H.R. 7050

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7050 Introduced in House (IH)]

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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 
Illinois) 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 Representatives 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 Transparency 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.
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 Congress that--
(1) homeopathic medicines are important to millions of 
American consumers, and continued consumer 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 continue to take 
appropriate action against products that are adulterated or 
misbranded, Federal agencies should not impose regulatory 
barriers that unreasonably 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--
(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 inserting before the period at the 
end the following: ``, and that a homeopathic 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 ingredients; 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 formulary; or
``(2) prepared pursuant to homeopathic safety and quality 
standards described in--
``(A) the Homeopathic Pharmacopoeia of the United 
States or any other officially recognized homeopathic 
pharmacopoeia; or
``(B) any accredited voluntary consensus standard 
for homeopathic drug products, as determined 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 REQUIREMENTS FOR HOMEOPATHIC 
DRUG PRODUCTS.

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended 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 products except this section 
and sections 501, 502, and 510.
``(2) Requirements for all provisions.--No provision of 
law, a regulation, or a guidance document (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--
``(A) does not conflict with this section; and
``(B) does not impose standards that are in 
conflict with standards in the Homeopathic 
Pharmacopoeia of the United States or in an accredited 
voluntary consensus standard for homeopathic drug 
products, as determined by the Secretary in compliance 
with section 12(d) of the National Technology Transfer 
and Advancement Act of 1995.
``(b) Adulteration; Good Manufacturing Practice Standards.--
``(1) Adulteration.--A homeopathic drug product shall be 
deemed to be adulterated if it does not comply with--
``(A) the safety and quality standards and 
manufacturing practices described in--
``(i) the Homeopathic Pharmacopoeia of the 
United States or any other officially 
recognized homeopathic pharmacopoeia; or
``(ii) an accredited voluntary consensus 
standard for homeopathic drug products, as 
determined by the Secretary in compliance with 
section 12(d) of the National Technology 
Transfer and Advancement Act of 1995; or
``(B) in the case that no standard or manufacturing 
practice described in subparagraph (A) applies to such 
homeopathic drug product, the regulations described in 
paragraph (2).
``(2) Alternative regulations.--The regulations described 
in this paragraph are the following:
``(A) Good manufacturing practice regulations 
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 section.
``(B) In the case that no regulation described in 
subparagraph (A) applies to the homeopathic drug 
product, a new good manufacturing practice regulation, 
which shall be promulgated by the Secretary after 
notice and opportunity for public comment pursuant to 
chapter 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 appropriate 
for homeopathic drug products; and
``(iii) with respect to which the Secretary 
has requested and received a favorable 
recommendation from the Homeopathic Drug 
Product Advisory Committee.
``(3) Petition for exemption, variance, or alternative 
standard or practice.--
``(A) Petition.--A manufacturer of a homeopathic 
drug product subject to a good manufacturing practice 
regulation may submit to the Secretary a petition for 
an exemption, variance, 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 petition. 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.
``(C) Standard for approval.--The Secretary may 
approve a petition submitted under subparagraph (A) and 
establish the proposed exemption, variance, or 
alternative standard or practice with respect to the 
homeopathic drug product only if such exemption, 
variance, or alternative standard or practice does not 
affect the safety of the homeopathic drug product.
``(D) Judicial review.--For the purposes of chapter 
7 of title 5, United States Code, a decision of the 
Secretary on a petition submitted under subparagraph 
(A) shall be considered final agency action.
``(4) Final and intermediate product testing.--
``(A) 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.
``(B) Intermediate testing for certain 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 illness 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 attenuations 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 
recognized standards for safety, 
including the Homeopathic Pharmacopoeia 
of the United States or an accredited 
voluntary consensus standard for 
homeopathic drug products, as 
determined by the Secretary in 
compliance with section 12(d) of the 
National Technology Transfer and 
Advancement Act of 1995; or
``(II) in the absence of a standard 
described in subclause (I), a level 
below an analytically detectable 
presence.
``(iii) Publication of safe levels.--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 technical 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 
substance 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, 
including any available methods to 
establish such level; and
``(III) a request for public 
comments.
``(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 requirements 
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 requirements 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').
``(C) If the homeopathic drug product is not 
intended for retail sale, the label of such product 
need not contain a purpose or indication for use.
``(D) If the homeopathic drug product is intended 
for retail sale, the label of such product shall 
contain--
``(i) 1 or more purposes or indications for 
use for self-limiting conditions that are 
supported by--
