S. 4692

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4692 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
S. 4692

To amend the Federal Food, Drug, and Cosmetic Act with respect to 
homeopathic drug products, and for other purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

June 4, 2026

Mr. Tuberville (for himself and Mr. Lee) introduced the following bill; 
which was read twice and referred to the Committee on Health, 
Education, Labor, and Pensions

_______________________________________________________________________

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Homeopathic Drug Product Safety, 
Quality, and Transparency Act''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) Homeopathic drug products have a long history of use in 
the United States and are prepared according to methods 
different from other drugs regulated under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(2) Federal regulatory oversight of homeopathic drug 
products has been implemented through mechanisms other than 
premarket approval, reflecting the distinct characteristics, 
methods of preparation, risk profile, and patterns of use of 
such products.
(3) A clear statutory framework consistent with the 
historical regulatory treatment of homeopathic drug products 
will promote safety, quality, and access, ensure consistent 
regulation, and reduce uncertainty.

SEC. 3. REGULATION OF HOMEOPATHIC DRUG PRODUCTS.

(a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended--
(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 inserting ``except a new 
animal drug, an animal feed bearing or containing a new animal 
drug, or a homeopathic drug product'';
(2) in paragraph (v), by adding at the end the following: 
``A homeopathic drug product is not a new animal drug.''; and
(3) by adding at the end the following:
``(tt)(1) The term `homeopathic drug product' means a drug that--
``(A) contains 1 or more homeopathic ingredients; and
``(B) contains no other active ingredient.
``(2) The term `homeopathic ingredient' means an ingredient--
``(A) listed in the Homeopathic Pharmacopoeia of the United 
States or a State homeopathic formulary; or
``(B) prepared pursuant to--
``(i) homeopathic manufacturing methods and safety 
and quality standards described in the Homeopathic 
Pharmacopoeia of the United States or any other 
officially recognized homeopathic pharmacopoeia; and
``(ii) other standards recognized by the 
Secretary.''.
(b) Safety, Quality, and Labeling Requirements for Homeopathic Drug 
Products.--
(1) In general.--Subchapter A of chapter V of the Federal 
Food, Drug, and Cosmetic Act is amended by inserting after 
section 503D (21 U.S.C. 353d) the following:

``SEC. 503E. HOMEOPATHIC DRUG PRODUCTS.

