PRIVATE
RIGHTS
OF
ACTION.—No 
private right of action for false or deceptive ad-
vertising may be predicated on the lack of clin-
ical trials to substantiate indications for a ho-
meopathic drug product. 
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‘‘(d) REGISTRATION AND LISTING.—For purposes of 
drug establishment registration and drug listing under 
section 510, the Secretary shall— 
‘‘(1) designate a homeopathic drug product es-
tablishment as a ‘homeopathic’ establishment; and 
‘‘(2) list a homeopathic drug product as ‘home-
opathic’, with no other designation. 
‘‘(e) NO PREMARKET APPROVAL.—The Secretary 
may not require premarket approval of a homeopathic 
drug product. 
‘‘(f) HOMEOPATHIC DRUG PRODUCT ADVISORY COM-
MITTEE.— 
‘‘(1) ESTABLISHMENT.—The Secretary shall es-
tablish a Homeopathic Drug Product Advisory Com-
mittee (in this subsection referred to as the ‘Com-
mittee’) to advise the Secretary on the regulation of 
homeopathic drug products. 
‘‘(2) MEMBERSHIP.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Committee shall be composed of 
10 members, to be appointed by the Secretary, 
as follows: 
‘‘(i) 1 representative from an organi-
zation of homeopathic product consumers 
that has been operating for a minimum of 
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3 continuous years with a minimum of 
10,000 members, who shall serve as the 
Chair of the Committee. 
‘‘(ii) 1 representative from a domestic 
homeopathic drug manufacturer that pro-
duces at least 50 distinct homeopathic 
drug products and has no fewer than 50 
employees. 
‘‘(iii) 1 representative from a domestic 
homeopathic drug manufacturer that pro-
duces at least 50 distinct homeopathic 
drug products and has no more than 50 
employees. 
‘‘(iv) 1 representative from the Home-
opathic Pharmacopoeia Convention of the 
United States. 
‘‘(v) 1 representative from an accred-
ited voluntary consensus standards body 
for homeopathic drug products that has 
been operating for a minimum of 3 contin-
uous years. 
‘‘(vi) 1 licensed medical doctor (M.D.) 
or doctor of osteopathy (D.O.) who holds a 
Diplomate, American Board of Homeo-
pathic Medicine (DABHM) or Diplomate, 
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Homeotherapeutics (DHt) and who main-
tains a homeopathic practice that has been 
in operation for a minimum of 3 contin-
uous years. 
‘‘(vii) 1 licensed naturopathic doctor 
(N.D.) who holds a Diplomate, American 
Board 
of 
Homeopathic 
Medicine 
(DABHM) or Diplomate, Homeopathic 
Academy 
of 
Naturopathic 
Physicians 
(DHANP) and who maintains a homeo-
pathic practice that has been in operation 
for a minimum of 3 continuous years. 
‘‘(viii) 1 licensed pharmacist or chem-
ist actively engaged in the preparation of 
homeopathic drug products for a minimum 
of 3 continuous years. 
‘‘(ix) 1 licensed veterinarian certified 
by the Academy of Veterinary Homeopathy 
or accredited by a recognized homeopathy 
institution who maintains a practice that 
has been in operation for a minimum of 3 
continuous years. 
‘‘(x) The Commissioner of Food and 
Drugs. 
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‘‘(B) ALTERNATIVE
MEMBERS.—If the 
Secretary is unable to find a suitable individual 
to serve in the position of a representative de-
scribed in clauses (i) through (ix), the other 
members of the Committee may appoint to such 
position, by majority vote, such other expert in 
the field of homeopathic drug products as the 
Committee determines appropriate. 
‘‘(C) BALANCE OF MEMBERSHIP.—In mak-
ing appointments under subparagraph (A), the 
Secretary shall ensure that the membership of 
the Committee reflects a proper balance of per-
spectives from the homeopathic practitioner, 
manufacturer, and consumer communities. 
‘‘(D) NO COMPENSATION.—The members 
of the Committee shall serve without compensa-
tion. 
‘‘(3) FREQUENCY OF SESSIONS.—The Secretary 
shall call the Committee into session at such times 
and in such places as the Secretary determines ap-
propriate, but in no case less frequently than once 
every 3 months. 
‘‘(4) INVESTIGATIONS.—The Committee may 
investigate any report of a homeopathic drug prod-
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uct to the FDA Adverse Event Reporting System to 
assist in post-market surveillance. 
‘‘(5) TERMINATION.—Section 1013 of chapter 
5, United States Code (relating to termination of ad-
visory committees), shall not apply to the Com-
mittee. 
‘‘(g) INSPECTORS.—All Federal inspectors whose du-
ties or authorities extend to homeopathic drug products 
shall be familiar with the requirements of this section, in-
cluding the safety and quality manufacturing standards 
in the Homeopathic Pharmacopoeia of the United States 
or an accredited voluntary consensus standard for homeo-
pathic drug products. 
‘‘(h) NON-PREEMPTION OF STATE LAW ON PRAC-
TICE OF HOMEOPATHY.—Nothing in this section shall be 
construed to preempt, limit, or interfere with State juris-
diction concerning the practice of homeopathy and related 
activities within the scope of the health care professional- 
patient relationship. 
‘‘(i) BURDEN OF PROOF.—The United States shall 
bear the burden of proof to establish a violation of this 
section. Any Federal court with jurisdiction shall decide 
any matter under this section on a de novo basis.’’. 
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SEC. 5. CONFORMING AMENDMENTS. 
(a) 
PHARMACEUTICAL
DISTRIBUTION
SUPPLY 
CHAIN.—Section 581(13) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360eee(13)) is amended by strik-
ing ‘‘homeopathic drugs marketed in accordance with ap-
plicable guidance under this Act’’ and inserting ‘‘homeo-
pathic drug products marketed in accordance with this 
Act’’. 
(b) SERIOUS ADVERSE EVENT REPORTING FOR NON-
PRESCRIPTION DRUGS.—Section 760(a)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379aa(a)(2)) 
is amended to read as follows: 
‘‘(2) NONPRESCRIPTION DRUG.—The term non-
prescription drug— 
‘‘(A) means a drug that is— 
‘‘(i) not subject to section 503(b); and 
‘‘(ii) not subject to approval in an ap-
plication submitted under section 505; and 
‘‘(B) includes a homeopathic drug prod-
uct.’’. 
(c) EXEMPTION FROM REGULATION OF BIOLOGICAL 
PRODUCTS.—Section 351(i)(1) of the Public Health Serv-
ice Act (42 U.S.C. 262(i)(1)) is amended by adding at 
the end the following: ‘‘Such term does not include a ho-
meopathic drug product (as defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act).’’. 
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SEC. 6. WITHDRAWAL OF GUIDANCE. 
The guidance of the Food and Drug Administration 
titled ‘‘Homeopathic Drug Products; Guidance for Food 
and Drug Administration Staff and Industry; Availability’’ 
(87 Fed. Reg. 75054; published on December 7, 2022) 
shall have no force or effect with respect to homeopathic 
drug products (as defined in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321), as 
amended by section 3(3)). 
SEC. 7. SEVERABILITY. 
If any provision of this Act (including the amend-
ments made by this Act) is declared unconstitutional, or 
the applicability of this Act (including the amendments 
made by this Act) to any person or circumstance is held 
invalid, the constitutionality of the remainder of this Act 
(including the amendments made by this Act) and the ap-
plicability thereof to other persons and circumstances shall 
not be affected. 
Æ 
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