``(I) the Homeopathic Pharmacopoeia 
of the United States, an official 
pharmacopeia of another country where 
the practice of homeopathy is licensed 
or certified, or an accredited 
voluntary consensus standard for 
homeopathic drug products, as 
determined by the Secretary in 
compliance with section 12(d) of the 
National Technology Transfer and 
Advancement Act of 1995;
``(II) a traditional homeopathic 
reference, including a homeopathic 
Materia Medica in general use by 
licensed medical practitioners who 
practice homeopathy or certified 
homeopaths in the United States or 
another country;
``(III) a peer-reviewed medical 
journal, including any homeopathic 
medical journal;
``(IV) citation to scientific 
evidence, including clinical data or 
trials;
``(V) beneficial clinical usage 
documented by clinical reports from 
national or international 
organizations, professionally 
recognized publications of clinical 
indications and contraindications, 
national or international instructional 
courses providing training in the use 
of homeopathic drug products, or 
professional peer review presentations 
of physicians' usage results 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
``(ii) adjacent to such purposes or 
indications for use, the following statement: 
`These indications have not been evaluated by 
the Food and Drug Administration. This product 
is intended for traditional homeopathic 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 
subparagraph (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 response code 
(commonly known as a `QR code') or similar mechanism 
that links to a publicly accessible website containing 
such information.
``(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 subsection 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.
``(B) Other provisions of federal or state law.--If 
a homeopathic drug product's label, labeling, 
advertising, and marketing materials 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 advertising may be 
predicated on the lack of clinical trials to 
substantiate indications for a homeopathic drug 
product.
``(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 establishment as 
a `homeopathic' establishment; and
``(2) list a homeopathic drug product as `homeopathic', 
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 Committee.--
``(1) Establishment.--The Secretary shall establish a 
Homeopathic Drug Product Advisory Committee (in this subsection 
referred to as the `Committee') to advise the Secretary on the 
regulation of homeopathic drug products.
``(2) Membership.--
``(A) In general.--Subject to subparagraph (B), the 
Committee shall be composed of 10 members, to be 
appointed by the Secretary, as follows:
``(i) 1 representative from an organization 
of homeopathic product consumers that has been 
operating for a minimum of 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 produces at 
least 50 distinct homeopathic drug products and 
has no fewer than 50 employees.
``(iii) 1 representative from a domestic 
homeopathic drug manufacturer that produces at 
least 50 distinct homeopathic drug products and 
has no more than 50 employees.
``(iv) 1 representative from the 
Homeopathic Pharmacopoeia Convention of the 
United States.
``(v) 1 representative from an accredited 
voluntary consensus standards body for 
homeopathic drug products that has been 
operating for a minimum of 3 continuous years.
``(vi) 1 licensed medical doctor (M.D.) or 
doctor of osteopathy (D.O.) who holds a 
Diplomate, American Board of Homeopathic 
Medicine (DABHM) or Diplomate, 
Homeotherapeutics (DHt) and who maintains a 
homeopathic practice that has been in operation 
for a minimum of 3 continuous 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 homeopathic 
practice that has been in operation for a 
minimum of 3 continuous years.
``(viii) 1 licensed pharmacist or chemist 
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.
``(B) Alternative members.--If the Secretary is 
unable to find a suitable individual to serve in the 
position of a representative described 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 making 
appointments under subparagraph (A), the Secretary 
shall ensure that the membership of the Committee 
reflects a proper balance of perspectives from the 
homeopathic practitioner, manufacturer, and consumer 
communities.
``(D) No compensation.--The members of the 
Committee shall serve without compensation.
``(3) Frequency of sessions.--The Secretary shall call the 
Committee into session at such times and in such places as the 
Secretary determines appropriate, but in no case less 
frequently than once every 3 months.
``(4) Investigations.--The Committee may investigate any 
report of a homeopathic drug product 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 advisory committees), 
shall not apply to the Committee.
``(g) Inspectors.--All Federal inspectors whose duties or 
authorities extend to homeopathic drug products shall be familiar with 
the requirements of this section, including the safety and quality 
manufacturing standards in the Homeopathic Pharmacopoeia of the United 
States or an accredited voluntary consensus standard for homeopathic 
drug products.
``(h) Non-Preemption of State Law on Practice of Homeopathy.--
Nothing in this section shall be construed to preempt, limit, or 
interfere with State jurisdiction 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.''.

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 striking ``homeopathic drugs marketed in accordance with 
applicable guidance under this Act'' and inserting ``homeopathic drug 
products marketed in accordance with this Act''.
(b) Serious Adverse Event Reporting for Nonprescription 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 nonprescription 
drug--
``(A) means a drug that is--
``(i) not subject to section 503(b); and
``(ii) not subject to approval in an 
application submitted under section 505; and
``(B) includes a homeopathic drug product.''.
(c) 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).''.

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 amendments 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 
applicability thereof to other persons and circumstances shall not be 
affected.
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