``(a) In General.--Homeopathic drug products constitute a distinct 
category of drugs and shall be regulated by the Secretary in a manner 
that is appropriate to their characteristics, methods of preparation, 
distinct risk profile, and patterns of use.
``(b) Provisions Applicable to Homeopathic Drug Products.--The only 
sections of this chapter that shall apply to homeopathic drug products 
are this section and sections 501, 502, and 510. Homeopathic drug 
products shall not be subject to section 505 and shall not be required 
to be the subject of an approved application under such section.
``(c) Safety and Quality Standards.--The Secretary shall regulate 
homeopathic drug products using standards appropriate to such products, 
taking into account the Homeopathic Pharmacopoeia of the United States 
and other standards recognized by the Secretary.
``(d) Final Rule Establishing Current Good Manufacturing Practices 
and Labeling Requirements.--
``(1) In general.--Not later than 3 years after the date of 
enactment of this section, the Secretary shall issue a final 
rule that establishes current good manufacturing practices and 
labeling requirements for homeopathic drug products.
``(2) Requirement.--In establishing current good 
manufacturing practices and labeling requirements pursuant to 
paragraph (1), the Secretary shall ensure that such 
requirements--
``(A) are appropriate;
``(B) do not conflict with standards established 
under subsection (c); and
``(C) do not impose standards for which there are 
no current and generally available analytical 
methodologies for homeopathic drug products.
``(e) Final and Intermediate Product Testing.--
``(1) Final product testing.--A finished homeopathic drug 
product shall be exempt from the requirement for a laboratory 
determination 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 as testing for contaminants and defects of the finished 
product, consistent with this section.
``(2) Intermediate testing for certain starting 
materials.--
``(A) In general.--The manufacturer of a 
homeopathic drug product made from a starting material 
containing a substance which may present a substantial 
risk of illness or injury in its undiluted form shall 
ensure and document that the quantity of such substance 
in an intermediate level preparation used to make all 
further attenuations does not exceed a safe level, as 
determined by the Secretary.
``(B) Safe level defined.--In this paragraph, the 
term `safe level' means--
``(i) a level set by nationally recognized 
standards for safety, such as the Homeopathic 
Pharmacopoeia of the United States or an 
accredited voluntary consensus standard for 
homeopathic drug products; or
``(ii) in the absence of a standard 
described in clause (i), a level below an 
analytically detectable presence.
``(f) Labeling; Intended Use; Claims.--
``(1) Labeling requirements.--Homeopathic drug products 
shall comply with labeling requirements under this Act, except 
that dosage units may be expressed in homeopathic attenuations 
and substantiation may include traditional homeopathic 
evidence.
``(2) Intended use.--
``(A) In general.--Homeopathic drug products 
intended for retail sale shall contain--
``(i) 1 or more intended uses for 1 or more 
self-limiting conditions; and
``(ii) the following statement: `These 
intended uses have not been evaluated by the 
Food and Drug Administration. This product is 
intended for traditional homeopathic uses.'.
``(B) Exception.--A homeopathic drug product not 
intended for retail sale shall not be required to 
contain 1 or more intended uses.
``(3) Claims.--Any claim made with respect to a homeopathic 
drug product--
``(A) shall be supported by competent and reliable 
evidence appropriate to the nature and risk profile of 
the homeopathic drug product, including traditional 
homeopathic principles, pharmacopoeial standards, and 
real-world evidence; and
``(B) that relates to a specific condition shall be 
preceded by the following: `Traditionally used for'.
``(4) Effect.--A homeopathic drug product that contains an 
intended use, or for which a claim is made, that is in 
compliance with this Act may not be considered a false 
advertisement 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.
``(g) Homeopathic Drug Product Advisory Committee.--
``(1) Establishment.--The Secretary shall establish a 
Homeopathic Drug Product Advisory Committee (in this subsection 
referred to as the `Committee') to provide advice and 
recommendations regarding the regulation of homeopathic drug 
products.
``(2) Membership.--In appointing members of the Committee, 
the Secretary shall ensure that the membership of the Committee 
reflects a proper balance of perspectives from the homeopathic 
practitioner, manufacturer, education, and consumer 
communities, including large and small domestic manufacturers, 
licensed and certified health care practitioners with not less 
than 3 years of active homeopathic practices and 
representatives of homeopathic standards and consumer 
organizations.
``(3) Duties.--With respect to the regulation of 
homeopathic drug products under this Act, the Committee--
``(A) shall--
``(i) provide recommendations on safety, 
quality, and labeling standards;
``(ii) advise on appropriate regulatory 
approaches;
``(iii) review guidance and rulemaking; and
``(iv) evaluate relevant scientific, 
traditional, and real-world evidence; and
``(B) may investigate any report of a homeopathic 
drug product to the Food and Drug Administration 
Adverse Event Monitoring System to assist in postmarket 
surveillance.
``(4) Triggered consultation.--The Secretary shall consult 
with the Committee prior--
``(A) to issuing or revising guidance regarding 
homeopathic drug products;
``(B) to initiating or finalizing rulemaking 
regarding homeopathic drug products;
``(C) to adopting or revising good manufacturing 
practice requirements applicable to homeopathic drug 
products; or
``(D) to undertaking any enforcement initiative of 
general applicability with respect to homeopathic drug 
products.
``(5) Administrative record.--The Secretary shall include 
in the administrative record a written response to significant 
recommendations of the Committee.
``(6) Limitation.--Nothing in this subsection shall require 
the Secretary to follow a recommendation of the Committee.
``(7) Termination.--Notwithstanding section 1013 of title 
5, United States Code, the Committee shall terminate on the 
date that is 7 years after the date on which the Committee is 
established.''.
(2) Misbranding.--
(A) Dietary supplements.--Section 403 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 
amended by adding at the end the following:
``(z) If it is a dietary supplement and its labeling bears the term 
`homeopathic', `homeopathy', `homeopath', or such similar term as is 
determined by the Secretary.''.
(B) Drugs.--Section 502 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 352) is amended by adding 
at the end the following:
``(hh) If it is a drug that is not a homeopathic drug product, and 
its labeling bears the term `homeopathic', `homeopathy', `homeopath', 
or such similar term as is determined by the Secretary.''.
(C) Cosmetics.--Section 602 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 362) is amended by 
adding at the end the following:
``(g) If it is a cosmetic and its labeling bears the term 
`homeopathic', `homeopathy', `homeopath', or such similar term as is 
determined by the Secretary.''.
(c) Conforming Amendments.--
(1) Pharmaceutical distribution supply chain.--Section 
581(13) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360eee(13)) is amended by striking ``homeopathic drugs marketed 
in accordance with applicable guidance under this Act'' and 
inserting ``homeopathic drug products marketed in accordance 
with this Act''.
(2) Serious adverse event reporting.--Section 760 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379aa) is 
amended--
(A) in the section heading, by inserting ``and 
homeopathic drug products'' after ``nonprescription 
drugs'';
(B) by inserting ``or homeopathic drug product'' 
after ``nonprescription drug'' each place it appears 
(other than in subsection (a)(2)); and
(C) by inserting ``or homeopathic drug products'' 
after ``nonprescription drugs'' each place it appears.
(3) Exemption from regulation of biological products.--
Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 
262(i)(1)) is amended by adding at the end the following: 
``Such term does not include a homeopathic drug product (as 
defined in section 201 of the Federal Food, Drug, and Cosmetic 
Act).''.
(d) Withdrawal of Guidance.--The guidance of the Food and Drug 
Administration entitled ``Homeopathic Drug Products; Guidance for FDA 
Staff and Industry'' (87 Fed. Reg. 75054 (December 7, 2022)) shall have 
no force or effect.
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