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S. 4692Senate119th Congress (2025-2027)In Committee

Homeopathic Drug Product Safety, Quality, and Transparency Act

Sponsored by Tommy TubervilleSen. Tommy Tuberville (R-AL)
Introduced June 4, 2026

AI-Generated Summary

Updated June 19, 2026 at 5:12 AM UTC

The Homeopathic Drug Product Safety, Quality, and Transparency Act rewrites the Federal Food, Drug, and Cosmetic Act to treat homeopathic products as a distinct drug category. It defines what qualifies as a homeopathic drug product, limits the FDA sections that apply to them, and requires the agency to issue tailored manufacturing and labeling rules within three years. The bill also creates an advisory committee, changes labeling and claim requirements, updates misbranding rules, and revokes prior FDA guidance.

Key Provisions

  • Adds a definition of “homeopathic drug product” (a drug containing only homeopathic ingredients listed in the Homeopathic Pharmacopoeia of the United States or a state formulary and prepared using recognized homeopathic methods).
  • Creates a new Section 503E that treats homeopathic drug products as a separate drug category, applying only sections 501, 502, 510 and the new section, and exempting them from the new‑drug approval requirements of section 505.
  • Requires the FDA Secretary to issue, within three years, a final rule establishing current good manufacturing practices and labeling requirements specifically for homeopathic drug products, tailored to available analytical methods.
  • Exempts finished homeopathic products from the usual laboratory identity and strength testing, but still requires testing for contaminants and defects; mandates safety testing of intermediate materials that could be hazardous in undiluted form.
  • Sets labeling rules that require dosage units in homeopathic attenuations, a disclaimer that intended uses have not been evaluated by the FDA, and that any health claim be supported by evidence appropriate to homeopathic products (including traditional and real‑world evidence).
  • Establishes a Homeopathic Drug Product Advisory Committee to advise the FDA on safety, quality, labeling, and rulemaking, with balanced representation from practitioners, manufacturers, educators, and consumers; the committee’s recommendations are advisory only and the committee expires after seven years.
  • Amends misbranding provisions so that any dietary supplement, drug, or cosmetic that uses the term “homeopathic” on its label is subject to specific labeling rules.
  • Updates various cross‑references in the FD&C Act and Public Health Service Act to reflect the new “homeopathic drug product” terminology.
  • Cancels the FDA’s December 2022 guidance on homeopathic drug products, removing its regulatory effect.

Legislative Activity

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

June 4, 2026

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SenateIntro Referral

Introduced in Senate

June 4, 2026

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

June 4, 2026

Bill Text

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Introduced in SenateIssued June 4, 2026

II

119th CONGRESS

2d Session

S. 4692

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.

1.

Short title

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

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.

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:

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.