Homeopathic Drug Product Safety, Quality, and Transparency Act

[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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