[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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